Drybench Patent.

Patent and exclusivity dates in 2028 for NDAs on FDA's Paragraph IV list, as FDA lists them

Each patent and exclusivity date in 2028 that FDA's Orange Book lists, as captured on 14 October 2026, for the 607 NDAs that FDA's Paragraph IV list names, as captured on 17 October 2026, and whose Orange Book capture lists a patent or exclusivity. Each entry is named by its rule and linked to its NDA page. A date here belongs to one patent or one exclusivity on the products named; the same NDA may have other listed dates, earlier or later, so no date here stands for a product.

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

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

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

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

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

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

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

Listed patent expiry (297)

3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 10,512,640, use patent
patent.txt line 4,090
Flags
use code U-1969
Product numbers
001
3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 10,828,369, product patent
patent.txt line 4,092
Flags
product
Product numbers
001
3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 11,213,519, use patent
patent.txt line 4,094
Flags
use code U-2720
Product numbers
001
3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 11,872,218, use patent
patent.txt line 4,096
Flags
use code U-1969
Product numbers
001
3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 9,566,272, use patent
patent.txt line 4,101
Flags
use code U-1969
Product numbers
001
3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 9,877,955, use patent
patent.txt line 4,104
Flags
use code U-1969
Product numbers
001
7 Jan 2028 · NDA 202020 · PREDNISONE
US 8,168,218, product and use patent
patent.txt line 2,618
Flags
product use code U-1269
Product numbers
003
7 Jan 2028 · NDA 207953 · TRABECTEDIN
US 8,895,557, product patent
patent.txt line 7,815
Flags
product
Product numbers
001
9 Jan 2028 · NDA 022560 · RISEDRONATE SODIUM
US 7,645,459, product and use patent
patent.txt line 2,086
Flags
product use code U-662
Product numbers
001
9 Jan 2028 · NDA 022560 · RISEDRONATE SODIUM
US 7,645,460, product and use patent
patent.txt line 2,087
Flags
product use code U-662
Product numbers
001
11 Jan 2028 · NDA 022287 · DEXLANSOPRAZOLE
US 8,871,273, product patent
patent.txt lines 1,561, 1,575
Flags
product
Product numbers
001, 002
18 Jan 2028 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 11,234,954, use patent
patent.txt lines 939, 955
Flags
use code U-620
Product numbers
001, 002
18 Jan 2028 · NDA 211321 · MIDAZOLAM
US 8,217,033, product and use patent
patent.txt line 12,684
Flags
product use code U-2526
Product numbers
001
18 Jan 2028 · NDA 211321 · MIDAZOLAM
US 8,809,322, product patent
patent.txt line 12,685
Flags
product
Product numbers
001
18 Jan 2028 · NDA 211321 · MIDAZOLAM
US 9,289,432, product and use patent
patent.txt line 12,686
Flags
product use code U-2526
Product numbers
001
18 Jan 2028 · NDA 211321 · MIDAZOLAM
US 9,687,495, product and use patent
patent.txt line 12,687
Flags
product use code U-2526
Product numbers
001
22 Jan 2028 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 8,389,578, use patent
patent.txt lines 9,625, 9,642
Flags
use code U-2105
Product numbers
001, 002
28 Jan 2028 · NDA 022075 · ISTRADEFYLLINE
US 7,727,993, product and use patent
patent.txt lines 1,036, 1,038
Flags
product use code U-2623
Product numbers
001, 002
28 Jan 2028 · NDA 022145 · RALTEGRAVIR POTASSIUM
US 8,852,632, substance and product and use patent
patent.txt line 1,116
Flags
substance product use code U-257
Product numbers
001
30 Jan 2028 · NDA 022252 · DIENOGEST; ESTRADIOL VALERATE
US 8,153,616, use patent
patent.txt line 1,408
Flags
use code U-1240
Product numbers
001
30 Jan 2028 · NDA 208745 · PLECANATIDE
US 7,041,786, substance patent
patent.txt line 9,308
Flags
substance
Product numbers
001
1 Feb 2028 · NDA 022004 · CICLESONIDE
US 8,371,292, use patent
patent.txt line 900
Flags
use code U-1356
Product numbers
001
2 Feb 2028 · NDA 205223 · METRONIDAZOLE
US 8,877,792, product patent
patent.txt line 5,275
Flags
product
Product numbers
001
3 Feb 2028 · NDA 050795 · DOXYCYCLINE HYCLATE
US 8,715,724, product patent
patent.txt lines 2,145–2,151, 2,155
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
5 Feb 2028 · NDA 021223 · ZOLEDRONIC ACID
US 7,932,241, product patent
patent.txt line 503
Flags
product
Product numbers
003
5 Feb 2028 · NDA 021817 · ZOLEDRONIC ACID
US 7,932,241, product patent
patent.txt line 701
Flags
product
Product numbers
001
7 Feb 2028 · NDA 204063 · DIMETHYL FUMARATE
US 8,399,514, use patent
patent.txt lines 4,261, 4,270
Flags
use code U-1384
Product numbers
001, 002
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt line 4,007
Flags
use code U-1432
Product numbers
001
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,008, 4,031, 4,056, 4,078
Flags
use code U-3312
Product numbers
001, 002, 003, 004
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,009, 4,032, 4,057, 4,079
Flags
use code U-3313
Product numbers
001, 002, 003, 004
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,010, 4,033, 4,058, 4,080
Flags
use code U-3314
Product numbers
001, 002, 003, 004
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,011, 4,034, 4,059, 4,081
Flags
use code U-3636
Product numbers
001, 002, 003, 004
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,028, 4,053
Flags
use code U-2555
Product numbers
002, 003
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,029, 4,054
Flags
use code U-2556
Product numbers
002, 003
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,030, 4,055
Flags
use code U-2557
Product numbers
002, 003
16 Feb 2028 · NDA 205437 · APREMILAST
US 7,427,638, substance and product patent
patent.txt lines 5,405, 5,417, 5,429
Flags
substance product
Product numbers
001, 002, 003
17 Feb 2028 · NDA 211280 · LASMIDITAN SUCCINATE
US 7,423,050, substance and product and use patent
patent.txt lines 12,666, 12,670, 12,673
Flags
substance product use code U-1719
Product numbers
001, 002, 003
19 Feb 2028 · NDA 205223 · METRONIDAZOLE
US 7,893,097, product patent
patent.txt line 5,273
Flags
product
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 8,461,140, product patent
patent.txt line 6,483
Flags
product
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 8,546,367, product and use patent
patent.txt line 6,484
Flags
product use code U-1690
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 8,883,770, product patent
patent.txt line 6,486
Flags
product
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 9,522,155, product and use patent
patent.txt line 6,487
Flags
product use code U-1940
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 9,636,349, use patent
patent.txt line 6,488
Flags
use code U-1940
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 9,949,986, use patent
patent.txt line 6,489
Flags
use code U-1940
Product numbers
001
7 Mar 2028 · NDA 022427 · KETOROLAC TROMETHAMINE
US 8,512,717, product patent
patent.txt line 1,893
Flags
product
Product numbers
001
7 Mar 2028 · NDA 022427 · KETOROLAC TROMETHAMINE
US 9,192,571, product patent
patent.txt line 1,894
Flags
product
Product numbers
001
8 Mar 2028 · NDA 021880 · LENALIDOMIDE
US 8,741,929, use patent
patent.txt lines 750, 752, 754, 756, 758, 760
Flags
use code U-1983
Product numbers
001, 002, 003, 004, 005, 006
10 Mar 2028 · NDA 022387 · TREPROSTINIL
US 9,339,507, product patent
patent.txt line 1,767
Flags
product
Product numbers
001
12 Mar 2028 · NDA 209500 · LUMATEPERONE TOSYLATE
US 10,464,938, product patent
patent.txt lines 10,435, 10,471, 10,502
Flags
product
Product numbers
001, 002, 003
13 Mar 2028 · NDA 021747 · ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
US 7,837,235, product patent
patent.txt line 696
Flags
product delist requested
Product numbers
001
13 Mar 2028 · NDA 021936 · TIOTROPIUM BROMIDE
US 7,837,235, product patent
patent.txt line 811
Flags
product delist requested
Product numbers
001
13 Mar 2028 · NDA 206756 · OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
US 7,837,235, product patent
patent.txt line 6,760
Flags
product delist requested
Product numbers
001
13 Mar 2028 · NDA 213756 · SELUMETINIB SULFATE
US 7,425,637, substance patent
patent.txt lines 15,258, 15,266
Flags
substance
Product numbers
001, 002
21 Mar 2028 · NDA 202293 · DAPAGLIFLOZIN
US 8,221,786, product patent
patent.txt lines 2,985, 3,023
Flags
product
Product numbers
001, 002
21 Mar 2028 · NDA 202293 · DAPAGLIFLOZIN
US 8,361,972, use patent
patent.txt lines 2,991, 3,029
Flags
use code U-2139
Product numbers
001, 002
21 Mar 2028 · NDA 202293 · DAPAGLIFLOZIN
US 8,361,972, use patent
patent.txt lines 2,992, 3,030
Flags
use code U-493
Product numbers
001, 002
21 Mar 2028 · NDA 202293 · DAPAGLIFLOZIN
US 8,716,251, product patent
patent.txt lines 2,998, 3,036
Flags
product
Product numbers
001, 002
21 Mar 2028 · NDA 204671 · SOFOSBUVIR
US 8,334,270, substance and product and use patent
patent.txt lines 4,948, 4,966
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 204671 · SOFOSBUVIR
US 8,580,765, substance and product and use patent
patent.txt lines 4,950, 4,968
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 204671 · SOFOSBUVIR
US 9,085,573, substance and product and use patent
patent.txt lines 4,958, 4,976
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,221,786, product patent
patent.txt lines 9,662, 9,678
Flags
product
Product numbers
001, 002
21 Mar 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,361,972, use patent
patent.txt line 9,664
Flags
use code U-1976
Product numbers
001
21 Mar 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,361,972, use patent
patent.txt line 9,665
Flags
use code U-1977
Product numbers
001
21 Mar 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,361,972, use patent
patent.txt lines 9,666, 9,680
Flags
use code U-493
Product numbers
001, 002
21 Mar 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,716,251, product patent
patent.txt lines 9,672, 9,684
Flags
product
Product numbers
001, 002
26 Mar 2028 · NDA 200796 · AZILSARTAN KAMEDOXOMIL
US 9,066,936, product patent
patent.txt lines 2,310–2,311
Flags
product
Product numbers
001, 002
26 Mar 2028 · NDA 202331 · AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
US 9,066,936, product patent
patent.txt lines 3,065, 3,068
Flags
product
Product numbers
001, 002
28 Mar 2028 · NDA 022192 · ILOPERIDONE
US 10,570,453, use patent
patent.txt lines 1,145, 1,159, 1,173, 1,187, 1,201, 1,215, 1,229
Flags
use code U-4562
Product numbers
001, 002, 003, 004, 005, 006, 007
28 Mar 2028 · NDA 022192 · ILOPERIDONE
US 10,570,453, use patent
patent.txt lines 1,146, 1,160, 1,174, 1,188, 1,202, 1,216, 1,230
Flags
use code U-4563
Product numbers
001, 002, 003, 004, 005, 006, 007
28 Mar 2028 · NDA 206316 · EDOXABAN TOSYLATE
US 9,149,532, product patent
patent.txt lines 6,464, 6,466, 6,468
Flags
product
Product numbers
001, 002, 003
4 Apr 2028 · NDA 201635 · TOPIRAMATE
US 8,298,576, product and use patent
patent.txt lines 2,443, 2,463, 2,483, 2,503
Flags
product use code U-106
Product numbers
001, 002, 003, 004
4 Apr 2028 · NDA 201635 · TOPIRAMATE
US 8,298,576, product and use patent
patent.txt lines 2,444, 2,464, 2,484, 2,504
Flags
product use code U-1992
Product numbers
001, 002, 003, 004
11 Apr 2028 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 10,548,871, use patent
patent.txt lines 934, 950
Flags
use code U-620
Product numbers
001, 002
11 Apr 2028 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 11,096,920, use patent
patent.txt lines 937, 953
Flags
use code U-620
Product numbers
001, 002
11 Apr 2028 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 9,907,780, product patent
patent.txt lines 948, 964
Flags
product
Product numbers
001, 002
21 Apr 2028 · NDA 200533 · TAPENTADOL HYDROCHLORIDE
US 11,344,512, use patent
patent.txt lines 2,221, 2,226, 2,231, 2,236, 2,241
Flags
use code U-3391
Product numbers
001, 002, 003, 004, 005
21 Apr 2028 · NDA 200533 · TAPENTADOL HYDROCHLORIDE
US 11,344,512, use patent
patent.txt lines 2,222, 2,227, 2,232, 2,237, 2,242
Flags
use code U-3392
Product numbers
001, 002, 003, 004, 005
21 Apr 2028 · NDA 204623 · DICLOFENAC SODIUM
US 8,252,838, product and use patent
patent.txt line 4,857
Flags
product use code U-1489
Product numbers
001
26 Apr 2028 · NDA 022421 · PRAMIPEXOLE DIHYDROCHLORIDE
US 7,695,734, product patent
patent.txt lines 1,861, 1,863, 1,865, 1,867, 1,869, 1,871, 1,873
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,525,045, use patent
patent.txt line 8,932
Flags
use code U-2371
Product numbers
001
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,925,866, use patent
patent.txt line 8,945
Flags
use code U-2371
Product numbers
001
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,033,538, use patent
patent.txt line 8,946
Flags
use code U-2371
Product numbers
001
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 12,599,595, use patent
patent.txt line 8,985
Flags
use code U-2371
Product numbers
001
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 9,999,618, use patent
patent.txt line 8,991
Flags
use code U-2372
Product numbers
001
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 9,999,618, use patent
patent.txt line 8,992
Flags
use code U-2373
Product numbers
001
1 May 2028 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 9,107,898, use patent
patent.txt lines 943, 959
Flags
use code U-620
Product numbers
001, 002
2 May 2028 · NDA 208552 · OXYMETAZOLINE HYDROCHLORIDE
US 7,812,049, use patent
patent.txt line 8,677
Flags
use code U-1959
Product numbers
001
3 May 2028 · NDA 214133 · LEVOKETOCONAZOLE
US 9,918,984, use patent
patent.txt line 15,564
Flags
use code U-3283
Product numbers
001
5 May 2028 · NDA 022387 · TREPROSTINIL
US 9,358,240, use patent
patent.txt line 1,768
Flags
use code U-1849
Product numbers
001
10 May 2028 · NDA 022535 · PIRFENIDONE
US 8,383,150, product and use patent
patent.txt line 2,068
Flags
product use code U-2361
Product numbers
001
10 May 2028 · NDA 208780 · PIRFENIDONE
US 8,383,150, product and use patent
patent.txt lines 9,347, 9,390, 9,433
Flags
product use code U-2361
Product numbers
001, 002, 003
16 May 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 8,242,294, substance patent
patent.txt line 6,481
Flags
substance
Product numbers
001
23 May 2028 · NDA 021883 · DALBAVANCIN HYDROCHLORIDE
US 6,900,175, use patent
patent.txt line 761
Flags
use code U-3499
Product numbers
001
30 May 2028 · NDA 206406 · TACROLIMUS
US 10,166,190, product patent
patent.txt lines 6,497, 6,512, 6,527
Flags
product
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 10,864,199, use patent
patent.txt lines 6,498, 6,513, 6,528
Flags
use code U-2677
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 10,864,199, use patent
patent.txt lines 6,499, 6,514, 6,529
Flags
use code U-2678
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 11,110,081, use patent
patent.txt lines 6,500, 6,515, 6,530
Flags
use code U-2678
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 11,123,331, use patent
patent.txt lines 6,501, 6,516, 6,531
Flags
use code U-2677
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 11,419,823, product patent
patent.txt lines 6,502, 6,517, 6,532
Flags
product
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 12,083,103, use patent
patent.txt lines 6,503, 6,518, 6,533
Flags
use code U-2678
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 12,403,095, product patent
patent.txt lines 6,504, 6,519, 6,534
Flags
product
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 9,549,918, product patent
patent.txt lines 6,511, 6,526, 6,541
Flags
product
Product numbers
001, 002, 003
3 Jun 2028 · NDA 207318 · PIMAVANSERIN TARTRATE
US 7,732,615, substance and product patent
patent.txt lines 7,236, 7,245
Flags
substance product
Product numbers
001, 002
3 Jun 2028 · NDA 210793 · PIMAVANSERIN TARTRATE
US 7,732,615, substance and product patent
patent.txt line 12,150
Flags
substance product
Product numbers
001
4 Jun 2028 · NDA 022203 · AZELASTINE HYDROCHLORIDE
US 8,071,073, product patent
patent.txt lines 1,338–1,339
Flags
product
Product numbers
001, 002
4 Jun 2028 · NDA 211580 · INDOCYANINE GREEN
US 8,185,176, use patent
patent.txt line 12,887
Flags
use code U-2462
Product numbers
001
4 Jun 2028 · NDA 213872 · AZELASTINE HYDROCHLORIDE
US 8,071,073, product patent
patent.txt lines 15,284–15,285
Flags
product
Product numbers
001, 002
6 Jun 2028 · NDA 021252 · MESALAMINE
US 8,217,083, product patent
patent.txt line 506
Flags
product
Product numbers
002
6 Jun 2028 · NDA 021252 · MESALAMINE
US 8,436,051, product patent
patent.txt line 507
Flags
product
Product numbers
002
8 Jun 2028 · NDA 021925 · GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
US 8,071,130, product patent
patent.txt lines 801, 803
Flags
product
Product numbers
001, 002
9 Jun 2028 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
US 8,895,057, use patent
patent.txt lines 2,111, 2,117, 2,123, 2,129
Flags
use code U-3398
Product numbers
001, 002, 003, 004
9 Jun 2028 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
US 8,895,058, product patent
patent.txt lines 2,112, 2,118, 2,124, 2,130
Flags
product
Product numbers
001, 002, 003, 004
9 Jun 2028 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
US 9,011,905, product patent
patent.txt lines 2,113, 2,119, 2,125, 2,131
Flags
product
Product numbers
001, 002, 003, 004
9 Jun 2028 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
US 9,011,906, use patent
patent.txt lines 2,114, 2,120, 2,126, 2,132
Flags
use code U-3398
Product numbers
001, 002, 003, 004
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 10,016,429, use patent
patent.txt lines 2,802, 2,831, 2,860, 2,889, 2,918
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 10,016,429, use patent
patent.txt lines 2,803, 2,832, 2,861, 2,890, 2,919
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,722,693, substance and product patent
patent.txt lines 2,810, 2,839, 2,868, 2,897, 2,926
Flags
substance product
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 2,812, 2,841, 2,870, 2,899, 2,928
Flags
use code U-1573
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 2,813, 2,842, 2,871, 2,900, 2,929
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 2,814, 2,843, 2,872, 2,901, 2,930
Flags
use code U-3227
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 2,815, 2,844, 2,873, 2,902, 2,931
Flags
use code U-3228
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 2,816, 2,845, 2,874, 2,903, 2,932
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 2,818, 2,847, 2,876, 2,905, 2,934
Flags
use code U-1201
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 2,819, 2,848, 2,877, 2,906, 2,935
Flags
use code U-1622
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 2,820, 2,849, 2,878, 2,907, 2,936
Flags
use code U-3227
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 2,821, 2,850, 2,879, 2,908, 2,937
Flags
use code U-3228
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 10,610,530, use patent
patent.txt line 16,733
Flags
use code U-3229
Product numbers
001
12 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 10,610,530, use patent
patent.txt line 16,734
Flags
use code U-3404
Product numbers
001
12 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,722,693, substance and product patent
patent.txt line 16,761
Flags
substance product
Product numbers
001
12 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt line 16,763
Flags
use code U-3229
Product numbers
001
12 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt line 16,764
Flags
use code U-3404
Product numbers
001
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 10,016,429, use patent
patent.txt lines 19,290, 19,343, 19,396, 19,449, 19,502
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 10,016,429, use patent
patent.txt lines 19,291, 19,344, 19,397, 19,450, 19,503
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 11,213,528, product patent
patent.txt lines 19,295, 19,348, 19,401, 19,454, 19,507
Flags
product
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,722,693, substance and product patent
patent.txt lines 19,325, 19,378, 19,431, 19,484, 19,537
Flags
substance product
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 19,327, 19,380, 19,433, 19,486, 19,539
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 19,328, 19,381, 19,434, 19,487, 19,540
Flags
use code U-3227
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 19,329, 19,382, 19,435, 19,488, 19,541
Flags
use code U-3228
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 19,330, 19,383, 19,436, 19,489, 19,542
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 19,332, 19,385, 19,438, 19,491, 19,544
Flags
use code U-3227
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 19,333, 19,386, 19,439, 19,492, 19,545
Flags
use code U-3228
Product numbers
001, 002, 003, 004, 005
15 Jun 2028 · NDA 021947 · FENTANYL CITRATE
US 7,862,832, product patent
patent.txt lines 821, 823, 825, 827, 829
Flags
product
Product numbers
001, 002, 003, 004, 005
15 Jun 2028 · NDA 021947 · FENTANYL CITRATE
US 7,862,833, product patent
patent.txt lines 822, 824, 826, 828, 830
Flags
product
Product numbers
001, 002, 003, 004, 005
17 Jun 2028 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,324,225, substance and product patent
patent.txt line 9,697
Flags
substance product
Product numbers
001
17 Jun 2028 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 8,324,225, substance and product patent
patent.txt line 11,042
Flags
substance product
Product numbers
001
20 Jun 2028 · NDA 205739 · PATIROMER SORBITEX CALCIUM
US 8,147,873, product patent
patent.txt lines 5,825, 5,832, 5,839, 5,846
Flags
product
Product numbers
001, 002, 003, 004
22 Jun 2028 · NDA 021892 · SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
US 7,687,075, substance and product patent
patent.txt line 762
Flags
substance product
Product numbers
001
27 Jun 2028 · NDA 022271 · ALOGLIPTIN BENZOATE
US 7,807,689, substance and product and use patent
patent.txt lines 1,435, 1,437, 1,439
Flags
substance product use code U-1337
Product numbers
001, 002, 003
27 Jun 2028 · NDA 203414 · ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
US 7,807,689, substance and product and use patent
patent.txt lines 3,853, 3,855
Flags
substance product use code U-1337
Product numbers
001, 002
27 Jun 2028 · NDA 205223 · METRONIDAZOLE
US 8,658,678, use patent
patent.txt line 5,274
Flags
use code U-1682
Product numbers
001
30 Jun 2028 · NDA 212327 · FEDRATINIB HYDROCHLORIDE
US 8,138,199, use patent
patent.txt line 13,953
Flags
use code U-2607
Product numbers
001
1 Jul 2028 · NDA 022334 · EVEROLIMUS
US 9,006,224, use patent
patent.txt lines 1,710, 1,713, 1,716, 1,719
Flags
use code U-1681
Product numbers
001, 002, 003, 004
7 Jul 2028 · NDA 206940 · ELUXADOLINE
US 8,691,860, substance and use patent
patent.txt lines 6,854, 6,868
Flags
substance use code U-1709
Product numbers
001, 002
7 Jul 2028 · NDA 206940 · ELUXADOLINE
US 9,115,091, substance and product and use patent
patent.txt lines 6,855, 6,869
Flags
substance product use code U-1738
Product numbers
001, 002
7 Jul 2028 · NDA 206940 · ELUXADOLINE
US 9,364,489, use patent
patent.txt lines 6,856, 6,870
Flags
use code U-1709
Product numbers
001, 002
7 Jul 2028 · NDA 206940 · ELUXADOLINE
US 9,789,125, product and use patent
patent.txt lines 6,858, 6,872
Flags
product use code U-1709
Product numbers
001, 002
7 Jul 2028 · NDA 206940 · ELUXADOLINE
US 9,789,125, product and use patent
patent.txt lines 6,859, 6,873
Flags
product use code U-2152
Product numbers
001, 002
9 Jul 2028 · NDA 203505 · OSPEMIFENE
US 8,642,079, product patent
patent.txt line 3,994
Flags
product
Product numbers
001
10 Jul 2028 · NDA 203752 · ESTRADIOL
US 9,724,310, substance and product patent
patent.txt line 4,138
Flags
substance product
Product numbers
005
10 Jul 2028 · NDA 203752 · ESTRADIOL
US 9,730,900, use patent
patent.txt lines 4,126, 4,129, 4,132, 4,135
Flags
use code U-2086
Product numbers
001, 002, 003, 004
10 Jul 2028 · NDA 203752 · ESTRADIOL
US 9,730,900, product and use patent
patent.txt line 4,139
Flags
product use code U-2086
Product numbers
005
10 Jul 2028 · NDA 203752 · ESTRADIOL
US 9,833,419, product patent
patent.txt lines 4,127, 4,130, 4,133, 4,136, 4,140
Flags
product
Product numbers
001, 002, 003, 004, 005
13 Jul 2028 · NDA 022107 · ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
US 8,618,172, product patent
patent.txt lines 1,051–1,054
Flags
product
Product numbers
001, 002, 003, 004
15 Jul 2028 · NDA 022051 · FLUTICASONE FUROATE
US 8,347,879, product patent
patent.txt line 978
Flags
product
Product numbers
002
21 Jul 2028 · NDA 022044 · METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
US 8,414,921, product and use patent
patent.txt lines 968, 972
Flags
product use code U-1036
Product numbers
001, 002
24 Jul 2028 · NDA 213433 · CLASCOTERONE
US 11,938,141, product patent
patent.txt line 15,008
Flags
product
Product numbers
001
24 Jul 2028 · NDA 213433 · CLASCOTERONE
US 12,337,002, product and use patent
patent.txt line 15,009
Flags
product use code U-3280
Product numbers
001
24 Jul 2028 · NDA 213433 · CLASCOTERONE
US 9,486,458, use patent
patent.txt line 15,012
Flags
use code U-2942
Product numbers
001
27 Jul 2028 · NDA 020873 · BIVALIRUDIN
US 7,582,727, product patent
patent.txt line 376
Flags
product
Product numbers
001
27 Jul 2028 · NDA 020873 · BIVALIRUDIN
US 7,598,343, product patent
patent.txt line 378
Flags
product
Product numbers
001
1 Aug 2028 · NDA 204629 · EMPAGLIFLOZIN
US 7,579,449, substance patent
patent.txt lines 4,900, 4,931
Flags
substance
Product numbers
001, 002
1 Aug 2028 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 7,579,449, substance patent
patent.txt lines 6,194, 6,226
Flags
substance
Product numbers
001, 002
1 Aug 2028 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,579,449, substance patent
patent.txt lines 6,315, 6,346, 6,375, 6,404
Flags
substance
Product numbers
001, 002, 003, 004
1 Aug 2028 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,579,449, substance patent
patent.txt lines 9,060, 9,092, 9,122, 9,152
Flags
substance
Product numbers
001, 002, 003, 004
1 Aug 2028 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 7,579,449, substance patent
patent.txt lines 14,244, 14,274, 14,304, 14,333
Flags
substance
Product numbers
001, 002, 003, 004
6 Aug 2028 · NDA 205525 · DRONABINOL
US 10,265,293, substance and product patent
patent.txt line 5,459
Flags
substance product
Product numbers
001
6 Aug 2028 · NDA 205525 · DRONABINOL
US 11,253,472, substance and product patent
patent.txt line 5,460
Flags
substance product
Product numbers
001
6 Aug 2028 · NDA 205525 · DRONABINOL
US 8,222,292, substance and product patent
patent.txt line 5,461
Flags
substance product
Product numbers
001
6 Aug 2028 · NDA 205525 · DRONABINOL
US 9,345,771, substance and product patent
patent.txt line 5,462
Flags
substance product
Product numbers
001
12 Aug 2028 · NDA 206544 · MORPHINE SULFATE
US 10,314,788, product patent
patent.txt lines 6,592, 6,594, 6,596, 6,598
Flags
product
Product numbers
001, 002, 003, 004
12 Aug 2028 · NDA 206544 · MORPHINE SULFATE
US 7,955,619, product patent
patent.txt lines 6,593, 6,595, 6,597, 6,599
Flags
product
Product numbers
001, 002, 003, 004
14 Aug 2028 · NDA 213433 · CLASCOTERONE
US 10,159,682, use patent
patent.txt line 15,006
Flags
use code U-2942
Product numbers
001
19 Aug 2028 · NDA 202293 · DAPAGLIFLOZIN
US 7,851,502, product patent
patent.txt lines 2,981, 3,019
Flags
product
Product numbers
001, 002
23 Aug 2028 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,163,904, substance and product patent
patent.txt lines 995, 1,009, 1,023
Flags
substance product
Product numbers
001, 002, 003
23 Aug 2028 · NDA 022497 · BUPROPION HYDROCHLORIDE
US 7,674,479, product patent
patent.txt line 1,996
Flags
product
Product numbers
001
24 Aug 2028 · NDA 214012 · INCLISIRAN SODIUM
US 10,131,907, substance and product and use patent
patent.txt line 15,428
Flags
substance product use code U-4249
Product numbers
001
24 Aug 2028 · NDA 214012 · INCLISIRAN SODIUM
US 10,131,907, substance and product and use patent
patent.txt line 15,429
Flags
substance product use code U-4413
Product numbers
001
24 Aug 2028 · NDA 214012 · INCLISIRAN SODIUM
US 10,131,907, substance and product and use patent
patent.txt line 15,430
Flags
substance product use code U-4414
Product numbers
001
24 Aug 2028 · NDA 215515 · VUTRISIRAN SODIUM
US 10,131,907, substance and product and use patent
patent.txt line 17,413
Flags
substance product use code U-3396
Product numbers
001
27 Aug 2028 · NDA 202107 · MIFEPRISTONE
US 8,921,348, use patent
patent.txt line 2,771
Flags
use code U-1643
Product numbers
001
27 Aug 2028 · NDA 209884 · SIPONIMOD
US 7,939,519, substance and product patent
patent.txt lines 10,988, 10,993, 10,998
Flags
substance product
Product numbers
001, 002, 003
30 Aug 2028 · NDA 206406 · TACROLIMUS
US 8,664,239, use patent
patent.txt lines 6,505, 6,520, 6,535
Flags
use code U-1752
Product numbers
001, 002, 003
30 Aug 2028 · NDA 206406 · TACROLIMUS
US 8,664,239, use patent
patent.txt lines 6,506, 6,521, 6,536
Flags
use code U-2677
Product numbers
001, 002, 003
30 Aug 2028 · NDA 206406 · TACROLIMUS
US 8,664,239, use patent
patent.txt lines 6,507, 6,522, 6,537
Flags
use code U-2678
Product numbers
001, 002, 003
30 Aug 2028 · NDA 206406 · TACROLIMUS
US 8,685,998, product and use patent
patent.txt lines 6,508, 6,523, 6,538
Flags
product use code U-1752
Product numbers
001, 002, 003
30 Aug 2028 · NDA 206406 · TACROLIMUS
US 8,685,998, product and use patent
patent.txt lines 6,509, 6,524, 6,539
Flags
product use code U-2677
Product numbers
001, 002, 003
30 Aug 2028 · NDA 206406 · TACROLIMUS
US 8,685,998, product and use patent
patent.txt lines 6,510, 6,525, 6,540
Flags
product use code U-2678
Product numbers
001, 002, 003
1 Sep 2028 · NDA 204141 · DESOXIMETASONE
US 8,277,780, product and use patent
patent.txt line 4,331
Flags
product use code U-1408
Product numbers
001
4 Sep 2028 · NDA 021572 · DAPTOMYCIN
US 8,003,673, use patent
patent.txt line 637
Flags
use code U-1180
Product numbers
002
5 Sep 2028 · NDA 021272 · TREPROSTINIL
US 8,653,137, use patent
patent.txt lines 510, 515, 520, 525, 530, 535, 540, 545
Flags
use code U-1437
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
5 Sep 2028 · NDA 021272 · TREPROSTINIL
US 8,658,694, use patent
patent.txt lines 511, 516, 521, 526, 531, 536, 541, 546
Flags
use code U-1437
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
7 Sep 2028 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 8,132,712, product patent
patent.txt lines 7,453, 7,470
Flags
product delist requested
Product numbers
001, 002
10 Sep 2028 · NDA 021923 · SORAFENIB TOSYLATE
US 9,737,488, product and use patent
patent.txt line 782
Flags
product use code U-1480
Product numbers
001
10 Sep 2028 · NDA 021923 · SORAFENIB TOSYLATE
US 9,737,488, product and use patent
patent.txt line 783
Flags
product use code U-1696
Product numbers
001
10 Sep 2028 · NDA 021923 · SORAFENIB TOSYLATE
US 9,737,488, product and use patent
patent.txt line 784
Flags
product use code U-2107
Product numbers
001
13 Sep 2028 · NDA 022416 · ESLICARBAZEPINE ACETATE
US 9,763,954, use patent
patent.txt lines 1,822, 1,830, 1,838, 1,846
Flags
use code U-2123
Product numbers
001, 002, 003, 004
16 Sep 2028 · NDA 204760 · NALOXEGOL OXALATE
US 7,786,133, substance and product patent
patent.txt lines 4,992, 4,994
Flags
substance product
Product numbers
001, 002
17 Sep 2028 · NDA 022285 · LEVETIRACETAM
US 7,858,122, product patent
patent.txt lines 1,549–1,550
Flags
product
Product numbers
001, 002
22 Sep 2028 · NDA 200533 · TAPENTADOL HYDROCHLORIDE
US 8,536,130, use patent
patent.txt lines 2,224, 2,229, 2,234, 2,239, 2,244
Flags
use code U-1276
Product numbers
001, 002, 003, 004, 005
4 Oct 2028 · NDA 204410 · MACITENTAN
US 8,367,685, product and use patent
patent.txt line 4,673
Flags
product use code U-1445
Product numbers
001
6 Oct 2028 · NDA 022352 · COLCHICINE
US 7,964,647, use patent
patent.txt line 1,747
Flags
use code U-1007
Product numbers
001
6 Oct 2028 · NDA 022352 · COLCHICINE
US 7,964,648, use patent
patent.txt line 1,748
Flags
use code U-1161
Product numbers
001
6 Oct 2028 · NDA 022352 · COLCHICINE
US 7,981,938, use patent
patent.txt line 1,749
Flags
use code U-1166
Product numbers
001
6 Oct 2028 · NDA 022352 · COLCHICINE
US 8,093,296, use patent
patent.txt line 1,750
Flags
use code U-1007
Product numbers
001
6 Oct 2028 · NDA 022352 · COLCHICINE
US 8,093,297, use patent
patent.txt line 1,751
Flags
use code U-1161
Product numbers
001
6 Oct 2028 · NDA 022352 · COLCHICINE
US 8,093,298, use patent
patent.txt line 1,752
Flags
use code U-1116
Product numbers
001
6 Oct 2028 · NDA 022352 · COLCHICINE
US 8,097,655, use patent
patent.txt line 1,753
Flags
use code U-1020
Product numbers
001
6 Oct 2028 · NDA 022352 · COLCHICINE
US 8,415,395, use patent
patent.txt line 1,754
Flags
use code U-1007
Product numbers
001
6 Oct 2028 · NDA 022352 · COLCHICINE
US 8,415,396, use patent
patent.txt line 1,755
Flags
use code U-1007
Product numbers
001
9 Oct 2028 · NDA 207997 · MIDOSTAURIN
US 7,973,031, use patent
patent.txt line 7,932
Flags
use code U-2007
Product numbers
001
9 Oct 2028 · NDA 208090 · OXYCODONE
US 7,771,707, product patent
patent.txt lines 8,227, 8,235, 8,243, 8,251, 8,259
Flags
product
Product numbers
001, 002, 003, 004, 005
10 Oct 2028 · NDA 202535 · CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
US 8,450,338, product patent
patent.txt line 3,098
Flags
product
Product numbers
001
10 Oct 2028 · NDA 202535 · CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
US 8,481,083, product patent
patent.txt line 3,099
Flags
product
Product numbers
001
15 Oct 2028 · NDA 022051 · FLUTICASONE FUROATE
US 8,147,461, product patent
patent.txt line 977
Flags
product
Product numbers
002
15 Oct 2028 · NDA 208051 · NERATINIB MALEATE
US 10,035,788, use patent
patent.txt line 8,014
Flags
use code U-2043
Product numbers
001
15 Oct 2028 · NDA 208051 · NERATINIB MALEATE
US 10,035,788, use patent
patent.txt line 8,015
Flags
use code U-3047
Product numbers
001
15 Oct 2028 · NDA 208051 · NERATINIB MALEATE
US 10,035,788, use patent
patent.txt line 8,016
Flags
use code U-3097
Product numbers
001
15 Oct 2028 · NDA 208051 · NERATINIB MALEATE
US 9,139,558, use patent
patent.txt line 8,025
Flags
use code U-2043
Product numbers
001
15 Oct 2028 · NDA 208051 · NERATINIB MALEATE
US 9,139,558, use patent
patent.txt line 8,026
Flags
use code U-3047
Product numbers
001
15 Oct 2028 · NDA 208051 · NERATINIB MALEATE
US 9,139,558, use patent
patent.txt line 8,027
Flags
use code U-3097
Product numbers
001
15 Oct 2028 · NDA 208051 · NERATINIB MALEATE
US 9,630,946, use patent
patent.txt line 8,031
Flags
use code U-2043
Product numbers
001
15 Oct 2028 · NDA 208051 · NERATINIB MALEATE
US 9,630,946, use patent
patent.txt line 8,032
Flags
use code U-3047
Product numbers
001
15 Oct 2028 · NDA 208051 · NERATINIB MALEATE
US 9,630,946, use patent
patent.txt line 8,033
Flags
use code U-3097
Product numbers
001
16 Oct 2028 · NDA 205410 · PROPRANOLOL HYDROCHLORIDE
US 8,338,489, use patent
patent.txt line 5,305
Flags
use code U-1496
Product numbers
001
16 Oct 2028 · NDA 205410 · PROPRANOLOL HYDROCHLORIDE
US 8,987,262, use patent
patent.txt line 5,306
Flags
use code U-1988
Product numbers
001
17 Oct 2028 · NDA 210361 · GLYCOPYRRONIUM TOSYLATE
US 10,052,267, product and use patent
patent.txt line 11,312
Flags
product use code U-2398
Product numbers
001
23 Oct 2028 · NDA 022416 · ESLICARBAZEPINE ACETATE
US 10,912,781, product patent
patent.txt lines 1,815, 1,823, 1,831, 1,839
Flags
product
Product numbers
001, 002, 003, 004
23 Oct 2028 · NDA 022416 · ESLICARBAZEPINE ACETATE
US 9,566,244, product patent
patent.txt lines 1,818, 1,826, 1,834, 1,842
Flags
product
Product numbers
001, 002, 003, 004
30 Oct 2028 · NDA 202611 · MIRABEGRON
US 8,772,315, use patent
patent.txt lines 3,122, 3,135
Flags
use code U-2300
Product numbers
001, 002
31 Oct 2028 · NDA 210598 · REVEFENACIN
US 7,288,657, substance patent
patent.txt line 12,044
Flags
substance
Product numbers
001
5 Nov 2028 · NDA 022013 · CLOBETASOL PROPIONATE
US 8,460,641, product and use patent
patent.txt line 909
Flags
product use code U-1410
Product numbers
001
6 Nov 2028 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,652,492, product patent
patent.txt lines 10,045, 10,059
Flags
product
Product numbers
001, 002
7 Nov 2028 · NDA 213388 · ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
US 11,459,305, product and use patent
patent.txt line 14,970
Flags
product use code U-2842
Product numbers
001
11 Nov 2028 · NDA 203388 · VISMODEGIB
US 7,888,364, substance and product patent
patent.txt line 3,803
Flags
substance product
Product numbers
001
12 Nov 2028 · NDA 213976 · BUDESONIDE
US 11,357,859, use patent
patent.txt line 15,397
Flags
use code U-3820
Product numbers
001
13 Nov 2028 · NDA 022450 · ACETAMINOPHEN
US 10,383,834, use patent
patent.txt line 1,911
Flags
use code U-2262
Product numbers
001
13 Nov 2028 · NDA 022450 · ACETAMINOPHEN
US 10,383,834, use patent
patent.txt line 1,912
Flags
use code U-2621
Product numbers
001
13 Nov 2028 · NDA 022450 · ACETAMINOPHEN
US 9,610,265, use patent
patent.txt line 1,917
Flags
use code U-2263
Product numbers
001
13 Nov 2028 · NDA 022450 · ACETAMINOPHEN
US 9,987,238, use patent
patent.txt line 1,919
Flags
use code U-2261
Product numbers
001
16 Nov 2028 · NDA 212904 · TIVOZANIB HYDROCHLORIDE
US 7,166,722, substance and product patent
patent.txt lines 14,497, 14,499
Flags
substance product
Product numbers
001, 002
20 Nov 2028 · NDA 213433 · CLASCOTERONE
US 11,207,332, product and use patent
patent.txt line 15,007
Flags
product use code U-3280
Product numbers
001
22 Nov 2028 · NDA 213976 · BUDESONIDE
US 10,293,052, product patent
patent.txt line 15,394
Flags
product
Product numbers
001
30 Nov 2028 · NDA 022350 · SAXAGLIPTIN HYDROCHLORIDE
US 7,951,400, product patent
patent.txt lines 1,739–1,740
Flags
product
Product numbers
001, 002
3 Dec 2028 · NDA 022352 · COLCHICINE
US 7,619,004, use patent
patent.txt line 1,742
Flags
use code U-1020
Product numbers
001
3 Dec 2028 · NDA 022352 · COLCHICINE
US 7,935,731, use patent
patent.txt line 1,746
Flags
use code U-1116
Product numbers
001
4 Dec 2028 · NDA 214012 · INCLISIRAN SODIUM
US 10,806,791, substance patent
patent.txt line 15,431
Flags
substance
Product numbers
001
4 Dec 2028 · NDA 214012 · INCLISIRAN SODIUM
US 8,828,956, substance and product and use patent
patent.txt line 15,445
Flags
substance product use code U-4249
Product numbers
001
4 Dec 2028 · NDA 214012 · INCLISIRAN SODIUM
US 8,828,956, substance and product and use patent
patent.txt line 15,446
Flags
substance product use code U-4413
Product numbers
001
4 Dec 2028 · NDA 214012 · INCLISIRAN SODIUM
US 8,828,956, substance and product and use patent
patent.txt line 15,447
Flags
substance product use code U-4414
Product numbers
001
4 Dec 2028 · NDA 214012 · INCLISIRAN SODIUM
US 9,370,582, substance and product and use patent
patent.txt line 15,448
Flags
substance product use code U-4249
Product numbers
001
4 Dec 2028 · NDA 214012 · INCLISIRAN SODIUM
US 9,370,582, substance and product and use patent
patent.txt line 15,449
Flags
substance product use code U-4413
Product numbers
001
4 Dec 2028 · NDA 214012 · INCLISIRAN SODIUM
US 9,370,582, substance and product and use patent
patent.txt line 15,450
Flags
substance product use code U-4414
Product numbers
001
4 Dec 2028 · NDA 215515 · VUTRISIRAN SODIUM
US 10,806,791, substance patent
patent.txt line 17,418
Flags
substance
Product numbers
001
4 Dec 2028 · NDA 215515 · VUTRISIRAN SODIUM
US 8,828,956, substance and product and use patent
patent.txt line 17,423
Flags
substance product use code U-3396
Product numbers
001
4 Dec 2028 · NDA 215515 · VUTRISIRAN SODIUM
US 9,370,581, substance and product and use patent
patent.txt line 17,424
Flags
substance product use code U-3396
Product numbers
001
5 Dec 2028 · NDA 021840 · ETHINYL ESTRADIOL; LEVONORGESTREL
US 7,855,190, use patent
patent.txt line 738
Flags
use code U-1
Product numbers
001
5 Dec 2028 · NDA 022262 · ETHINYL ESTRADIOL; LEVONORGESTREL
US 7,855,190, use patent
patent.txt line 1,419
Flags
use code U-1
Product numbers
001
8 Dec 2028 · NDA 022474 · ULIPRISTAL ACETATE
US 9,844,510, product patent
patent.txt line 1,927
Flags
product
Product numbers
001
14 Dec 2028 · NDA 202091 · CEFIXIME
US 9,233,112, product and use patent
patent.txt line 2,748
Flags
product use code U-1676
Product numbers
001
15 Dec 2028 · NDA 021272 · TREPROSTINIL
US 11,723,887, substance patent
patent.txt lines 508, 513, 518, 523, 528, 533, 538, 543
Flags
substance
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
15 Dec 2028 · NDA 021272 · TREPROSTINIL
US 9,593,066, substance patent
patent.txt lines 512, 517, 522, 527, 532, 537, 542, 547
Flags
substance
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
15 Dec 2028 · NDA 022387 · TREPROSTINIL
US 11,723,887, substance patent
patent.txt line 1,765
Flags
substance
Product numbers
001
15 Dec 2028 · NDA 022387 · TREPROSTINIL
US 9,593,066, substance patent
patent.txt line 1,769
Flags
substance
Product numbers
001
15 Dec 2028 · NDA 203388 · VISMODEGIB
US 9,278,961, use patent
patent.txt line 3,804
Flags
use code U-1825
Product numbers
001
15 Dec 2028 · NDA 203496 · TREPROSTINIL DIOLAMINE
US 11,723,887, substance patent
patent.txt lines 3,946, 3,955, 3,964, 3,973, 3,982
Flags
substance
Product numbers
001, 002, 003, 004, 005
15 Dec 2028 · NDA 203496 · TREPROSTINIL DIOLAMINE
US 8,497,393, substance patent
patent.txt lines 3,959, 3,968, 3,977
Flags
substance delist requested
Product numbers
002, 003, 004
15 Dec 2028 · NDA 203496 · TREPROSTINIL DIOLAMINE
US 9,593,066, substance patent
patent.txt lines 3,953, 3,963, 3,972, 3,981, 3,989
Flags
substance
Product numbers
001, 002, 003, 004, 005
15 Dec 2028 · NDA 203496 · TREPROSTINIL DIOLAMINE
US 9,604,901, substance patent
patent.txt lines 3,954, 3,990
Flags
substance delist requested
Product numbers
001, 005
16 Dec 2028 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US 7,943,621, substance and product patent
patent.txt lines 4,557, 4,581, 4,597, 4,612
Flags
substance product
Product numbers
001, 002, 003, 004
20 Dec 2028 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US 7,943,621, substance and product patent
patent.txt lines 4,628, 4,645
Flags
substance product
Product numbers
005, 006
23 Dec 2028 · NDA 200179 · VARDENAFIL HYDROCHLORIDE
US 8,613,950, product patent
patent.txt line 2,215
Flags
product
Product numbers
001
23 Dec 2028 · NDA 205422 · BREXPIPRAZOLE
US RE48059, substance patent
patent.txt lines 5,319, 5,332, 5,345, 5,358, 5,371, 5,382
Flags
substance
Product numbers
001, 002, 003, 004, 005, 006
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 8,377,474, product and use patent
patent.txt lines 3,704, 3,719, 3,734, 3,749
Flags
product use code U-1645
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 8,377,474, product and use patent
patent.txt lines 3,705, 3,720, 3,735, 3,750
Flags
product use code U-219
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 8,454,998, product and use patent
patent.txt lines 3,706, 3,721, 3,736, 3,751
Flags
product use code U-1645
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 8,454,998, product and use patent
patent.txt lines 3,707, 3,722, 3,737, 3,752
Flags
product use code U-1646
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 8,454,998, product and use patent
patent.txt lines 3,708, 3,723, 3,738, 3,753
Flags
product use code U-1647
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 8,454,998, product and use patent
patent.txt lines 3,709, 3,724, 3,739, 3,754
Flags
product use code U-1649
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 8,454,998, product and use patent
patent.txt lines 3,710, 3,725, 3,740, 3,755
Flags
product use code U-219
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 8,557,283, product and use patent
patent.txt lines 3,711, 3,726, 3,741, 3,756
Flags
product use code U-1645
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 8,557,283, product and use patent
patent.txt lines 3,712, 3,727, 3,742, 3,757
Flags
product use code U-219
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 9,089,607, product and use patent
patent.txt lines 3,713, 3,728, 3,743, 3,758
Flags
product use code U-1645
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 9,089,607, product and use patent
patent.txt lines 3,714, 3,729, 3,744, 3,759
Flags
product use code U-1720
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 9,089,608, product patent
patent.txt lines 3,715, 3,730, 3,745, 3,760
Flags
product
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 9,463,246, product and use patent
patent.txt lines 3,716, 3,731, 3,746, 3,761
Flags
product use code U-219
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 9,533,046, product and use patent
patent.txt lines 3,717, 3,732, 3,747, 3,762
Flags
product use code U-219
Product numbers
001, 002, 003, 004
26 Dec 2028 · NDA 203312 · CARBIDOPA; LEVODOPA
US 9,901,640, product and use patent
patent.txt lines 3,718, 3,733, 3,748, 3,763
Flags
product use code U-219
Product numbers
001, 002, 003, 004

Pediatric exclusivity, as listed (63)

14 Jan 2028 · NDA 204042 · CANAGLIFLOZIN
US 7,943,788 with pediatric exclusivity, as listed
patent.txt lines 4,236, 4,246
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
14 Jan 2028 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,788 with pediatric exclusivity, as listed
patent.txt lines 4,511, 4,522, 4,533, 4,544
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
14 Jan 2028 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,788 with pediatric exclusivity, as listed
patent.txt lines 6,003, 6,013, 6,023, 6,033
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
27 Jan 2028 · NDA 206947 · LENVATINIB MESYLATE
US 9,006,256 with pediatric exclusivity, as listed
patent.txt lines 6,893, 6,914
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
31 Jan 2028 · NDA 201699 · FIDAXOMICIN
US 7,378,508 with pediatric exclusivity, as listed
patent.txt line 2,550
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
31 Jan 2028 · NDA 201699 · FIDAXOMICIN
US 7,863,249 with pediatric exclusivity, as listed
patent.txt line 2,552
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
31 Jan 2028 · NDA 201699 · FIDAXOMICIN
US 8,859,510 with pediatric exclusivity, as listed
patent.txt line 2,557
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Feb 2028 · NDA 203188 · IVACAFTOR
US 8,324,242 with pediatric exclusivity, as listed
patent.txt line 3,659
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Feb 2028 · NDA 207925 · IVACAFTOR
US 8,324,242 with pediatric exclusivity, as listed
patent.txt lines 7,507, 7,540, 7,573, 7,606, 7,634
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
14 Mar 2028 · NDA 207500 · ISAVUCONAZONIUM SULFATE
US 10,206,879 with pediatric exclusivity, as listed
patent.txt lines 7,260, 7,266
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
14 Mar 2028 · NDA 207500 · ISAVUCONAZONIUM SULFATE
US 10,603,280 with pediatric exclusivity, as listed
patent.txt lines 7,262, 7,268
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
22 Mar 2028 · NDA 203389 · CYSTEAMINE BITARTRATE
US 8,026,284 with pediatric exclusivity, as listed
patent.txt lines 3,813, 3,837
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
22 Mar 2028 · NDA 213491 · CYSTEAMINE BITARTRATE
US 8,026,284 with pediatric exclusivity, as listed
patent.txt lines 15,028, 15,052
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
25 Mar 2028 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,293,756 with pediatric exclusivity, as listed
patent.txt lines 996, 1,010, 1,024
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
5 Apr 2028 · NDA 204790 · DOLUTEGRAVIR SODIUM
US 8,129,385 with pediatric exclusivity, as listed
patent.txt lines 5,003, 5,007, 5,011
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
5 Apr 2028 · NDA 205551 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385 with pediatric exclusivity, as listed
patent.txt line 5,463
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Apr 2028 · NDA 210192 · DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
US 8,129,385 with pediatric exclusivity, as listed
patent.txt line 11,206
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Apr 2028 · NDA 211994 · DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385 with pediatric exclusivity, as listed
patent.txt line 13,376
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Apr 2028 · NDA 213983 · DOLUTEGRAVIR SODIUM
US 8,129,385 with pediatric exclusivity, as listed
patent.txt line 15,418
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Apr 2028 · NDA 215413 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385 with pediatric exclusivity, as listed
patent.txt line 16,885
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
13 May 2028 · NDA 205552 · IBRUTINIB
US 8,008,309 with pediatric exclusivity, as listed
patent.txt lines 5,509, 5,606
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
13 May 2028 · NDA 210563 · IBRUTINIB
US 8,008,309 with pediatric exclusivity, as listed
patent.txt lines 11,632, 11,736, 11,840, 11,942
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
3 Jun 2028 · NDA 204042 · CANAGLIFLOZIN
US 8,513,202 with pediatric exclusivity, as listed
patent.txt lines 4,238, 4,248
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
3 Jun 2028 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202 with pediatric exclusivity, as listed
patent.txt lines 4,513, 4,524, 4,535, 4,546
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
3 Jun 2028 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202 with pediatric exclusivity, as listed
patent.txt lines 6,005, 6,015, 6,025, 6,035
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
7 Jun 2028 · NDA 202714 · CARFILZOMIB
US 7,737,112 with pediatric exclusivity, as listed
patent.txt lines 3,140, 3,150, 3,160
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
24 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 7,598,257 with pediatric exclusivity, as listed
patent.txt lines 2,804, 2,833, 2,862, 2,891, 2,920
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
24 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,415,362 with pediatric exclusivity, as listed
patent.txt lines 2,807, 2,836, 2,865, 2,894, 2,923
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
24 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 7,598,257 with pediatric exclusivity, as listed
patent.txt line 16,756
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
24 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,415,362 with pediatric exclusivity, as listed
patent.txt line 16,758
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
24 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 7,598,257 with pediatric exclusivity, as listed
patent.txt lines 19,318, 19,371, 19,424, 19,477, 19,530
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
24 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,415,362 with pediatric exclusivity, as listed
patent.txt lines 19,321, 19,374, 19,427, 19,480, 19,533
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
7 Jul 2028 · NDA 207953 · TRABECTEDIN
US 8,895,557 with pediatric exclusivity, as listed
patent.txt line 7,814
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Aug 2028 · NDA 021817 · ZOLEDRONIC ACID
US 7,932,241 with pediatric exclusivity, as listed
patent.txt line 700
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
16 Aug 2028 · NDA 205437 · APREMILAST
US 7,427,638 with pediatric exclusivity, as listed
patent.txt lines 5,404, 5,416, 5,428
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
13 Sep 2028 · NDA 021936 · TIOTROPIUM BROMIDE
US 7,837,235 with pediatric exclusivity, as listed
patent.txt line 810
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
13 Sep 2028 · NDA 206756 · OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
US 7,837,235 with pediatric exclusivity, as listed
patent.txt line 6,759
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
21 Sep 2028 · NDA 202293 · DAPAGLIFLOZIN
US 8,221,786 with pediatric exclusivity, as listed
patent.txt lines 2,984, 3,022
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 202293 · DAPAGLIFLOZIN
US 8,361,972 with pediatric exclusivity, as listed
patent.txt lines 2,990, 3,028
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 202293 · DAPAGLIFLOZIN
US 8,716,251 with pediatric exclusivity, as listed
patent.txt lines 2,997, 3,035
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 204671 · SOFOSBUVIR
US 8,334,270 with pediatric exclusivity, as listed
patent.txt lines 4,947, 4,965
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 204671 · SOFOSBUVIR
US 8,580,765 with pediatric exclusivity, as listed
patent.txt lines 4,949, 4,967
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 204671 · SOFOSBUVIR
US 9,085,573 with pediatric exclusivity, as listed
patent.txt lines 4,957, 4,975
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,221,786 with pediatric exclusivity, as listed
patent.txt lines 9,661, 9,677
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,361,972 with pediatric exclusivity, as listed
patent.txt lines 9,663, 9,679
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,716,251 with pediatric exclusivity, as listed
patent.txt lines 9,671, 9,683
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Oct 2028 · NDA 200533 · TAPENTADOL HYDROCHLORIDE
US 11,344,512 with pediatric exclusivity, as listed
patent.txt lines 2,220, 2,225, 2,230, 2,235, 2,240
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
3 Dec 2028 · NDA 207318 · PIMAVANSERIN TARTRATE
US 7,732,615 with pediatric exclusivity, as listed
patent.txt lines 7,235, 7,244
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
3 Dec 2028 · NDA 210793 · PIMAVANSERIN TARTRATE
US 7,732,615 with pediatric exclusivity, as listed
patent.txt line 12,149
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
12 Dec 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 10,016,429 with pediatric exclusivity, as listed
patent.txt lines 2,801, 2,830, 2,859, 2,888, 2,917
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
12 Dec 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,722,693 with pediatric exclusivity, as listed
patent.txt lines 2,809, 2,838, 2,867, 2,896, 2,925
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
12 Dec 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,822,481 with pediatric exclusivity, as listed
patent.txt lines 2,811, 2,840, 2,869, 2,898, 2,927
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
12 Dec 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,829,013 with pediatric exclusivity, as listed
patent.txt lines 2,817, 2,846, 2,875, 2,904, 2,933
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
12 Dec 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 10,610,530 with pediatric exclusivity, as listed
patent.txt line 16,732
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
12 Dec 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,722,693 with pediatric exclusivity, as listed
patent.txt line 16,760
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
12 Dec 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,822,481 with pediatric exclusivity, as listed
patent.txt line 16,762
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
12 Dec 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 10,016,429 with pediatric exclusivity, as listed
patent.txt lines 19,289, 19,342, 19,395, 19,448, 19,501
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
12 Dec 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 11,213,528 with pediatric exclusivity, as listed
patent.txt lines 19,294, 19,347, 19,400, 19,453, 19,506
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
12 Dec 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,722,693 with pediatric exclusivity, as listed
patent.txt lines 19,324, 19,377, 19,430, 19,483, 19,536
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
12 Dec 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,822,481 with pediatric exclusivity, as listed
patent.txt lines 19,326, 19,379, 19,432, 19,485, 19,538
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
12 Dec 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,829,013 with pediatric exclusivity, as listed
patent.txt lines 19,331, 19,384, 19,437, 19,490, 19,543
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
17 Dec 2028 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,324,225 with pediatric exclusivity, as listed
patent.txt line 9,696
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
17 Dec 2028 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 8,324,225 with pediatric exclusivity, as listed
patent.txt line 11,041
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001

Non-patent exclusivity (91)

16 Jan 2028 · NDA 210259 · ACALABRUTINIB
I-960 exclusivity
exclusivity.txt line 869
Definition
New indication (to be checked against FDA's list)
Product numbers
001
16 Jan 2028 · NDA 216387 · ACALABRUTINIB MALEATE
I-960 exclusivity
exclusivity.txt line 1,752
Definition
New indication (to be checked against FDA's list)
Product numbers
001
17 Jan 2028 · NDA 211243 · ESKETAMINE HYDROCHLORIDE
I-959 exclusivity
exclusivity.txt line 950
Definition
New indication (to be checked against FDA's list)
Product numbers
001
21 Jan 2028 · NDA 212690 · CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
PED exclusivity
exclusivity.txt line 1,105
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
28 Jan 2028 · NDA 209637 · SEMAGLUTIDE
I-961 exclusivity
exclusivity.txt lines 797–800
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
30 Jan 2028 · NDA 215431 · MELOXICAM; RIZATRIPTAN BENZOATE
NP exclusivity
exclusivity.txt line 1,565
Definition
New product (to be checked against FDA's list)
Product numbers
001
21 Feb 2028 · NDA 203214 · TOFACITINIB CITRATE
M-14 exclusivity
exclusivity.txt line 305
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
21 Feb 2028 · NDA 213082 · TOFACITINIB CITRATE
M-14 exclusivity
exclusivity.txt line 1,153
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
28 Feb 2028 · NDA 204410 · MACITENTAN
M-187 exclusivity
exclusivity.txt line 426
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
3 Mar 2028 · NDA 210868 · LORLATINIB
ODE-349 exclusivity
exclusivity.txt lines 923–924
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
17 Mar 2028 · NDA 209092 · RIBOCICLIB SUCCINATE
PED exclusivity
exclusivity.txt line 763
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
17 Mar 2028 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
PED exclusivity
exclusivity.txt line 817
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
20 Mar 2028 · NDA 215515 · VUTRISIRAN SODIUM
I-964 exclusivity
exclusivity.txt line 1,587
Definition
New indication (to be checked against FDA's list)
Product numbers
001
26 Mar 2028 · NDA 216665 · DIAZOXIDE CHOLINE
NP exclusivity
exclusivity.txt lines 1,777, 1,779, 1,781
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002, 003
27 Mar 2028 · NDA 213246 · SELPERCATINIB
PED exclusivity
exclusivity.txt lines 1,182–1,183, 1,204–1,205
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
15 Apr 2028 · NDA 211635 · DIAZEPAM
NPP exclusivity
exclusivity.txt lines 970, 972, 974
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003
17 Apr 2028 · NDA 202155 · APIXABAN
NPP exclusivity
exclusivity.txt lines 231, 233
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
17 Apr 2028 · NDA 202155 · APIXABAN
NS exclusivity
exclusivity.txt line 235
Definition
New strength (to be checked against FDA's list)
Product numbers
003
28 Apr 2028 · NDA 211675 · UPADACITINIB
I-966 exclusivity
exclusivity.txt line 985
Definition
New indication (to be checked against FDA's list)
Product numbers
001
30 Apr 2028 · NDA 021825 · DEFERIPRONE
ODE-417 exclusivity
exclusivity.txt lines 125, 128
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
30 Apr 2028 · NDA 021825 · DEFERIPRONE
ODE-420 exclusivity
exclusivity.txt lines 126, 129
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
30 Apr 2028 · NDA 021825 · DEFERIPRONE
ODE-421 exclusivity
exclusivity.txt lines 127, 130
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
9 May 2028 · NDA 205422 · BREXPIPRAZOLE
M-315 exclusivity
exclusivity.txt lines 452, 457, 462, 467, 472, 477
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
14 May 2028 · NDA 215383 · BELZUTIFAN
I-968 exclusivity
exclusivity.txt line 1,555
Definition
New indication (to be checked against FDA's list)
Product numbers
001
22 May 2028 · NDA 202714 · CARFILZOMIB
M-14 exclusivity
exclusivity.txt lines 280, 282, 284
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
22 May 2028 · NDA 207925 · IVACAFTOR
M-14 exclusivity
exclusivity.txt lines 626, 632, 638, 644, 650
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
3 Jun 2028 · NDA 212099 · DAROLUTAMIDE
I-971 exclusivity
exclusivity.txt line 1,020
Definition
New indication (to be checked against FDA's list)
Product numbers
001
3 Jun 2028 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 1,299, 1,301
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
11 Jun 2028 · NDA 020862 · DOXERCALCIFEROL
M-14 exclusivity
exclusivity.txt lines 108–110
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
12 Jun 2028 · NDA 022225 · SUGAMMADEX SODIUM
PED exclusivity
exclusivity.txt lines 171, 173
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
17 Jun 2028 · NDA 205053 · POSACONAZOLE
ODE-355 exclusivity
exclusivity.txt line 447
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
17 Jun 2028 · NDA 205596 · POSACONAZOLE
ODE-355 exclusivity
exclusivity.txt line 511
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
18 Jun 2028 · NDA 204042 · CANAGLIFLOZIN
PED exclusivity
exclusivity.txt lines 365, 367
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
18 Jun 2028 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 389, 391, 393, 395
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
18 Jun 2028 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 537, 539, 541, 543
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
20 Jun 2028 · NDA 203094 · COBICISTAT
NPP exclusivity
exclusivity.txt line 299
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
20 Jun 2028 · NDA 203094 · COBICISTAT
NS exclusivity
exclusivity.txt line 301
Definition
New strength (to be checked against FDA's list)
Product numbers
002
20 Jun 2028 · NDA 208215 · EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
M-316 exclusivity
exclusivity.txt lines 696, 698
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
21 Jun 2028 · NDA 203188 · IVACAFTOR
PED exclusivity
exclusivity.txt line 304
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
21 Jun 2028 · NDA 207925 · IVACAFTOR
PED exclusivity
exclusivity.txt lines 629, 635, 641
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
11 Jul 2028 · NDA 215341 · FINERENONE
I-970 exclusivity
exclusivity.txt lines 1,524, 1,527
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
11 Jul 2028 · NDA 215341 · FINERENONE
NS exclusivity
exclusivity.txt line 1,532
Definition
New strength (to be checked against FDA's list)
Product numbers
003
16 Jul 2028 · NDA 214783 · BELUMOSUDIL MESYLATE
ODE-362 exclusivity
exclusivity.txt line 1,390
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
12 Aug 2028 · NDA 212690 · CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
ODE-369 exclusivity
exclusivity.txt line 1,104
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
13 Aug 2028 · NDA 215383 · BELZUTIFAN
ODE-364 exclusivity
exclusivity.txt line 1,558
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
15 Aug 2028 · NDA 215256 · SEMAGLUTIDE
I-973 exclusivity
exclusivity.txt lines 1,503, 1,505, 1,507, 1,510, 1,512, 1,515
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 012
15 Aug 2028 · NDA 219428 · CYCLOBENZAPRINE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 2,286
Definition
New product (to be checked against FDA's list)
Product numbers
001
21 Aug 2028 · NDA 203214 · TOFACITINIB CITRATE
PED exclusivity
exclusivity.txt line 306
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
21 Aug 2028 · NDA 213082 · TOFACITINIB CITRATE
PED exclusivity
exclusivity.txt line 1,154
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
25 Aug 2028 · NDA 211192 · IVOSIDENIB
ODE-368 exclusivity
exclusivity.txt line 944
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
28 Aug 2028 · NDA 204410 · MACITENTAN
PED exclusivity
exclusivity.txt line 427
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
31 Aug 2028 · NDA 213217 · ZANUBRUTINIB
ODE-371 exclusivity
exclusivity.txt line 1,166
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
31 Aug 2028 · NDA 218785 · ZANUBRUTINIB
ODE* exclusivity
exclusivity.txt line 2,197
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
10 Sep 2028 · NDA 213756 · SELUMETINIB SULFATE
NPP exclusivity
exclusivity.txt lines 1,257, 1,261
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
14 Sep 2028 · NDA 213217 · ZANUBRUTINIB
ODE-370 exclusivity
exclusivity.txt line 1,165
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
14 Sep 2028 · NDA 218785 · ZANUBRUTINIB
ODE* exclusivity
exclusivity.txt line 2,201
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
16 Sep 2028 · NDA 207103 · PALBOCICLIB
M-14 exclusivity
exclusivity.txt lines 574, 577, 580
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
16 Sep 2028 · NDA 212436 · PALBOCICLIB
M-14 exclusivity
exclusivity.txt lines 1,066, 1,069, 1,072
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
17 Sep 2028 · NDA 208692 · CABOZANTINIB S-MALATE
ODE-375 exclusivity
exclusivity.txt lines 739, 742, 745
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
18 Sep 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
NPP exclusivity
exclusivity.txt line 1,519
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
22 Sep 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
ODE-373 exclusivity
exclusivity.txt lines 239, 245, 251, 257, 263
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
22 Sep 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
ODE* exclusivity
exclusivity.txt lines 1,844, 1,846, 1,848, 1,850, 1,852
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
23 Sep 2028 · NDA 022068 · NILOTINIB HYDROCHLORIDE
ODE-380 exclusivity
exclusivity.txt lines 157, 159, 161
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
29 Sep 2028 · NDA 214662 · MARALIXIBAT CHLORIDE
ODE-379 exclusivity
exclusivity.txt line 1,350
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
29 Sep 2028 · NDA 214662 · MARALIXIBAT CHLORIDE
ODE* exclusivity
exclusivity.txt line 1,356
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
002
2 Oct 2028 · NDA 213702 · LURBINECTEDIN
I-977 exclusivity
exclusivity.txt line 1,244
Definition
New indication (to be checked against FDA's list)
Product numbers
001
2 Oct 2028 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
M-318 exclusivity
exclusivity.txt lines 1,537, 1,545, 1,551
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
4 Oct 2028 · NDA 215985 · ROFLUMILAST
NS exclusivity
exclusivity.txt line 1,685
Definition
New strength (to be checked against FDA's list)
Product numbers
003
7 Oct 2028 · NDA 210251 · BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
ODE-378 exclusivity
exclusivity.txt line 865
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
002
7 Oct 2028 · NDA 214487 · AVACOPAN
ODE-377 exclusivity
exclusivity.txt line 1,336
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
17 Oct 2028 · NDA 202155 · APIXABAN
PED exclusivity
exclusivity.txt lines 232, 234, 236
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
17 Oct 2028 · NDA 213051 · SEMAGLUTIDE
I-976 exclusivity
exclusivity.txt lines 1,147–1,152
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
29 Oct 2028 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
ODE-381 exclusivity
exclusivity.txt lines 1,539, 1,547
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
29 Oct 2028 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
ODE-382 exclusivity
exclusivity.txt lines 1,540, 1,548
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
29 Oct 2028 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
ODE* exclusivity
exclusivity.txt line 1,553
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
003
4 Nov 2028 · NDA 202811 · LINACLOTIDE
NPP exclusivity
exclusivity.txt line 295
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
5 Nov 2028 · NDA 209500 · LUMATEPERONE TOSYLATE
I-904 exclusivity
exclusivity.txt lines 788, 790, 792
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
19 Nov 2028 · NDA 213756 · SELUMETINIB SULFATE
NPP exclusivity
exclusivity.txt lines 1,256, 1,260
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
19 Nov 2028 · NDA 214938 · VOSORITIDE
ODE-387 exclusivity
exclusivity.txt lines 1,426, 1,430, 1,434
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
22 Nov 2028 · NDA 202714 · CARFILZOMIB
PED exclusivity
exclusivity.txt lines 281, 283, 285
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
22 Nov 2028 · NDA 207925 · IVACAFTOR
PED exclusivity
exclusivity.txt lines 630, 636, 642, 647, 653
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
23 Nov 2028 · NDA 215596 · MARIBAVIR
ODE-388 exclusivity
exclusivity.txt line 1,602
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
15 Dec 2028 · NDA 215935 · BUDESONIDE
ODE-389 exclusivity
exclusivity.txt line 1,675
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
17 Dec 2028 · NDA 213137 · VOXELOTOR
ODE-394 exclusivity
exclusivity.txt lines 1,156–1,157
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
17 Dec 2028 · NDA 216157 · VOXELOTOR
ODE-394 exclusivity
exclusivity.txt line 1,730
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
18 Dec 2028 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
M-14 exclusivity
exclusivity.txt lines 396, 400, 404, 408, 410, 414
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
18 Dec 2028 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 397, 401, 405, 411, 415
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003, 005, 006
19 Dec 2028 · NDA 215866 · TIRZEPATIDE
NPP exclusivity
exclusivity.txt lines 1,626, 1,628, 1,630, 1,632, 1,636, 1,638, 1,640, 1,642, 1,646, 1,648, 1,650, 1,652, 1,654, 1,656, 1,658, 1,660, 1,662, 1,664
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 007, 008, 009, 010, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022
22 Dec 2028 · NDA 218316 · SEMAGLUTIDE
NP exclusivity
exclusivity.txt lines 2,143, 2,145, 2,147, 2,149
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
23 Dec 2028 · NDA 216196 · MITAPIVAT SULFATE
NP exclusivity
exclusivity.txt line 1,743
Definition
New product (to be checked against FDA's list)
Product numbers
004
30 Dec 2028 · NDA 214133 · LEVOKETOCONAZOLE
ODE-385 exclusivity
exclusivity.txt line 1,309
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001