Drybench Patent.

Patent and exclusivity dates in 2027 for NDAs on FDA's Paragraph IV list, as FDA lists them

Each patent and exclusivity date in 2027 that FDA's Orange Book lists, as captured on 14 October 2026, for the 607 NDAs that FDA's Paragraph IV list names, as captured on 17 October 2026, and whose Orange Book capture lists a patent or exclusivity. Each entry is named by its rule and linked to its NDA page. A date here belongs to one patent or one exclusivity on the products named; the same NDA may have other listed dates, earlier or later, so no date here stands for a product.

FDA capture · review pending. Each date is shown as captured from FDA's Orange Book files. Dates are as FDA lists them, and Drybench computes none; patent dates are submitted by the applicant, and FDA does not verify them. Spreadsheet day numbers are shown as dates; a cell that cannot be read as one date is left off this page and shown as written on its NDA page. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured: 14 October 2026
Paragraph IV list captured: 17 October 2026

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

This page covers only NDAs that FDA's Paragraph IV list names and that have Orange Book listings. It does not cover other NDAs or any BLA. NCE exclusivity dates are here as FDA lists them; NCE-1 dates, computed from them, are on the NCE-1 calendar.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.

NCE-1, one year before a listed NCE exclusivity date and the one date Drybench computes, is on its own page: NCE-1 dates from the Orange Book

Listed patent expiry (423)

8 Jan 2027 · NDA 201532 · ERIBULIN MESYLATE
US RE46965, product patent
patent.txt line 2,440
Flags
product
Product numbers
001
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 11,364,260, use patent
patent.txt lines 3,997, 4,018, 4,043, 4,068
Flags
use code U-3637
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 11,433,091, use patent
patent.txt lines 3,998, 4,019, 4,044, 4,069
Flags
use code U-3435
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 11,433,091, use patent
patent.txt lines 3,999, 4,020, 4,045, 4,070
Flags
use code U-3436
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 11,433,091, use patent
patent.txt lines 4,000, 4,021, 4,046, 4,071
Flags
use code U-3437
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 11,433,091, use patent
patent.txt lines 4,001, 4,022, 4,047, 4,072
Flags
use code U-3438
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 11,433,091, use patent
patent.txt lines 4,002, 4,023, 4,048, 4,073
Flags
use code U-3634
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 11,478,502, use patent
patent.txt lines 4,003, 4,024, 4,049, 4,074
Flags
use code U-3472
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 11,478,502, use patent
patent.txt lines 4,004, 4,025, 4,050, 4,075
Flags
use code U-3473
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 11,478,502, use patent
patent.txt lines 4,005, 4,026, 4,051, 4,076
Flags
use code U-3474
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 8,895,612, use patent
patent.txt lines 4,012, 4,035, 4,060
Flags
use code U-1620
Product numbers
001, 002, 003
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 8,895,612, use patent
patent.txt lines 4,013, 4,038, 4,063, 4,082
Flags
use code U-3115
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 8,895,612, use patent
patent.txt lines 4,014, 4,039, 4,064, 4,083
Flags
use code U-3116
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 8,895,612, use patent
patent.txt lines 4,015, 4,040, 4,065, 4,084
Flags
use code U-3315
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 8,895,612, use patent
patent.txt lines 4,016, 4,041, 4,066, 4,085
Flags
use code U-3316
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 8,895,612, use patent
patent.txt lines 4,017, 4,042, 4,067, 4,086
Flags
use code U-3635
Product numbers
001, 002, 003, 004
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 8,895,612, use patent
patent.txt lines 4,036, 4,061
Flags
use code U-3050
Product numbers
002, 003
8 Jan 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 8,895,612, use patent
patent.txt lines 4,037, 4,062
Flags
use code U-3051
Product numbers
002, 003
19 Jan 2027 · NDA 206756 · OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
US 7,727,984, substance patent
patent.txt line 6,758
Flags
substance
Product numbers
001
23 Jan 2027 · NDA 021908 · LUBIPROSTONE
US 8,338,639, product patent
patent.txt lines 768, 771
Flags
product
Product numbers
001, 002
23 Jan 2027 · NDA 021908 · LUBIPROSTONE
US 8,779,187, product patent
patent.txt lines 769, 772
Flags
product
Product numbers
001, 002
24 Jan 2027 · NDA 203469 · PONATINIB HYDROCHLORIDE
US 8,114,874, substance and product patent
patent.txt lines 3,884, 3,901, 3,918, 3,935
Flags
substance product
Product numbers
001, 002, 003, 004
25 Jan 2027 · NDA 202788 · FENTANYL
US 10,016,403, product patent
patent.txt lines 3,166, 3,176, 3,185, 3,195, 3,205, 3,214, 3,224
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
25 Jan 2027 · NDA 202788 · FENTANYL
US 10,610,523, product patent
patent.txt lines 3,167, 3,177, 3,186, 3,196, 3,206, 3,215, 3,225
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
25 Jan 2027 · NDA 202788 · FENTANYL
US 8,835,459, product patent
patent.txt lines 3,170, 3,189, 3,199, 3,218, 3,228
Flags
product
Product numbers
001, 003, 004, 006, 007
25 Jan 2027 · NDA 202788 · FENTANYL
US 8,835,460, product and use patent
patent.txt lines 3,171, 3,180, 3,190, 3,200, 3,209, 3,219, 3,229
Flags
product use code U-55
Product numbers
001, 002, 003, 004, 005, 006, 007
25 Jan 2027 · NDA 202788 · FENTANYL
US 9,241,935, product patent
patent.txt lines 3,172, 3,181, 3,191, 3,201, 3,210, 3,220, 3,230
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
25 Jan 2027 · NDA 202788 · FENTANYL
US 9,289,387, product and use patent
patent.txt lines 3,173, 3,182, 3,192, 3,202, 3,211, 3,221, 3,231
Flags
product use code U-55
Product numbers
001, 002, 003, 004, 005, 006, 007
25 Jan 2027 · NDA 202788 · FENTANYL
US 9,642,797, product and use patent
patent.txt lines 3,174, 3,183, 3,193, 3,203, 3,212, 3,222, 3,232
Flags
product use code U-55
Product numbers
001, 002, 003, 004, 005, 006, 007
25 Jan 2027 · NDA 202788 · FENTANYL
US 9,642,844, product patent
patent.txt lines 3,175, 3,184, 3,194, 3,204, 3,213, 3,223, 3,233
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
26 Jan 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,192,590, use patent
patent.txt lines 3,818, 3,842
Flags
use code U-1399
Product numbers
001, 002
26 Jan 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,198,882, use patent
patent.txt lines 3,820, 3,844
Flags
use code U-1399
Product numbers
001, 002
26 Jan 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,925,156, substance and product and use patent
patent.txt lines 3,824, 3,848
Flags
substance product use code U-1399
Product numbers
001, 002
26 Jan 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,925,157, substance and product and use patent
patent.txt lines 3,826, 3,850
Flags
substance product use code U-1399
Product numbers
001, 002
26 Jan 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,925,158, substance and product and use patent
patent.txt lines 3,828, 3,852
Flags
substance product use code U-1399
Product numbers
001, 002
26 Jan 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,192,590, use patent
patent.txt lines 15,033, 15,057
Flags
use code U-1399
Product numbers
001, 002
26 Jan 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,198,882, use patent
patent.txt lines 15,035, 15,059
Flags
use code U-1399
Product numbers
001, 002
26 Jan 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,925,156, product and use patent
patent.txt lines 15,039, 15,063
Flags
product use code U-1399
Product numbers
001, 002
26 Jan 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,925,157, product and use patent
patent.txt lines 15,041, 15,065
Flags
product use code U-1399
Product numbers
001, 002
26 Jan 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,925,158, product and use patent
patent.txt lines 15,043, 15,067
Flags
product use code U-1399
Product numbers
001, 002
30 Jan 2027 · NDA 021925 · GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
US 7,700,128, product patent
patent.txt lines 800, 802
Flags
product
Product numbers
001, 002
1 Feb 2027 · NDA 018613 · MALATHION
US 7,560,445, substance and product and use patent
patent.txt line 138
Flags
substance product use code U-986
Product numbers
001
2 Feb 2027 · NDA 022161 · REGADENOSON
US 8,106,183, substance patent
patent.txt line 1,132
Flags
substance
Product numbers
001
2 Feb 2027 · NDA 022161 · REGADENOSON
US RE47301, product patent
patent.txt line 1,133
Flags
product
Product numbers
001
2 Feb 2027 · NDA 022260 · EPOPROSTENOL SODIUM
US 8,598,227, unflagged patent
patent.txt lines 1,416, 1,418
Flags
not flagged
Product numbers
001, 002
5 Feb 2027 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,612,109, substance and product patent
patent.txt lines 4,006, 4,027, 4,052, 4,077
Flags
substance product
Product numbers
001, 002, 003, 004
16 Feb 2027 · NDA 207695 · CRISABOROLE
US 8,501,712, use patent
patent.txt line 7,410
Flags
use code U-1932
Product numbers
001
16 Feb 2027 · NDA 207695 · CRISABOROLE
US 9,682,092, use patent
patent.txt line 7,412
Flags
use code U-1932
Product numbers
001
21 Feb 2027 · NDA 207999 · OBETICHOLIC ACID
US RE48286, substance and product patent
patent.txt lines 7,940, 7,947
Flags
substance product
Product numbers
001, 002
26 Feb 2027 · NDA 022504 · TESTOSTERONE
US 8,419,307, use patent
patent.txt line 2,007
Flags
use code U-1386
Product numbers
001
26 Feb 2027 · NDA 022504 · TESTOSTERONE
US 8,807,861, product and use patent
patent.txt line 2,009
Flags
product use code U-1563
Product numbers
001
26 Feb 2027 · NDA 022504 · TESTOSTERONE
US 9,289,586, use patent
patent.txt line 2,012
Flags
use code U-1390
Product numbers
001
27 Feb 2027 · NDA 209637 · SEMAGLUTIDE
US 9,687,611, product patent
patent.txt lines 10,698, 10,716, 10,733, 10,751
Flags
product delist requested
Product numbers
001, 002, 003, 004
2 Mar 2027 · NDA 021436 · ARIPIPRAZOLE
US 8,759,350, use patent
patent.txt lines 601, 603, 605, 607, 609, 611
Flags
use code U-1529
Product numbers
001, 002, 003, 004, 005, 006
2 Mar 2027 · NDA 021713 · ARIPIPRAZOLE
US 8,759,350, use patent
patent.txt line 683
Flags
use code U-1529
Product numbers
001
2 Mar 2027 · NDA 021729 · ARIPIPRAZOLE
US 8,759,350, use patent
patent.txt lines 688, 690
Flags
use code U-1529
Product numbers
002, 003
4 Mar 2027 · NDA 201699 · FIDAXOMICIN
US 7,906,489, use patent
patent.txt line 2,555
Flags
use code U-2741
Product numbers
001
4 Mar 2027 · NDA 201699 · FIDAXOMICIN
US 7,906,489, use patent
patent.txt line 2,556
Flags
use code U-319
Product numbers
001
5 Mar 2027 · NDA 207103 · PALBOCICLIB
US RE47739, substance and product patent
patent.txt lines 7,039, 7,043, 7,047
Flags
substance product
Product numbers
001, 002, 003
5 Mar 2027 · NDA 212436 · PALBOCICLIB
US RE47739, substance and product patent
patent.txt lines 13,971, 13,977, 13,983
Flags
substance product
Product numbers
001, 002, 003
7 Mar 2027 · NDA 050808 · MINOCYCLINE HYDROCHLORIDE
US 7,919,483, use patent
patent.txt lines 2,160, 2,163–2,165, 2,167, 2,169–2,171
Flags
use code U-1078
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
13 Mar 2027 · NDA 210498 · BINIMETINIB
US 7,777,050, substance and product patent
patent.txt line 11,552
Flags
substance product
Product numbers
001
14 Mar 2027 · NDA 022219 · TESTOSTERONE UNDECANOATE
US 7,718,640, product patent
patent.txt line 1,349
Flags
product
Product numbers
001
14 Mar 2027 · NDA 205739 · PATIROMER SORBITEX CALCIUM
US 8,216,560, use patent
patent.txt lines 5,826, 5,833, 5,840, 5,847
Flags
use code U-1766
Product numbers
001, 002, 003, 004
15 Mar 2027 · NDA 022260 · EPOPROSTENOL SODIUM
US 8,318,802, product patent
patent.txt lines 1,415, 1,417
Flags
product
Product numbers
001, 002
15 Mar 2027 · NDA 207960 · METHYLPHENIDATE HYDROCHLORIDE
US 8,202,537, product patent
patent.txt lines 7,840, 7,850, 7,860
Flags
product
Product numbers
001, 002, 003
15 Mar 2027 · NDA 210526 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 8,337,890, product patent
patent.txt lines 11,562, 11,568, 11,574, 11,580
Flags
product
Product numbers
001, 002, 003, 004
15 Mar 2027 · NDA 210526 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 8,747,902, product patent
patent.txt lines 11,563, 11,569, 11,575, 11,581
Flags
product
Product numbers
001, 002, 003, 004
15 Mar 2027 · NDA 210526 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 9,675,704, product patent
patent.txt lines 11,564, 11,570, 11,576, 11,582
Flags
product
Product numbers
001, 002, 003, 004
19 Mar 2027 · NDA 022134 · ALCAFTADINE
US 10,617,695, product and use patent
patent.txt line 1,111
Flags
product use code U-3267
Product numbers
001
20 Mar 2027 · NDA 211243 · ESKETAMINE HYDROCHLORIDE
US 9,592,207, use patent
patent.txt line 12,661
Flags
use code U-2502
Product numbers
001
20 Mar 2027 · NDA 211243 · ESKETAMINE HYDROCHLORIDE
US 9,592,207, use patent
patent.txt line 12,662
Flags
use code U-4112
Product numbers
001
22 Mar 2027 · NDA 022396 · DICLOFENAC SODIUM
US 8,946,292, use patent
patent.txt line 1,774
Flags
use code U-1659
Product numbers
001
27 Mar 2027 · NDA 022411 · TRAZODONE HYDROCHLORIDE
US 7,829,120, product and use patent
patent.txt lines 1,811, 1,813
Flags
product use code U-796
Product numbers
001, 002
27 Mar 2027 · NDA 210951 · APALUTAMIDE
US 8,802,689, use patent
patent.txt lines 12,442, 12,460
Flags
use code U-2237
Product numbers
001, 002
27 Mar 2027 · NDA 210951 · APALUTAMIDE
US 8,802,689, use patent
patent.txt lines 12,443, 12,461
Flags
use code U-2624
Product numbers
001, 002
27 Mar 2027 · NDA 210951 · APALUTAMIDE
US 9,388,159, substance and product patent
patent.txt lines 12,444, 12,462
Flags
substance product
Product numbers
001, 002
27 Mar 2027 · NDA 210951 · APALUTAMIDE
US 9,987,261, product patent
patent.txt lines 12,448, 12,466
Flags
product
Product numbers
001, 002
31 Mar 2027 · NDA 021747 · ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
US 9,027,967, product patent
patent.txt line 698
Flags
product delist requested
Product numbers
001
31 Mar 2027 · NDA 021936 · TIOTROPIUM BROMIDE
US 9,027,967, product patent
patent.txt line 815
Flags
product delist requested
Product numbers
001
31 Mar 2027 · NDA 206756 · OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
US 9,027,967, product patent
patent.txt line 6,762
Flags
product delist requested
Product numbers
001
2 Apr 2027 · NDA 050808 · MINOCYCLINE HYDROCHLORIDE
US 7,541,347, use patent
patent.txt line 2,161
Flags
use code U-917
Product numbers
002
2 Apr 2027 · NDA 050808 · MINOCYCLINE HYDROCHLORIDE
US 7,544,373, product patent
patent.txt line 2,162
Flags
product
Product numbers
002
6 Apr 2027 · NDA 021997 · ZOLPIDEM TARTRATE
US 9,597,281, use patent
patent.txt lines 897, 899
Flags
use code U-674
Product numbers
001, 002
13 Apr 2027 · NDA 202810 · OXCARBAZEPINE
US 10,220,042, use patent
patent.txt lines 3,298, 3,309, 3,320
Flags
use code U-2501
Product numbers
001, 002, 003
13 Apr 2027 · NDA 202810 · OXCARBAZEPINE
US 11,166,960, product patent
patent.txt lines 3,299, 3,310, 3,321
Flags
product
Product numbers
001, 002, 003
13 Apr 2027 · NDA 202810 · OXCARBAZEPINE
US 11,896,599, product patent
patent.txt lines 3,300, 3,311, 3,322
Flags
product
Product numbers
001, 002, 003
13 Apr 2027 · NDA 202810 · OXCARBAZEPINE
US 7,722,898, product patent
patent.txt lines 3,301, 3,312, 3,323
Flags
product
Product numbers
001, 002, 003
13 Apr 2027 · NDA 202810 · OXCARBAZEPINE
US 7,910,131, use patent
patent.txt lines 3,302, 3,313, 3,324
Flags
use code U-2041
Product numbers
001, 002, 003
13 Apr 2027 · NDA 202810 · OXCARBAZEPINE
US 8,617,600, product patent
patent.txt lines 3,303, 3,314, 3,325
Flags
product
Product numbers
001, 002, 003
13 Apr 2027 · NDA 202810 · OXCARBAZEPINE
US 8,821,930, product patent
patent.txt lines 3,304, 3,315, 3,326
Flags
product
Product numbers
001, 002, 003
13 Apr 2027 · NDA 202810 · OXCARBAZEPINE
US 9,119,791, use patent
patent.txt lines 3,305, 3,316, 3,327
Flags
use code U-2041
Product numbers
001, 002, 003
13 Apr 2027 · NDA 202810 · OXCARBAZEPINE
US 9,351,975, product patent
patent.txt lines 3,306, 3,317, 3,328
Flags
product
Product numbers
001, 002, 003
13 Apr 2027 · NDA 202810 · OXCARBAZEPINE
US 9,370,525, product patent
patent.txt lines 3,307, 3,318, 3,329
Flags
product
Product numbers
001, 002, 003
13 Apr 2027 · NDA 202810 · OXCARBAZEPINE
US 9,855,278, product patent
patent.txt lines 3,308, 3,319, 3,330
Flags
product
Product numbers
001, 002, 003
15 Apr 2027 · NDA 022328 · ZOLPIDEM TARTRATE
US 7,658,945, product and use patent
patent.txt lines 1,704, 1,706
Flags
product use code U-1194
Product numbers
001, 002
15 Apr 2027 · NDA 204629 · EMPAGLIFLOZIN
US 7,713,938, substance and product patent
patent.txt lines 4,902, 4,933
Flags
substance product
Product numbers
001, 002
15 Apr 2027 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 7,713,938, substance and product patent
patent.txt lines 6,196, 6,228
Flags
substance product
Product numbers
001, 002
15 Apr 2027 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,713,938, substance and product patent
patent.txt lines 6,317, 6,348, 6,377, 6,406
Flags
substance product
Product numbers
001, 002, 003, 004
15 Apr 2027 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,713,938, substance and product patent
patent.txt lines 9,062, 9,094, 9,124, 9,154
Flags
substance product
Product numbers
001, 002, 003, 004
15 Apr 2027 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 7,713,938, substance and product patent
patent.txt lines 14,246, 14,276, 14,306, 14,335
Flags
substance product
Product numbers
001, 002, 003, 004
18 Apr 2027 · NDA 019734 · NICARDIPINE HYDROCHLORIDE
US 10,758,616, product patent
patent.txt lines 158, 164, 170
Flags
product
Product numbers
002, 003, 004
18 Apr 2027 · NDA 019734 · NICARDIPINE HYDROCHLORIDE
US 11,547,758, use patent
patent.txt lines 159, 165, 171
Flags
use code U-1029
Product numbers
002, 003, 004
18 Apr 2027 · NDA 019734 · NICARDIPINE HYDROCHLORIDE
US 7,659,291, use patent
patent.txt lines 161, 167, 173, 177
Flags
use code U-1029
Product numbers
002, 003, 004, 005
18 Apr 2027 · NDA 019734 · NICARDIPINE HYDROCHLORIDE
US 8,455,524, use patent
patent.txt lines 162, 168, 174, 178
Flags
use code U-1029
Product numbers
002, 003, 004, 005
18 Apr 2027 · NDA 206316 · EDOXABAN TOSYLATE
US 7,365,205, substance patent
patent.txt lines 6,463, 6,465, 6,467
Flags
substance
Product numbers
001, 002, 003
26 Apr 2027 · NDA 205552 · IBRUTINIB
US 8,563,563, use patent
patent.txt lines 5,522, 5,619
Flags
use code U-1491
Product numbers
001, 002
26 Apr 2027 · NDA 205552 · IBRUTINIB
US 8,563,563, use patent
patent.txt lines 5,523, 5,620
Flags
use code U-1650
Product numbers
001, 002
26 Apr 2027 · NDA 205552 · IBRUTINIB
US 8,563,563, use patent
patent.txt lines 5,524, 5,621
Flags
use code U-1946
Product numbers
001, 002
26 Apr 2027 · NDA 205552 · IBRUTINIB
US 8,563,563, use patent
patent.txt lines 5,525, 5,622
Flags
use code U-2219
Product numbers
001, 002
26 Apr 2027 · NDA 210563 · IBRUTINIB
US 8,563,563, use patent
patent.txt lines 11,646, 11,750, 11,854, 11,959
Flags
use code U-1491
Product numbers
001, 002, 003, 004
26 Apr 2027 · NDA 210563 · IBRUTINIB
US 8,563,563, use patent
patent.txt lines 11,647, 11,751, 11,855, 11,960
Flags
use code U-1650
Product numbers
001, 002, 003, 004
26 Apr 2027 · NDA 210563 · IBRUTINIB
US 8,563,563, use patent
patent.txt lines 11,648, 11,752, 11,856, 11,961
Flags
use code U-1946
Product numbers
001, 002, 003, 004
26 Apr 2027 · NDA 210563 · IBRUTINIB
US 8,563,563, use patent
patent.txt lines 11,649, 11,753, 11,857, 11,962
Flags
use code U-2241
Product numbers
001, 002, 003, 004
26 Apr 2027 · NDA 210563 · IBRUTINIB
US 8,563,563, use patent
patent.txt lines 11,650, 11,754, 11,858, 11,963
Flags
use code U-2242
Product numbers
001, 002, 003, 004
27 Apr 2027 · NDA 021880 · LENALIDOMIDE
US 7,465,800, substance and product patent
patent.txt lines 749, 751, 753, 755, 757, 759
Flags
substance product
Product numbers
001, 002, 003, 004, 005, 006
4 May 2027 · NDA 201280 · LINAGLIPTIN
US 11,033,552, product patent
patent.txt line 2,329
Flags
product
Product numbers
001
4 May 2027 · NDA 201280 · LINAGLIPTIN
US 12,178,819, product patent
patent.txt line 2,331
Flags
product
Product numbers
001
4 May 2027 · NDA 201280 · LINAGLIPTIN
US 8,673,927, use patent
patent.txt line 2,335
Flags
use code U-1503 delist requested
Product numbers
001
4 May 2027 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,673,927, use patent
patent.txt lines 2,353, 2,371, 2,389
Flags
use code U-1503 delist requested
Product numbers
001, 002, 003
4 May 2027 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 11,033,552, product patent
patent.txt lines 6,176, 6,208
Flags
product
Product numbers
001, 002
4 May 2027 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 12,178,819, product patent
patent.txt lines 6,184, 6,216
Flags
product
Product numbers
001, 002
4 May 2027 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 8,673,927, use patent
patent.txt lines 6,200, 6,232
Flags
use code U-1652 delist requested
Product numbers
001, 002
4 May 2027 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 9,173,859, product and use patent
patent.txt lines 6,203, 6,235
Flags
product use code U-1772 delist requested
Product numbers
001, 002
4 May 2027 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,673,927, use patent
patent.txt lines 7,979, 7,998
Flags
use code U-1503 delist requested
Product numbers
001, 002
4 May 2027 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 9,173,859, product and use patent
patent.txt lines 7,985, 8,004
Flags
product use code U-1503 delist requested
Product numbers
001, 002
8 May 2027 · NDA 022219 · TESTOSTERONE UNDECANOATE
US 8,338,395, use patent
patent.txt line 1,350
Flags
use code U-1500
Product numbers
001
10 May 2027 · NDA 214012 · INCLISIRAN SODIUM
US 8,809,292, substance and product and use patent
patent.txt line 15,442
Flags
substance product use code U-4249
Product numbers
001
10 May 2027 · NDA 214012 · INCLISIRAN SODIUM
US 8,809,292, substance and product and use patent
patent.txt line 15,443
Flags
substance product use code U-4413
Product numbers
001
10 May 2027 · NDA 214012 · INCLISIRAN SODIUM
US 8,809,292, substance and product and use patent
patent.txt line 15,444
Flags
substance product use code U-4414
Product numbers
001
14 May 2027 · NDA 022387 · TREPROSTINIL
US 10,376,525, use patent
patent.txt line 1,764
Flags
use code U-1849
Product numbers
001
16 May 2027 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,383,864, use patent
patent.txt line 8,929
Flags
use code U-2371
Product numbers
001
16 May 2027 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,406,143, use patent
patent.txt line 8,930
Flags
use code U-2371
Product numbers
001
16 May 2027 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,241,422, use patent
patent.txt line 8,948
Flags
use code U-2371
Product numbers
001
16 May 2027 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 9,000,011, use patent
patent.txt line 8,987
Flags
use code U-2371
Product numbers
001
16 May 2027 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 9,480,682, use patent
patent.txt line 8,989
Flags
use code U-2371
Product numbers
001
16 May 2027 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 9,987,263, use patent
patent.txt line 8,990
Flags
use code U-2371
Product numbers
001
18 May 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 10,238,620, use patent
patent.txt lines 933, 949
Flags
use code U-620
Product numbers
001, 002
18 May 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 10,653,662, use patent
patent.txt lines 936, 952
Flags
use code U-620
Product numbers
001, 002
18 May 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 12,083,090, use patent
patent.txt lines 940, 956
Flags
use code U-620
Product numbers
001, 002
18 May 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 9,486,437, use patent
patent.txt lines 944, 960
Flags
use code U-620
Product numbers
001, 002
18 May 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 9,861,607, use patent
patent.txt lines 947, 963
Flags
use code U-620
Product numbers
001, 002
20 May 2027 · NDA 203188 · IVACAFTOR
US 7,495,103, substance and product patent
patent.txt line 3,658
Flags
substance product
Product numbers
001
20 May 2027 · NDA 207925 · IVACAFTOR
US 7,495,103, substance and product patent
patent.txt lines 7,506, 7,539, 7,572, 7,605, 7,633
Flags
substance product
Product numbers
001, 002, 003, 004, 005
24 May 2027 · NDA 021528 · KETOROLAC TROMETHAMINE
US 8,008,338, substance and product and use patent
patent.txt line 622
Flags
substance product use code U-1181
Product numbers
001
27 May 2027 · NDA 207620 · SACUBITRIL; VALSARTAN
US 8,877,938, substance and product patent
patent.txt lines 7,378, 7,386, 7,394
Flags
substance product
Product numbers
001, 002, 003
29 May 2027 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 7,378,423, substance and product patent
patent.txt lines 4,274, 4,294, 4,314
Flags
substance product
Product numbers
001, 002, 003
29 May 2027 · NDA 204410 · MACITENTAN
US 9,265,762, product and use patent
patent.txt line 4,675
Flags
product use code U-1820
Product numbers
001
29 May 2027 · NDA 205739 · PATIROMER SORBITEX CALCIUM
US 8,282,913, product patent
patent.txt lines 5,827, 5,834, 5,841, 5,848
Flags
product
Product numbers
001, 002, 003, 004
31 May 2027 · NDA 021529 · ETONOGESTREL
US 10,821,277, product patent
patent.txt line 624
Flags
product
Product numbers
002
31 May 2027 · NDA 202057 · ICOSAPENT ETHYL
US 9,700,537, use patent
patent.txt lines 2,681, 2,743
Flags
use code U-2707
Product numbers
001, 002
1 Jun 2027 · NDA 208612 · ETHINYL ESTRADIOL; LEVONORGESTREL
US 7,838,042, substance and use patent
patent.txt line 8,926
Flags
substance use code U-3251
Product numbers
001
4 Jun 2027 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 9,107,837, use patent
patent.txt line 2,211
Flags
use code U-1639
Product numbers
001
7 Jun 2027 · NDA 022030 · FESOTERODINE FUMARATE
US 7,807,715, product and use patent
patent.txt lines 921, 927
Flags
product use code U-913
Product numbers
001, 002
7 Jun 2027 · NDA 022030 · FESOTERODINE FUMARATE
US 8,088,398, product and use patent
patent.txt lines 923, 929
Flags
product use code U-913
Product numbers
001, 002
7 Jun 2027 · NDA 022030 · FESOTERODINE FUMARATE
US 8,501,723, product patent
patent.txt lines 925, 931
Flags
product
Product numbers
001, 002
13 Jun 2027 · NDA 022184 · BIMATOPROST
US 7,851,504, substance and product patent
patent.txt line 1,142
Flags
substance product
Product numbers
001
14 Jun 2027 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 8,511,304, product and use patent
patent.txt line 4,430
Flags
product use code U-1424
Product numbers
001
14 Jun 2027 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 8,511,304, product and use patent
patent.txt lines 4,431, 4,441
Flags
product use code U-1691
Product numbers
001, 002
14 Jun 2027 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 8,511,304, product and use patent
patent.txt lines 4,432, 4,442, 4,450
Flags
product use code U-3623
Product numbers
001, 002, 003
15 Jun 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 11,458,134, product and use patent
patent.txt lines 4,697, 4,717, 4,737, 4,757
Flags
product use code U-3463
Product numbers
001, 002, 003, 004
15 Jun 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 8,969,355, use patent
patent.txt lines 4,703, 4,723, 4,743, 4,763
Flags
use code U-1668
Product numbers
001, 002, 003, 004
15 Jun 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,125,908, use patent
patent.txt lines 4,705, 4,725, 4,745, 4,765
Flags
use code U-2309
Product numbers
001, 002, 003, 004
15 Jun 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,125,909, use patent
patent.txt lines 4,707, 4,727, 4,747, 4,767
Flags
use code U-2309
Product numbers
001, 002, 003, 004
15 Jun 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,125,910, use patent
patent.txt lines 4,709, 4,729, 4,749, 4,769
Flags
use code U-2309
Product numbers
001, 002, 003, 004
15 Jun 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,227,946, use patent
patent.txt lines 4,711, 4,731, 4,751, 4,771
Flags
use code U-1668
Product numbers
001, 002, 003, 004
15 Jun 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,861,630, use patent
patent.txt lines 4,715, 4,735, 4,755, 4,775
Flags
use code U-1668
Product numbers
001, 002, 003, 004
19 Jun 2027 · NDA 022321 · MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
US 7,682,633, use patent
patent.txt lines 1,649, 1,656, 1,663, 1,670, 1,677, 1,684
Flags
use code U-1510
Product numbers
001, 002, 003, 004, 005, 006
19 Jun 2027 · NDA 022321 · MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
US 7,682,634, product patent
patent.txt lines 1,650, 1,657, 1,664, 1,671, 1,678, 1,685
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
19 Jun 2027 · NDA 022321 · MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
US 8,158,156, use patent
patent.txt lines 1,652, 1,659, 1,666, 1,673, 1,680, 1,687
Flags
use code U-1510
Product numbers
001, 002, 003, 004, 005, 006
19 Jun 2027 · NDA 022321 · MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
US 8,846,104, product patent
patent.txt lines 1,654, 1,661, 1,668, 1,675, 1,682, 1,689
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
19 Jun 2027 · NDA 022321 · MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
US 8,877,247, product patent
patent.txt lines 1,655, 1,662, 1,669, 1,676, 1,683, 1,690
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
20 Jun 2027 · NDA 202293 · DAPAGLIFLOZIN
US 8,501,698, product and use patent
patent.txt lines 2,994, 3,032
Flags
product use code U-493
Product numbers
001, 002
20 Jun 2027 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,501,698, product and use patent
patent.txt lines 5,715, 5,725, 5,735, 5,745, 5,755
Flags
product use code U-493
Product numbers
001, 002, 003, 004, 005
20 Jun 2027 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,501,698, product and use patent
patent.txt line 9,668
Flags
product use code U-1976
Product numbers
001
20 Jun 2027 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,501,698, product and use patent
patent.txt line 9,669
Flags
product use code U-1977
Product numbers
001
20 Jun 2027 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,501,698, product and use patent
patent.txt lines 9,670, 9,682
Flags
product use code U-493
Product numbers
001, 002
21 Jun 2027 · NDA 201655 · OXYMORPHONE HYDROCHLORIDE
US 8,808,737, use patent
patent.txt lines 2,522, 2,525, 2,528, 2,531, 2,534, 2,537, 2,540
Flags
use code U-1598
Product numbers
001, 002, 003, 004, 005, 006, 007
30 Jun 2027 · NDA 020696 · FOMEPIZOLE
US 7,553,863, substance and product patent
patent.txt line 192
Flags
substance product
Product numbers
001
5 Jul 2027 · NDA 021992 · DESVENLAFAXINE SUCCINATE
US 8,269,040, substance patent
patent.txt lines 884–886
Flags
substance
Product numbers
001, 002, 003
6 Jul 2027 · NDA 202833 · INGENOL MEBUTATE
US 8,278,292, product patent
patent.txt lines 3,379, 3,391
Flags
product
Product numbers
001, 002
10 Jul 2027 · NDA 212295 · REMIMAZOLAM BESYLATE
US 10,472,365, use patent
patent.txt line 13,801
Flags
use code U-2968
Product numbers
001
10 Jul 2027 · NDA 212295 · REMIMAZOLAM BESYLATE
US 10,961,250, product and use patent
patent.txt line 13,803
Flags
product use code U-2968
Product numbers
001
10 Jul 2027 · NDA 212295 · REMIMAZOLAM BESYLATE
US 9,777,007, product patent
patent.txt line 13,806
Flags
product
Product numbers
001
10 Jul 2027 · NDA 212295 · REMIMAZOLAM BESYLATE
US 9,914,738, product patent
patent.txt line 13,808
Flags
product
Product numbers
001
11 Jul 2027 · NDA 209531 · NUSINERSEN SODIUM
US 7,838,657, substance patent
patent.txt line 10,617
Flags
substance
Product numbers
001
11 Jul 2027 · NDA 209531 · NUSINERSEN SODIUM
US 7,838,657, substance and product patent
patent.txt lines 10,625, 10,632
Flags
substance product
Product numbers
002, 003
14 Jul 2027 · NDA 204042 · CANAGLIFLOZIN
US 7,943,788, substance and product patent
patent.txt lines 4,237, 4,247
Flags
substance product
Product numbers
001, 002
14 Jul 2027 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,788, substance and product patent
patent.txt lines 4,512, 4,523, 4,534, 4,545
Flags
substance product
Product numbers
001, 002, 003, 004
14 Jul 2027 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,788, substance and product patent
patent.txt lines 6,004, 6,014, 6,024, 6,034
Flags
substance product
Product numbers
001, 002, 003, 004
18 Jul 2027 · NDA 022320 · ADAPALENE; BENZOYL PEROXIDE
US 8,071,644, product and use patent
patent.txt line 1,646
Flags
product use code U-1078
Product numbers
001
18 Jul 2027 · NDA 022320 · ADAPALENE; BENZOYL PEROXIDE
US 8,080,537, use patent
patent.txt line 1,647
Flags
use code U-1078
Product numbers
001
18 Jul 2027 · NDA 022320 · ADAPALENE; BENZOYL PEROXIDE
US 8,129,362, use patent
patent.txt line 1,648
Flags
use code U-1078
Product numbers
001
20 Jul 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 10,653,660, use patent
patent.txt lines 935, 951
Flags
use code U-620
Product numbers
001, 002
20 Jul 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 11,110,074, use patent
patent.txt lines 938, 954
Flags
use code U-620
Product numbers
001, 002
20 Jul 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 9,572,814, use patent
patent.txt lines 946, 962
Flags
use code U-620
Product numbers
001, 002
20 Jul 2027 · NDA 022581 · CALCIUM ACETATE
US 8,592,480, use patent
patent.txt line 2,134
Flags
use code U-1469
Product numbers
001
20 Jul 2027 · NDA 022581 · CALCIUM ACETATE
US 9,089,528, use patent
patent.txt line 2,135
Flags
use code U-1469
Product numbers
001
23 Jul 2027 · NDA 021400 · VARDENAFIL HYDROCHLORIDE
US 8,273,876, use patent
patent.txt lines 597–600
Flags
use code U-1288
Product numbers
001, 002, 003, 004
23 Jul 2027 · NDA 205637 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 8,147,866, product and use patent
patent.txt lines 5,698, 5,702, 5,706
Flags
product use code U-1521
Product numbers
001, 002, 003
23 Jul 2027 · NDA 205637 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 9,655,843, product and use patent
patent.txt lines 5,701, 5,705, 5,709
Flags
product use code U-2017
Product numbers
001, 002, 003
23 Jul 2027 · NDA 207932 · BUPRENORPHINE HYDROCHLORIDE
US 8,147,866, product and use patent
patent.txt lines 7,655, 7,658, 7,661, 7,664, 7,667, 7,670, 7,673
Flags
product use code U-1769
Product numbers
001, 002, 003, 004, 005, 006, 007
23 Jul 2027 · NDA 207932 · BUPRENORPHINE HYDROCHLORIDE
US 9,655,843, product and use patent
patent.txt lines 7,656, 7,659, 7,662, 7,665, 7,668, 7,671, 7,674
Flags
product use code U-1556
Product numbers
001, 002, 003, 004, 005, 006, 007
27 Jul 2027 · NDA 206947 · LENVATINIB MESYLATE
US 9,006,256, use patent
patent.txt lines 6,894, 6,915
Flags
use code U-1695
Product numbers
001, 002
31 Jul 2027 · NDA 201699 · FIDAXOMICIN
US 7,378,508, substance and product patent
patent.txt line 2,551
Flags
substance product
Product numbers
001
31 Jul 2027 · NDA 201699 · FIDAXOMICIN
US 7,863,249, substance and product patent
patent.txt line 2,553
Flags
substance product
Product numbers
001
31 Jul 2027 · NDA 201699 · FIDAXOMICIN
US 8,859,510, use patent
patent.txt line 2,558
Flags
use code U-2741
Product numbers
001
31 Jul 2027 · NDA 201699 · FIDAXOMICIN
US 8,859,510, use patent
patent.txt line 2,559
Flags
use code U-319
Product numbers
001
3 Aug 2027 · NDA 021964 · METHYLNALTREXONE BROMIDE
US 12,303,592, product and use patent
patent.txt lines 831, 838, 845
Flags
product use code U-4197
Product numbers
001, 002, 003
3 Aug 2027 · NDA 021964 · METHYLNALTREXONE BROMIDE
US 12,303,592, product and use patent
patent.txt lines 832, 839, 846
Flags
product use code U-4198
Product numbers
001, 002, 003
3 Aug 2027 · NDA 202020 · PREDNISONE
US 9,504,699, use patent
patent.txt lines 2,616–2,617, 2,619
Flags
use code U-1362
Product numbers
001, 002, 003
5 Aug 2027 · NDA 203188 · IVACAFTOR
US 8,324,242, use patent
patent.txt line 3,660
Flags
use code U-1311
Product numbers
001
5 Aug 2027 · NDA 203188 · IVACAFTOR
US 8,324,242, use patent
patent.txt line 3,661
Flags
use code U-1906
Product numbers
001
5 Aug 2027 · NDA 207925 · IVACAFTOR
US 8,324,242, use patent
patent.txt lines 7,510, 7,543
Flags
use code U-2527
Product numbers
001, 002
5 Aug 2027 · NDA 207925 · IVACAFTOR
US 8,324,242, use patent
patent.txt lines 7,508, 7,541, 7,574
Flags
use code U-1311
Product numbers
001, 002, 003
5 Aug 2027 · NDA 207925 · IVACAFTOR
US 8,324,242, use patent
patent.txt lines 7,509, 7,542, 7,575
Flags
use code U-1906
Product numbers
001, 002, 003
5 Aug 2027 · NDA 207925 · IVACAFTOR
US 8,324,242, use patent
patent.txt line 7,576
Flags
use code U-2963
Product numbers
003
5 Aug 2027 · NDA 207925 · IVACAFTOR
US 8,324,242, use patent
patent.txt lines 7,607, 7,635
Flags
use code U-3609
Product numbers
004, 005
6 Aug 2027 · NDA 208462 · IXAZOMIB CITRATE
US 7,687,662, substance and product patent
patent.txt lines 8,639, 8,646, 8,653
Flags
substance product
Product numbers
001, 002, 003
6 Aug 2027 · NDA 208462 · IXAZOMIB CITRATE
US 8,003,819, substance and product and use patent
patent.txt lines 8,640, 8,647, 8,654
Flags
substance product use code U-2434
Product numbers
001, 002, 003
6 Aug 2027 · NDA 208462 · IXAZOMIB CITRATE
US 8,530,694, substance and product and use patent
patent.txt lines 8,641, 8,648, 8,655
Flags
substance product use code U-2434
Product numbers
001, 002, 003
6 Aug 2027 · NDA 208462 · IXAZOMIB CITRATE
US 8,871,745, use patent
patent.txt lines 8,643, 8,650, 8,657
Flags
use code U-2434
Product numbers
001, 002, 003
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,689, 8,746
Flags
use code U-2480
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,690, 8,747
Flags
use code U-2482
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,691, 8,748
Flags
use code U-2483
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,692, 8,749
Flags
use code U-2716
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,693, 8,750
Flags
use code U-2819
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,694, 8,751
Flags
use code U-2820
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,695, 8,752
Flags
use code U-2821
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,696, 8,753
Flags
use code U-2822
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,697, 8,754
Flags
use code U-2823
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,698, 8,755
Flags
use code U-2824
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,699, 8,756
Flags
use code U-2832
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,700, 8,757
Flags
use code U-2833
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,701, 8,758
Flags
use code U-3333
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,702, 8,759
Flags
use code U-3631
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,703, 8,760
Flags
use code U-3695
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,704, 8,761
Flags
use code U-2480
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,705, 8,762
Flags
use code U-2482
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,706, 8,763
Flags
use code U-2483
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,707, 8,764
Flags
use code U-2716
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,708, 8,765
Flags
use code U-2819
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,709, 8,766
Flags
use code U-2820
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,710, 8,767
Flags
use code U-2821
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,711, 8,768
Flags
use code U-2822
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,712, 8,769
Flags
use code U-2823
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,713, 8,770
Flags
use code U-2824
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,714, 8,771
Flags
use code U-2832
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,715, 8,772
Flags
use code U-2833
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,716, 8,773
Flags
use code U-3333
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,717, 8,774
Flags
use code U-3631
Product numbers
001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,718, 8,775
Flags
use code U-3695
Product numbers
001, 002
12 Aug 2027 · NDA 214876 · NIRAPARIB TOSYLATE
US 8,071,579, use patent
patent.txt lines 16,277, 16,286, 16,295
Flags
use code U-2655
Product numbers
001, 002, 003
12 Aug 2027 · NDA 214876 · NIRAPARIB TOSYLATE
US 8,143,241, use patent
patent.txt lines 16,279, 16,288, 16,297
Flags
use code U-2655
Product numbers
001, 002, 003
13 Aug 2027 · NDA 203415 · ENZALUTAMIDE
US 7,709,517, substance and product patent
patent.txt line 3,861
Flags
substance product
Product numbers
001
13 Aug 2027 · NDA 213674 · ENZALUTAMIDE
US 7,709,517, substance and product patent
patent.txt lines 15,170, 15,188
Flags
substance product
Product numbers
001, 002
24 Aug 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 7,915,307, use patent
patent.txt lines 941, 957
Flags
use code U-620
Product numbers
001, 002
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 11,304,908, product patent
patent.txt lines 1,441, 1,456, 1,471, 1,486, 1,501, 1,515, 1,529
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 11,304,909, use patent
patent.txt lines 1,442, 1,457, 1,472, 1,487, 1,502, 1,516, 1,530
Flags
use code U-1556
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 11,964,056, product patent
patent.txt lines 1,443, 1,458, 1,473, 1,488, 1,503, 1,517, 1,531
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 12,246,094, product patent
patent.txt lines 1,444, 1,459, 1,474, 1,489, 1,504, 1,518, 1,532
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 12,280,152, product patent
patent.txt lines 1,445, 1,460, 1,475, 1,490, 1,505, 1,519, 1,533
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 8,808,741, use patent
patent.txt lines 1,446, 1,461, 1,476, 1,491, 1,506, 1,520, 1,534
Flags
use code U-1556
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 8,894,988, product patent
patent.txt lines 1,448, 1,463, 1,478, 1,493, 1,507, 1,521, 1,535
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,492,389, product patent
patent.txt lines 1,449, 1,464, 1,479, 1,494, 1,508, 1,522, 1,536
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,492,391, use patent
patent.txt lines 1,450, 1,465, 1,480, 1,495, 1,509, 1,523, 1,537
Flags
use code U-1556
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,492,392, product patent
patent.txt lines 1,451, 1,466, 1,481, 1,496, 1,510, 1,524, 1,538
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,492,393, use patent
patent.txt lines 1,452, 1,467, 1,482, 1,497, 1,511, 1,525, 1,539
Flags
use code U-1556
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,763,933, product patent
patent.txt lines 1,453, 1,468, 1,483, 1,498, 1,512, 1,526, 1,540
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,770,416, product patent
patent.txt lines 1,454, 1,469, 1,484, 1,499, 1,513, 1,527, 1,541
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,775,808, product patent
patent.txt lines 1,455, 1,470, 1,485, 1,500, 1,514, 1,528, 1,542
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 11,304,908, product patent
patent.txt lines 6,615, 6,634, 6,653, 6,672, 6,691, 6,710, 6,729
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 11,304,909, use patent
patent.txt lines 6,616, 6,635, 6,654, 6,673, 6,692, 6,711, 6,730
Flags
use code U-1556
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,084,816, product patent
patent.txt lines 6,618, 6,637, 6,656, 6,675, 6,694, 6,713, 6,732
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,095,614, use patent
patent.txt lines 6,619, 6,638, 6,657, 6,676, 6,695, 6,714, 6,733
Flags
use code U-1556
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,095,615, product patent
patent.txt lines 6,620, 6,639, 6,658, 6,677, 6,696, 6,715, 6,734
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,486,412, product patent
patent.txt lines 6,621, 6,640, 6,659, 6,678, 6,697, 6,716, 6,735
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,486,413, product patent
patent.txt lines 6,622, 6,641, 6,660, 6,679, 6,698, 6,717, 6,736
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,492,389, product patent
patent.txt lines 6,623, 6,642, 6,661, 6,680, 6,699, 6,718, 6,737
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,492,390, use patent
patent.txt lines 6,624, 6,643, 6,662, 6,681, 6,700, 6,719, 6,738
Flags
use code U-1556
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,492,391, use patent
patent.txt lines 6,625, 6,644, 6,663, 6,682, 6,701, 6,720, 6,739
Flags
use code U-1556
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,545,380, use patent
patent.txt lines 6,626, 6,645, 6,664, 6,683, 6,702, 6,721, 6,740
Flags
use code U-1556
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,763,933, product patent
patent.txt lines 6,629, 6,648, 6,667, 6,686, 6,705, 6,724, 6,743
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,770,416, product patent
patent.txt lines 6,630, 6,649, 6,668, 6,687, 6,706, 6,725, 6,744
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,775,809, product patent
patent.txt lines 6,631, 6,650, 6,669, 6,688, 6,707, 6,726, 6,745
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
27 Aug 2027 · NDA 021641 · RASAGILINE MESYLATE
US 7,815,942, substance and product and use patent
patent.txt lines 654, 656
Flags
substance product use code U-219
Product numbers
001, 002
1 Sep 2027 · NDA 021829 · ROTIGOTINE
US 8,246,979, product and use patent
patent.txt lines 710, 715, 720, 725, 730, 735
Flags
product use code U-1272
Product numbers
001, 002, 003, 004, 005, 006
1 Sep 2027 · NDA 021829 · ROTIGOTINE
US 8,246,979, product and use patent
patent.txt lines 711, 716, 721, 726, 731, 736
Flags
product use code U-1273
Product numbers
001, 002, 003, 004, 005, 006
2 Sep 2027 · NDA 021361 · RIFAXIMIN
US 8,193,196, substance and product patent
patent.txt line 561
Flags
substance product
Product numbers
001
2 Sep 2027 · NDA 021361 · RIFAXIMIN
US 8,193,196, substance and product and use patent
patent.txt line 577
Flags
substance product use code U-1707
Product numbers
002
2 Sep 2027 · NDA 021361 · RIFAXIMIN
US 8,193,196, substance and product and use patent
patent.txt line 578
Flags
substance product use code U-1708
Product numbers
002
5 Sep 2027 · NDA 022075 · ISTRADEFYLLINE
US 8,318,201, product patent
patent.txt lines 1,037, 1,039
Flags
product
Product numbers
001, 002
8 Sep 2027 · NDA 208558 · OLAPARIB
US 7,449,464, substance and product patent
patent.txt lines 8,688, 8,745
Flags
substance product
Product numbers
001, 002
14 Sep 2027 · NDA 207500 · ISAVUCONAZONIUM SULFATE
US 10,206,879, product patent
patent.txt lines 7,261, 7,267
Flags
product
Product numbers
001, 002
14 Sep 2027 · NDA 207500 · ISAVUCONAZONIUM SULFATE
US 10,603,280, product patent
patent.txt lines 7,263, 7,269
Flags
product
Product numbers
001, 002
18 Sep 2027 · NDA 207071 · AZELAIC ACID
US 7,700,076, product patent
patent.txt line 7,006
Flags
product
Product numbers
001
20 Sep 2027 · NDA 021994 · TRAVOPROST
US 8,323,630, product patent
patent.txt line 888
Flags
product
Product numbers
001
20 Sep 2027 · NDA 021994 · TRAVOPROST
US 8,388,941, product patent
patent.txt line 889
Flags
product
Product numbers
001
22 Sep 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 8,026,284, use patent
patent.txt lines 3,814, 3,838
Flags
use code U-1399
Product numbers
001, 002
22 Sep 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 8,026,284, use patent
patent.txt lines 15,029, 15,053
Flags
use code U-1399
Product numbers
001, 002
25 Sep 2027 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,293,756, product patent
patent.txt lines 997, 1,011, 1,025
Flags
product
Product numbers
001, 002, 003
25 Sep 2027 · NDA 202057 · ICOSAPENT ETHYL
US 9,198,892, use patent
patent.txt lines 2,674, 2,736
Flags
use code U-2706
Product numbers
001, 002
26 Sep 2027 · NDA 021549 · APREPITANT
US 8,258,132, product and use patent
patent.txt lines 631, 633, 635
Flags
product use code U-1743
Product numbers
001, 002, 003
26 Sep 2027 · NDA 021549 · APREPITANT
US 8,258,132, product and use patent
patent.txt lines 632, 634, 636
Flags
product use code U-901
Product numbers
001, 002, 003
26 Sep 2027 · NDA 022434 · ARGATROBAN
US 7,589,106, product and use patent
patent.txt line 1,907
Flags
product use code U-1163
Product numbers
001
26 Sep 2027 · NDA 022434 · ARGATROBAN
US 7,687,516, product and use patent
patent.txt line 1,908
Flags
product use code U-1164
Product numbers
001
26 Sep 2027 · NDA 207865 · APREPITANT
US 8,258,132, product and use patent
patent.txt line 7,433
Flags
product use code U-1916
Product numbers
001
27 Sep 2027 · NDA 022504 · TESTOSTERONE
US 8,435,944, use patent
patent.txt line 2,008
Flags
use code U-1390
Product numbers
001
28 Sep 2027 · NDA 021529 · ETONOGESTREL
US 8,722,037, product patent
patent.txt line 625
Flags
product
Product numbers
002
29 Sep 2027 · NDA 209637 · SEMAGLUTIDE
US 9,457,154, product patent
patent.txt lines 10,696, 10,714, 10,731, 10,749
Flags
product delist requested
Product numbers
001, 002, 003, 004
3 Oct 2027 · NDA 208743 · ABALOPARATIDE
US 8,748,382, use patent
patent.txt line 9,299
Flags
use code U-2009
Product numbers
001
3 Oct 2027 · NDA 208743 · ABALOPARATIDE
US 8,748,382, use patent
patent.txt line 9,300
Flags
use code U-3543
Product numbers
001
4 Oct 2027 · NDA 206302 · NEBIVOLOL HYDROCHLORIDE; VALSARTAN
US 7,838,552, use patent
patent.txt line 6,458
Flags
use code U-185
Product numbers
001
5 Oct 2027 · NDA 204790 · DOLUTEGRAVIR SODIUM
US 8,129,385, substance and product patent
patent.txt lines 5,004, 5,008, 5,012
Flags
substance product
Product numbers
001, 002, 003
5 Oct 2027 · NDA 205551 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385, substance and product patent
patent.txt line 5,464
Flags
substance product
Product numbers
001
5 Oct 2027 · NDA 210192 · DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
US 8,129,385, substance and product patent
patent.txt line 11,207
Flags
substance product
Product numbers
001
5 Oct 2027 · NDA 211994 · DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385, substance and product patent
patent.txt line 13,377
Flags
substance product
Product numbers
001
5 Oct 2027 · NDA 213983 · DOLUTEGRAVIR SODIUM
US 8,129,385, substance and product patent
patent.txt line 15,419
Flags
substance product
Product numbers
001
5 Oct 2027 · NDA 215413 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385, substance and product patent
patent.txt line 16,886
Flags
substance product
Product numbers
001
16 Oct 2027 · NDA 209090 · LEVOCETIRIZINE DIHYDROCHLORIDE
US 8,633,194, product patent
patent.txt line 9,656
Flags
product
Product numbers
001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 8,563,613, product and use patent
patent.txt line 4,860
Flags
product use code U-1488
Product numbers
001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 8,871,809, use patent
patent.txt line 4,863
Flags
use code U-1614
Product numbers
001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,066,913, product and use patent
patent.txt line 4,864
Flags
product use code U-1488
Product numbers
001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,101,591, product and use patent
patent.txt line 4,865
Flags
product use code U-1488
Product numbers
001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,132,110, use patent
patent.txt line 4,866
Flags
use code U-1488
Product numbers
001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,168,304, product patent
patent.txt line 4,867
Flags
product
Product numbers
001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,168,305, use patent
patent.txt line 4,868
Flags
use code U-1488
Product numbers
001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,220,784, use patent
patent.txt line 4,869
Flags
use code U-1488
Product numbers
001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,339,551, use patent
patent.txt line 4,870
Flags
use code U-1488
Product numbers
001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,339,552, product and use patent
patent.txt line 4,871
Flags
product use code U-1488
Product numbers
001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,539,335, use patent
patent.txt line 4,875
Flags
use code U-1614
Product numbers
001
17 Oct 2027 · NDA 213716 · VOCLOSPORIN
US 7,332,472, substance and product and use patent
patent.txt line 15,214
Flags
substance product use code U-3056
Product numbers
001
18 Oct 2027 · NDA 207071 · AZELAIC ACID
US 10,117,812, product and use patent
patent.txt line 7,005
Flags
product use code U-1796
Product numbers
001
25 Oct 2027 · NDA 021908 · LUBIPROSTONE
US 8,026,393, product patent
patent.txt lines 767, 770
Flags
product
Product numbers
001, 002
27 Oct 2027 · NDA 206256 · BELINOSTAT
US 8,835,501, product patent
patent.txt line 6,454
Flags
product
Product numbers
001
2 Nov 2027 · NDA 022192 · ILOPERIDONE
US 8,586,610, use patent
patent.txt lines 1,149, 1,163, 1,177, 1,191, 1,205, 1,219, 1,233
Flags
use code U-1625
Product numbers
001, 002, 003, 004, 005, 006, 007
8 Nov 2027 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 10,307,376, use patent
patent.txt line 2,198
Flags
use code U-1585
Product numbers
001
8 Nov 2027 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 12,048,769, use patent
patent.txt line 2,206
Flags
use code U-1585
Product numbers
001
8 Nov 2027 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 8,318,788, use patent
patent.txt line 2,208
Flags
use code U-1584
Product numbers
001
8 Nov 2027 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 8,722,085, use patent
patent.txt line 2,209
Flags
use code U-1585
Product numbers
001
8 Nov 2027 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 9,125,868, use patent
patent.txt line 2,212
Flags
use code U-1585
Product numbers
001
8 Nov 2027 · NDA 208743 · ABALOPARATIDE
US 8,148,333, product patent
patent.txt line 9,298
Flags
product
Product numbers
001
8 Nov 2027 · NDA 209241 · VALBENAZINE TOSYLATE
US 8,357,697, use patent
patent.txt lines 9,953, 9,986, 10,019
Flags
use code U-1995
Product numbers
001, 002, 003
8 Nov 2027 · NDA 209241 · VALBENAZINE TOSYLATE
US 8,357,697, use patent
patent.txt lines 9,954, 9,987, 10,020
Flags
use code U-3055
Product numbers
001, 002, 003
8 Nov 2027 · NDA 218390 · VALBENAZINE TOSYLATE
US 8,357,697, use patent
patent.txt lines 21,011, 21,044, 21,077
Flags
use code U-1995
Product numbers
001, 002, 003
8 Nov 2027 · NDA 218390 · VALBENAZINE TOSYLATE
US 8,357,697, use patent
patent.txt lines 21,012, 21,045, 21,078
Flags
use code U-3055
Product numbers
001, 002, 003
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 10,017,536, substance and use patent
patent.txt line 16,325
Flags
substance use code U-3204
Product numbers
001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 10,138,270, use patent
patent.txt line 16,326
Flags
use code U-3204
Product numbers
001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 10,793,596, substance and product and use patent
patent.txt line 16,327
Flags
substance product use code U-3204
Product numbers
001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 7,713,937, substance and product and use patent
patent.txt line 16,329
Flags
substance product use code U-3204
Product numbers
001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 7,727,963, substance and product and use patent
patent.txt line 16,330
Flags
substance product use code U-3204
Product numbers
001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 8,217,007, use patent
patent.txt line 16,331
Flags
use code U-3204
Product numbers
001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 8,236,766, use patent
patent.txt line 16,332
Flags
use code U-3204
Product numbers
001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 8,486,894, use patent
patent.txt line 16,333
Flags
use code U-3204
Product numbers
001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 8,536,131, substance and product and use patent
patent.txt line 16,334
Flags
substance product use code U-3204
Product numbers
001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 9,334,305, use patent
patent.txt line 16,335
Flags
use code U-3204
Product numbers
001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 9,359,399, use patent
patent.txt line 16,336
Flags
use code U-3204
Product numbers
001
13 Nov 2027 · NDA 205552 · IBRUTINIB
US 8,008,309, substance and product patent
patent.txt lines 5,510, 5,607
Flags
substance product
Product numbers
001, 002
13 Nov 2027 · NDA 210563 · IBRUTINIB
US 8,008,309, substance and product patent
patent.txt lines 11,633, 11,737, 11,841, 11,943
Flags
substance product
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 10,314,790, product and use patent
patent.txt lines 2,441, 2,461, 2,481, 2,501
Flags
product use code U-1675
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 10,314,790, product and use patent
patent.txt lines 2,442, 2,462, 2,482, 2,502
Flags
product use code U-1992
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,298,580, product and use patent
patent.txt lines 2,445, 2,465, 2,485, 2,505
Flags
product use code U-106
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,298,580, product and use patent
patent.txt lines 2,446, 2,466, 2,486, 2,506
Flags
product use code U-1992
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,663,683, product and use patent
patent.txt lines 2,447, 2,467, 2,487, 2,507
Flags
product use code U-106
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,663,683, product and use patent
patent.txt lines 2,448, 2,468, 2,488, 2,508
Flags
product use code U-1992
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,877,248, product and use patent
patent.txt lines 2,449, 2,469, 2,489, 2,509
Flags
product use code U-106
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,877,248, product and use patent
patent.txt lines 2,450, 2,470, 2,490, 2,510
Flags
product use code U-1992
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,889,191, use patent
patent.txt lines 2,451, 2,471, 2,491, 2,511
Flags
use code U-106
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,889,191, use patent
patent.txt lines 2,452, 2,472, 2,492, 2,512
Flags
use code U-1992
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,992,989, product and use patent
patent.txt lines 2,453, 2,473, 2,493, 2,513
Flags
product use code U-1675
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,992,989, product and use patent
patent.txt lines 2,454, 2,474, 2,494, 2,514
Flags
product use code U-1992
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,549,940, product and use patent
patent.txt lines 2,455, 2,475, 2,495, 2,515
Flags
product use code U-1675
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,549,940, product and use patent
patent.txt lines 2,456, 2,476, 2,496, 2,516
Flags
product use code U-1992
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,555,004, product and use patent
patent.txt lines 2,457, 2,477, 2,497, 2,517
Flags
product use code U-1675
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,555,004, product and use patent
patent.txt lines 2,458, 2,478, 2,498, 2,518
Flags
product use code U-1992
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,622,983, product and use patent
patent.txt lines 2,459, 2,479, 2,499, 2,519
Flags
product use code U-1675
Product numbers
001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,622,983, product and use patent
patent.txt lines 2,460, 2,480, 2,500, 2,520
Flags
product use code U-1992
Product numbers
001, 002, 003, 004
19 Nov 2027 · NDA 213591 · CAPMATINIB HYDROCHLORIDE
US 12,084,449, use patent
patent.txt lines 15,139, 15,146
Flags
use code U-2813
Product numbers
001, 002
19 Nov 2027 · NDA 213591 · CAPMATINIB HYDROCHLORIDE
US 8,461,330, substance and product patent
patent.txt lines 15,143, 15,150
Flags
substance product
Product numbers
001, 002
3 Dec 2027 · NDA 204042 · CANAGLIFLOZIN
US 8,513,202, substance and product and use patent
patent.txt lines 4,239, 4,249
Flags
substance product use code U-2441
Product numbers
001, 002
3 Dec 2027 · NDA 204042 · CANAGLIFLOZIN
US 8,513,202, substance and product and use patent
patent.txt lines 4,240, 4,250
Flags
substance product use code U-2632
Product numbers
001, 002
3 Dec 2027 · NDA 204042 · CANAGLIFLOZIN
US 8,513,202, substance and product and use patent
patent.txt lines 4,241, 4,251
Flags
substance product use code U-493
Product numbers
001, 002
3 Dec 2027 · NDA 204242 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 8,658,198, product and use patent
patent.txt lines 4,376, 4,386, 4,395, 4,404, 4,413, 4,420
Flags
product use code U-1494
Product numbers
001, 002, 003, 004, 005, 006
3 Dec 2027 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 4,514, 4,525, 4,536, 4,547
Flags
substance product use code U-2441
Product numbers
001, 002, 003, 004
3 Dec 2027 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 4,515, 4,526, 4,537, 4,548
Flags
substance product use code U-2632
Product numbers
001, 002, 003, 004
3 Dec 2027 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 4,516, 4,527, 4,538, 4,549
Flags
substance product use code U-493
Product numbers
001, 002, 003, 004
3 Dec 2027 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 6,006, 6,016, 6,026, 6,036
Flags
substance product use code U-2441
Product numbers
001, 002, 003, 004
3 Dec 2027 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 6,007, 6,017, 6,027, 6,037
Flags
substance product use code U-2632
Product numbers
001, 002, 003, 004
3 Dec 2027 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 6,008, 6,018, 6,028, 6,038
Flags
substance product use code U-493
Product numbers
001, 002, 003, 004
7 Dec 2027 · NDA 202714 · CARFILZOMIB
US 7,737,112, product patent
patent.txt lines 3,141, 3,151, 3,161
Flags
product
Product numbers
001, 002, 003
8 Dec 2027 · NDA 207071 · AZELAIC ACID
US 9,265,725, product patent
patent.txt line 7,008
Flags
product
Product numbers
001
10 Dec 2027 · NDA 206333 · DEOXYCHOLIC ACID
US 7,622,130, use patent
patent.txt line 6,478
Flags
use code U-1690
Product numbers
001
10 Dec 2027 · NDA 206333 · DEOXYCHOLIC ACID
US 7,754,230, use patent
patent.txt line 6,479
Flags
use code U-1690
Product numbers
001
11 Dec 2027 · NDA 022081 · AMBRISENTAN
US 8,377,933, use patent
patent.txt lines 1,040, 1,043
Flags
use code U-1754
Product numbers
001, 002
11 Dec 2027 · NDA 022081 · AMBRISENTAN
US 9,474,752, use patent
patent.txt lines 1,041, 1,044
Flags
use code U-1754
Product numbers
001, 002
11 Dec 2027 · NDA 022257 · VALGANCICLOVIR HYDROCHLORIDE
US 8,889,109, product patent
patent.txt line 1,413
Flags
product
Product numbers
001
11 Dec 2027 · NDA 022257 · VALGANCICLOVIR HYDROCHLORIDE
US 9,642,911, product patent
patent.txt line 1,414
Flags
product
Product numbers
001
12 Dec 2027 · NDA 022321 · MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
US 7,815,934, product patent
patent.txt lines 1,651, 1,658, 1,665, 1,672, 1,679, 1,686
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
18 Dec 2027 · NDA 022535 · PIRFENIDONE
US 7,696,236, use patent
patent.txt line 2,059
Flags
use code U-1601
Product numbers
001
18 Dec 2027 · NDA 022535 · PIRFENIDONE
US 7,767,700, use patent
patent.txt line 2,061
Flags
use code U-1601
Product numbers
001
18 Dec 2027 · NDA 022535 · PIRFENIDONE
US 8,420,674, product and use patent
patent.txt line 2,069
Flags
product use code U-1608
Product numbers
001
18 Dec 2027 · NDA 208780 · PIRFENIDONE
US 7,767,700, use patent
patent.txt lines 9,336, 9,379, 9,422
Flags
use code U-2080
Product numbers
001, 002, 003
18 Dec 2027 · NDA 208780 · PIRFENIDONE
US 8,420,674, use patent
patent.txt lines 9,348, 9,391, 9,434
Flags
use code U-2079
Product numbers
001, 002, 003
18 Dec 2027 · NDA 209482 · FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 7,488,827, substance and product patent
patent.txt lines 10,407, 10,414
Flags
substance product
Product numbers
001, 002
19 Dec 2027 · NDA 050805 · DOXYCYCLINE
US 7,749,532, product and use patent
patent.txt line 2,159
Flags
product use code U-1063
Product numbers
001
23 Dec 2027 · NDA 022134 · ALCAFTADINE
US 8,664,215, use patent
patent.txt line 1,112
Flags
use code U-3267
Product numbers
001
24 Dec 2027 · NDA 021923 · SORAFENIB TOSYLATE
US 8,877,933, substance and product and use patent
patent.txt line 781
Flags
substance product use code U-1624
Product numbers
001
24 Dec 2027 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 7,598,257, substance and product and use patent
patent.txt lines 2,805, 2,834, 2,863, 2,892, 2,921
Flags
substance product use code U-3227
Product numbers
001, 002, 003, 004, 005
24 Dec 2027 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 7,598,257, substance and product and use patent
patent.txt lines 2,806, 2,835, 2,864, 2,893, 2,922
Flags
substance product use code U-3228
Product numbers
001, 002, 003, 004, 005
24 Dec 2027 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,415,362, substance and product patent
patent.txt lines 2,808, 2,837, 2,866, 2,895, 2,924
Flags
substance product
Product numbers
001, 002, 003, 004, 005
24 Dec 2027 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 7,598,257, substance and product patent
patent.txt line 16,757
Flags
substance product
Product numbers
001
24 Dec 2027 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,415,362, substance and product patent
patent.txt line 16,759
Flags
substance product
Product numbers
001
24 Dec 2027 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 7,598,257, substance and product and use patent
patent.txt lines 19,319, 19,372, 19,425, 19,478, 19,531
Flags
substance product use code U-3227
Product numbers
001, 002, 003, 004, 005
24 Dec 2027 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 7,598,257, substance and product and use patent
patent.txt lines 19,320, 19,373, 19,426, 19,479, 19,532
Flags
substance product use code U-3228
Product numbers
001, 002, 003, 004, 005
24 Dec 2027 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,415,362, substance and product patent
patent.txt lines 19,322, 19,375, 19,428, 19,481, 19,534
Flags
substance product
Product numbers
001, 002, 003, 004, 005
25 Dec 2027 · NDA 022527 · FINGOLIMOD HYDROCHLORIDE
US 10,543,179, use patent
patent.txt line 2,049
Flags
use code U-2719
Product numbers
001
26 Dec 2027 · NDA 019734 · NICARDIPINE HYDROCHLORIDE
US 7,612,102, product patent
patent.txt lines 160, 166, 172, 176
Flags
product
Product numbers
002, 003, 004, 005
26 Dec 2027 · NDA 019734 · NICARDIPINE HYDROCHLORIDE
US 9,364,564, product patent
patent.txt lines 163, 169, 175, 179
Flags
product
Product numbers
002, 003, 004, 005
28 Dec 2027 · NDA 209279 · BOSENTAN
US 7,959,945, product patent
patent.txt line 10,023
Flags
product
Product numbers
001
28 Dec 2027 · NDA 213189 · TIRBANIBULIN
US 10,323,001, product patent
patent.txt line 14,720
Flags
product
Product numbers
001
29 Dec 2027 · NDA 214012 · INCLISIRAN SODIUM
US 8,222,222, use patent
patent.txt line 15,439
Flags
use code U-4249
Product numbers
001
29 Dec 2027 · NDA 214012 · INCLISIRAN SODIUM
US 8,222,222, use patent
patent.txt line 15,440
Flags
use code U-4413
Product numbers
001
29 Dec 2027 · NDA 214012 · INCLISIRAN SODIUM
US 8,222,222, use patent
patent.txt line 15,441
Flags
use code U-4414
Product numbers
001

Pediatric exclusivity, as listed (123)

6 Jan 2027 · NDA 203188 · IVACAFTOR
US 8,354,427 with pediatric exclusivity, as listed
patent.txt line 3,662
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
6 Jan 2027 · NDA 207925 · IVACAFTOR
US 8,354,427 with pediatric exclusivity, as listed
patent.txt lines 7,511, 7,544, 7,577, 7,608, 7,636
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
18 Jan 2027 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,389,537 with pediatric exclusivity, as listed
patent.txt lines 998, 1,012, 1,026
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
18 Jan 2027 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,415,363 with pediatric exclusivity, as listed
patent.txt lines 1,000, 1,014, 1,028
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
18 Jan 2027 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,501,760 with pediatric exclusivity, as listed
patent.txt lines 1,003, 1,017, 1,031
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
20 Jan 2027 · NDA 202714 · CARFILZOMIB
US 7,417,042 with pediatric exclusivity, as listed
patent.txt lines 3,138, 3,148, 3,158
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
2 Feb 2027 · NDA 022287 · DEXLANSOPRAZOLE
US 7,790,755 with pediatric exclusivity, as listed
patent.txt lines 1,551, 1,565
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
13 Feb 2027 · NDA 021660 · PACLITAXEL
US 8,034,375 with pediatric exclusivity, as listed
patent.txt line 661
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
18 Feb 2027 · NDA 202293 · DAPAGLIFLOZIN
US 8,329,648 with pediatric exclusivity, as listed
patent.txt lines 2,986, 3,024
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
18 Feb 2027 · NDA 202293 · DAPAGLIFLOZIN
US 8,906,851 with pediatric exclusivity, as listed
patent.txt lines 3,001, 3,039
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
24 Feb 2027 · NDA 020610 · BALSALAZIDE DISODIUM
US 7,452,872 with pediatric exclusivity, as listed
patent.txt line 188
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
24 Feb 2027 · NDA 020610 · BALSALAZIDE DISODIUM
US 7,625,884 with pediatric exclusivity, as listed
patent.txt line 190
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
27 Feb 2027 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 7,176,220 with pediatric exclusivity, as listed
patent.txt line 3,631
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
27 Feb 2027 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 7,176,220 with pediatric exclusivity, as listed
patent.txt line 7,348
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Feb 2027 · NDA 202811 · LINACLOTIDE
US 7,304,036 with pediatric exclusivity, as listed
patent.txt lines 3,331, 3,347, 3,365
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
11 Mar 2027 · NDA 204410 · MACITENTAN
US 10,946,015 with pediatric exclusivity, as listed
patent.txt line 4,666
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
12 Mar 2027 · NDA 202992 · TERIFLUNOMIDE
US 6,794,410 with pediatric exclusivity, as listed
patent.txt lines 3,588, 3,594
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
19 Mar 2027 · NDA 206947 · LENVATINIB MESYLATE
US 7,612,208 with pediatric exclusivity, as listed
patent.txt lines 6,891, 6,912
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
27 Mar 2027 · NDA 022287 · DEXLANSOPRAZOLE
US 8,105,626 with pediatric exclusivity, as listed
patent.txt lines 1,553, 1,567
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
10 Apr 2027 · NDA 021936 · TIOTROPIUM BROMIDE
US 7,396,341 with pediatric exclusivity, as listed
patent.txt line 808
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
10 Apr 2027 · NDA 206756 · OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
US 7,396,341 with pediatric exclusivity, as listed
patent.txt line 6,756
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
26 Apr 2027 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 7,635,704 with pediatric exclusivity, as listed
patent.txt line 3,633
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
26 Apr 2027 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 8,981,103 with pediatric exclusivity, as listed
patent.txt line 3,639
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
26 Apr 2027 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 7,635,704 with pediatric exclusivity, as listed
patent.txt line 7,350
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
26 Apr 2027 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,981,103 with pediatric exclusivity, as listed
patent.txt line 7,358
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
30 Apr 2027 · NDA 207947 · SELEXIPAG
US 7,205,302 with pediatric exclusivity, as listed
patent.txt lines 7,698, 7,710, 7,722, 7,734, 7,746, 7,758, 7,770, 7,782, 7,794, 7,806
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 010, 011
30 Apr 2027 · NDA 214275 · SELEXIPAG
US 7,205,302 with pediatric exclusivity, as listed
patent.txt line 15,658
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
2 May 2027 · NDA 209501 · PREGABALIN
US 10,022,447 with pediatric exclusivity, as listed
patent.txt lines 10,531, 10,539, 10,547
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
2 May 2027 · NDA 209501 · PREGABALIN
US 8,945,620 with pediatric exclusivity, as listed
patent.txt lines 10,534, 10,542, 10,550
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
2 May 2027 · NDA 209501 · PREGABALIN
US 9,144,559 with pediatric exclusivity, as listed
patent.txt lines 10,537, 10,545, 10,553
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
8 May 2027 · NDA 207620 · SACUBITRIL; VALSARTAN
US 9,388,134 with pediatric exclusivity, as listed
patent.txt lines 7,379, 7,387, 7,395
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
9 May 2027 · NDA 201292 · AFATINIB DIMALEATE
US 9,539,258 with pediatric exclusivity, as listed
patent.txt lines 2,404, 2,414, 2,424
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
21 May 2027 · NDA 202155 · APIXABAN
US 6,967,208 with pediatric exclusivity, as listed
patent.txt lines 2,776, 2,789, 2,797
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
23 May 2027 · NDA 203341 · BOSUTINIB MONOHYDRATE
US 7,767,678 with pediatric exclusivity, as listed
patent.txt lines 3,777, 3,788, 3,799
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
24 May 2027 · NDA 021995 · SITAGLIPTIN PHOSPHATE
US 7,326,708 with pediatric exclusivity, as listed
patent.txt lines 890, 892, 894
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
24 May 2027 · NDA 022044 · METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
US 7,326,708 with pediatric exclusivity, as listed
patent.txt lines 965, 969
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
24 May 2027 · NDA 202270 · METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
US 7,326,708 with pediatric exclusivity, as listed
patent.txt lines 2,960, 2,962, 2,964
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
12 Jun 2027 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,079,912 with pediatric exclusivity, as listed
patent.txt lines 2,822, 2,851, 2,880, 2,909, 2,938
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
12 Jun 2027 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,814,722 with pediatric exclusivity, as listed
patent.txt lines 2,827, 2,856, 2,885, 2,914, 2,943
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
12 Jun 2027 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,867,996 with pediatric exclusivity, as listed
patent.txt lines 6,414, 6,422
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
12 Jun 2027 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 10,639,310 with pediatric exclusivity, as listed
patent.txt line 16,735
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
12 Jun 2027 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 9,079,912 with pediatric exclusivity, as listed
patent.txt line 16,765
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
12 Jun 2027 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 9,974,790 with pediatric exclusivity, as listed
patent.txt line 16,768
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
26 Jun 2027 · NDA 021976 · DARUNAVIR
US 7,700,645 with pediatric exclusivity, as listed
patent.txt lines 852, 854, 856, 858, 860, 862
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006
26 Jun 2027 · NDA 205395 · COBICISTAT; DARUNAVIR ETHANOLATE
US 7,700,645 with pediatric exclusivity, as listed
patent.txt lines 5,296, 5,302
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 203188 · IVACAFTOR
US 8,410,274 with pediatric exclusivity, as listed
patent.txt line 3,665
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Jun 2027 · NDA 203188 · IVACAFTOR
US 8,754,224 with pediatric exclusivity, as listed
patent.txt line 3,667
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Jun 2027 · NDA 203188 · IVACAFTOR
US 9,670,163 with pediatric exclusivity, as listed
patent.txt line 3,669
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Jun 2027 · NDA 205552 · IBRUTINIB
US 7,514,444 with pediatric exclusivity, as listed
patent.txt lines 5,507, 5,604
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 205552 · IBRUTINIB
US 8,476,284 with pediatric exclusivity, as listed
patent.txt lines 5,511, 5,608
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 205552 · IBRUTINIB
US 8,497,277 with pediatric exclusivity, as listed
patent.txt lines 5,514, 5,611
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 205552 · IBRUTINIB
US 8,697,711 with pediatric exclusivity, as listed
patent.txt lines 5,526, 5,623
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 205552 · IBRUTINIB
US 8,703,780 with pediatric exclusivity, as listed
patent.txt lines 5,528, 5,625
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 205552 · IBRUTINIB
US 8,735,403 with pediatric exclusivity, as listed
patent.txt lines 5,530, 5,627
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 205552 · IBRUTINIB
US 8,754,091 with pediatric exclusivity, as listed
patent.txt lines 5,532, 5,629
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 205552 · IBRUTINIB
US 8,952,015 with pediatric exclusivity, as listed
patent.txt lines 5,534, 5,631
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 205552 · IBRUTINIB
US 8,957,079 with pediatric exclusivity, as listed
patent.txt lines 5,538, 5,635
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 205552 · IBRUTINIB
US 9,181,257 with pediatric exclusivity, as listed
patent.txt line 5,545
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Jun 2027 · NDA 205552 · IBRUTINIB
US 9,181,257 with pediatric exclusivity, as listed
patent.txt line 5,643
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
002
28 Jun 2027 · NDA 207925 · IVACAFTOR
US 8,410,274 with pediatric exclusivity, as listed
patent.txt lines 7,515, 7,548, 7,581, 7,610, 7,638
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
28 Jun 2027 · NDA 207925 · IVACAFTOR
US 8,754,224 with pediatric exclusivity, as listed
patent.txt lines 7,517, 7,550, 7,583, 7,612, 7,640
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
28 Jun 2027 · NDA 207925 · IVACAFTOR
US 9,670,163 with pediatric exclusivity, as listed
patent.txt lines 7,521, 7,554, 7,587, 7,616, 7,644
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
28 Jun 2027 · NDA 210563 · IBRUTINIB
US 7,514,444 with pediatric exclusivity, as listed
patent.txt lines 11,630, 11,734, 11,838, 11,940
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
28 Jun 2027 · NDA 210563 · IBRUTINIB
US 8,476,284 with pediatric exclusivity, as listed
patent.txt lines 11,634, 11,738, 11,842, 11,944
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
28 Jun 2027 · NDA 210563 · IBRUTINIB
US 8,497,277 with pediatric exclusivity, as listed
patent.txt lines 11,638, 11,742, 11,846, 11,950
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
28 Jun 2027 · NDA 210563 · IBRUTINIB
US 8,697,711 with pediatric exclusivity, as listed
patent.txt lines 11,651, 11,755, 11,859, 11,964
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
28 Jun 2027 · NDA 210563 · IBRUTINIB
US 8,703,780 with pediatric exclusivity, as listed
patent.txt lines 11,653, 11,757, 11,861, 11,966
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
28 Jun 2027 · NDA 210563 · IBRUTINIB
US 8,735,403 with pediatric exclusivity, as listed
patent.txt lines 11,656, 11,760, 11,864, 11,969
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
28 Jun 2027 · NDA 210563 · IBRUTINIB
US 8,754,091 with pediatric exclusivity, as listed
patent.txt lines 11,658, 11,762, 11,866, 11,973
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
28 Jun 2027 · NDA 210563 · IBRUTINIB
US 8,952,015 with pediatric exclusivity, as listed
patent.txt lines 11,660, 11,764, 11,868, 11,975
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
28 Jun 2027 · NDA 210563 · IBRUTINIB
US 8,957,079 with pediatric exclusivity, as listed
patent.txt lines 11,666, 11,770, 11,874, 11,983
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
28 Jun 2027 · NDA 210563 · IBRUTINIB
US 9,181,257 with pediatric exclusivity, as listed
patent.txt lines 11,675, 11,779, 11,883, 11,992
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
8 Jul 2027 · NDA 201532 · ERIBULIN MESYLATE
US RE46965 with pediatric exclusivity, as listed
patent.txt line 2,439
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
26 Jul 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,192,590 with pediatric exclusivity, as listed
patent.txt lines 3,817, 3,841
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Jul 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,198,882 with pediatric exclusivity, as listed
patent.txt lines 3,819, 3,843
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Jul 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,925,156 with pediatric exclusivity, as listed
patent.txt lines 3,823, 3,847
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Jul 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,925,157 with pediatric exclusivity, as listed
patent.txt lines 3,825, 3,849
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Jul 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,925,158 with pediatric exclusivity, as listed
patent.txt lines 3,827, 3,851
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Jul 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,192,590 with pediatric exclusivity, as listed
patent.txt lines 15,032, 15,056
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Jul 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,198,882 with pediatric exclusivity, as listed
patent.txt lines 15,034, 15,058
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Jul 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,925,156 with pediatric exclusivity, as listed
patent.txt lines 15,038, 15,062
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Jul 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,925,157 with pediatric exclusivity, as listed
patent.txt lines 15,040, 15,064
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Jul 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,925,158 with pediatric exclusivity, as listed
patent.txt lines 15,042, 15,066
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
16 Aug 2027 · NDA 207695 · CRISABOROLE
US 8,501,712 with pediatric exclusivity, as listed
patent.txt line 7,409
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
16 Aug 2027 · NDA 207695 · CRISABOROLE
US 9,682,092 with pediatric exclusivity, as listed
patent.txt line 7,411
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
4 Sep 2027 · NDA 201699 · FIDAXOMICIN
US 7,906,489 with pediatric exclusivity, as listed
patent.txt line 2,554
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Sep 2027 · NDA 207103 · PALBOCICLIB
US RE47739 with pediatric exclusivity, as listed
patent.txt lines 7,038, 7,042, 7,046
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
5 Sep 2027 · NDA 212436 · PALBOCICLIB
US RE47739 with pediatric exclusivity, as listed
patent.txt lines 13,970, 13,976, 13,982
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
30 Sep 2027 · NDA 021936 · TIOTROPIUM BROMIDE
US 9,027,967 with pediatric exclusivity, as listed
patent.txt line 814
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
15 Oct 2027 · NDA 204629 · EMPAGLIFLOZIN
US 7,713,938 with pediatric exclusivity, as listed
patent.txt lines 4,901, 4,932
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
15 Oct 2027 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 7,713,938 with pediatric exclusivity, as listed
patent.txt lines 6,195, 6,227
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
15 Oct 2027 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,713,938 with pediatric exclusivity, as listed
patent.txt lines 6,316, 6,347, 6,376, 6,405
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
15 Oct 2027 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,713,938 with pediatric exclusivity, as listed
patent.txt lines 9,061, 9,093, 9,123, 9,153
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
15 Oct 2027 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 7,713,938 with pediatric exclusivity, as listed
patent.txt lines 14,245, 14,275, 14,305, 14,334
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
26 Oct 2027 · NDA 205552 · IBRUTINIB
US 8,563,563 with pediatric exclusivity, as listed
patent.txt lines 5,521, 5,618
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Oct 2027 · NDA 210563 · IBRUTINIB
US 8,563,563 with pediatric exclusivity, as listed
patent.txt lines 11,645, 11,749, 11,853, 11,958
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
4 Nov 2027 · NDA 201280 · LINAGLIPTIN
US 11,033,552 with pediatric exclusivity, as listed
patent.txt line 2,328
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
4 Nov 2027 · NDA 201280 · LINAGLIPTIN
US 8,673,927 with pediatric exclusivity, as listed
patent.txt line 2,334
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
4 Nov 2027 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,673,927 with pediatric exclusivity, as listed
patent.txt lines 2,352, 2,370, 2,388
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
4 Nov 2027 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 11,033,552 with pediatric exclusivity, as listed
patent.txt lines 6,175, 6,207
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Nov 2027 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 8,673,927 with pediatric exclusivity, as listed
patent.txt lines 6,199, 6,231
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Nov 2027 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,673,927 with pediatric exclusivity, as listed
patent.txt lines 7,978, 7,997
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Nov 2027 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 9,173,859 with pediatric exclusivity, as listed
patent.txt lines 7,984, 8,003
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
20 Nov 2027 · NDA 203188 · IVACAFTOR
US 7,495,103 with pediatric exclusivity, as listed
patent.txt line 3,657
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
20 Nov 2027 · NDA 207925 · IVACAFTOR
US 7,495,103 with pediatric exclusivity, as listed
patent.txt lines 7,505, 7,538, 7,571, 7,604, 7,632
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
24 Nov 2027 · NDA 021528 · KETOROLAC TROMETHAMINE
US 8,008,338 with pediatric exclusivity, as listed
patent.txt line 621
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
27 Nov 2027 · NDA 207620 · SACUBITRIL; VALSARTAN
US 8,877,938 with pediatric exclusivity, as listed
patent.txt lines 7,377, 7,385, 7,393
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
29 Nov 2027 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 7,378,423 with pediatric exclusivity, as listed
patent.txt lines 4,273, 4,293, 4,313
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
29 Nov 2027 · NDA 204410 · MACITENTAN
US 9,265,762 with pediatric exclusivity, as listed
patent.txt line 4,674
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
7 Dec 2027 · NDA 022030 · FESOTERODINE FUMARATE
US 7,807,715 with pediatric exclusivity, as listed
patent.txt lines 920, 926
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
7 Dec 2027 · NDA 022030 · FESOTERODINE FUMARATE
US 8,088,398 with pediatric exclusivity, as listed
patent.txt lines 922, 928
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
7 Dec 2027 · NDA 022030 · FESOTERODINE FUMARATE
US 8,501,723 with pediatric exclusivity, as listed
patent.txt lines 924, 930
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
14 Dec 2027 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 8,511,304 with pediatric exclusivity, as listed
patent.txt lines 4,429, 4,440, 4,449
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 11,458,134 with pediatric exclusivity, as listed
patent.txt lines 4,696, 4,716, 4,736, 4,756
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 8,969,355 with pediatric exclusivity, as listed
patent.txt lines 4,702, 4,722, 4,742, 4,762
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,125,908 with pediatric exclusivity, as listed
patent.txt lines 4,704, 4,724, 4,744, 4,764
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,125,909 with pediatric exclusivity, as listed
patent.txt lines 4,706, 4,726, 4,746, 4,766
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,125,910 with pediatric exclusivity, as listed
patent.txt lines 4,708, 4,728, 4,748, 4,768
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,227,946 with pediatric exclusivity, as listed
patent.txt lines 4,710, 4,730, 4,750, 4,770
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,861,630 with pediatric exclusivity, as listed
patent.txt lines 4,714, 4,734, 4,754, 4,774
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
20 Dec 2027 · NDA 202293 · DAPAGLIFLOZIN
US 8,501,698 with pediatric exclusivity, as listed
patent.txt lines 2,993, 3,031
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
20 Dec 2027 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,501,698 with pediatric exclusivity, as listed
patent.txt lines 5,714, 5,724, 5,734, 5,744, 5,754
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
20 Dec 2027 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,501,698 with pediatric exclusivity, as listed
patent.txt lines 9,667, 9,681
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002

Non-patent exclusivity (120)

3 Jan 2027 · NDA 022304 · TAPENTADOL HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 186, 188, 190
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
3 Jan 2027 · NDA 203794 · TAPENTADOL HYDROCHLORIDE
PED exclusivity
exclusivity.txt line 341
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
10 Jan 2027 · NDA 211635 · DIAZEPAM
ODE-279 exclusivity
exclusivity.txt lines 971, 973, 975
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
13 Jan 2027 · NDA 214787 · REMDESIVIR
PED exclusivity
exclusivity.txt lines 1,396, 1,402
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
14 Jan 2027 · NDA 213871 · ABROCITINIB
NCE exclusivity
exclusivity.txt lines 1,270, 1,272, 1,274
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
19 Jan 2027 · NDA 205437 · APREMILAST
PED exclusivity
exclusivity.txt lines 485, 491, 497
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
19 Jan 2027 · NDA 212018 · ERDAFITINIB
I-930 exclusivity
exclusivity.txt lines 1,015–1,017
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
20 Jan 2027 · NDA 205437 · APREMILAST
PED exclusivity
exclusivity.txt lines 486, 492, 498
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
24 Jan 2027 · NDA 201699 · FIDAXOMICIN
ODE-367 exclusivity
exclusivity.txt line 225
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
26 Jan 2027 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
NPP exclusivity
exclusivity.txt line 559
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
9 Feb 2027 · NDA 213976 · BUDESONIDE
NP exclusivity
exclusivity.txt line 1,284
Definition
New product (to be checked against FDA's list)
Product numbers
001
16 Feb 2027 · NDA 208065 · OSIMERTINIB MESYLATE
I-941 exclusivity
exclusivity.txt lines 688, 691
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
17 Feb 2027 · NDA 216196 · MITAPIVAT SULFATE
NCE exclusivity
exclusivity.txt lines 1,736, 1,738, 1,740, 1,742
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
23 Feb 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
PED exclusivity
exclusivity.txt lines 429, 431, 433, 435
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
23 Feb 2027 · NDA 210251 · BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
I-942 exclusivity
exclusivity.txt lines 859, 864
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
28 Feb 2027 · NDA 214787 · REMDESIVIR
NPP exclusivity
exclusivity.txt lines 1,393, 1,399
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
6 Mar 2027 · NDA 205832 · NINTEDANIB ESYLATE
PED exclusivity
exclusivity.txt lines 531, 533
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
7 Mar 2027 · NDA 213217 · ZANUBRUTINIB
I-936 exclusivity
exclusivity.txt line 1,162
Definition
New indication (to be checked against FDA's list)
Product numbers
001
7 Mar 2027 · NDA 218785 · ZANUBRUTINIB
I-936 exclusivity
exclusivity.txt line 2,196
Definition
New indication (to be checked against FDA's list)
Product numbers
001
8 Mar 2027 · NDA 215256 · SEMAGLUTIDE
I-935 exclusivity
exclusivity.txt lines 1,502, 1,504, 1,506, 1,509, 1,511, 1,514
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 012
8 Mar 2027 · NDA 218316 · SEMAGLUTIDE
I-935 exclusivity
exclusivity.txt lines 2,142, 2,144, 2,146, 2,148
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
13 Mar 2027 · NDA 214662 · MARALIXIBAT CHLORIDE
I-938 exclusivity
exclusivity.txt line 1,347
Definition
New indication (to be checked against FDA's list)
Product numbers
001
13 Mar 2027 · NDA 219485 · MARALIXIBAT CHLORIDE
I-938 exclusivity
exclusivity.txt lines 2,289, 2,291, 2,293, 2,295
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
19 Mar 2027 · NDA 203469 · PONATINIB HYDROCHLORIDE
I-934 exclusivity
exclusivity.txt lines 323, 325, 327, 329
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
22 Mar 2027 · NDA 211616 · BEMPEDOIC ACID
I-943 exclusivity
exclusivity.txt line 966
Definition
New indication (to be checked against FDA's list)
Product numbers
001
22 Mar 2027 · NDA 211616 · BEMPEDOIC ACID
I-944 exclusivity
exclusivity.txt line 967
Definition
New indication (to be checked against FDA's list)
Product numbers
001
22 Mar 2027 · NDA 211617 · BEMPEDOIC ACID; EZETIMIBE
I-943 exclusivity
exclusivity.txt line 968
Definition
New indication (to be checked against FDA's list)
Product numbers
001
22 Mar 2027 · NDA 211617 · BEMPEDOIC ACID; EZETIMIBE
I-945 exclusivity
exclusivity.txt line 969
Definition
New indication (to be checked against FDA's list)
Product numbers
001
26 Mar 2027 · NDA 203341 · BOSUTINIB MONOHYDRATE
PED exclusivity
exclusivity.txt lines 309, 313, 317
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
27 Mar 2027 · NDA 208464 · TENOFOVIR ALAFENAMIDE FUMARATE
NPP exclusivity
exclusivity.txt line 711
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
2 Apr 2027 · NDA 022192 · ILOPERIDONE
I-939 exclusivity
exclusivity.txt lines 163–169
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006, 007
3 Apr 2027 · NDA 206947 · LENVATINIB MESYLATE
M-14 exclusivity
exclusivity.txt lines 564, 568
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
5 Apr 2027 · NDA 211994 · DOLUTEGRAVIR SODIUM; LAMIVUDINE
NPP exclusivity
exclusivity.txt line 1,013
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
10 Apr 2027 · NDA 213756 · SELUMETINIB SULFATE
ODE-288 exclusivity
exclusivity.txt lines 1,258, 1,262
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
15 Apr 2027 · NDA 211728 · MITOMYCIN
ODE-289 exclusivity
exclusivity.txt line 999
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
17 Apr 2027 · NDA 213736 · PEMIGATINIB
ODE-292 exclusivity
exclusivity.txt lines 1,250, 1,252, 1,254
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
18 Apr 2027 · NDA 208434 · ALECTINIB HYDROCHLORIDE
I-947 exclusivity
exclusivity.txt line 707
Definition
New indication (to be checked against FDA's list)
Product numbers
001
23 Apr 2027 · NDA 208700 · LUTETIUM LU-177 DOTATATE
NPP exclusivity
exclusivity.txt line 747
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
24 Apr 2027 · NDA 210251 · BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
M-305 exclusivity
exclusivity.txt line 860
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
25 Apr 2027 · NDA 205437 · APREMILAST
NPP exclusivity
exclusivity.txt lines 483, 489, 495
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003
26 Apr 2027 · NDA 211675 · UPADACITINIB
I-946 exclusivity
exclusivity.txt lines 984, 990, 994
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
26 Apr 2027 · NDA 211675 · UPADACITINIB
NPP exclusivity
exclusivity.txt lines 986, 991, 995
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003
26 Apr 2027 · NDA 218347 · UPADACITINIB
NP exclusivity
exclusivity.txt line 2,150
Definition
New product (to be checked against FDA's list)
Product numbers
001
28 Apr 2027 · NDA 214998 · MAVACAMTEN
NCE exclusivity
exclusivity.txt lines 1,447, 1,450, 1,453, 1,456
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
6 May 2027 · NDA 213591 · CAPMATINIB HYDROCHLORIDE
ODE-291 exclusivity
exclusivity.txt lines 1,239–1,240
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
8 May 2027 · NDA 205422 · BREXPIPRAZOLE
M-14 exclusivity
exclusivity.txt lines 451, 456, 461, 466, 471, 476
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
8 May 2027 · NDA 208558 · OLAPARIB
ODE-306 exclusivity
exclusivity.txt lines 714, 717
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
8 May 2027 · NDA 213246 · SELPERCATINIB
ODE-301 exclusivity
exclusivity.txt lines 1,172, 1,194
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
8 May 2027 · NDA 213246 · SELPERCATINIB
ODE-302 exclusivity
exclusivity.txt lines 1,173, 1,195
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
8 May 2027 · NDA 213246 · SELPERCATINIB
ODE-303 exclusivity
exclusivity.txt lines 1,174, 1,196
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
13 May 2027 · NDA 215866 · TIRZEPATIDE
NCE exclusivity
exclusivity.txt lines 1,625, 1,627, 1,629, 1,631, 1,633–1,635, 1,637, 1,639, 1,641, 1,643–1,645, 1,647, 1,649, 1,651, 1,653, 1,655, 1,657, 1,659, 1,661, 1,663, 1,665–1,666
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024
13 May 2027 · NDA 217806 · TIRZEPATIDE
NCE exclusivity
exclusivity.txt lines 1,944, 1,948, 1,952, 1,956, 1,960, 1,964, 1,968, 1,971, 1,974, 1,977, 1,980, 1,983, 1,986, 1,989, 1,992, 1,995, 1,998, 2,001, 2,004, 2,007, 2,010, 2,013, 2,016, 2,019
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024
14 May 2027 · NDA 204026 · POMALIDOMIDE
ODE-296 exclusivity
exclusivity.txt lines 348, 352, 356, 360
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
14 May 2027 · NDA 204026 · POMALIDOMIDE
ODE-297 exclusivity
exclusivity.txt lines 349, 353, 357, 361
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
23 May 2027 · NDA 215272 · TAPINAROF
NCE exclusivity
exclusivity.txt line 1,517
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
29 May 2027 · NDA 213246 · SELPERCATINIB
NPP exclusivity
exclusivity.txt lines 1,171, 1,193
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
7 Jun 2027 · NDA 213189 · TIRBANIBULIN
D-192 exclusivity
exclusivity.txt line 1,160
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001
8 Jun 2027 · NDA 207500 · ISAVUCONAZONIUM SULFATE
PED exclusivity
exclusivity.txt lines 597, 607
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
8 Jun 2027 · NDA 207501 · ISAVUCONAZONIUM SULFATE
PED exclusivity
exclusivity.txt line 618
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
12 Jun 2027 · NDA 202293 · DAPAGLIFLOZIN
NPP exclusivity
exclusivity.txt lines 268, 272
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
12 Jun 2027 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 515, 517, 519, 521, 523
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
13 Jun 2027 · NDA 215515 · VUTRISIRAN SODIUM
NCE exclusivity
exclusivity.txt line 1,588
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
15 Jun 2027 · NDA 213702 · LURBINECTEDIN
ODE-304 exclusivity
exclusivity.txt line 1,245
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
21 Jun 2027 · NDA 211150 · PITOLISANT HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 932, 937
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
25 Jun 2027 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
ODE-312 exclusivity
exclusivity.txt line 1,021
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
26 Jun 2027 · NDA 208232 · OCTREOTIDE ACETATE
ODE-474 exclusivity
exclusivity.txt line 701
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
30 Jun 2027 · NDA 213687 · TRIHEPTANOIN
ODE-311 exclusivity
exclusivity.txt line 1,243
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
9 Jul 2027 · NDA 215985 · ROFLUMILAST
NS exclusivity
exclusivity.txt line 1,684
Definition
New strength (to be checked against FDA's list)
Product numbers
002
21 Jul 2027 · NDA 212690 · CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
ODE-361 exclusivity
exclusivity.txt line 1,103
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
31 Jul 2027 · NDA 210365 · CANNABIDIOL
ODE-326 exclusivity
exclusivity.txt line 874
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
31 Jul 2027 · NDA 210365 · CANNABIDIOL
ODE-332 exclusivity
exclusivity.txt line 875
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
5 Aug 2027 · NDA 022372 · MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
ODE-315 exclusivity
exclusivity.txt line 197
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
7 Aug 2027 · NDA 213535 · RISDIPLAM
ODE-334 exclusivity
exclusivity.txt line 1,230
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
7 Aug 2027 · NDA 217186 · CARBIDOPA; LEVODOPA
NP exclusivity
exclusivity.txt lines 1,854–1,857
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
12 Aug 2027 · NDA 020988 · PANTOPRAZOLE SODIUM
NPP exclusivity
exclusivity.txt line 112
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
28 Aug 2027 · NDA 214787 · REMDESIVIR
PED exclusivity
exclusivity.txt lines 1,395, 1,401
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
30 Aug 2027 · NDA 209939 · LETERMOVIR
NPP exclusivity
exclusivity.txt lines 820, 826
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
30 Aug 2027 · NDA 209940 · LETERMOVIR
NPP exclusivity
exclusivity.txt lines 832, 838
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
1 Sep 2027 · NDA 214120 · AZACITIDINE
ODE-320 exclusivity
exclusivity.txt lines 1,306–1,307
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
6 Sep 2027 · NDA 207500 · ISAVUCONAZONIUM SULFATE
GAIN exclusivity
exclusivity.txt lines 590–591, 602
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001, 002
6 Sep 2027 · NDA 207501 · ISAVUCONAZONIUM SULFATE
GAIN exclusivity
exclusivity.txt lines 611–612
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
13 Sep 2027 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
M-308 exclusivity
exclusivity.txt lines 203–206
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
17 Sep 2027 · NDA 209092 · RIBOCICLIB SUCCINATE
I-950 exclusivity
exclusivity.txt line 760
Definition
New indication (to be checked against FDA's list)
Product numbers
001
17 Sep 2027 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
I-951 exclusivity
exclusivity.txt line 814
Definition
New indication (to be checked against FDA's list)
Product numbers
001
25 Sep 2027 · NDA 208065 · OSIMERTINIB MESYLATE
I-952 exclusivity
exclusivity.txt lines 689, 692
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
27 Sep 2027 · NDA 213246 · SELPERCATINIB
M-311 exclusivity
exclusivity.txt lines 1,169, 1,191
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
27 Sep 2027 · NDA 213246 · SELPERCATINIB
M-312 exclusivity
exclusivity.txt lines 1,170, 1,192
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
3 Oct 2027 · NDA 206947 · LENVATINIB MESYLATE
PED exclusivity
exclusivity.txt lines 567, 571
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
11 Oct 2027 · NDA 022350 · SAXAGLIPTIN HYDROCHLORIDE
M-14 exclusivity
exclusivity.txt lines 195–196
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
11 Oct 2027 · NDA 200678 · METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
M-14 exclusivity
exclusivity.txt lines 212–214
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
13 Oct 2027 · NDA 211150 · PITOLISANT HYDROCHLORIDE
ODE-331 exclusivity
exclusivity.txt lines 934, 939
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
18 Oct 2027 · NDA 217806 · TIRZEPATIDE
M-82 exclusivity
exclusivity.txt lines 1,943, 1,947, 1,951, 1,955, 1,959, 1,963, 1,967, 1,970, 1,973, 1,976, 1,979, 1,982, 1,985, 1,988, 1,991, 1,994, 1,997, 2,000, 2,003, 2,006, 2,009, 2,012, 2,015, 2,018
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024
23 Oct 2027 · NDA 208700 · LUTETIUM LU-177 DOTATATE
PED exclusivity
exclusivity.txt line 749
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
25 Oct 2027 · NDA 205437 · APREMILAST
PED exclusivity
exclusivity.txt lines 487, 493, 499
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
29 Oct 2027 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
I-953 exclusivity
exclusivity.txt lines 1,535, 1,543
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
29 Oct 2027 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
I-954 exclusivity
exclusivity.txt lines 1,536, 1,544
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
1 Nov 2027 · NDA 219015 · MINOCYCLINE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 2,227
Definition
New product (to be checked against FDA's list)
Product numbers
001
8 Nov 2027 · NDA 205422 · BREXPIPRAZOLE
PED exclusivity
exclusivity.txt lines 454, 459, 464, 469, 474, 479
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
8 Nov 2027 · NDA 213246 · SELPERCATINIB
PED exclusivity
exclusivity.txt lines 1,188–1,190, 1,210–1,212
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
14 Nov 2027 · NDA 204026 · POMALIDOMIDE
PED exclusivity
exclusivity.txt lines 350–351, 354–355, 358–359, 362–363
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
26 Nov 2027 · NDA 021539 · ACETYLCYSTEINE
D-196 exclusivity
exclusivity.txt line 124
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001
29 Nov 2027 · NDA 213246 · SELPERCATINIB
PED exclusivity
exclusivity.txt lines 1,184, 1,206
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
1 Dec 2027 · NDA 205677 · TASIMELTEON
ODE-330 exclusivity
exclusivity.txt line 525
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
1 Dec 2027 · NDA 214517 · TASIMELTEON
ODE-329 exclusivity
exclusivity.txt line 1,338
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
3 Dec 2027 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
ODE-333 exclusivity
exclusivity.txt lines 1,298, 1,300
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
12 Dec 2027 · NDA 022225 · SUGAMMADEX SODIUM
NPP exclusivity
exclusivity.txt lines 170, 172
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
12 Dec 2027 · NDA 202293 · DAPAGLIFLOZIN
PED exclusivity
exclusivity.txt lines 269, 273
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
12 Dec 2027 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 516, 518, 520, 522, 524
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
12 Dec 2027 · NDA 215272 · TAPINAROF
I-956 exclusivity
exclusivity.txt line 1,516
Definition
New indication (to be checked against FDA's list)
Product numbers
001
18 Dec 2027 · NDA 204042 · CANAGLIFLOZIN
NPP exclusivity
exclusivity.txt lines 364, 366
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
18 Dec 2027 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 388, 390, 392, 394
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
18 Dec 2027 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 536, 538, 540, 542
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
18 Dec 2027 · NDA 208065 · OSIMERTINIB MESYLATE
ODE-337 exclusivity
exclusivity.txt lines 690, 693
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
18 Dec 2027 · NDA 213006 · VIBEGRON
I-955 exclusivity
exclusivity.txt line 1,143
Definition
New indication (to be checked against FDA's list)
Product numbers
001
19 Dec 2027 · NDA 210854 · BALOXAVIR MARBOXIL
M-187 exclusivity
exclusivity.txt lines 914–916
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
20 Dec 2027 · NDA 210496 · ENCORAFENIB
I-957 exclusivity
exclusivity.txt lines 881, 885
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
20 Dec 2027 · NDA 217806 · TIRZEPATIDE
I-958 exclusivity
exclusivity.txt lines 1,942, 1,946, 1,950, 1,954, 1,958, 1,962, 1,966, 1,969, 1,972, 1,975, 1,978, 1,981, 1,984, 1,987, 1,990, 1,993, 1,996, 1,999, 2,002, 2,005, 2,008, 2,011, 2,014, 2,017
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024
21 Dec 2027 · NDA 203188 · IVACAFTOR
ODE-338 exclusivity
exclusivity.txt line 303
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
21 Dec 2027 · NDA 207925 · IVACAFTOR
ODE-338 exclusivity
exclusivity.txt lines 628, 634, 640
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
25 Dec 2027 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
PED exclusivity
exclusivity.txt line 1,023
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001