Drybench Patent.

Patent and exclusivity dates from January to June 2027 for NDAs, as FDA's Orange Book lists them

Each patent and exclusivity date from January to June 2027 that FDA's Orange Book lists for an NDA, as captured on 14 October 2026. That capture lists a patent or exclusivity for 1,411 NDAs. 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

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 every NDA whose Orange Book capture lists a patent or exclusivity. It does not cover ANDAs 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.

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 dates, 2027 July to December 2027

Listed patent expiry (377)

1 Jan 2027 · NDA 022110 · TELAVANCIN HYDROCHLORIDE
US 7,531,623, substance patent
patent.txt lines 1,079–1,080
Flags
substance
Product numbers
001, 002
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 10,245,228, product and use patent
patent.txt line 9,785
Flags
product use code U-1351
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 10,342,762, product patent
patent.txt line 9,786
Flags
product
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 10,507,180, product and use patent
patent.txt line 9,787
Flags
product use code U-1351
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 8,226,978, product and use patent
patent.txt line 9,793
Flags
product use code U-1351
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 8,231,900, product patent
patent.txt line 9,794
Flags
product
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 8,252,328, product patent
patent.txt line 9,795
Flags
product
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 8,252,329, product patent
patent.txt line 9,796
Flags
product
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 8,535,714, product and use patent
patent.txt line 9,797
Flags
product use code U-1351
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 8,778,393, use patent
patent.txt line 9,799
Flags
use code U-1351
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 8,778,394, use patent
patent.txt line 9,800
Flags
use code U-1351
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 8,865,211, use patent
patent.txt line 9,801
Flags
use code U-1351
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 9,320,710, use patent
patent.txt line 9,804
Flags
use code U-1351
Product numbers
001
5 Jan 2027 · NDA 209128 · SUFENTANIL CITRATE
US 9,744,129, product patent
patent.txt line 9,805
Flags
product
Product numbers
001
6 Jan 2027 · NDA 206089 · TESTOSTERONE UNDECANOATE
US 11,331,325, use patent
patent.txt lines 6,241, 6,252, 6,263
Flags
use code U-2506
Product numbers
001, 002, 003
6 Jan 2027 · NDA 207793 · IRINOTECAN HYDROCHLORIDE
US 8,329,213, substance and product patent
patent.txt line 7,423
Flags
substance product
Product numbers
001
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
10 Jan 2027 · NDA 210136 · BUPRENORPHINE
US 8,236,292, product and use patent
patent.txt lines 11,153, 11,161, 11,169, 11,177, 11,185, 11,193, 11,201
Flags
product use code U-3619
Product numbers
001, 002, 003, 004, 005, 006, 007
15 Jan 2027 · NDA 217865 · GIVINOSTAT HYDROCHLORIDE
US 7,329,689, substance and product patent
patent.txt line 20,749
Flags
substance product
Product numbers
001
16 Jan 2027 · NDA 211488 · LEUPROLIDE MESYLATE
US 10,646,572, product patent
patent.txt line 12,874
Flags
product
Product numbers
001
16 Jan 2027 · NDA 211488 · LEUPROLIDE MESYLATE
US 9,744,207, product patent
patent.txt line 12,878
Flags
product
Product numbers
001
16 Jan 2027 · NDA 219745 · LEUPROLIDE MESYLATE
US 10,646,572, product patent
patent.txt line 21,874
Flags
product
Product numbers
001
16 Jan 2027 · NDA 219745 · LEUPROLIDE MESYLATE
US 9,744,207, product patent
patent.txt line 21,878
Flags
product
Product numbers
001
19 Jan 2027 · NDA 203108 · OLODATEROL HYDROCHLORIDE
US 7,727,984, substance patent
patent.txt line 3,643
Flags
substance
Product numbers
001
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
20 Jan 2027 · NDA 215244 · ELAMIPRETIDE HYDROCHLORIDE
US 7,576,061, substance and product patent
patent.txt line 16,601
Flags
substance product
Product numbers
001
22 Jan 2027 · NDA 021842 · METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
US 9,101,660, product patent
patent.txt lines 739, 741
Flags
product
Product numbers
001, 002
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
23 Jan 2027 · NDA 209401 · CYTARABINE; DAUNORUBICIN
US 7,850,990, product and use patent
patent.txt line 10,334
Flags
product use code U-3147
Product numbers
001
23 Jan 2027 · NDA 209401 · CYTARABINE; DAUNORUBICIN
US 9,271,931, product patent
patent.txt line 10,341
Flags
product
Product numbers
001
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
29 Jan 2027 · NDA 203568 · MIPOMERSEN SODIUM
US 7,511,131, substance patent
patent.txt line 4,105
Flags
substance
Product numbers
001
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
31 Jan 2027 · NDA 021862 · NEPAFENAC
US 7,834,059, use patent
patent.txt line 747
Flags
use code U-1095
Product numbers
001
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
2 Feb 2027 · NDA 208010 · CALCIFEDIOL
US 10,213,442, product patent
patent.txt line 7,948
Flags
product
Product numbers
001
2 Feb 2027 · NDA 208010 · CALCIFEDIOL
US 8,906,410, product patent
patent.txt line 7,960
Flags
product
Product numbers
001
2 Feb 2027 · NDA 208010 · CALCIFEDIOL
US 9,943,530, use patent
patent.txt line 7,969
Flags
use code U-2274
Product numbers
001
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
7 Feb 2027 · NDA 203159 · LEVONORGESTREL
US 11,628,088, product patent
patent.txt line 3,647
Flags
product
Product numbers
001
7 Feb 2027 · NDA 208224 · LEVONORGESTREL
US 11,628,088, product patent
patent.txt line 8,355
Flags
product
Product numbers
001
9 Feb 2027 · NDA 219616 · AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
US 7,897,792, substance and product patent
patent.txt line 21,799
Flags
substance product
Product numbers
001
12 Feb 2027 · NDA 206426 · PERAMIVIR
US 10,391,075, use patent
patent.txt line 6,542
Flags
use code U-2622
Product numbers
001
12 Feb 2027 · NDA 206426 · PERAMIVIR
US 10,391,075, use patent
patent.txt line 6,543
Flags
use code U-3069
Product numbers
001
14 Feb 2027 · NDA 022055 · RETAPAMULIN
US 7,875,630, substance patent
patent.txt line 979
Flags
substance
Product numbers
001
14 Feb 2027 · NDA 217225 · AVACINCAPTAD PEGOL SODIUM
US 7,579,456, substance patent
patent.txt line 19,808
Flags
substance
Product numbers
001
14 Feb 2027 · NDA 217225 · AVACINCAPTAD PEGOL SODIUM
US 9,617,546, substance and use patent
patent.txt line 19,810
Flags
substance use code U-3673
Product numbers
001
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
20 Feb 2027 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 9,238,108, product patent
patent.txt line 5,887
Flags
product
Product numbers
001
20 Feb 2027 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 9,238,108, product patent
patent.txt line 10,911
Flags
product
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 201739 · EPINEPHRINE
US 8,206,360, product patent
patent.txt lines 2,563, 2,572, 2,581
Flags
product
Product numbers
001, 002, 003
27 Feb 2027 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 8,206,360, product patent
patent.txt line 5,880
Flags
product
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
27 Feb 2027 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 8,206,360, product patent
patent.txt line 10,904
Flags
product
Product numbers
001
28 Feb 2027 · NDA 021441 · CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
US 7,863,287, product patent
patent.txt line 613
Flags
product
Product numbers
001
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
2 Mar 2027 · NDA 207202 · ARIPIPRAZOLE
US 8,759,350, use patent
patent.txt lines 7,074, 7,101, 7,128, 7,155, 7,182, 7,209
Flags
use code U-1529
Product numbers
001, 002, 003, 004, 005, 006
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
4 Mar 2027 · NDA 213138 · FIDAXOMICIN
US 7,906,489, use patent
patent.txt line 14,697
Flags
use code U-2741
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
6 Mar 2027 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 10,124,132, product and use patent
patent.txt line 6,274
Flags
product use code U-1719
Product numbers
001
6 Mar 2027 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 10,124,132, product and use patent
patent.txt line 6,275
Flags
product use code U-2010
Product numbers
001
6 Mar 2027 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 10,124,132, product and use patent
patent.txt line 6,276
Flags
product use code U-2011
Product numbers
001
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
7 Mar 2027 · NDA 201922 · MINOCYCLINE HYDROCHLORIDE
US 7,919,483, use patent
patent.txt lines 2,598, 2,601, 2,604
Flags
use code U-124
Product numbers
001, 003, 005
10 Mar 2027 · NDA 022247 · BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED
US 7,683,051, substance and product and use patent
patent.txt line 1,359
Flags
substance product use code U-594
Product numbers
001
10 Mar 2027 · NDA 022247 · BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED
US 7,683,051, substance and product and use patent
patent.txt line 1,360
Flags
substance product use code U-904
Product numbers
001
11 Mar 2027 · NDA 021991 · VORINOSTAT
US 7,456,219, substance patent
patent.txt line 881
Flags
substance
Product numbers
001
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 207768 · CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX
US 8,790,700, product patent
patent.txt line 7,414
Flags
product
Product numbers
001
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 208147 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 10,086,087, product patent
patent.txt line 8,273
Flags
product
Product numbers
001
15 Mar 2027 · NDA 208147 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 8,597,684, product patent
patent.txt line 8,276
Flags
product
Product numbers
001
15 Mar 2027 · NDA 208147 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 8,747,902, product patent
patent.txt line 8,277
Flags
product
Product numbers
001
15 Mar 2027 · NDA 208147 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 8,883,217, product patent
patent.txt line 8,278
Flags
product
Product numbers
001
15 Mar 2027 · NDA 208147 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 9,675,703, product patent
patent.txt line 8,279
Flags
product
Product numbers
001
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
16 Mar 2027 · NDA 216993 · QUIZARTINIB DIHYDROCHLORIDE
US 8,129,374, use patent
patent.txt lines 19,127, 19,138
Flags
use code U-3661
Product numbers
001, 002
16 Mar 2027 · NDA 216993 · QUIZARTINIB DIHYDROCHLORIDE
US 8,557,810, product patent
patent.txt lines 19,129, 19,140
Flags
product
Product numbers
001, 002
16 Mar 2027 · NDA 216993 · QUIZARTINIB DIHYDROCHLORIDE
US 8,883,783, substance patent
patent.txt lines 19,132, 19,143
Flags
substance
Product numbers
001, 002
16 Mar 2027 · NDA 216993 · QUIZARTINIB DIHYDROCHLORIDE
US 9,585,892, use patent
patent.txt lines 19,134, 19,145
Flags
use code U-3661
Product numbers
001, 002
17 Mar 2027 · NDA 202258 · BOCEPREVIR
US 8,119,602, use patent
patent.txt line 2,959
Flags
use code U-1233
Product numbers
001
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
23 Mar 2027 · NDA 203791 · ACYCLOVIR
US 8,791,127, product and use patent
patent.txt line 4,159
Flags
product use code U-1460
Product numbers
001
26 Mar 2027 · NDA 217347 · SOFPIRONIUM BROMIDE
US 8,147,809, substance and product patent
patent.txt line 19,861
Flags
substance product
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
2 Apr 2027 · NDA 201922 · MINOCYCLINE HYDROCHLORIDE
US 7,541,347, use patent
patent.txt lines 2,596, 2,599, 2,602
Flags
use code U-917
Product numbers
001, 003, 005
2 Apr 2027 · NDA 201922 · MINOCYCLINE HYDROCHLORIDE
US 7,544,373, product patent
patent.txt lines 2,597, 2,600, 2,603
Flags
product
Product numbers
001, 003, 005
4 Apr 2027 · NDA 206500 · ROLAPITANT HYDROCHLORIDE
US 7,563,801, product patent
patent.txt line 6,584
Flags
product
Product numbers
001
4 Apr 2027 · NDA 206500 · ROLAPITANT HYDROCHLORIDE
US 7,981,905, use patent
patent.txt line 6,585
Flags
use code U-1741
Product numbers
001
4 Apr 2027 · NDA 206500 · ROLAPITANT HYDROCHLORIDE
US 8,178,550, substance and product patent
patent.txt line 6,586
Flags
substance product
Product numbers
001
4 Apr 2027 · NDA 206500 · ROLAPITANT HYDROCHLORIDE
US 8,404,702, use patent
patent.txt line 6,588
Flags
use code U-1741
Product numbers
001
4 Apr 2027 · NDA 208399 · ROLAPITANT HYDROCHLORIDE
US 7,981,905, use patent
patent.txt line 8,567
Flags
use code U-1741
Product numbers
001
4 Apr 2027 · NDA 208399 · ROLAPITANT HYDROCHLORIDE
US 8,178,550, substance and product patent
patent.txt line 8,568
Flags
substance product
Product numbers
001
4 Apr 2027 · NDA 208399 · ROLAPITANT HYDROCHLORIDE
US 8,404,702, use patent
patent.txt line 8,569
Flags
use code U-1741
Product numbers
001
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
7 Apr 2027 · NDA 211911 · BIMATOPROST
US 8,206,737, use patent
patent.txt line 13,225
Flags
use code U-2759
Product numbers
001
7 Apr 2027 · NDA 217171 · PEGCETACOPLAN
US 8,168,584, use patent
patent.txt line 19,285
Flags
use code U-3540
Product numbers
001
7 Apr 2027 · NDA 217171 · PEGCETACOPLAN
US 8,168,584, use patent
patent.txt line 19,286
Flags
use code U-3542
Product numbers
001
9 Apr 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 10,022,352, product and use patent
patent.txt lines 11,414, 11,447
Flags
product use code U-2343
Product numbers
001, 002
9 Apr 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 10,022,352, product and use patent
patent.txt lines 11,415, 11,448
Flags
product use code U-2573
Product numbers
001, 002
9 Apr 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 10,239,867, substance and product and use patent
patent.txt lines 11,422, 11,455
Flags
substance product use code U-2512
Product numbers
001, 002
9 Apr 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 10,239,867, substance and product and use patent
patent.txt lines 11,423, 11,456
Flags
substance product use code U-2569
Product numbers
001, 002
9 Apr 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 11,639,347, substance and product and use patent
patent.txt lines 11,427, 11,460
Flags
substance product use code U-2569
Product numbers
001, 002
9 Apr 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 9,974,781, product and use patent
patent.txt lines 11,444, 11,476
Flags
product use code U-2318
Product numbers
001, 002
9 Apr 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 9,974,781, product and use patent
patent.txt lines 11,445, 11,477
Flags
product use code U-2574
Product numbers
001, 002
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,022,352, product and use patent
patent.txt line 13,654
Flags
product use code U-2651
Product numbers
001
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,022,352, product and use patent
patent.txt lines 13,655, 13,731
Flags
product use code U-3156
Product numbers
001, 002
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,239,867, substance and product and use patent
patent.txt line 13,660
Flags
substance product use code U-3033
Product numbers
001
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,239,867, substance and product and use patent
patent.txt lines 13,661, 13,735
Flags
substance product use code U-3158
Product numbers
001, 002
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,239,867, substance and product and use patent
patent.txt lines 13,662, 13,736
Flags
substance product use code U-4056
Product numbers
001, 002
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,239,867, substance and product and use patent
patent.txt lines 13,663, 13,737
Flags
substance product use code U-4475
Product numbers
001, 002
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,639,347, substance and product and use patent
patent.txt lines 13,689, 13,761
Flags
substance product use code U-3587
Product numbers
001, 002
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,639,347, substance and product and use patent
patent.txt lines 13,690, 13,762
Flags
substance product use code U-4056
Product numbers
001, 002
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,639,347, substance and product and use patent
patent.txt lines 13,691, 13,763
Flags
substance product use code U-4475
Product numbers
001, 002
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,974,781, product and use patent
patent.txt line 13,726
Flags
product use code U-3028
Product numbers
001
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,974,781, product and use patent
patent.txt lines 13,727, 13,791
Flags
product use code U-3144
Product numbers
001, 002
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,974,781, product and use patent
patent.txt lines 13,728, 13,792
Flags
product use code U-4073
Product numbers
001, 002
9 Apr 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,974,781, product and use patent
patent.txt lines 13,729, 13,793
Flags
product use code U-4475
Product numbers
001, 002
9 Apr 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,022,352, product and use patent
patent.txt lines 20,062, 20,135
Flags
product use code U-3596
Product numbers
001, 002
9 Apr 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,239,867, substance and product and use patent
patent.txt lines 20,066, 20,139
Flags
substance product use code U-3590
Product numbers
001, 002
9 Apr 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,239,867, substance and product and use patent
patent.txt lines 20,067, 20,140
Flags
substance product use code U-4053
Product numbers
001, 002
9 Apr 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,239,867, substance and product and use patent
patent.txt lines 20,068, 20,141
Flags
substance product use code U-4476
Product numbers
001, 002
9 Apr 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,639,347, substance and product and use patent
patent.txt lines 20,098, 20,171
Flags
substance product use code U-3583
Product numbers
001, 002
9 Apr 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,639,347, substance and product and use patent
patent.txt lines 20,099, 20,172
Flags
substance product use code U-4053
Product numbers
001, 002
9 Apr 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,639,347, substance and product and use patent
patent.txt lines 20,100, 20,173
Flags
substance product use code U-4476
Product numbers
001, 002
9 Apr 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,974,781, product and use patent
patent.txt lines 20,131, 20,206
Flags
product use code U-3589
Product numbers
001, 002
9 Apr 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,974,781, product and use patent
patent.txt lines 20,132, 20,207
Flags
product use code U-4066
Product numbers
001, 002
9 Apr 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,974,781, product and use patent
patent.txt lines 20,133, 20,208
Flags
product use code U-4476
Product numbers
001, 002
9 Apr 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 10,022,352, product and use patent
patent.txt lines 21,184, 21,227
Flags
product use code U-4081
Product numbers
001, 002
9 Apr 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 10,239,867, substance and product and use patent
patent.txt lines 21,188, 21,234
Flags
substance product use code U-4090
Product numbers
001, 002
9 Apr 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 10,239,867, substance and product and use patent
patent.txt lines 21,189, 21,235
Flags
substance product use code U-4464
Product numbers
001, 002
9 Apr 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 11,639,347, substance and product and use patent
patent.txt lines 21,196, 21,242
Flags
substance product use code U-4090
Product numbers
001, 002
9 Apr 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 11,639,347, substance and product and use patent
patent.txt lines 21,197, 21,243
Flags
substance product use code U-4464
Product numbers
001, 002
9 Apr 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 9,974,781, product and use patent
patent.txt lines 21,224, 21,275
Flags
product use code U-4082
Product numbers
001, 002
9 Apr 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 9,974,781, product and use patent
patent.txt lines 21,225, 21,276
Flags
product use code U-4463
Product numbers
001, 002
12 Apr 2027 · NDA 202278 · SUMATRIPTAN SUCCINATE
US 7,973,058, use patent
patent.txt line 2,966
Flags
use code U-1328
Product numbers
001
12 Apr 2027 · NDA 202278 · SUMATRIPTAN SUCCINATE
US 8,155,737, use patent
patent.txt line 2,967
Flags
use code U-1328
Product numbers
001
12 Apr 2027 · NDA 202278 · SUMATRIPTAN SUCCINATE
US 8,470,853, use patent
patent.txt line 2,969
Flags
use code U-1328
Product numbers
001
12 Apr 2027 · NDA 202278 · SUMATRIPTAN SUCCINATE
US 8,597,272, product patent
patent.txt line 2,970
Flags
product
Product numbers
001
12 Apr 2027 · NDA 202278 · SUMATRIPTAN SUCCINATE
US 9,427,578, product and use patent
patent.txt line 2,974
Flags
product use code U-1328
Product numbers
001
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
17 Apr 2027 · NDA 022500 · CLONIDINE
US 8,337,890, product patent
patent.txt lines 1,997, 1,999
Flags
product
Product numbers
001, 002
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
21 Apr 2027 · NDA 202860 · NITRIC OXIDE
US 7,560,076, product patent
patent.txt line 3,414
Flags
product
Product numbers
001
25 Apr 2027 · NDA 020832 · CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
US 7,422,388, product and use patent
patent.txt lines 193–195
Flags
product use code U-1397
Product numbers
002, 005, 007
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 206679 · SIMVASTATIN
US 10,300,041, product patent
patent.txt lines 6,752, 6,754
Flags
product
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
26 Apr 2027 · NDA 217003 · IBRUTINIB
US 8,563,563, use patent
patent.txt line 19,193
Flags
use code U-2666
Product numbers
001
26 Apr 2027 · NDA 217003 · IBRUTINIB
US 8,563,563, use patent
patent.txt line 19,194
Flags
use code U-3842
Product numbers
001
26 Apr 2027 · NDA 217003 · IBRUTINIB
US 8,563,563, use patent
patent.txt line 19,195
Flags
use code U-3843
Product numbers
001
26 Apr 2027 · NDA 217003 · IBRUTINIB
US 8,563,563, use patent
patent.txt line 19,196
Flags
use code U-3844
Product numbers
001
26 Apr 2027 · NDA 217003 · IBRUTINIB
US 8,563,563, use patent
patent.txt line 19,197
Flags
use code U-3845
Product numbers
001
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
30 Apr 2027 · NDA 202008 · FLORBETAPIR F-18
US 7,687,052, substance and product and use patent
patent.txt lines 2,608, 2,610, 2,612, 2,614
Flags
substance product use code U-4217
Product numbers
001, 002, 003, 004
30 Apr 2027 · NDA 202008 · FLORBETAPIR F-18
US 8,506,929, substance and product and use patent
patent.txt lines 2,609, 2,611, 2,613, 2,615
Flags
substance product use code U-4217
Product numbers
001, 002, 003, 004
1 May 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 7,645,789, substance and product patent
patent.txt lines 11,431, 11,463
Flags
substance product
Product numbers
001, 002
1 May 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 8,598,181, use patent
patent.txt lines 11,437, 11,469
Flags
use code U-2246
Product numbers
001, 002
1 May 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 8,623,905, substance and product patent
patent.txt lines 11,438, 11,470
Flags
substance product
Product numbers
001, 002
1 May 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 7,645,789, substance and product patent
patent.txt lines 13,697, 13,769
Flags
substance product
Product numbers
001, 002
1 May 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,598,181, use patent
patent.txt line 13,710
Flags
use code U-3028
Product numbers
001
1 May 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,598,181, use patent
patent.txt lines 13,711, 13,779
Flags
use code U-3144
Product numbers
001, 002
1 May 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,598,181, use patent
patent.txt lines 13,712, 13,780
Flags
use code U-4056
Product numbers
001, 002
1 May 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,598,181, use patent
patent.txt lines 13,713, 13,781
Flags
use code U-4475
Product numbers
001, 002
1 May 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,623,905, substance and product patent
patent.txt lines 13,714, 13,782
Flags
substance product
Product numbers
001, 002
1 May 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 7,645,789, substance and product patent
patent.txt lines 20,109, 20,184
Flags
substance product
Product numbers
001, 002
1 May 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,598,181, use patent
patent.txt lines 20,119, 20,194
Flags
use code U-3589
Product numbers
001, 002
1 May 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,598,181, use patent
patent.txt lines 20,120, 20,195
Flags
use code U-4066
Product numbers
001, 002
1 May 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,598,181, use patent
patent.txt lines 20,121, 20,196
Flags
use code U-4476
Product numbers
001, 002
1 May 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,623,905, substance and product patent
patent.txt lines 20,122, 20,197
Flags
substance product
Product numbers
001, 002
1 May 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 7,645,789, substance and product patent
patent.txt lines 21,203, 21,253
Flags
substance product
Product numbers
001, 002
1 May 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 8,598,181, use patent
patent.txt lines 21,211, 21,261
Flags
use code U-4090
Product numbers
001, 002
1 May 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 8,598,181, use patent
patent.txt lines 21,212, 21,262
Flags
use code U-4463
Product numbers
001, 002
1 May 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 8,623,905, substance and product patent
patent.txt lines 21,213, 21,263
Flags
substance product
Product numbers
001, 002
2 May 2027 · NDA 211950 · TRIAMCINOLONE ACETONIDE
US 8,636,713, use patent
patent.txt line 13,247
Flags
use code U-3234
Product numbers
001
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
7 May 2027 · NDA 050813 · AMOXICILLIN
US 8,299,052, use patent
patent.txt line 2,172
Flags
use code U-1304
Product numbers
001
7 May 2027 · NDA 206426 · PERAMIVIR
US 8,778,997, use patent
patent.txt line 6,544
Flags
use code U-1627
Product numbers
001
7 May 2027 · NDA 206426 · PERAMIVIR
US 8,778,997, use patent
patent.txt line 6,545
Flags
use code U-2622
Product numbers
001
7 May 2027 · NDA 206426 · PERAMIVIR
US 8,778,997, use patent
patent.txt line 6,546
Flags
use code U-3069
Product numbers
001
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
9 May 2027 · NDA 213411 · TUCATINIB
US 9,693,989, product and use patent
patent.txt lines 14,988, 14,995
Flags
product use code U-2788
Product numbers
001, 002
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
12 May 2027 · NDA 202570 · CRIZOTINIB
US 7,825,137, use patent
patent.txt lines 3,100, 3,105
Flags
use code U-3057
Product numbers
001, 002
12 May 2027 · NDA 202570 · CRIZOTINIB
US 7,825,137, use patent
patent.txt lines 3,101, 3,106
Flags
use code U-3058
Product numbers
001, 002
12 May 2027 · NDA 202570 · CRIZOTINIB
US 7,825,137, use patent
patent.txt lines 3,102, 3,107
Flags
use code U-3403
Product numbers
001, 002
12 May 2027 · NDA 212489 · OPICAPONE
US 8,907,099, substance patent
patent.txt lines 14,090, 14,101
Flags
substance
Product numbers
001, 002
12 May 2027 · NDA 217581 · CRIZOTINIB
US 7,825,137, use patent
patent.txt lines 20,010, 20,015, 20,020
Flags
use code U-3057
Product numbers
001, 002, 003
12 May 2027 · NDA 217581 · CRIZOTINIB
US 7,825,137, use patent
patent.txt lines 20,011, 20,016, 20,021
Flags
use code U-3058
Product numbers
001, 002, 003
12 May 2027 · NDA 217581 · CRIZOTINIB
US 7,825,137, use patent
patent.txt lines 20,012, 20,017, 20,022
Flags
use code U-3403
Product numbers
001, 002, 003
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
14 May 2027 · NDA 214324 · TREPROSTINIL
US 11,357,782, use patent
patent.txt lines 15,677, 15,685, 15,693, 15,701, 15,709
Flags
use code U-1849
Product numbers
001, 002, 003, 004, 005
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 206038 · IVACAFTOR; LUMACAFTOR
US 7,495,103, substance and product patent
patent.txt lines 6,094, 6,142
Flags
substance product
Product numbers
001, 002
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
20 May 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 7,495,103, substance and product patent
patent.txt lines 11,430, 11,462
Flags
substance product
Product numbers
001, 002
20 May 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 7,495,103, substance and product patent
patent.txt lines 12,726, 12,768, 12,810
Flags
substance product
Product numbers
001, 002, 003
20 May 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 7,495,103, substance and product patent
patent.txt lines 13,696, 13,768
Flags
substance product
Product numbers
001, 002
20 May 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 7,495,103, substance and product patent
patent.txt lines 20,108, 20,183
Flags
substance product
Product numbers
001, 002
20 May 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 7,495,103, substance and product patent
patent.txt lines 21,202, 21,252
Flags
substance product
Product numbers
001, 002
23 May 2027 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 9,724,471, product and use patent
patent.txt line 5,891
Flags
product use code U-2092
Product numbers
001
23 May 2027 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 9,724,471, product and use patent
patent.txt line 10,915
Flags
product use code U-2092
Product numbers
001
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
27 May 2027 · NDA 218591 · SACUBITRIL; VALSARTAN
US 8,877,938, substance and product patent
patent.txt lines 21,132, 21,135
Flags
substance product
Product numbers
001, 002
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
29 May 2027 · NDA 217513 · TRAMETINIB DIMETHYL SULFOXIDE
US 7,378,423, substance and product patent
patent.txt line 19,989
Flags
substance product
Product numbers
001
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
31 May 2027 · NDA 216964 · DORAVIRINE; ISLATRAVIR
US 7,339,053, substance patent
patent.txt line 19,087
Flags
substance
Product numbers
001
1 Jun 2027 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
US 7,976,870, use patent
patent.txt line 4,220
Flags
use code U-1498
Product numbers
001
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
3 Jun 2027 · NDA 203791 · ACYCLOVIR
US 8,747,896, product and use patent
patent.txt line 4,158
Flags
product use code U-1460
Product numbers
001
3 Jun 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 7,776,905, substance and product patent
patent.txt lines 11,432, 11,464
Flags
substance product
Product numbers
001, 002
3 Jun 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 7,776,905, substance and product patent
patent.txt lines 13,698, 13,770
Flags
substance product
Product numbers
001, 002
3 Jun 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 7,776,905, substance and product patent
patent.txt lines 20,110, 20,185
Flags
substance product
Product numbers
001, 002
3 Jun 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 7,776,905, substance and product patent
patent.txt lines 21,204, 21,254
Flags
substance product
Product numbers
001, 002
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
8 Jun 2027 · NDA 207145 · SAFINAMIDE MESYLATE
US 8,278,485, substance and use patent
patent.txt lines 7,049, 7,052
Flags
substance use code U-1993
Product numbers
001, 002
12 Jun 2027 · NDA 209310 · MOMETASONE FUROATE
US 8,025,635, product and use patent
patent.txt line 10,075
Flags
product use code U-2272
Product numbers
001
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 203975 · UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 8,511,304, product and use patent
patent.txt line 4,191
Flags
product use code U-1476
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 022556 · CARBINOXAMINE MALEATE
US 9,522,191, product patent
patent.txt line 2,085
Flags
product
Product numbers
001
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 022200 · EXENATIDE SYNTHETIC
US 8,501,698, product and use patent
patent.txt lines 1,258, 1,294
Flags
product use code U-2588
Product numbers
001, 002
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
20 Jun 2027 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,501,698, use patent
patent.txt line 9,891
Flags
use code U-2588
Product numbers
001
20 Jun 2027 · NDA 210874 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
US 8,501,698, product and use patent
patent.txt lines 12,279, 12,289, 12,299, 12,309
Flags
product use code U-493
Product numbers
001, 002, 003, 004
21 Jun 2027 · NDA 021610 · OXYMORPHONE HYDROCHLORIDE
US 8,808,737, use patent
patent.txt lines 639, 641, 643, 645, 647, 649, 651
Flags
use code U-3085
Product numbers
001, 002, 003, 004, 005, 006, 007
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
21 Jun 2027 · NDA 215064 · BIRCH TRITERPENES
US 8,828,444, product patent
patent.txt line 16,460
Flags
product
Product numbers
001
22 Jun 2027 · NDA 216951 · DAPRODUSTAT
US 11,643,397, substance and use patent
patent.txt lines 19,045, 19,051, 19,057, 19,063, 19,069
Flags
substance use code U-3535
Product numbers
001, 002, 003, 004, 005
22 Jun 2027 · NDA 216951 · DAPRODUSTAT
US 8,557,834, use patent
patent.txt lines 19,048, 19,054, 19,060, 19,066, 19,072
Flags
use code U-1238
Product numbers
001, 002, 003, 004, 005
22 Jun 2027 · NDA 216951 · DAPRODUSTAT
US 8,815,884, product and use patent
patent.txt lines 19,049, 19,055, 19,061, 19,067, 19,073
Flags
product use code U-1238
Product numbers
001, 002, 003, 004, 005
26 Jun 2027 · NDA 215192 · VADADUSTAT
US 8,598,210, substance and product patent
patent.txt lines 16,525, 16,539, 16,553
Flags
substance product
Product numbers
001, 002, 003
26 Jun 2027 · NDA 215192 · VADADUSTAT
US 8,940,773, use patent
patent.txt lines 16,526, 16,540, 16,554
Flags
use code U-3876
Product numbers
001, 002, 003
26 Jun 2027 · NDA 215192 · VADADUSTAT
US RE47437, substance and product patent
patent.txt lines 16,529, 16,543, 16,557
Flags
substance product
Product numbers
001, 002, 003
30 Jun 2027 · NDA 020696 · FOMEPIZOLE
US 7,553,863, substance and product patent
patent.txt line 192
Flags
substance product
Product numbers
001
30 Jun 2027 · NDA 212888 · CABOTEGRAVIR; RILPIVIRINE
US 11,389,447, use patent
patent.txt lines 14,478, 14,488
Flags
use code U-3405
Product numbers
001, 002

Pediatric exclusivity, as listed (109)

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 022200 · EXENATIDE SYNTHETIC
US 8,329,648 with pediatric exclusivity, as listed
patent.txt lines 1,244, 1,280
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
18 Feb 2027 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,906,851 with pediatric exclusivity, as listed
patent.txt lines 1,259, 1,295
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
18 Feb 2027 · NDA 022200 · EXENATIDE SYNTHETIC
US 9,884,092 with pediatric exclusivity, as listed
patent.txt lines 1,267, 1,303
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
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
18 Feb 2027 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,329,648 with pediatric exclusivity, as listed
patent.txt line 9,877
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
18 Feb 2027 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,906,851 with pediatric exclusivity, as listed
patent.txt line 9,901
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
18 Feb 2027 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092 with pediatric exclusivity, as listed
patent.txt line 9,910
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
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 203093 · ELVITEGRAVIR
US 7,176,220 with pediatric exclusivity, as listed
patent.txt lines 3,609, 3,615
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
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
11 Mar 2027 · NDA 218490 · MACITENTAN; TADALAFIL
US 10,946,015 with pediatric exclusivity, as listed
patent.txt lines 21,092, 21,098
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
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
5 Apr 2027 · NDA 206192 · COBIMETINIB FUMARATE
US 8,362,002 with pediatric exclusivity, as listed
patent.txt line 6,442
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
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 203093 · ELVITEGRAVIR
US 7,635,704 with pediatric exclusivity, as listed
patent.txt lines 3,611, 3,617
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Apr 2027 · NDA 203093 · ELVITEGRAVIR
US 8,981,103 with pediatric exclusivity, as listed
patent.txt lines 3,613, 3,619
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
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 206038 · IVACAFTOR; LUMACAFTOR
US 7,973,038 with pediatric exclusivity, as listed
patent.txt lines 6,095, 6,143
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
8 May 2027 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,741,933 with pediatric exclusivity, as listed
patent.txt lines 6,109, 6,155
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
8 May 2027 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 9,216,969 with pediatric exclusivity, as listed
patent.txt line 6,123
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
8 May 2027 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 9,216,969 with pediatric exclusivity, as listed
patent.txt line 6,167
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
002
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
8 May 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 7,973,038 with pediatric exclusivity, as listed
patent.txt lines 12,727, 12,769, 12,811
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
8 May 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,741,933 with pediatric exclusivity, as listed
patent.txt lines 12,739, 12,781, 12,823
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
8 May 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,216,969 with pediatric exclusivity, as listed
patent.txt lines 12,751, 12,793, 12,835
Flags
product 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
21 May 2027 · NDA 220073 · APIXABAN
US 6,967,208 with pediatric exclusivity, as listed
patent.txt line 22,089
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
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
23 May 2027 · NDA 217729 · BOSUTINIB MONOHYDRATE
US 7,767,678 with pediatric exclusivity, as listed
patent.txt lines 20,345, 20,355
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
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
24 May 2027 · NDA 209805 · ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
US 7,326,708 with pediatric exclusivity, as listed
patent.txt lines 10,802, 10,807
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
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 202895 · DARUNAVIR
US 7,700,645 with pediatric exclusivity, as listed
patent.txt line 3,518
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
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 206038 · IVACAFTOR; LUMACAFTOR
US 8,410,274 with pediatric exclusivity, as listed
patent.txt lines 6,100, 6,147
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,754,224 with pediatric exclusivity, as listed
patent.txt lines 6,112, 6,157
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 9,670,163 with pediatric exclusivity, as listed
patent.txt lines 6,125, 6,169
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
28 Jun 2027 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 9,931,334 with pediatric exclusivity, as listed
patent.txt lines 6,127, 6,171
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 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
28 Jun 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,410,274 with pediatric exclusivity, as listed
patent.txt lines 12,731, 12,773, 12,815
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
28 Jun 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,754,224 with pediatric exclusivity, as listed
patent.txt lines 12,741, 12,783, 12,825
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
28 Jun 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,670,163 with pediatric exclusivity, as listed
patent.txt lines 12,753, 12,795, 12,837
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
28 Jun 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,931,334 with pediatric exclusivity, as listed
patent.txt lines 12,755, 12,797, 12,839
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
28 Jun 2027 · NDA 217003 · IBRUTINIB
US 7,514,444 with pediatric exclusivity, as listed
patent.txt line 19,178
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Jun 2027 · NDA 217003 · IBRUTINIB
US 8,497,277 with pediatric exclusivity, as listed
patent.txt line 19,185
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Jun 2027 · NDA 217003 · IBRUTINIB
US 8,697,711 with pediatric exclusivity, as listed
patent.txt line 19,198
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Jun 2027 · NDA 217003 · IBRUTINIB
US 8,735,403 with pediatric exclusivity, as listed
patent.txt line 19,202
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Jun 2027 · NDA 217003 · IBRUTINIB
US 8,754,091 with pediatric exclusivity, as listed
patent.txt line 19,204
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Jun 2027 · NDA 217003 · IBRUTINIB
US 8,957,079 with pediatric exclusivity, as listed
patent.txt line 19,211
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Jun 2027 · NDA 217003 · IBRUTINIB
US 9,181,257 with pediatric exclusivity, as listed
patent.txt line 19,218
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001

Non-patent exclusivity (114)

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
8 Jan 2027 · NDA 204630 · METHYLENE BLUE
M-303 exclusivity
exclusivity.txt lines 442–443
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
9 Jan 2027 · NDA 212608 · AVAPRITINIB
ODE-366 exclusivity
exclusivity.txt lines 1,088, 1,091, 1,094, 1,098, 1,101
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
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
18 Jan 2027 · NDA 212526 · ALPELISIB
I-937 exclusivity
exclusivity.txt lines 1,082–1,084
Definition
New indication (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 210745 · APREMILAST
PED exclusivity
exclusivity.txt line 907
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
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
20 Jan 2027 · NDA 210745 · APREMILAST
PED exclusivity
exclusivity.txt line 908
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
23 Jan 2027 · NDA 211723 · TAZEMETOSTAT HYDROBROMIDE
ODE-299 exclusivity
exclusivity.txt line 997
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
23 Jan 2027 · NDA 211988 · BUPIVACAINE; MELOXICAM
I-933 exclusivity
exclusivity.txt lines 1,009–1,012
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
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
24 Jan 2027 · NDA 213138 · FIDAXOMICIN
ODE-367 exclusivity
exclusivity.txt line 1,158
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
13 Feb 2027 · NDA 207793 · IRINOTECAN HYDROCHLORIDE
I-932 exclusivity
exclusivity.txt line 624
Definition
New indication (to be checked against FDA's list)
Product numbers
001
13 Feb 2027 · NDA 215040 · ACETYLCYSTEINE LYSINE
NP exclusivity
exclusivity.txt lines 1,468–1,469
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002
13 Feb 2027 · NDA 217933 · ILOPROST
NP exclusivity
exclusivity.txt line 2,029
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 208712 · PACRITINIB CITRATE
NCE exclusivity
exclusivity.txt line 752
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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
4 Mar 2027 · NDA 218158 · CLOBETASOL PROPIONATE
NP exclusivity
exclusivity.txt line 2,038
Definition
New product (to be checked against FDA's list)
Product numbers
001
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
6 Mar 2027 · NDA 212801 · OSILODROSTAT PHOSPHATE
ODE-286 exclusivity
exclusivity.txt lines 1,114, 1,116, 1,118
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
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
15 Mar 2027 · NDA 202022 · RILPIVIRINE HYDROCHLORIDE
NPP exclusivity
exclusivity.txt line 228
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
15 Mar 2027 · NDA 209022 · FLUTICASONE PROPIONATE
I-940 exclusivity
exclusivity.txt line 759
Definition
New indication (to be checked against FDA's list)
Product numbers
001
15 Mar 2027 · NDA 219016 · RILPIVIRINE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 2,228
Definition
New product (to be checked against FDA's list)
Product numbers
001
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
19 Mar 2027 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
ODE-293 exclusivity
exclusivity.txt lines 703, 705
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
19 Mar 2027 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
ODE* exclusivity
exclusivity.txt line 1,313
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
002
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
22 Mar 2027 · NDA 218490 · MACITENTAN; TADALAFIL
NP exclusivity
exclusivity.txt lines 2,156, 2,160
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002
23 Mar 2027 · NDA 215833 · LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
NCE exclusivity
exclusivity.txt line 1,612
Definition
New chemical entity (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
26 Mar 2027 · NDA 217729 · BOSUTINIB MONOHYDRATE
PED exclusivity
exclusivity.txt lines 1,922, 1,926
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
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
29 Mar 2027 · NDA 214835 · RISPERIDONE
NP exclusivity
exclusivity.txt lines 1,408–1,409
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002
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
4 Apr 2027 · NDA 216593 · HYDROXYUREA
NP exclusivity
exclusivity.txt line 1,772
Definition
New product (to be checked against FDA's list)
Product numbers
001
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
7 Apr 2027 · NDA 214985 · DARIDOREXANT HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 1,441, 1,444
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
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
10 Apr 2027 · NDA 219943 · SELUMETINIB SULFATE
ODE* exclusivity
exclusivity.txt lines 2,358, 2,362
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 213411 · TUCATINIB
ODE-309 exclusivity
exclusivity.txt lines 1,219, 1,222
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
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
19 Apr 2027 · NDA 215487 · NALOXONE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 1,567
Definition
New product (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 204508 · OLIVE OIL; SOYBEAN OIL
NPP exclusivity
exclusivity.txt line 436
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 215888 · OTESECONAZOLE
NCE exclusivity
exclusivity.txt line 1,670
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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
29 Apr 2027 · NDA 208447 · NIRAPARIB TOSYLATE
ODE-295 exclusivity
exclusivity.txt line 710
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
3 May 2027 · NDA 215151 · VONOPRAZAN FUMARATE
NCE exclusivity
exclusivity.txt lines 1,478, 1,481
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
3 May 2027 · NDA 215152 · AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE
NCE exclusivity
exclusivity.txt line 1,484
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
3 May 2027 · NDA 215153 · AMOXICILLIN; VONOPRAZAN FUMARATE
NCE exclusivity
exclusivity.txt line 1,486
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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
8 May 2027 · NDA 218160 · SELPERCATINIB
ODE* exclusivity
exclusivity.txt lines 2,044–2,046, 2,064–2,066, 2,084–2,086, 2,104–2,106
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
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
15 May 2027 · NDA 213973 · RIPRETINIB
ODE-298 exclusivity
exclusivity.txt line 1,283
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
22 May 2027 · NDA 208772 · BRIGATINIB
ODE-300 exclusivity
exclusivity.txt lines 755–757
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
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
26 May 2027 · NDA 213036 · ARTESUNATE
ODE-290 exclusivity
exclusivity.txt line 1,146
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
27 May 2027 · NDA 204384 · BEDAQUILINE FUMARATE
ODE-307 exclusivity
exclusivity.txt lines 421, 425
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
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
1 Jun 2027 · NDA 215904 · GANAXOLONE
NCE exclusivity
exclusivity.txt line 1,672
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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
18 Jun 2027 · NDA 211723 · TAZEMETOSTAT HYDROBROMIDE
ODE-314 exclusivity
exclusivity.txt line 998
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
19 Jun 2027 · NDA 208610 · DELAFLOXACIN MEGLUMINE
GAIN exclusivity
exclusivity.txt line 721
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
19 Jun 2027 · NDA 208611 · DELAFLOXACIN MEGLUMINE
GAIN exclusivity
exclusivity.txt line 723
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
21 Jun 2027 · NDA 204384 · BEDAQUILINE FUMARATE
M-306 exclusivity
exclusivity.txt lines 418, 422
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
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
22 Jun 2027 · NDA 212306 · SELINEXOR
ODE-310 exclusivity
exclusivity.txt line 1,047
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
22 Jun 2027 · NDA 212306 · SELINEXOR
ODE* exclusivity
exclusivity.txt lines 1,051, 1,054, 1,057, 1,060
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
002, 003, 004, 005
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
28 Jun 2027 · NDA 018680 · COPPER
D-193 exclusivity
exclusivity.txt line 101
Definition
New dosing schedule (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