Drybench Patent.

Patent and exclusivity dates from July to December 2028 for NDAs, as FDA's Orange Book lists them

Each patent and exclusivity date from July to December 2028 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, 2028 January to June 2028

Listed patent expiry (270)

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
4 Jul 2028 · NDA 214096 · TEPOTINIB HYDROCHLORIDE
US 8,658,643, use patent
patent.txt line 15,529
Flags
use code U-3077
Product numbers
001
4 Jul 2028 · NDA 214096 · TEPOTINIB HYDROCHLORIDE
US 9,062,029, product patent
patent.txt line 15,532
Flags
product
Product numbers
001
4 Jul 2028 · NDA 214096 · TEPOTINIB HYDROCHLORIDE
US 9,403,799, use patent
patent.txt line 15,534
Flags
use code U-3077
Product numbers
001
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
8 Jul 2028 · NDA 212725 · ENTRECTINIB
US 8,673,893, use patent
patent.txt lines 14,378, 14,397
Flags
use code U-2617
Product numbers
001, 002
8 Jul 2028 · NDA 212725 · ENTRECTINIB
US 8,673,893, use patent
patent.txt lines 14,379, 14,398
Flags
use code U-2618
Product numbers
001, 002
8 Jul 2028 · NDA 212725 · ENTRECTINIB
US 9,029,356, substance and product patent
patent.txt lines 14,380, 14,399
Flags
substance product
Product numbers
001, 002
8 Jul 2028 · NDA 212725 · ENTRECTINIB
US 9,085,558, product patent
patent.txt lines 14,381, 14,400
Flags
product
Product numbers
001, 002
8 Jul 2028 · NDA 212725 · ENTRECTINIB
US 9,255,087, use patent
patent.txt lines 14,383, 14,402
Flags
use code U-2617
Product numbers
001, 002
8 Jul 2028 · NDA 212725 · ENTRECTINIB
US 9,255,087, use patent
patent.txt lines 14,384, 14,403
Flags
use code U-2618
Product numbers
001, 002
8 Jul 2028 · NDA 212725 · ENTRECTINIB
US 9,616,059, use patent
patent.txt lines 14,385, 14,404
Flags
use code U-2618
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
10 Jul 2028 · NDA 204017 · ETHINYL ESTRADIOL; LEVONORGESTREL
US 8,747,888, product patent
patent.txt line 4,194
Flags
product
Product numbers
001
10 Jul 2028 · NDA 204017 · ETHINYL ESTRADIOL; LEVONORGESTREL
US 9,050,348, product patent
patent.txt line 4,195
Flags
product
Product numbers
001
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
19 Jul 2028 · NDA 208010 · CALCIFEDIOL
US 8,361,488, product patent
patent.txt line 7,957
Flags
product
Product numbers
001
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
21 Jul 2028 · NDA 214096 · TEPOTINIB HYDROCHLORIDE
US 8,927,540, use patent
patent.txt line 15,531
Flags
use code U-3078
Product numbers
001
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
29 Jul 2028 · NDA 210923 · LUSUTROMBOPAG
US 8,889,722, substance and product patent
patent.txt line 12,408
Flags
substance 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
3 Aug 2028 · NDA 050818 · DEXAMETHASONE; TOBRAMYCIN
US 7,795,316, product and use patent
patent.txt line 2,175
Flags
product use code U-1082
Product numbers
001
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
6 Aug 2028 · NDA 214622 · INFIGRATINIB PHOSPHATE
US 9,067,896, substance patent
patent.txt lines 15,895, 15,899
Flags
substance
Product numbers
001, 002
7 Aug 2028 · NDA 208470 · PRASTERONE
US 8,629,129, product patent
patent.txt line 8,668
Flags
product
Product numbers
001
8 Aug 2028 · NDA 022405 · VANDETANIB
US 8,067,427, product patent
patent.txt lines 1,783–1,784
Flags
product
Product numbers
001, 002
8 Aug 2028 · NDA 214510 · BENZOYL PEROXIDE
US 9,868,103, product and use patent
patent.txt line 15,828
Flags
product use code U-3356
Product numbers
001
8 Aug 2028 · NDA 214902 · BENZOYL PEROXIDE; TRETINOIN
US 9,868,103, product and use patent
patent.txt line 16,318
Flags
product use code U-3194
Product numbers
001
10 Aug 2028 · NDA 209521 · SARECYCLINE HYDROCHLORIDE
US 9,481,639, use patent
patent.txt lines 10,593, 10,598, 10,603
Flags
use code U-2409
Product numbers
001, 002, 003
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
12 Aug 2028 · NDA 209777 · OXYCODONE HYDROCHLORIDE
US 10,314,788, product patent
patent.txt lines 10,792, 10,794, 10,796, 10,798
Flags
product
Product numbers
001, 002, 003, 004
12 Aug 2028 · NDA 209777 · OXYCODONE HYDROCHLORIDE
US 7,955,619, product patent
patent.txt lines 10,793, 10,795, 10,797, 10,799
Flags
product
Product numbers
001, 002, 003, 004
14 Aug 2028 · NDA 022306 · SOTALOL HYDROCHLORIDE
US 12,403,109, use patent
patent.txt line 1,613
Flags
use code U-2769
Product numbers
001
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
15 Aug 2028 · NDA 207356 · AMIKACIN SULFATE
US 8,226,975, product patent
patent.txt line 7,254
Flags
product
Product numbers
001
15 Aug 2028 · NDA 215833 · LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
US 10,406,240, substance and product and use patent
patent.txt line 17,539
Flags
substance product use code U-4169
Product numbers
001
15 Aug 2028 · NDA 215833 · LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
US 10,406,240, substance and product and use patent
patent.txt line 17,540
Flags
substance product use code U-4593
Product numbers
001
15 Aug 2028 · NDA 215833 · LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
US 10,406,240, substance and product and use patent
patent.txt line 17,541
Flags
substance product use code U-4594
Product numbers
001
15 Aug 2028 · NDA 215833 · LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
US 11,318,121, substance and product and use patent
patent.txt line 17,542
Flags
substance product use code U-4169
Product numbers
001
15 Aug 2028 · NDA 215833 · LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
US 11,318,121, substance and product and use patent
patent.txt line 17,543
Flags
substance product use code U-4593
Product numbers
001
15 Aug 2028 · NDA 215833 · LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
US 11,318,121, substance and product and use patent
patent.txt line 17,544
Flags
substance product use code U-4594
Product numbers
001
15 Aug 2028 · NDA 215841 · GALLIUM GA-68 GOZETOTIDE
US 11,369,590, substance and product and use patent
patent.txt line 17,551
Flags
substance product use code U-3400
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
19 Aug 2028 · NDA 206500 · ROLAPITANT HYDROCHLORIDE
US 7,049,320, substance and product and use patent
patent.txt line 6,583
Flags
substance product use code U-1741
Product numbers
001
19 Aug 2028 · NDA 208399 · ROLAPITANT HYDROCHLORIDE
US 7,049,320, substance and product and use patent
patent.txt line 8,566
Flags
substance product use code U-1741
Product numbers
001
22 Aug 2028 · NDA 214373 · BEXAGLIFLOZIN
US 8,106,021, use patent
patent.txt line 15,731
Flags
use code U-2214
Product numbers
001
22 Aug 2028 · NDA 214373 · BEXAGLIFLOZIN
US 8,802,637, substance and product and use patent
patent.txt line 15,732
Flags
substance product use code U-2214
Product numbers
001
22 Aug 2028 · NDA 219208 · ATRASENTAN HYDROCHLORIDE
US 8,623,819, use patent
patent.txt line 21,555
Flags
use code U-3980
Product numbers
001
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 212194 · GIVOSIRAN SODIUM
US 10,131,907, substance and product and use patent
patent.txt line 13,616
Flags
substance product use code U-2672
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 214103 · LUMASIRAN SODIUM
US 10,131,907, substance and product and use patent
patent.txt line 15,535
Flags
substance product use code U-2995
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
26 Aug 2028 · NDA 204017 · ETHINYL ESTRADIOL; LEVONORGESTREL
US 8,246,978, product patent
patent.txt line 4,193
Flags
product
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 208010 · CALCIFEDIOL
US 8,426,391, use patent
patent.txt line 7,958
Flags
use code U-1872
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
29 Aug 2028 · NDA 207793 · IRINOTECAN HYDROCHLORIDE
US 8,147,867, substance and product patent
patent.txt line 7,422
Flags
substance product
Product numbers
001
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
8 Sep 2028 · NDA 208383 · BETRIXABAN
US 8,557,852, use patent
patent.txt lines 8,556, 8,562
Flags
use code U-1167
Product numbers
001, 002
8 Sep 2028 · NDA 208383 · BETRIXABAN
US 8,557,852, use patent
patent.txt lines 8,557, 8,563
Flags
use code U-2030
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
12 Sep 2028 · NDA 201688 · TOBRAMYCIN
US 8,869,794, product and use patent
patent.txt line 2,549
Flags
product use code U-909
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 203137 · FLUTEMETAMOL F-18
US 8,916,131, product patent
patent.txt lines 3,644–3,645
Flags
product
Product numbers
001, 002
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
17 Sep 2028 · NDA 208624 · DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
US 8,501,238, substance and product and use patent
patent.txt line 9,001
Flags
substance product use code U-1636
Product numbers
001
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
24 Sep 2028 · NDA 206162 · OLAPARIB
US 8,247,416, substance patent
patent.txt line 6,427
Flags
substance
Product numbers
001
26 Sep 2028 · NDA 216993 · QUIZARTINIB DIHYDROCHLORIDE
US 7,820,657, substance patent
patent.txt lines 19,125, 19,136
Flags
substance
Product numbers
001, 002
3 Oct 2028 · NDA 022484 · ITRACONAZOLE
US 8,486,456, product and use patent
patent.txt line 1,943
Flags
product use code U-1054
Product numbers
001
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
10 Oct 2028 · NDA 218197 · CAPIVASERTIB
US 10,059,714, substance and product patent
patent.txt lines 20,874, 20,884
Flags
substance product
Product numbers
001, 002
10 Oct 2028 · NDA 218197 · CAPIVASERTIB
US 10,654,855, use patent
patent.txt lines 20,875, 20,885
Flags
use code U-3762
Product numbers
001, 002
10 Oct 2028 · NDA 218197 · CAPIVASERTIB
US 11,236,095, use patent
patent.txt lines 20,876, 20,886
Flags
use code U-4559
Product numbers
001, 002
10 Oct 2028 · NDA 218197 · CAPIVASERTIB
US 11,760,760, use patent
patent.txt lines 20,877, 20,887
Flags
use code U-3762
Product numbers
001, 002
10 Oct 2028 · NDA 218197 · CAPIVASERTIB
US 12,252,495, use patent
patent.txt lines 20,878, 20,888
Flags
use code U-3762
Product numbers
001, 002
10 Oct 2028 · NDA 218197 · CAPIVASERTIB
US 9,492,453, use patent
patent.txt lines 20,881, 20,891
Flags
use code U-4559
Product numbers
001, 002
11 Oct 2028 · NDA 022067 · PREDNISOLONE ACETATE
US 7,799,331, product and use patent
patent.txt lines 990, 992
Flags
product use code U-1068
Product numbers
001, 002
11 Oct 2028 · NDA 022067 · PREDNISOLONE ACETATE
US 7,799,331, product and use patent
patent.txt lines 991, 993
Flags
product use code U-139
Product numbers
001, 002
11 Oct 2028 · NDA 022383 · INDACATEROL MALEATE
US 8,479,730, product patent
patent.txt line 1,763
Flags
product
Product numbers
001
11 Oct 2028 · NDA 207923 · GLYCOPYRROLATE
US 8,479,730, product patent
patent.txt line 7,473
Flags
product
Product numbers
001
11 Oct 2028 · NDA 207930 · GLYCOPYRROLATE; INDACATEROL MALEATE
US 8,479,730, product patent
patent.txt line 7,647
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 206185 · LATANOPROST
US 9,539,262, use patent
patent.txt line 6,429
Flags
use code U-2400
Product numbers
001
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
16 Oct 2028 · NDA 212576 · CEDAZURIDINE; DECITABINE
US 8,618,075, use patent
patent.txt line 14,182
Flags
use code U-2864
Product numbers
001
16 Oct 2028 · NDA 212576 · CEDAZURIDINE; DECITABINE
US 8,618,075, use patent
patent.txt line 14,183
Flags
use code U-2867
Product numbers
001
16 Oct 2028 · NDA 212576 · CEDAZURIDINE; DECITABINE
US 9,567,363, substance patent
patent.txt line 14,184
Flags
substance
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
20 Oct 2028 · NDA 207923 · GLYCOPYRROLATE
US 8,182,838, product patent
patent.txt line 7,472
Flags
product
Product numbers
001
20 Oct 2028 · NDA 207930 · GLYCOPYRROLATE; INDACATEROL MALEATE
US 8,182,838, product patent
patent.txt line 7,646
Flags
product
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
24 Oct 2028 · NDA 021821 · TIGECYCLINE
US 8,975,242, product patent
patent.txt line 705
Flags
product
Product numbers
001
27 Oct 2028 · NDA 206488 · ETEPLIRSEN
US RE48468, use patent
patent.txt lines 6,565, 6,572
Flags
use code U-2097
Product numbers
001, 002
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
30 Oct 2028 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 7,749,194, product patent
patent.txt line 5,877
Flags
product
Product numbers
001
30 Oct 2028 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 7,749,194, product patent
patent.txt line 10,901
Flags
product
Product numbers
001
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 201923 · FLUOCINOLONE ACETONIDE
US 9,849,027, product and use patent
patent.txt line 2,606
Flags
product use code U-4157
Product numbers
001
7 Nov 2028 · NDA 201923 · FLUOCINOLONE ACETONIDE
US 9,849,027, product and use patent
patent.txt line 2,607
Flags
product use code U-708
Product numbers
001
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
9 Nov 2028 · NDA 206619 · DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
US 9,139,536, use patent
patent.txt line 6,613
Flags
use code U-1753
Product numbers
001
9 Nov 2028 · NDA 208624 · DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
US 9,139,536, use patent
patent.txt line 9,009
Flags
use code U-1753
Product numbers
001
10 Nov 2028 · NDA 206030 · CARBAMAZEPINE
US 9,629,797, use patent
patent.txt line 6,074
Flags
use code U-2004
Product numbers
001
10 Nov 2028 · NDA 206030 · CARBAMAZEPINE
US 9,629,797, use patent
patent.txt line 6,075
Flags
use code U-2005
Product numbers
001
10 Nov 2028 · NDA 206030 · CARBAMAZEPINE
US 9,629,797, use patent
patent.txt line 6,076
Flags
use code U-2006
Product numbers
001
10 Nov 2028 · NDA 206030 · CARBAMAZEPINE
US 9,770,407, product patent
patent.txt line 6,078
Flags
product
Product numbers
001
10 Nov 2028 · NDA 215029 · LIDOCAINE
US 8,722,065, product patent
patent.txt line 16,444
Flags
product
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
13 Nov 2028 · NDA 205109 · FERRIC OXYHYDROXIDE
US 10,682,376, product patent
patent.txt line 5,218
Flags
product
Product numbers
001
13 Nov 2028 · NDA 205109 · FERRIC OXYHYDROXIDE
US 10,695,367, product patent
patent.txt line 5,220
Flags
product
Product numbers
001
13 Nov 2028 · NDA 205109 · FERRIC OXYHYDROXIDE
US 10,925,896, product patent
patent.txt line 5,222
Flags
product
Product numbers
001
13 Nov 2028 · NDA 205109 · FERRIC OXYHYDROXIDE
US 10,925,897, product patent
patent.txt line 5,224
Flags
product
Product numbers
001
13 Nov 2028 · NDA 205109 · FERRIC OXYHYDROXIDE
US 10,933,090, product patent
patent.txt line 5,226
Flags
product
Product numbers
001
13 Nov 2028 · NDA 205109 · FERRIC OXYHYDROXIDE
US 11,013,761, product patent
patent.txt line 5,228
Flags
product
Product numbers
001
13 Nov 2028 · NDA 205109 · FERRIC OXYHYDROXIDE
US 11,013,762, product patent
patent.txt line 5,230
Flags
product
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
21 Nov 2028 · NDA 210303 · PLAZOMICIN SULFATE
US 8,822,424, product patent
patent.txt line 11,301
Flags
product
Product numbers
001
21 Nov 2028 · NDA 210303 · PLAZOMICIN SULFATE
US 9,266,919, use patent
patent.txt line 11,302
Flags
use code U-2328
Product numbers
001
21 Nov 2028 · NDA 210303 · PLAZOMICIN SULFATE
US 9,688,711, substance and use patent
patent.txt line 11,303
Flags
substance use code U-2328
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
25 Nov 2028 · NDA 201739 · EPINEPHRINE
US 8,231,573, product patent
patent.txt lines 2,565, 2,574, 2,583
Flags
product
Product numbers
001, 002, 003
25 Nov 2028 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 8,231,573, product patent
patent.txt line 5,882
Flags
product
Product numbers
001
25 Nov 2028 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 8,231,573, product patent
patent.txt line 10,906
Flags
product
Product numbers
001
26 Nov 2028 · NDA 207988 · LESINURAD
US 10,183,012, use patent
patent.txt line 7,921
Flags
use code U-2311
Product numbers
001
26 Nov 2028 · NDA 207988 · LESINURAD
US 8,283,369, use patent
patent.txt line 7,923
Flags
use code U-1802
Product numbers
001
26 Nov 2028 · NDA 207988 · LESINURAD
US 8,283,369, use patent
patent.txt line 7,924
Flags
use code U-1804
Product numbers
001
26 Nov 2028 · NDA 209203 · ALLOPURINOL; LESINURAD
US 10,183,012, use patent
patent.txt lines 9,859, 9,867
Flags
use code U-2104
Product numbers
001, 002
26 Nov 2028 · NDA 209203 · ALLOPURINOL; LESINURAD
US 8,283,369, use patent
patent.txt lines 9,861, 9,869
Flags
use code U-2104
Product numbers
001, 002
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 206038 · IVACAFTOR; LUMACAFTOR
US 10,076,513, product and use patent
patent.txt line 6,080
Flags
product use code U-2411
Product numbers
001
4 Dec 2028 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 10,597,384, substance and product and use patent
patent.txt lines 6,082, 6,130
Flags
substance product use code U-2777
Product numbers
001, 002
4 Dec 2028 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 11,052,075, product and use patent
patent.txt lines 6,086, 6,134
Flags
product use code U-3181
Product numbers
001, 002
4 Dec 2028 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 12,065,432, use patent
patent.txt lines 6,090, 6,138
Flags
use code U-3984
Product numbers
001, 002
4 Dec 2028 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,653,103, product patent
patent.txt lines 6,105, 6,152
Flags
product
Product numbers
001, 002
4 Dec 2028 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 9,150,552, use patent
patent.txt lines 6,120, 6,164
Flags
use code U-1908
Product numbers
001, 002
4 Dec 2028 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 10,597,384, substance and product and use patent
patent.txt lines 12,716, 12,758
Flags
substance product use code U-2778
Product numbers
001, 002
4 Dec 2028 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 10,597,384, substance and product and use patent
patent.txt line 12,800
Flags
substance product use code U-3430
Product numbers
003
4 Dec 2028 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 12,065,432, use patent
patent.txt lines 12,722, 12,764, 12,806
Flags
use code U-3983
Product numbers
001, 002, 003
4 Dec 2028 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,653,103, product patent
patent.txt lines 12,736, 12,778, 12,820
Flags
product
Product numbers
001, 002, 003
4 Dec 2028 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,150,552, use patent
patent.txt lines 12,748, 12,790
Flags
use code U-2375
Product numbers
001, 002
4 Dec 2028 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,150,552, use patent
patent.txt line 12,832
Flags
use code U-3427
Product numbers
003
4 Dec 2028 · NDA 212194 · GIVOSIRAN SODIUM
US 8,828,956, substance and product and use patent
patent.txt line 13,619
Flags
substance product use code U-2672
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 214103 · LUMASIRAN SODIUM
US 8,828,956, substance and product and use patent
patent.txt line 15,548
Flags
substance product use code U-2995
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
7 Dec 2028 · NDA 208437 · GLYCOPYRROLATE
US 9,265,900, product patent
patent.txt line 8,627
Flags
product
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
10 Dec 2028 · NDA 207145 · SAFINAMIDE MESYLATE
US 8,076,515, substance and product and use patent
patent.txt lines 7,048, 7,051
Flags
substance product use code U-1993
Product numbers
001, 002
11 Dec 2028 · NDA 216951 · DAPRODUSTAT
US 8,324,208, substance and product patent
patent.txt lines 19,047, 19,053, 19,059, 19,065, 19,071
Flags
substance product
Product numbers
001, 002, 003, 004, 005
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 022395 · CAPSAICIN
US 9,226,903, product patent
patent.txt line 1,773
Flags
product
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
15 Dec 2028 · NDA 208276 · TREPROSTINIL
US 9,593,066, substance patent
patent.txt lines 8,437–8,440
Flags
substance
Product numbers
001, 002, 003, 004
15 Dec 2028 · NDA 214324 · TREPROSTINIL
US 11,723,887, substance patent
patent.txt lines 15,678, 15,686, 15,694, 15,702, 15,710
Flags
substance
Product numbers
001, 002, 003, 004, 005
15 Dec 2028 · NDA 214324 · TREPROSTINIL
US 9,593,066, substance patent
patent.txt lines 15,682, 15,690, 15,698, 15,706, 15,714
Flags
substance
Product numbers
001, 002, 003, 004, 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
16 Dec 2028 · NDA 207202 · ARIPIPRAZOLE
US 9,119,554, product patent
patent.txt lines 7,080, 7,107, 7,134, 7,161, 7,188, 7,215
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
19 Dec 2028 · NDA 206619 · DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
US 8,501,238, substance and product and use patent
patent.txt line 6,605
Flags
substance product use code U-1636
Product numbers
001
19 Dec 2028 · NDA 208794 · TELOTRISTAT ETIPRATE
US 8,653,094, use patent
patent.txt line 9,462
Flags
use code U-1979
Product numbers
001
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
30 Dec 2028 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 10,722,667, product patent
patent.txt line 6,279
Flags
product
Product numbers
001

Pediatric exclusivity, as listed (59)

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
11 Jul 2028 · NDA 208056 · DEXLANSOPRAZOLE
US 8,871,273 with pediatric exclusivity, as listed
patent.txt line 8,044
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 022200 · EXENATIDE SYNTHETIC
US 8,361,972 with pediatric exclusivity, as listed
patent.txt lines 1,255, 1,291
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
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 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,334,270 with pediatric exclusivity, as listed
patent.txt lines 5,918, 5,951
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,580,765 with pediatric exclusivity, as listed
patent.txt lines 5,920, 5,953
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,735,372 with pediatric exclusivity, as listed
patent.txt lines 5,926, 5,959
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 9,085,573 with pediatric exclusivity, as listed
patent.txt lines 5,934, 5,967
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,334,270 with pediatric exclusivity, as listed
patent.txt lines 8,489, 8,519
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,580,765 with pediatric exclusivity, as listed
patent.txt lines 8,493, 8,523
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,735,372 with pediatric exclusivity, as listed
patent.txt lines 8,499, 8,529
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 9,085,573 with pediatric exclusivity, as listed
patent.txt lines 8,507, 8,537
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 Sep 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,334,270 with pediatric exclusivity, as listed
patent.txt line 9,822
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
21 Sep 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,580,765 with pediatric exclusivity, as listed
patent.txt line 9,828
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
21 Sep 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,735,372 with pediatric exclusivity, as listed
patent.txt line 9,837
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
21 Sep 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 9,085,573 with pediatric exclusivity, as listed
patent.txt line 9,851
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
21 Sep 2028 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,361,972 with pediatric exclusivity, as listed
patent.txt line 9,888
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
21 Sep 2028 · NDA 210874 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
US 8,716,251 with pediatric exclusivity, as listed
patent.txt lines 12,280, 12,290, 12,300, 12,310
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
21 Sep 2028 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,334,270 with pediatric exclusivity, as listed
patent.txt lines 13,991, 14,022
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,580,765 with pediatric exclusivity, as listed
patent.txt lines 13,993, 14,024
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,735,372 with pediatric exclusivity, as listed
patent.txt lines 13,999, 14,030
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 9,085,573 with pediatric exclusivity, as listed
patent.txt lines 14,007, 14,038
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 212480 · SOFOSBUVIR
US 8,334,270 with pediatric exclusivity, as listed
patent.txt lines 14,055, 14,071
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 212480 · SOFOSBUVIR
US 8,580,765 with pediatric exclusivity, as listed
patent.txt lines 14,057, 14,073
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 212480 · SOFOSBUVIR
US 9,085,573 with pediatric exclusivity, as listed
patent.txt lines 14,065, 14,081
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,334,270 with pediatric exclusivity, as listed
patent.txt lines 15,582, 15,610
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,580,765 with pediatric exclusivity, as listed
patent.txt lines 15,586, 15,614
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,735,372 with pediatric exclusivity, as listed
patent.txt lines 15,592, 15,620
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Sep 2028 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 9,085,573 with pediatric exclusivity, as listed
patent.txt lines 15,600, 15,628
Flags
substance 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
15 Nov 2028 · NDA 206829 · CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US 7,129,232 with pediatric exclusivity, as listed
patent.txt line 6,797
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
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 (120)

10 Jul 2028 · NDA 210166 · PRUCALOPRIDE SUCCINATE
M-14 exclusivity
exclusivity.txt lines 854–855
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
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 050708 · TACROLIMUS
ODE-360 exclusivity
exclusivity.txt lines 207–209
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
16 Jul 2028 · NDA 050709 · TACROLIMUS
ODE-360 exclusivity
exclusivity.txt line 210
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
16 Jul 2028 · NDA 210115 · TACROLIMUS
ODE-360 exclusivity
exclusivity.txt lines 844–845
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
16 Jul 2028 · NDA 214429 · FEXINIDAZOLE
ODE-359 exclusivity
exclusivity.txt line 1,332
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
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
20 Jul 2028 · NDA 215498 · ODEVIXIBAT
ODE-363 exclusivity
exclusivity.txt lines 1,570, 1,574, 1,578, 1,582
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
20 Jul 2028 · NDA 216993 · QUIZARTINIB DIHYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 1,827, 1,829
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
21 Jul 2028 · NDA 212905 · CANTHARIDIN
NCE exclusivity
exclusivity.txt line 1,132
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
24 Jul 2028 · NDA 210238 · AVATROMBOPAG MALEATE
I-974 exclusivity
exclusivity.txt line 856
Definition
New indication (to be checked against FDA's list)
Product numbers
001
24 Jul 2028 · NDA 217603 · LOTILANER
NCE exclusivity
exclusivity.txt line 1,893
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
24 Jul 2028 · NDA 219696 · AVATROMBOPAG MALEATE
NP exclusivity
exclusivity.txt line 2,318
Definition
New product (to be checked against FDA's list)
Product numbers
001
28 Jul 2028 · NDA 204384 · BEDAQUILINE FUMARATE
NPP exclusivity
exclusivity.txt lines 419, 423
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
28 Jul 2028 · NDA 215014 · PEGCETACOPLAN
I-972 exclusivity
exclusivity.txt line 1,458
Definition
New indication (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 218643 · ARTICAINE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 2,175
Definition
New product (to be checked against FDA's list)
Product numbers
001
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
16 Aug 2028 · NDA 215559 · PALOVAROTENE
NCE exclusivity
exclusivity.txt lines 1,591, 1,593, 1,595, 1,597, 1,599
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
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
25 Aug 2028 · NDA 219745 · LEUPROLIDE MESYLATE
NS exclusivity
exclusivity.txt line 2,322
Definition
New strength (to be checked against FDA's list)
Product numbers
001
27 Aug 2028 · NDA 211109 · ERAVACYCLINE DIHYDROCHLORIDE
GAIN exclusivity
exclusivity.txt lines 928, 930
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001, 002
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
8 Sep 2028 · NDA 217159 · MOTIXAFORTIDE ACETATE
NCE exclusivity
exclusivity.txt line 1,840
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
9 Sep 2028 · NDA 217307 · BIMATOPROST
NDF exclusivity
exclusivity.txt line 1,864
Definition
New dosage form (to be checked against FDA's list)
Product numbers
001
9 Sep 2028 · NDA 219683 · GEMCITABINE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 2,315
Definition
New product (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
10 Sep 2028 · NDA 217026 · TROFINETIDE
PED exclusivity
exclusivity.txt line 1,837
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
10 Sep 2028 · NDA 219884 · TROFINETIDE
PED exclusivity
exclusivity.txt lines 2,344, 2,348, 2,352
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
10 Sep 2028 · NDA 219943 · SELUMETINIB SULFATE
NP exclusivity
exclusivity.txt lines 2,357, 2,361
Definition
New product (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
15 Sep 2028 · NDA 214070 · ALBUTEROL SULFATE; BUDESONIDE
M-317 exclusivity
exclusivity.txt line 1,296
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
15 Sep 2028 · NDA 215310 · MOBOCERTINIB SUCCINATE
ODE-374 exclusivity
exclusivity.txt line 1,522
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
15 Sep 2028 · NDA 216873 · MOMELOTINIB DIHYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 1,797, 1,799, 1,801
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
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 021164 · GEPIRONE HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 113–116
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
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
24 Sep 2028 · NDA 215029 · LIDOCAINE
NP exclusivity
exclusivity.txt line 1,464
Definition
New product (to be checked against FDA's list)
Product numbers
001
26 Sep 2028 · NDA 217628 · CLOTRIMAZOLE
NP exclusivity
exclusivity.txt line 1,896
Definition
New product (to be checked against FDA's list)
Product numbers
001
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
29 Sep 2028 · NDA 215842 · NEDOSIRAN SODIUM
NCE exclusivity
exclusivity.txt lines 1,613, 1,617, 1,621
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
30 Sep 2028 · NDA 209401 · CYTARABINE; DAUNORUBICIN
PED exclusivity
exclusivity.txt line 783
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
2 Oct 2028 · NDA 209816 · OMADACYCLINE TOSYLATE
GAIN exclusivity
exclusivity.txt line 803
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
2 Oct 2028 · NDA 209817 · OMADACYCLINE TOSYLATE
GAIN exclusivity
exclusivity.txt line 806
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
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
10 Oct 2028 · NDA 018735 · IOPAMIDOL
I-975 exclusivity
exclusivity.txt lines 102–105
Definition
New indication (to be checked against FDA's list)
Product numbers
002, 003, 006, 007
12 Oct 2028 · NDA 216956 · ETRASIMOD ARGININE
NCE exclusivity
exclusivity.txt line 1,808
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
16 Oct 2028 · NDA 215904 · GANAXOLONE
D-197 exclusivity
exclusivity.txt line 1,671
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001
16 Oct 2028 · NDA 219868 · FERUMOXYTOL
NP exclusivity
exclusivity.txt lines 2,336–2,337
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002
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
17 Oct 2028 · NDA 216834 · ZILUCOPLAN SODIUM
NCE exclusivity
exclusivity.txt lines 1,791, 1,793, 1,795
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
17 Oct 2028 · NDA 219910 · RIBOFLAVIN 5'-PHOSPHATE SODIUM
NP exclusivity
exclusivity.txt line 2,355
Definition
New product (to be checked against FDA's list)
Product numbers
001
17 Oct 2028 · NDA 220073 · APIXABAN
PED exclusivity
exclusivity.txt line 2,373
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
22 Oct 2028 · NDA 212271 · FOSFOMYCIN DISODIUM
NP exclusivity
exclusivity.txt line 1,033
Definition
New product (to be checked against FDA's list)
Product numbers
001
26 Oct 2028 · NDA 215239 · VAMOROLONE
NCE exclusivity
exclusivity.txt line 1,498
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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
31 Oct 2028 · NDA 217369 · ZURANOLONE
NCE exclusivity
exclusivity.txt lines 1,866–1,868
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 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
8 Nov 2028 · NDA 217564 · FRUQUINTINIB
NCE exclusivity
exclusivity.txt lines 1,891–1,892
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
15 Nov 2028 · NDA 214520 · HEPARIN SODIUM; TAUROLIDINE
NCE exclusivity
exclusivity.txt lines 1,340, 1,342
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
15 Nov 2028 · NDA 218213 · REPOTRECTINIB
NCE exclusivity
exclusivity.txt lines 2,126, 2,129
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
16 Nov 2028 · NDA 210910 · RIFAMYCIN SODIUM
GAIN exclusivity
exclusivity.txt line 925
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
16 Nov 2028 · NDA 218197 · CAPIVASERTIB
NCE exclusivity
exclusivity.txt lines 2,122, 2,124
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
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
19 Nov 2028 · NDA 215390 · DEXMEDETOMIDINE HYDROCHLORIDE
M-82 exclusivity
exclusivity.txt lines 1,559–1,560
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
19 Nov 2028 · NDA 219943 · SELUMETINIB SULFATE
NPP exclusivity
exclusivity.txt lines 2,356, 2,360
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
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
22 Nov 2028 · NDA 213312 · SIROLIMUS
ODE-386 exclusivity
exclusivity.txt line 1,213
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
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
27 Nov 2028 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
NCE exclusivity
exclusivity.txt lines 1,911, 1,913, 1,915
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
29 Nov 2028 · NDA 214907 · PAFOLACIANINE SODIUM
ODE-390 exclusivity
exclusivity.txt line 1,414
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
2 Dec 2028 · NDA 216059 · PIRTOBRUTINIB
I-981 exclusivity
exclusivity.txt lines 1,713, 1,718
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
5 Dec 2028 · NDA 218276 · IPTACOPAN HYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 2,139
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
9 Dec 2028 · NDA 212819 · CILASTATIN SODIUM; IMIPENEM; RELEBACTAM
NPP exclusivity
exclusivity.txt line 1,122
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
10 Dec 2028 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
PED exclusivity
exclusivity.txt line 779
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
10 Dec 2028 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
PED exclusivity
exclusivity.txt line 1,312
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
10 Dec 2028 · NDA 215110 · GLECAPREVIR; PIBRENTASVIR
PED exclusivity
exclusivity.txt line 1,475
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
11 Dec 2028 · NDA 218230 · GEPOTIDACIN MESYLATE
I-978 exclusivity
exclusivity.txt line 2,133
Definition
New indication (to be checked against FDA's list)
Product numbers
001
11 Dec 2028 · NDA 219776 · BEROTRALSTAT DIHYDROCHLORIDE
NP exclusivity
exclusivity.txt lines 2,323, 2,325, 2,327, 2,329
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
12 Dec 2028 · NDA 216793 · ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
I-980 exclusivity
exclusivity.txt lines 1,787, 1,789
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
13 Dec 2028 · NDA 022526 · FLIBANSERIN
I-983 exclusivity
exclusivity.txt line 201
Definition
New indication (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
16 Dec 2028 · NDA 210858 · SILDENAFIL CITRATE
NP exclusivity
exclusivity.txt lines 917–920
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
17 Dec 2028 · NDA 209115 · RUCAPARIB CAMSYLATE
I-982 exclusivity
exclusivity.txt lines 764–766
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
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
18 Dec 2028 · NDA 215064 · BIRCH TRITERPENES
NCE exclusivity
exclusivity.txt line 1,470
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
19 Dec 2028 · NDA 212320 · FERRIC MALTOL
NPP exclusivity
exclusivity.txt line 1,063
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
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
19 Dec 2028 · NDA 218764 · NERANDOMILAST
I-979 exclusivity
exclusivity.txt lines 2,185, 2,188
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
21 Dec 2028 · NDA 217388 · EPLONTERSEN SODIUM
NCE exclusivity
exclusivity.txt line 1,870
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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