Drybench Patent.

Patent and exclusivity dates in 2026 for NDAs on FDA's Paragraph IV list, as FDA lists them

Each patent and exclusivity date in 2026 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 (397)

7 Jan 2026 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 7,112,592, substance and product and use patent
patent.txt line 6,573
Flags
substance product use code U-2244
Product numbers
001
7 Jan 2026 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 7,112,592, substance and product and use patent
patent.txt line 6,574
Flags
substance product use code U-2508
Product numbers
001
7 Jan 2026 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 7,112,592, substance and product and use patent
patent.txt line 6,575
Flags
substance product use code U-282
Product numbers
001
7 Jan 2026 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 7,112,592, substance and product and use patent
patent.txt line 6,576
Flags
substance product use code U-3818
Product numbers
001
8 Jan 2026 · NDA 205832 · NINTEDANIB ESYLATE
US 10,154,990, use patent
patent.txt lines 5,895, 5,903
Flags
use code U-2620
Product numbers
001, 002
10 Jan 2026 · NDA 214133 · LEVOKETOCONAZOLE
US 10,098,877, use patent
patent.txt line 15,556
Flags
use code U-3283
Product numbers
001
10 Jan 2026 · NDA 214133 · LEVOKETOCONAZOLE
US 10,517,868, use patent
patent.txt line 15,557
Flags
use code U-3283
Product numbers
001
10 Jan 2026 · NDA 214133 · LEVOKETOCONAZOLE
US 10,835,530, use patent
patent.txt line 15,558
Flags
use code U-3283
Product numbers
001
10 Jan 2026 · NDA 214133 · LEVOKETOCONAZOLE
US 11,478,471, use patent
patent.txt line 15,561
Flags
use code U-3283
Product numbers
001
11 Jan 2026 · NDA 204168 · LEVOMILNACIPRAN HYDROCHLORIDE
US RE43879, use patent
patent.txt lines 4,339, 4,342, 4,345, 4,348
Flags
use code U-839
Product numbers
001, 002, 003, 004
12 Jan 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,609,863, product patent
patent.txt lines 1,366, 1,383
Flags
product
Product numbers
001, 002
12 Jan 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,791,270, product and use patent
patent.txt lines 1,370, 1,387, 1,400, 1,406
Flags
product use code U-1542
Product numbers
001, 002, 003, 004
12 Jan 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,895,756, product patent
patent.txt lines 1,374, 1,391
Flags
product
Product numbers
001, 002
12 Jan 2026 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 8,791,270, product and use patent
patent.txt line 5,676
Flags
product use code U-1971
Product numbers
001
12 Jan 2026 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 8,791,270, product and use patent
patent.txt line 5,677
Flags
product use code U-1972
Product numbers
001
12 Jan 2026 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 8,791,270, product and use patent
patent.txt line 8,312
Flags
product use code U-1790
Product numbers
001
13 Jan 2026 · NDA 201292 · AFATINIB DIMALEATE
US RE43431, substance patent
patent.txt lines 2,407, 2,417, 2,427
Flags
substance
Product numbers
001, 002, 003
16 Jan 2026 · NDA 022560 · RISEDRONATE SODIUM
US 8,246,989, product patent
patent.txt line 2,088
Flags
product
Product numbers
001
17 Jan 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 8,461,187, product patent
patent.txt lines 1,560, 1,574
Flags
product
Product numbers
001, 002
17 Jan 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 9,238,029, product patent
patent.txt lines 1,564, 1,578
Flags
product
Product numbers
001, 002
19 Jan 2026 · NDA 021395 · TIOTROPIUM BROMIDE
US 8,022,082, product and use patent
patent.txt line 596
Flags
product use code U-1186
Product numbers
001
19 Jan 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,211,889, substance patent
patent.txt lines 10,042, 10,056
Flags
substance
Product numbers
001, 002
19 Jan 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 9,266,912, use patent
patent.txt lines 10,049, 10,063
Flags
use code U-2294
Product numbers
001, 002
19 Jan 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US RE48898, product patent
patent.txt lines 10,051, 10,065
Flags
product
Product numbers
001, 002
20 Jan 2026 · NDA 022088 · TEMSIROLIMUS
US 8,026,276, product patent
patent.txt line 1,047
Flags
product
Product numbers
001
20 Jan 2026 · NDA 209637 · SEMAGLUTIDE
US 10,357,616, product patent
patent.txt lines 10,688, 10,704, 10,721, 10,739
Flags
product delist requested
Product numbers
001, 002, 003, 004
20 Jan 2026 · NDA 209637 · SEMAGLUTIDE
US 10,376,652, product patent
patent.txt lines 10,689, 10,705, 10,722, 10,740
Flags
product delist requested
Product numbers
001, 002, 003, 004
20 Jan 2026 · NDA 209637 · SEMAGLUTIDE
US 9,108,002, product patent
patent.txt lines 10,694, 10,712, 10,729, 10,747
Flags
product delist requested
Product numbers
001, 002, 003, 004
20 Jan 2026 · NDA 209637 · SEMAGLUTIDE
US 9,616,180, product patent
patent.txt lines 10,697, 10,715, 10,732, 10,750
Flags
product delist requested
Product numbers
001, 002, 003, 004
20 Jan 2026 · NDA 209637 · SEMAGLUTIDE
US 9,861,757, product patent
patent.txt lines 10,700, 10,718, 10,735, 10,753
Flags
product delist requested
Product numbers
001, 002, 003, 004
27 Jan 2026 · NDA 022225 · SUGAMMADEX SODIUM
US RE44733, substance and product and use patent
patent.txt lines 1,353, 1,355
Flags
substance product use code U-1794
Product numbers
001, 002
28 Jan 2026 · NDA 214621 · RELUGOLIX
US 8,058,280, substance and product patent
patent.txt line 15,891
Flags
substance product
Product numbers
001
28 Jan 2026 · NDA 214846 · ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
US 8,058,280, substance and product patent
patent.txt line 16,243
Flags
substance product
Product numbers
001
6 Feb 2026 · NDA 013217 · METAXALONE
US 7,122,566, use patent
patent.txt line 132
Flags
use code U-915
Product numbers
003
6 Feb 2026 · NDA 211150 · PITOLISANT HYDROCHLORIDE
US 8,354,430, use patent
patent.txt lines 12,481, 12,486
Flags
use code U-1101
Product numbers
001, 002
6 Feb 2026 · NDA 211150 · PITOLISANT HYDROCHLORIDE
US 8,354,430, use patent
patent.txt lines 12,482, 12,487
Flags
use code U-1102
Product numbers
001, 002
19 Feb 2026 · NDA 021985 · ALISKIREN HEMIFUMARATE
US 8,617,595, product patent
patent.txt lines 866, 868
Flags
product
Product numbers
001, 002
21 Feb 2026 · NDA 021660 · PACLITAXEL
US 7,758,891, use patent
patent.txt line 660
Flags
use code U-1434
Product numbers
001
21 Feb 2026 · NDA 021660 · PACLITAXEL
US 8,268,348, use patent
patent.txt line 664
Flags
use code U-1290
Product numbers
001
21 Feb 2026 · NDA 021660 · PACLITAXEL
US 9,101,543, use patent
patent.txt line 666
Flags
use code U-1434
Product numbers
001
21 Feb 2026 · NDA 205836 · BRIVARACETAM
US 6,911,461, substance and product and use patent
patent.txt lines 5,976, 5,978, 5,980, 5,982, 5,984
Flags
substance product use code U-2295
Product numbers
001, 002, 003, 004, 005
21 Feb 2026 · NDA 205837 · BRIVARACETAM
US 6,911,461, substance and product and use patent
patent.txt line 5,985
Flags
substance product use code U-1815
Product numbers
001
21 Feb 2026 · NDA 205837 · BRIVARACETAM
US 6,911,461, substance and product and use patent
patent.txt line 5,986
Flags
substance product use code U-2130
Product numbers
001
21 Feb 2026 · NDA 205838 · BRIVARACETAM
US 6,911,461, substance and product and use patent
patent.txt line 5,987
Flags
substance product use code U-2295
Product numbers
001
22 Feb 2026 · NDA 203567 · EFINACONAZOLE
US 7,214,506, use patent
patent.txt line 4,097
Flags
use code U-281
Product numbers
001
22 Feb 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,361,649, substance and product and use patent
patent.txt lines 6,411, 6,419
Flags
substance product use code U-1694
Product numbers
001, 002
22 Feb 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,361,650, substance and product and use patent
patent.txt lines 6,413, 6,421
Flags
substance product use code U-1694
Product numbers
001, 002
22 Feb 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,879,842, substance and product and use patent
patent.txt lines 6,417, 6,425
Flags
substance product use code U-1694
Product numbers
001, 002
24 Feb 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 9,011,926, product patent
patent.txt lines 1,562, 1,576
Flags
product
Product numbers
001, 002
24 Feb 2026 · NDA 202236 · AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
US 8,168,620, product patent
patent.txt line 2,957
Flags
product
Product numbers
001
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 10,703,763, use patent
patent.txt line 559
Flags
use code U-2848
Product numbers
001
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 10,703,763, use patent
patent.txt line 569
Flags
use code U-1708
Product numbers
002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 10,703,763, use patent
patent.txt line 570
Flags
use code U-2847
Product numbers
002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 8,518,949, product patent
patent.txt lines 562, 581
Flags
product
Product numbers
001, 002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 8,741,904, substance and product and use patent
patent.txt line 563
Flags
substance product use code U-2848
Product numbers
001
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 8,741,904, substance and product and use patent
patent.txt line 583
Flags
substance product use code U-1707
Product numbers
002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 8,741,904, substance and product and use patent
patent.txt line 584
Flags
substance product use code U-1708
Product numbers
002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 8,741,904, substance and product and use patent
patent.txt line 585
Flags
substance product use code U-2847
Product numbers
002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 9,271,968, product patent
patent.txt lines 564, 589
Flags
product
Product numbers
001, 002
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 10,022,344, product and use patent
patent.txt line 773
Flags
product use code U-1731
Product numbers
001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 10,022,344, product and use patent
patent.txt line 774
Flags
product use code U-1732
Product numbers
001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 10,028,925, product and use patent
patent.txt line 775
Flags
product use code U-1731
Product numbers
001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 10,028,925, product and use patent
patent.txt line 776
Flags
product use code U-1732
Product numbers
001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 11,090,280, product and use patent
patent.txt line 777
Flags
product use code U-1731
Product numbers
001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 11,090,280, product and use patent
patent.txt line 778
Flags
product use code U-1732
Product numbers
001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 9,693,978, product patent
patent.txt line 779
Flags
product
Product numbers
001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 9,693,979, product patent
patent.txt line 780
Flags
product
Product numbers
001
13 Mar 2026 · NDA 213756 · SELUMETINIB SULFATE
US 8,178,693, substance and product patent
patent.txt lines 15,259, 15,267
Flags
substance product
Product numbers
001, 002
20 Mar 2026 · NDA 209637 · SEMAGLUTIDE
US 8,536,122, substance and product and use patent
patent.txt lines 10,692, 10,710
Flags
substance product use code U-2202
Product numbers
001, 002
20 Mar 2026 · NDA 209637 · SEMAGLUTIDE
US 8,536,122, substance and product and use patent
patent.txt line 10,727
Flags
substance product use code U-3355
Product numbers
003
20 Mar 2026 · NDA 209637 · SEMAGLUTIDE
US 8,536,122, substance and product and use patent
patent.txt line 10,745
Flags
substance product use code U-3469
Product numbers
004
20 Mar 2026 · NDA 213051 · SEMAGLUTIDE
US 8,536,122, substance and product and use patent
patent.txt lines 14,592, 14,607, 14,622, 14,632, 14,641, 14,650
Flags
substance product use code U-2628
Product numbers
001, 002, 003, 004, 005, 006
20 Mar 2026 · NDA 215256 · SEMAGLUTIDE
US 8,536,122, substance and product patent
patent.txt lines 16,609, 16,617, 16,625, 16,633, 16,643
Flags
substance product
Product numbers
001, 002, 003, 004, 005
20 Mar 2026 · NDA 218316 · SEMAGLUTIDE
US 8,536,122, substance and product patent
patent.txt lines 20,940, 20,948, 20,956, 20,965
Flags
substance product
Product numbers
001, 002, 003, 004
28 Mar 2026 · NDA 021986 · DASATINIB
US 7,491,725, substance and product patent
patent.txt lines 870, 872, 874, 876, 878, 880
Flags
substance product
Product numbers
001, 002, 003, 004, 005, 006
28 Mar 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 7,538,108, substance and use patent
patent.txt lines 10,039, 10,053
Flags
substance use code U-2294
Product numbers
001, 002
5 Apr 2026 · NDA 022051 · FLUTICASONE FUROATE
US 8,062,264, product patent
patent.txt line 976
Flags
product
Product numbers
002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt lines 1,091, 1,099
Flags
substance product use code U-1064
Product numbers
001, 002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt lines 1,092, 1,100
Flags
substance product use code U-1960
Product numbers
001, 002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt lines 1,093, 1,101
Flags
substance product use code U-1961
Product numbers
001, 002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt lines 1,094, 1,102
Flags
substance product use code U-1962
Product numbers
001, 002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt lines 1,095, 1,103
Flags
substance product use code U-1963
Product numbers
001, 002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt line 1,107
Flags
substance product use code U-1893
Product numbers
003
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt line 1,108
Flags
substance product use code U-1966
Product numbers
003
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 8,022,228, substance and product patent
patent.txt lines 1,097, 1,105, 1,110
Flags
substance product
Product numbers
001, 002, 003
9 Apr 2026 · NDA 204326 · AMPHETAMINE
US 8,840,924, product patent
patent.txt lines 4,477, 4,482, 4,487, 4,492, 4,497, 4,502
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
11 Apr 2026 · NDA 022399 · GABAPENTIN ENACARBIL
US 8,114,909, use patent
patent.txt lines 1,776, 1,780
Flags
use code U-1231
Product numbers
001, 002
11 Apr 2026 · NDA 202343 · SIMVASTATIN; SITAGLIPTIN PHOSPHATE
US 7,326,708, substance and product and use patent
patent.txt lines 3,072, 3,074, 3,076, 3,078, 3,080, 3,082
Flags
substance product use code U-1188
Product numbers
001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 8,349,840, product and use patent
patent.txt lines 5,310, 5,323, 5,336, 5,349, 5,362, 5,373
Flags
product use code U-1529
Product numbers
001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 8,618,109, use patent
patent.txt lines 5,312, 5,325, 5,338, 5,351, 5,364, 5,375
Flags
use code U-3281
Product numbers
001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 8,618,109, use patent
patent.txt lines 5,313, 5,326, 5,339, 5,352, 5,365, 5,376
Flags
use code U-543
Product numbers
001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 9,839,637, product and use patent
patent.txt lines 5,315, 5,328, 5,341, 5,354, 5,367, 5,378
Flags
product use code U-1529
Product numbers
001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 9,839,637, product and use patent
patent.txt lines 5,316, 5,329, 5,342, 5,355, 5,368, 5,379
Flags
product use code U-3281
Product numbers
001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 9,839,637, product and use patent
patent.txt lines 5,317, 5,330, 5,343, 5,356, 5,369, 5,380
Flags
product use code U-543
Product numbers
001, 002, 003, 004, 005, 006
21 Apr 2026 · NDA 022416 · ESLICARBAZEPINE ACETATE
US 9,206,135, substance patent
patent.txt lines 1,817, 1,825, 1,833, 1,841
Flags
substance
Product numbers
001, 002, 003, 004
21 Apr 2026 · NDA 022416 · ESLICARBAZEPINE ACETATE
US 9,643,929, product patent
patent.txt lines 1,819, 1,827, 1,835, 1,843
Flags
product
Product numbers
001, 002, 003, 004
21 Apr 2026 · NDA 205874 · FERRIC CITRATE
US 8,093,423, use patent
patent.txt line 5,997
Flags
use code U-1577
Product numbers
001
27 Apr 2026 · NDA 203496 · TREPROSTINIL DIOLAMINE
US 9,393,203, product and use patent
patent.txt lines 3,952, 3,962, 3,971, 3,980, 3,988
Flags
product use code U-1877
Product numbers
001, 002, 003, 004, 005
12 May 2026 · NDA 022063 · AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
US 9,173,857, use patent
patent.txt lines 983, 985, 987, 989
Flags
use code U-2025
Product numbers
001, 002, 003, 004
13 May 2026 · NDA 022252 · DIENOGEST; ESTRADIOL VALERATE
US 8,071,577, product and use patent
patent.txt line 1,407
Flags
product use code U-1
Product numbers
001
15 May 2026 · NDA 203415 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt line 3,867
Flags
use code U-1588
Product numbers
001
15 May 2026 · NDA 203415 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt line 3,868
Flags
use code U-2345
Product numbers
001
15 May 2026 · NDA 203415 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt line 3,869
Flags
use code U-2708
Product numbers
001
15 May 2026 · NDA 203415 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt line 3,870
Flags
use code U-3763
Product numbers
001
15 May 2026 · NDA 209279 · BOSENTAN
US 8,309,126, product patent
patent.txt line 10,024
Flags
product
Product numbers
001
15 May 2026 · NDA 213674 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt lines 15,174, 15,192
Flags
use code U-2345
Product numbers
001, 002
15 May 2026 · NDA 213674 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt lines 15,175, 15,193
Flags
use code U-2708
Product numbers
001, 002
15 May 2026 · NDA 213674 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt lines 15,176, 15,194
Flags
use code U-3763
Product numbers
001, 002
17 May 2026 · NDA 208073 · LIFITEGRAST
US 8,084,047, substance and product patent
patent.txt line 8,085
Flags
substance product
Product numbers
001
17 May 2026 · NDA 208073 · LIFITEGRAST
US 8,592,450, use patent
patent.txt line 8,088
Flags
use code U-1880
Product numbers
001
21 May 2026 · NDA 021539 · ACETYLCYSTEINE
US 8,148,356, product patent
patent.txt line 628
Flags
product
Product numbers
001
26 May 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 8,729,085, product patent
patent.txt lines 2,246, 2,257, 2,268, 2,279, 2,290
Flags
product
Product numbers
001, 002, 003, 004, 005
26 May 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 8,883,794, product patent
patent.txt lines 2,248, 2,259, 2,270, 2,281, 2,292
Flags
product
Product numbers
001, 002, 003, 004, 005
26 May 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 9,555,027, product and use patent
patent.txt lines 2,251, 2,262, 2,273, 2,284, 2,295
Flags
product use code U-543
Product numbers
001, 002, 003, 004, 005
26 May 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 9,907,794, product patent
patent.txt lines 2,255, 2,266, 2,277, 2,288, 2,299
Flags
product
Product numbers
001, 002, 003, 004, 005
26 May 2026 · NDA 204141 · DESOXIMETASONE
US 8,715,624, product and use patent
patent.txt line 4,332
Flags
product use code U-1408
Product numbers
001
2 Jun 2026 · NDA 022504 · TESTOSTERONE
US 8,993,520, use patent
patent.txt line 2,010
Flags
use code U-1390
Product numbers
001
2 Jun 2026 · NDA 022504 · TESTOSTERONE
US 9,180,194, use patent
patent.txt line 2,011
Flags
use code U-1390
Product numbers
001
5 Jun 2026 · NDA 205489 · METHYLPHENIDATE
US 8,840,924, product patent
patent.txt lines 5,440, 5,444, 5,448
Flags
product
Product numbers
001, 002, 003
7 Jun 2026 · NDA 022020 · PANTOPRAZOLE SODIUM
US 7,544,370, product patent
patent.txt line 911
Flags
product
Product numbers
001
7 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 10,351,517, use patent
patent.txt lines 12,558, 12,600
Flags
use code U-2548
Product numbers
001, 002
7 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,753,368, use patent
patent.txt lines 12,567, 12,608
Flags
use code U-2548
Product numbers
001, 002
7 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 12,209,059, use patent
patent.txt lines 12,591, 12,632
Flags
use code U-2548
Product numbers
001, 002
7 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 8,877,806, use patent
patent.txt lines 12,597, 12,636
Flags
use code U-2548
Product numbers
001, 002
7 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 9,604,917, use patent
patent.txt lines 12,598, 12,637
Flags
use code U-2548
Product numbers
001, 002
12 Jun 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 7,989,448, substance and use patent
patent.txt lines 10,040, 10,054
Flags
substance use code U-2294
Product numbers
001, 002
13 Jun 2026 · NDA 021937 · EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 9,018,192, use patent
patent.txt line 817
Flags
use code U-1170
Product numbers
001
13 Jun 2026 · NDA 021937 · EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 9,018,192, use patent
patent.txt line 818
Flags
use code U-750
Product numbers
001
13 Jun 2026 · NDA 021937 · EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 9,545,414, product and use patent
patent.txt line 819
Flags
product use code U-1170
Product numbers
001
13 Jun 2026 · NDA 021937 · EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 9,545,414, product and use patent
patent.txt line 820
Flags
product use code U-750
Product numbers
001
16 Jun 2026 · NDA 022165 · DICLOFENAC POTASSIUM
US 7,759,394, substance and product and use patent
patent.txt line 1,134
Flags
substance product use code U-436
Product numbers
001
16 Jun 2026 · NDA 022165 · DICLOFENAC POTASSIUM
US 8,097,651, substance and product and use patent
patent.txt line 1,135
Flags
substance product use code U-436
Product numbers
001
16 Jun 2026 · NDA 022165 · DICLOFENAC POTASSIUM
US 8,927,604, use patent
patent.txt line 1,136
Flags
use code U-436
Product numbers
001
16 Jun 2026 · NDA 022165 · DICLOFENAC POTASSIUM
US 9,827,197, product patent
patent.txt line 1,137
Flags
product
Product numbers
001
17 Jun 2026 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 7,144,884, substance and product and use patent
patent.txt lines 4,699, 4,719, 4,739, 4,759
Flags
substance product use code U-1439
Product numbers
001, 002, 003, 004
17 Jun 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,163,902, substance and use patent
patent.txt lines 10,041, 10,055
Flags
substance use code U-2294
Product numbers
001, 002
17 Jun 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,445,485, product patent
patent.txt lines 10,044, 10,058
Flags
product
Product numbers
001, 002
17 Jun 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,912,170, use patent
patent.txt lines 10,047, 10,061
Flags
use code U-2294
Product numbers
001, 002
17 Jun 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 9,283,238, use patent
patent.txt lines 10,050, 10,064
Flags
use code U-2294
Product numbers
001, 002
26 Jun 2026 · NDA 205494 · ELIGLUSTAT TARTRATE
US 7,196,205, substance patent
patent.txt line 5,458
Flags
substance
Product numbers
001
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,241,805, product patent
patent.txt lines 1,055, 1,063, 1,071
Flags
product
Product numbers
001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,569,610, use patent
patent.txt lines 1,056, 1,064, 1,072
Flags
use code U-997
Product numbers
001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,572,935, product patent
patent.txt lines 1,057, 1,065, 1,073
Flags
product
Product numbers
001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,585,897, product patent
patent.txt lines 1,058, 1,066, 1,074
Flags
product
Product numbers
001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,645,802, product patent
patent.txt lines 1,059, 1,067, 1,075
Flags
product
Product numbers
001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,649,019, product patent
patent.txt lines 1,060, 1,068, 1,076
Flags
product
Product numbers
001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,662,407, product patent
patent.txt lines 1,061, 1,069, 1,077
Flags
product
Product numbers
001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,671,094, product patent
patent.txt lines 1,062, 1,070, 1,078
Flags
product
Product numbers
001, 002, 003
1 Jul 2026 · NDA 202834 · PERAMPANEL
US 8,772,497, substance patent
patent.txt lines 3,402–3,407
Flags
substance
Product numbers
001, 002, 003, 004, 005, 006
1 Jul 2026 · NDA 208277 · PERAMPANEL
US 8,772,497, substance patent
patent.txt line 8,441
Flags
substance
Product numbers
001
6 Jul 2026 · NDA 203188 · IVACAFTOR
US 8,354,427, use patent
patent.txt line 3,663
Flags
use code U-1311
Product numbers
001
6 Jul 2026 · NDA 203188 · IVACAFTOR
US 8,354,427, use patent
patent.txt line 3,664
Flags
use code U-1905
Product numbers
001
6 Jul 2026 · NDA 207925 · IVACAFTOR
US 8,354,427, use patent
patent.txt lines 7,514, 7,547
Flags
use code U-2528
Product numbers
001, 002
6 Jul 2026 · NDA 207925 · IVACAFTOR
US 8,354,427, use patent
patent.txt lines 7,512, 7,545, 7,578
Flags
use code U-1311
Product numbers
001, 002, 003
6 Jul 2026 · NDA 207925 · IVACAFTOR
US 8,354,427, use patent
patent.txt lines 7,513, 7,546, 7,579
Flags
use code U-1905
Product numbers
001, 002, 003
6 Jul 2026 · NDA 207925 · IVACAFTOR
US 8,354,427, use patent
patent.txt line 7,580
Flags
use code U-2964
Product numbers
003
6 Jul 2026 · NDA 207925 · IVACAFTOR
US 8,354,427, use patent
patent.txt lines 7,609, 7,637
Flags
use code U-3608
Product numbers
004, 005
11 Jul 2026 · NDA 208254 · NETARSUDIL MESYLATE
US 10,532,993, use patent
patent.txt line 8,393
Flags
use code U-1524
Product numbers
001
11 Jul 2026 · NDA 208254 · NETARSUDIL MESYLATE
US 10,882,840, use patent
patent.txt line 8,396
Flags
use code U-1524
Product numbers
001
11 Jul 2026 · NDA 208254 · NETARSUDIL MESYLATE
US 11,021,456, use patent
patent.txt line 8,398
Flags
use code U-1524
Product numbers
001
11 Jul 2026 · NDA 208254 · NETARSUDIL MESYLATE
US 8,450,344, substance and product and use patent
patent.txt line 8,403
Flags
substance product use code U-1524
Product numbers
001
11 Jul 2026 · NDA 208254 · NETARSUDIL MESYLATE
US 9,096,569, substance and product and use patent
patent.txt line 8,404
Flags
substance product use code U-1524
Product numbers
001
11 Jul 2026 · NDA 208259 · LATANOPROST; NETARSUDIL DIMESYLATE
US 10,532,993, use patent
patent.txt line 8,408
Flags
use code U-1524
Product numbers
001
11 Jul 2026 · NDA 208259 · LATANOPROST; NETARSUDIL DIMESYLATE
US 10,882,840, use patent
patent.txt line 8,411
Flags
use code U-1524
Product numbers
001
11 Jul 2026 · NDA 208259 · LATANOPROST; NETARSUDIL DIMESYLATE
US 11,021,456, use patent
patent.txt line 8,413
Flags
use code U-1524
Product numbers
001
11 Jul 2026 · NDA 208259 · LATANOPROST; NETARSUDIL DIMESYLATE
US 8,450,344, substance and product and use patent
patent.txt line 8,419
Flags
substance product use code U-1524
Product numbers
001
11 Jul 2026 · NDA 208259 · LATANOPROST; NETARSUDIL DIMESYLATE
US 9,096,569, substance and product and use patent
patent.txt line 8,420
Flags
substance product use code U-1524
Product numbers
001
17 Jul 2026 · NDA 209637 · SEMAGLUTIDE
US 10,220,155, product patent
patent.txt lines 10,686, 10,702, 10,720, 10,737
Flags
product delist requested
Product numbers
001, 002, 003, 004
17 Jul 2026 · NDA 209637 · SEMAGLUTIDE
US 11,097,063, product patent
patent.txt lines 10,690, 10,706, 10,723, 10,741
Flags
product delist requested
Product numbers
001, 002, 003, 004
17 Jul 2026 · NDA 209637 · SEMAGLUTIDE
US 8,920,383, product patent
patent.txt lines 10,693, 10,711, 10,728, 10,746
Flags
product delist requested
Product numbers
001, 002, 003, 004
17 Jul 2026 · NDA 209637 · SEMAGLUTIDE
US 9,775,953, product patent
patent.txt lines 10,699, 10,717, 10,734, 10,752
Flags
product delist requested
Product numbers
001, 002, 003, 004
18 Jul 2026 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,389,537, use patent
patent.txt lines 999, 1,013, 1,027
Flags
use code U-1374
Product numbers
001, 002, 003
18 Jul 2026 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,415,363, substance and product and use patent
patent.txt lines 1,001, 1,015, 1,029
Flags
substance product use code U-1374
Product numbers
001, 002, 003
18 Jul 2026 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,415,363, substance and product and use patent
patent.txt lines 1,002, 1,016, 1,030
Flags
substance product use code U-1407
Product numbers
001, 002, 003
18 Jul 2026 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,501,760, product patent
patent.txt lines 1,004, 1,018, 1,032
Flags
product
Product numbers
001, 002, 003
18 Jul 2026 · NDA 022519 · FAMOTIDINE; IBUPROFEN
US 8,067,451, product and use patent
patent.txt line 2,031
Flags
product use code U-1196
Product numbers
001
18 Jul 2026 · NDA 022519 · FAMOTIDINE; IBUPROFEN
US 8,309,127, product patent
patent.txt line 2,032
Flags
product
Product numbers
001
18 Jul 2026 · NDA 022519 · FAMOTIDINE; IBUPROFEN
US 8,318,202, product patent
patent.txt line 2,033
Flags
product
Product numbers
001
18 Jul 2026 · NDA 022519 · FAMOTIDINE; IBUPROFEN
US 8,449,910, product patent
patent.txt line 2,034
Flags
product
Product numbers
001
18 Jul 2026 · NDA 022519 · FAMOTIDINE; IBUPROFEN
US 8,501,228, use patent
patent.txt line 2,035
Flags
use code U-1196
Product numbers
001
20 Jul 2026 · NDA 202714 · CARFILZOMIB
US 7,417,042, substance and product patent
patent.txt lines 3,139, 3,149, 3,159
Flags
substance product
Product numbers
001, 002, 003
28 Jul 2026 · NDA 021436 · ARIPIPRAZOLE
US 9,125,939, use patent
patent.txt lines 602, 604, 606, 608, 610, 612
Flags
use code U-1749
Product numbers
001, 002, 003, 004, 005, 006
28 Jul 2026 · NDA 021729 · ARIPIPRAZOLE
US 9,125,939, use patent
patent.txt lines 689, 691
Flags
use code U-1749
Product numbers
002, 003
30 Jul 2026 · NDA 203496 · TREPROSTINIL DIOLAMINE
US 7,417,070, substance patent
patent.txt lines 3,947, 3,956, 3,965, 3,974, 3,983
Flags
substance
Product numbers
001, 002, 003, 004, 005
31 Jul 2026 · NDA 022024 · METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
US 7,785,627, product patent
patent.txt lines 912, 914
Flags
product
Product numbers
001, 002
31 Jul 2026 · NDA 022024 · METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
US 7,959,946, product patent
patent.txt lines 913, 915
Flags
product
Product numbers
001, 002
2 Aug 2026 · NDA 022205 · BALSALAZIDE DISODIUM
US 9,192,616, use patent
patent.txt line 1,346
Flags
use code U-1229
Product numbers
001
2 Aug 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 7,790,755, product patent
patent.txt lines 1,552, 1,566
Flags
product
Product numbers
001, 002
3 Aug 2026 · NDA 209637 · SEMAGLUTIDE
US RE46363, product patent
patent.txt lines 10,701, 10,719, 10,736, 10,754
Flags
product delist requested
Product numbers
001, 002, 003, 004
4 Aug 2026 · NDA 204516 · PAROXETINE MESYLATE
US 8,946,251, substance and product and use patent
patent.txt line 4,824
Flags
substance product use code U-904
Product numbers
001
4 Aug 2026 · NDA 204516 · PAROXETINE MESYLATE
US 9,393,237, use patent
patent.txt line 4,825
Flags
use code U-904
Product numbers
001
10 Aug 2026 · NDA 206256 · BELINOSTAT
US 6,888,027, substance and product and use patent
patent.txt line 6,453
Flags
substance product use code U-1544
Product numbers
001
11 Aug 2026 · NDA 203505 · OSPEMIFENE
US 8,236,861, use patent
patent.txt line 3,991
Flags
use code U-1369
Product numbers
001
11 Aug 2026 · NDA 203505 · OSPEMIFENE
US 8,236,861, use patent
patent.txt line 3,992
Flags
use code U-1370
Product numbers
001
11 Aug 2026 · NDA 203505 · OSPEMIFENE
US 8,236,861, use patent
patent.txt line 3,993
Flags
use code U-905
Product numbers
001
13 Aug 2026 · NDA 021660 · PACLITAXEL
US 8,034,375, use patent
patent.txt line 662
Flags
use code U-1290
Product numbers
001
13 Aug 2026 · NDA 021879 · DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
US 7,659,282, use patent
patent.txt line 748
Flags
use code U-1093
Product numbers
001
14 Aug 2026 · NDA 018613 · MALATHION
US 7,977,324, product patent
patent.txt line 139
Flags
product
Product numbers
001
14 Aug 2026 · NDA 208692 · CABOZANTINIB S-MALATE
US 7,579,473, substance and product patent
patent.txt lines 9,194, 9,214, 9,234
Flags
substance product
Product numbers
001, 002, 003
18 Aug 2026 · NDA 202293 · DAPAGLIFLOZIN
US 8,329,648, use patent
patent.txt lines 2,987, 3,025
Flags
use code U-2139
Product numbers
001, 002
18 Aug 2026 · NDA 202293 · DAPAGLIFLOZIN
US 8,329,648, use patent
patent.txt lines 2,988, 3,026
Flags
use code U-2212
Product numbers
001, 002
18 Aug 2026 · NDA 202293 · DAPAGLIFLOZIN
US 8,329,648, use patent
patent.txt lines 2,989, 3,027
Flags
use code U-2213
Product numbers
001, 002
18 Aug 2026 · NDA 202293 · DAPAGLIFLOZIN
US 8,906,851, use patent
patent.txt lines 3,002, 3,040
Flags
use code U-2139
Product numbers
001, 002
24 Aug 2026 · NDA 020610 · BALSALAZIDE DISODIUM
US 7,452,872, use patent
patent.txt line 189
Flags
use code U-141
Product numbers
001
24 Aug 2026 · NDA 020610 · BALSALAZIDE DISODIUM
US 7,625,884, use patent
patent.txt line 191
Flags
use code U-141
Product numbers
001
24 Aug 2026 · NDA 022205 · BALSALAZIDE DISODIUM
US 7,452,872, use patent
patent.txt line 1,343
Flags
use code U-1229
Product numbers
001
24 Aug 2026 · NDA 022205 · BALSALAZIDE DISODIUM
US 7,625,884, use patent
patent.txt line 1,344
Flags
use code U-1229
Product numbers
001
24 Aug 2026 · NDA 203415 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt line 3,862
Flags
use code U-1281
Product numbers
001
24 Aug 2026 · NDA 203415 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt line 3,863
Flags
use code U-1588
Product numbers
001
24 Aug 2026 · NDA 203415 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt line 3,864
Flags
use code U-2345
Product numbers
001
24 Aug 2026 · NDA 203415 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt line 3,865
Flags
use code U-2708
Product numbers
001
24 Aug 2026 · NDA 203415 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt line 3,866
Flags
use code U-3763
Product numbers
001
24 Aug 2026 · NDA 207318 · PIMAVANSERIN TARTRATE
US 7,659,285, use patent
patent.txt lines 7,234, 7,243
Flags
use code U-1844
Product numbers
001, 002
24 Aug 2026 · NDA 210793 · PIMAVANSERIN TARTRATE
US 7,659,285, use patent
patent.txt line 12,148
Flags
use code U-1844
Product numbers
001
24 Aug 2026 · NDA 213674 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt lines 15,171, 15,189
Flags
use code U-2345
Product numbers
001, 002
24 Aug 2026 · NDA 213674 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt lines 15,172, 15,190
Flags
use code U-2708
Product numbers
001, 002
24 Aug 2026 · NDA 213674 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt lines 15,173, 15,191
Flags
use code U-3763
Product numbers
001, 002
27 Aug 2026 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 7,176,220, substance and product and use patent
patent.txt line 3,632
Flags
substance product use code U-257
Product numbers
001
27 Aug 2026 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 7,176,220, substance and product and use patent
patent.txt line 7,349
Flags
substance product use code U-257
Product numbers
001
28 Aug 2026 · NDA 021529 · ETONOGESTREL
US 8,888,745, product patent
patent.txt line 626
Flags
product
Product numbers
002
29 Aug 2026 · NDA 206302 · NEBIVOLOL HYDROCHLORIDE; VALSARTAN
US 7,803,838, product patent
patent.txt line 6,457
Flags
product
Product numbers
001
30 Aug 2026 · NDA 202811 · LINACLOTIDE
US 7,304,036, substance and product and use patent
patent.txt line 3,334
Flags
substance product use code U-4345
Product numbers
001
30 Aug 2026 · NDA 202811 · LINACLOTIDE
US 7,304,036, substance and product and use patent
patent.txt lines 3,332, 3,348
Flags
substance product use code U-1278
Product numbers
001, 002
30 Aug 2026 · NDA 202811 · LINACLOTIDE
US 7,304,036, substance and product and use patent
patent.txt lines 3,333, 3,349, 3,366
Flags
substance product use code U-1516
Product numbers
001, 002, 003
30 Aug 2026 · NDA 202811 · LINACLOTIDE
US 7,304,036, substance and product and use patent
patent.txt line 3,367
Flags
substance product use code U-3644
Product numbers
003
30 Aug 2026 · NDA 202811 · LINACLOTIDE
US 7,304,036, substance and product and use patent
patent.txt line 3,368
Flags
substance product use code U-4566
Product numbers
003
1 Sep 2026 · NDA 022275 · TOLVAPTAN
US 8,501,730, substance patent
patent.txt lines 1,544, 1,546, 1,548
Flags
substance
Product numbers
001, 002, 003
1 Sep 2026 · NDA 204441 · TOLVAPTAN
US 8,501,730, substance patent
patent.txt lines 4,687, 4,689, 4,691, 4,693, 4,695
Flags
substance
Product numbers
001, 002, 003, 004, 005
11 Sep 2026 · NDA 204410 · MACITENTAN
US 10,946,015, product and use patent
patent.txt line 4,667
Flags
product use code U-1445
Product numbers
001
12 Sep 2026 · NDA 202992 · TERIFLUNOMIDE
US 6,794,410, use patent
patent.txt lines 3,589, 3,595
Flags
use code U-1285
Product numbers
001, 002
19 Sep 2026 · NDA 206947 · LENVATINIB MESYLATE
US 7,612,208, substance and product patent
patent.txt lines 6,892, 6,913
Flags
substance product
Product numbers
001, 002
22 Sep 2026 · NDA 021688 · CINACALCET HYDROCHLORIDE
US 7,829,595, product and use patent
patent.txt lines 675, 677, 679
Flags
product use code U-1098
Product numbers
001, 002, 003
22 Sep 2026 · NDA 021688 · CINACALCET HYDROCHLORIDE
US 9,375,405, product patent
patent.txt lines 676, 678, 680
Flags
product
Product numbers
001, 002, 003
22 Sep 2026 · NDA 022535 · PIRFENIDONE
US 7,767,225, product and use patent
patent.txt line 2,060
Flags
product use code U-1602
Product numbers
001
22 Sep 2026 · NDA 022535 · PIRFENIDONE
US 7,988,994, product and use patent
patent.txt line 2,064
Flags
product use code U-1602
Product numbers
001
22 Sep 2026 · NDA 022535 · PIRFENIDONE
US 8,753,679, product and use patent
patent.txt line 2,073
Flags
product use code U-1602
Product numbers
001
27 Sep 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 8,105,626, product patent
patent.txt lines 1,554, 1,568
Flags
product
Product numbers
001, 002
4 Oct 2026 · NDA 022568 · DONEPEZIL HYDROCHLORIDE
US 8,481,565, product patent
patent.txt line 2,097
Flags
product
Product numbers
001
10 Oct 2026 · NDA 021747 · ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
US 7,396,341, product patent
patent.txt line 695
Flags
product delist requested
Product numbers
001
10 Oct 2026 · NDA 021936 · TIOTROPIUM BROMIDE
US 7,396,341, product patent
patent.txt line 809
Flags
product delist requested
Product numbers
001
10 Oct 2026 · NDA 206756 · OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
US 7,396,341, product patent
patent.txt line 6,757
Flags
product delist requested
Product numbers
001
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,466,136, product patent
patent.txt lines 1,620, 1,628, 1,636
Flags
product
Product numbers
001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,466,137, use patent
patent.txt lines 1,621, 1,629, 1,637
Flags
use code U-1103
Product numbers
001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,466,138, use patent
patent.txt lines 1,622, 1,630, 1,638
Flags
use code U-1103
Product numbers
001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,486,925, product patent
patent.txt lines 1,623, 1,631, 1,639
Flags
product
Product numbers
001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,729,057, product patent
patent.txt lines 1,624, 1,632, 1,640
Flags
product
Product numbers
001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,741,881, use patent
patent.txt lines 1,625, 1,633, 1,641
Flags
use code U-1103
Product numbers
001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,754,070, product patent
patent.txt lines 1,626, 1,634, 1,642
Flags
product
Product numbers
001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,759,329, product patent
patent.txt lines 1,627, 1,635, 1,643
Flags
product
Product numbers
001, 002, 003
26 Oct 2026 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 7,635,704, substance and product and use patent
patent.txt line 3,634
Flags
substance product use code U-257
Product numbers
001
26 Oct 2026 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 8,981,103, substance and product patent
patent.txt line 3,640
Flags
substance product
Product numbers
001
26 Oct 2026 · NDA 203585 · OMACETAXINE MEPESUCCINATE
US 6,987,103, use patent
patent.txt line 4,106
Flags
use code U-1300
Product numbers
001
26 Oct 2026 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 7,635,704, substance and product and use patent
patent.txt line 7,351
Flags
substance product use code U-257
Product numbers
001
26 Oct 2026 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,981,103, substance and product patent
patent.txt line 7,359
Flags
substance product
Product numbers
001
31 Oct 2026 · NDA 207947 · SELEXIPAG
US 7,205,302, substance and product and use patent
patent.txt lines 7,699, 7,711, 7,723, 7,735, 7,747, 7,759, 7,771, 7,783, 7,795, 7,807
Flags
substance product use code U-1797
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 010, 011
31 Oct 2026 · NDA 214275 · SELEXIPAG
US 7,205,302, substance and product and use patent
patent.txt line 15,659
Flags
substance product use code U-1797
Product numbers
001
2 Nov 2026 · NDA 209501 · PREGABALIN
US 10,022,447, use patent
patent.txt lines 10,532, 10,540, 10,548
Flags
use code U-2136
Product numbers
001, 002, 003
2 Nov 2026 · NDA 209501 · PREGABALIN
US 10,022,447, use patent
patent.txt lines 10,533, 10,541, 10,549
Flags
use code U-2137
Product numbers
001, 002, 003
2 Nov 2026 · NDA 209501 · PREGABALIN
US 8,945,620, product and use patent
patent.txt lines 10,535, 10,543, 10,551
Flags
product use code U-2136
Product numbers
001, 002, 003
2 Nov 2026 · NDA 209501 · PREGABALIN
US 8,945,620, product and use patent
patent.txt lines 10,536, 10,544, 10,552
Flags
product use code U-2137
Product numbers
001, 002, 003
2 Nov 2026 · NDA 209501 · PREGABALIN
US 9,144,559, product patent
patent.txt lines 10,538, 10,546, 10,554
Flags
product
Product numbers
001, 002, 003
8 Nov 2026 · NDA 207620 · SACUBITRIL; VALSARTAN
US 9,388,134, use patent
patent.txt lines 7,380, 7,388, 7,396
Flags
use code U-1723
Product numbers
001, 002, 003
9 Nov 2026 · NDA 201292 · AFATINIB DIMALEATE
US 9,539,258, use patent
patent.txt lines 2,405, 2,415, 2,425
Flags
use code U-1950
Product numbers
001, 002, 003
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 11,197,822, product patent
patent.txt line 15,395
Flags
product
Product numbers
001
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 11,413,296, product patent
patent.txt line 15,398
Flags
product
Product numbers
001
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 8,497,258, use patent
patent.txt line 15,401
Flags
use code U-3820
Product numbers
001
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 8,679,545, product patent
patent.txt line 15,402
Flags
product
Product numbers
001
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 8,975,243, use patent
patent.txt line 15,403
Flags
use code U-3820
Product numbers
001
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 9,119,863, use patent
patent.txt line 15,405
Flags
use code U-3820
Product numbers
001
10 Nov 2026 · NDA 022399 · GABAPENTIN ENACARBIL
US 8,026,279, substance and product patent
patent.txt lines 1,775, 1,779
Flags
substance product
Product numbers
001, 002
12 Nov 2026 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 7,612,087, product patent
patent.txt line 6,577
Flags
product
Product numbers
001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,777
Flags
substance product use code U-1167
Product numbers
001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,782
Flags
substance product use code U-1501
Product numbers
001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,783
Flags
substance product use code U-1502
Product numbers
001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,784
Flags
substance product use code U-1729
Product numbers
001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,785
Flags
substance product use code U-1730
Product numbers
001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt lines 2,778, 2,790
Flags
substance product use code U-1200
Product numbers
001, 002
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt lines 2,779, 2,791
Flags
substance product use code U-1301
Product numbers
001, 002
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt lines 2,780, 2,792
Flags
substance product use code U-1302
Product numbers
001, 002
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt lines 2,781, 2,793
Flags
substance product use code U-1323
Product numbers
001, 002
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt lines 2,786, 2,794
Flags
substance product use code U-4178
Product numbers
001, 002
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,798
Flags
substance product use code U-4179
Product numbers
003
23 Nov 2026 · NDA 203341 · BOSUTINIB MONOHYDRATE
US 7,767,678, substance and product patent
patent.txt lines 3,778, 3,789, 3,800
Flags
substance product
Product numbers
001, 002, 003
24 Nov 2026 · NDA 021995 · SITAGLIPTIN PHOSPHATE
US 7,326,708, substance and product and use patent
patent.txt lines 891, 893, 895
Flags
substance product use code U-802
Product numbers
001, 002, 003
24 Nov 2026 · NDA 022044 · METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
US 7,326,708, substance and product and use patent
patent.txt lines 966, 970
Flags
substance product use code U-802
Product numbers
001, 002
24 Nov 2026 · NDA 202270 · METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
US 7,326,708, substance and product and use patent
patent.txt lines 2,961, 2,963, 2,965
Flags
substance product use code U-1227
Product numbers
001, 002, 003
24 Nov 2026 · NDA 210259 · ACALABRUTINIB
US 7,459,554, substance patent
patent.txt line 11,263
Flags
substance
Product numbers
001
24 Nov 2026 · NDA 216387 · ACALABRUTINIB MALEATE
US 7,459,554, substance patent
patent.txt line 18,790
Flags
substance
Product numbers
001
28 Nov 2026 · NDA 020533 · ROPIVACAINE HYDROCHLORIDE
US 7,857,802, product patent
patent.txt lines 186–187
Flags
product
Product numbers
006, 007
2 Dec 2026 · NDA 050793 · CLINDAMYCIN PHOSPHATE
US 9,789,057, product and use patent
patent.txt line 2,144
Flags
product use code U-137
Product numbers
001
4 Dec 2026 · NDA 204819 · RIOCIGUAT
US 7,173,037, substance and product patent
patent.txt lines 5,023, 5,030, 5,037, 5,044, 5,051
Flags
substance product
Product numbers
001, 002, 003, 004, 005
5 Dec 2026 · NDA 021641 · RASAGILINE MESYLATE
US 7,572,834, product patent
patent.txt lines 653, 655
Flags
product
Product numbers
001, 002
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 2,823, 2,852, 2,881, 2,910, 2,939
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 2,824, 2,853, 2,882, 2,911, 2,940
Flags
use code U-3227
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 2,825, 2,854, 2,883, 2,912, 2,941
Flags
use code U-3228
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 2,826, 2,855, 2,884, 2,913, 2,942
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,814,722, use patent
patent.txt lines 2,828, 2,857, 2,886, 2,915, 2,944
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,814,722, use patent
patent.txt lines 2,829, 2,858, 2,887, 2,916, 2,945
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,867,996, substance and product and use patent
patent.txt lines 6,415, 6,423
Flags
substance product use code U-1694
Product numbers
001, 002
12 Dec 2026 · NDA 213756 · SELUMETINIB SULFATE
US 9,156,795, substance and product patent
patent.txt lines 15,260, 15,268
Flags
substance product
Product numbers
001, 002
12 Dec 2026 · NDA 213756 · SELUMETINIB SULFATE
US 9,562,017, substance and use patent
patent.txt lines 15,261, 15,269
Flags
substance use code U-4357
Product numbers
001, 002
12 Dec 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 10,639,310, use patent
patent.txt line 16,736
Flags
use code U-3229
Product numbers
001
12 Dec 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt line 16,766
Flags
use code U-3229
Product numbers
001
12 Dec 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt line 16,767
Flags
use code U-3404
Product numbers
001
12 Dec 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 9,974,790, use patent
patent.txt line 16,769
Flags
use code U-3229
Product numbers
001
12 Dec 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 9,974,790, use patent
patent.txt line 16,770
Flags
use code U-3404
Product numbers
001
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 11,744,832, use patent
patent.txt lines 19,311, 19,364, 19,417, 19,470, 19,523
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 11,744,832, use patent
patent.txt lines 19,312, 19,365, 19,418, 19,471, 19,524
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,530,485, product patent
patent.txt lines 19,323, 19,376, 19,429, 19,482, 19,535
Flags
product
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 19,334, 19,387, 19,440, 19,493, 19,546
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 19,335, 19,388, 19,441, 19,494, 19,547
Flags
use code U-3227
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 19,336, 19,389, 19,442, 19,495, 19,548
Flags
use code U-3228
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 19,337, 19,390, 19,443, 19,496, 19,549
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,206,187, use patent
patent.txt lines 19,338, 19,391, 19,444, 19,497, 19,550
Flags
use code U-3227
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,206,187, use patent
patent.txt lines 19,339, 19,392, 19,445, 19,498, 19,551
Flags
use code U-3228
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,814,722, use patent
patent.txt lines 19,340, 19,393, 19,446, 19,499, 19,552
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,814,722, use patent
patent.txt lines 19,341, 19,394, 19,447, 19,500, 19,553
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
16 Dec 2026 · NDA 212327 · FEDRATINIB HYDROCHLORIDE
US 7,825,246, substance patent
patent.txt line 13,952
Flags
substance
Product numbers
001
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,372,827, product patent
patent.txt lines 3,380, 3,392
Flags
product
Product numbers
001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,372,828, product patent
patent.txt lines 3,381, 3,393
Flags
product
Product numbers
001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,377,919, product patent
patent.txt lines 3,382, 3,394
Flags
product
Product numbers
001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,536,163, use patent
patent.txt lines 3,383, 3,395
Flags
use code U-1440
Product numbers
001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,716,271, use patent
patent.txt lines 3,384, 3,396
Flags
use code U-1440
Product numbers
001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,735,375, use patent
patent.txt lines 3,385, 3,397
Flags
use code U-1440
Product numbers
001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 9,820,959, product and use patent
patent.txt lines 3,387, 3,398
Flags
product use code U-1440
Product numbers
001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 9,833,428, product patent
patent.txt lines 3,388, 3,399
Flags
product
Product numbers
001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 9,833,429, product patent
patent.txt lines 3,389, 3,400
Flags
product
Product numbers
001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 9,861,603, use patent
patent.txt lines 3,390, 3,401
Flags
use code U-1440
Product numbers
001, 002
19 Dec 2026 · NDA 211996 · TAFAMIDIS MEGLUMINE
US 7,214,695, substance and product patent
patent.txt line 13,380
Flags
substance product
Product numbers
001
19 Dec 2026 · NDA 211996 · TAFAMIDIS MEGLUMINE
US 7,214,696, use patent
patent.txt line 13,381
Flags
use code U-2524
Product numbers
001
19 Dec 2026 · NDA 212161 · TAFAMIDIS
US 7,214,695, substance and product patent
patent.txt line 13,611
Flags
substance product
Product numbers
001
19 Dec 2026 · NDA 212161 · TAFAMIDIS
US 7,214,696, use patent
patent.txt line 13,612
Flags
use code U-2524
Product numbers
001
20 Dec 2026 · NDA 216665 · DIAZOXIDE CHOLINE
US 7,572,789, substance and product patent
patent.txt lines 18,898, 18,904, 18,910
Flags
substance product
Product numbers
001, 002, 003
22 Dec 2026 · NDA 203469 · PONATINIB HYDROCHLORIDE
US 9,029,533, use patent
patent.txt lines 3,885, 3,902, 3,919, 3,936
Flags
use code U-1283
Product numbers
001, 002, 003, 004
22 Dec 2026 · NDA 203469 · PONATINIB HYDROCHLORIDE
US 9,029,533, use patent
patent.txt lines 3,886, 3,903, 3,920, 3,937
Flags
use code U-1699
Product numbers
001, 002, 003, 004
22 Dec 2026 · NDA 203469 · PONATINIB HYDROCHLORIDE
US 9,029,533, use patent
patent.txt lines 3,887, 3,904, 3,921, 3,938
Flags
use code U-1700
Product numbers
001, 002, 003, 004
22 Dec 2026 · NDA 203469 · PONATINIB HYDROCHLORIDE
US 9,029,533, use patent
patent.txt lines 3,888, 3,905, 3,922, 3,939
Flags
use code U-1701
Product numbers
001, 002, 003, 004
22 Dec 2026 · NDA 203469 · PONATINIB HYDROCHLORIDE
US 9,029,533, use patent
patent.txt lines 3,889, 3,906, 3,923, 3,940
Flags
use code U-836
Product numbers
001, 002, 003, 004
26 Dec 2026 · NDA 021976 · DARUNAVIR
US 7,700,645, substance and product patent
patent.txt lines 853, 855, 857, 859, 861, 863
Flags
substance product
Product numbers
001, 002, 003, 004, 005, 006
26 Dec 2026 · NDA 205395 · COBICISTAT; DARUNAVIR ETHANOLATE
US 7,700,645, substance and product patent
patent.txt lines 5,297, 5,303
Flags
substance product
Product numbers
001, 002
26 Dec 2026 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 7,700,645, substance and product patent
patent.txt line 11,403
Flags
substance product
Product numbers
001
28 Dec 2026 · NDA 203188 · IVACAFTOR
US 8,410,274, product patent
patent.txt line 3,666
Flags
product
Product numbers
001
28 Dec 2026 · NDA 203188 · IVACAFTOR
US 8,754,224, substance and product patent
patent.txt line 3,668
Flags
substance product
Product numbers
001
28 Dec 2026 · NDA 203188 · IVACAFTOR
US 9,670,163, product and use patent
patent.txt line 3,670
Flags
product use code U-1311
Product numbers
001
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 7,514,444, substance and product patent
patent.txt lines 5,508, 5,605
Flags
substance product
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,476,284, use patent
patent.txt lines 5,512, 5,609
Flags
use code U-1650
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,476,284, use patent
patent.txt lines 5,513, 5,610
Flags
use code U-1946
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,515, 5,612
Flags
use code U-1491
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,516, 5,613
Flags
use code U-1650
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,517, 5,614
Flags
use code U-1946
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,518, 5,615
Flags
use code U-2241
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,519, 5,616
Flags
use code U-2242
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,520, 5,617
Flags
use code U-3422
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,697,711, substance and product patent
patent.txt lines 5,527, 5,624
Flags
substance product
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,703,780, use patent
patent.txt lines 5,529, 5,626
Flags
use code U-1491
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,735,403, substance and product patent
patent.txt lines 5,531, 5,628
Flags
substance product
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,754,091, product patent
patent.txt lines 5,533, 5,630
Flags
product
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 5,535, 5,632
Flags
use code U-1491
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 5,536, 5,633
Flags
use code U-1650
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 5,537, 5,634
Flags
use code U-1946
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,957,079, substance and product patent
patent.txt lines 5,539, 5,636
Flags
substance product
Product numbers
001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 9,181,257, substance and product patent
patent.txt line 5,546
Flags
substance product
Product numbers
001
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 9,181,257, substance patent
patent.txt line 5,644
Flags
substance
Product numbers
002
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 8,410,274, product patent
patent.txt lines 7,516, 7,549, 7,582, 7,611, 7,639
Flags
product
Product numbers
001, 002, 003, 004, 005
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 8,754,224, substance and product patent
patent.txt lines 7,518, 7,551, 7,584, 7,613, 7,641
Flags
substance product
Product numbers
001, 002, 003, 004, 005
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 7,523, 7,556
Flags
product use code U-2530
Product numbers
001, 002
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 7,522, 7,555, 7,588
Flags
product use code U-1311
Product numbers
001, 002, 003
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 9,670,163, product and use patent
patent.txt line 7,589
Flags
product use code U-2966
Product numbers
003
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 7,617, 7,645
Flags
product use code U-3606
Product numbers
004, 005
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 7,514,444, substance and product patent
patent.txt lines 11,631, 11,735, 11,839, 11,941
Flags
substance product
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,476,284, use patent
patent.txt lines 11,635, 11,739, 11,843, 11,946
Flags
use code U-1650
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,476,284, use patent
patent.txt lines 11,636, 11,740, 11,844, 11,947
Flags
use code U-1946
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,476,284, use patent
patent.txt lines 11,637, 11,741, 11,845, 11,949
Flags
use code U-2241
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,476,284, use patent
patent.txt line 11,945
Flags
use code U-1456
Product numbers
004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,476,284, use patent
patent.txt line 11,948
Flags
use code U-1947
Product numbers
004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,644, 11,748, 11,852
Flags
use code U-3422
Product numbers
001, 002, 003
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,639, 11,743, 11,847, 11,952
Flags
use code U-1491
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,640, 11,744, 11,848, 11,953
Flags
use code U-1650
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,641, 11,745, 11,849, 11,954
Flags
use code U-1946
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,642, 11,746, 11,850, 11,956
Flags
use code U-2241
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,643, 11,747, 11,851, 11,957
Flags
use code U-2242
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt line 11,951
Flags
use code U-1456
Product numbers
004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt line 11,955
Flags
use code U-1947
Product numbers
004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,697,711, substance and product patent
patent.txt lines 11,652, 11,756, 11,860, 11,965
Flags
substance product
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,703,780, use patent
patent.txt lines 11,654, 11,758, 11,862, 11,967
Flags
use code U-1491
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,703,780, use patent
patent.txt lines 11,655, 11,759, 11,863, 11,968
Flags
use code U-2242
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,735,403, substance and product patent
patent.txt lines 11,657, 11,761, 11,865, 11,970
Flags
substance product
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,754,091, product patent
patent.txt lines 11,659, 11,763, 11,867, 11,974
Flags
product
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 11,661, 11,765, 11,869, 11,977
Flags
use code U-1491
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 11,662, 11,766, 11,870, 11,978
Flags
use code U-1650
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 11,663, 11,767, 11,871, 11,979
Flags
use code U-1946
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 11,664, 11,768, 11,872, 11,981
Flags
use code U-2241
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 11,665, 11,769, 11,873, 11,982
Flags
use code U-2242
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt line 11,976
Flags
use code U-1456
Product numbers
004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt line 11,980
Flags
use code U-1947
Product numbers
004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,957,079, substance and product patent
patent.txt lines 11,667, 11,771, 11,875, 11,984
Flags
substance product
Product numbers
001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 9,181,257, substance patent
patent.txt lines 11,676, 11,780, 11,884, 11,993
Flags
substance
Product numbers
001, 002, 003, 004

Pediatric exclusivity, as listed (61)

13 Jan 2026 · NDA 022291 · ELTROMBOPAG OLAMINE
US 7,547,719 with pediatric exclusivity, as listed
patent.txt lines 1,579, 1,584, 1,590, 1,596, 1,601
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
13 Jan 2026 · NDA 207027 · ELTROMBOPAG OLAMINE
US 7,547,719 with pediatric exclusivity, as listed
patent.txt lines 6,995, 7,000
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
13 Feb 2026 · NDA 022341 · LIRAGLUTIDE
US 8,114,833 with pediatric exclusivity, as listed
patent.txt line 1,721
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
13 Feb 2026 · NDA 206321 · LIRAGLUTIDE
US 8,114,833 with pediatric exclusivity, as listed
patent.txt line 6,470
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
7 Mar 2026 · NDA 022512 · DABIGATRAN ETEXILATE MESYLATE
US 7,932,273 with pediatric exclusivity, as listed
patent.txt lines 2,013, 2,017, 2,021
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
11 Mar 2026 · NDA 022012 · CARVEDILOL PHOSPHATE
US 8,101,209 with pediatric exclusivity, as listed
patent.txt lines 901, 903, 905, 907
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
1 Apr 2026 · NDA 205832 · NINTEDANIB ESYLATE
US 6,762,180 with pediatric exclusivity, as listed
patent.txt lines 5,896, 5,904
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
2 Apr 2026 · NDA 021926 · NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
US 7,332,183 with pediatric exclusivity, as listed
patent.txt lines 804, 806
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Apr 2026 · NDA 202293 · DAPAGLIFLOZIN
US 6,515,117 with pediatric exclusivity, as listed
patent.txt lines 2,977, 3,015
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Apr 2026 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 6,515,117 with pediatric exclusivity, as listed
patent.txt lines 5,710, 5,720, 5,730, 5,740, 5,750
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
4 Apr 2026 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 6,515,117 with pediatric exclusivity, as listed
patent.txt lines 9,657, 9,673
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
24 Apr 2026 · NDA 206947 · LENVATINIB MESYLATE
US 7,253,286 with pediatric exclusivity, as listed
patent.txt lines 6,889, 6,910
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
30 Apr 2026 · NDA 021445 · EZETIMIBE
US 7,612,058 with pediatric exclusivity, as listed
patent.txt line 614
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
30 Apr 2026 · NDA 207500 · ISAVUCONAZONIUM SULFATE
US 6,812,238 with pediatric exclusivity, as listed
patent.txt lines 7,264, 7,270
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
30 Apr 2026 · NDA 207501 · ISAVUCONAZONIUM SULFATE
US 6,812,238 with pediatric exclusivity, as listed
patent.txt line 7,272
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001
1 May 2026 · NDA 022334 · EVEROLIMUS
US 8,410,131 with pediatric exclusivity, as listed
patent.txt lines 1,708, 1,711, 1,714, 1,717
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
1 May 2026 · NDA 203441 · TEDUGLUTIDE
US 7,847,061 with pediatric exclusivity, as listed
patent.txt line 3,871
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
1 May 2026 · NDA 203441 · TEDUGLUTIDE
US 9,060,992 with pediatric exclusivity, as listed
patent.txt line 3,873
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
16 May 2026 · NDA 022181 · SAPROPTERIN DIHYDROCHLORIDE
US 7,566,462 with pediatric exclusivity, as listed
patent.txt line 1,138
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
16 May 2026 · NDA 022181 · SAPROPTERIN DIHYDROCHLORIDE
US 8,003,126 with pediatric exclusivity, as listed
patent.txt line 1,140
Flags
pediatric, as listed by FDA
Product numbers
001
26 May 2026 · NDA 201280 · LINAGLIPTIN
US 8,883,805 with pediatric exclusivity, as listed
patent.txt line 2,340
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
26 May 2026 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,883,805 with pediatric exclusivity, as listed
patent.txt lines 2,356, 2,374, 2,392
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
26 May 2026 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 8,883,805 with pediatric exclusivity, as listed
patent.txt lines 6,201, 6,233
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 May 2026 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,883,805 with pediatric exclusivity, as listed
patent.txt lines 7,980, 7,999
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 May 2026 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,883,805 with pediatric exclusivity, as listed
patent.txt lines 14,249, 14,279, 14,309, 14,338
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
5 Jun 2026 · NDA 204410 · MACITENTAN
US 7,094,781 with pediatric exclusivity, as listed
patent.txt line 4,668
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
8 Jun 2026 · NDA 203214 · TOFACITINIB CITRATE
US RE41783 with pediatric exclusivity, as listed
patent.txt lines 3,671, 3,673
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
8 Jun 2026 · NDA 208246 · TOFACITINIB CITRATE
US RE41783 with pediatric exclusivity, as listed
patent.txt lines 8,380, 8,389
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
8 Jun 2026 · NDA 213082 · TOFACITINIB CITRATE
US RE41783 with pediatric exclusivity, as listed
patent.txt line 14,660
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001
10 Jun 2026 · NDA 201023 · CABAZITAXEL
US 7,241,907 with pediatric exclusivity, as listed
patent.txt line 2,318
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001
11 Jun 2026 · NDA 203341 · BOSUTINIB MONOHYDRATE
US 7,417,148 with pediatric exclusivity, as listed
patent.txt lines 3,773, 3,784, 3,795
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
11 Jun 2026 · NDA 203341 · BOSUTINIB MONOHYDRATE
US 7,919,625 with pediatric exclusivity, as listed
patent.txt lines 3,779, 3,790, 3,801
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
8 Jul 2026 · NDA 205832 · NINTEDANIB ESYLATE
US 10,154,990 with pediatric exclusivity, as listed
patent.txt lines 5,894, 5,902
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
12 Jul 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,609,863 with pediatric exclusivity, as listed
patent.txt lines 1,365, 1,382
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
12 Jul 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,791,270 with pediatric exclusivity, as listed
patent.txt lines 1,369, 1,386, 1,399, 1,405
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
12 Jul 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,895,756 with pediatric exclusivity, as listed
patent.txt lines 1,373, 1,390
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
13 Jul 2026 · NDA 201292 · AFATINIB DIMALEATE
US RE43431 with pediatric exclusivity, as listed
patent.txt lines 2,406, 2,416, 2,426
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
17 Jul 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 8,461,187 with pediatric exclusivity, as listed
patent.txt lines 1,559, 1,573
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
19 Jul 2026 · NDA 021395 · TIOTROPIUM BROMIDE
US 8,022,082 with pediatric exclusivity, as listed
patent.txt line 595
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
20 Jul 2026 · NDA 022088 · TEMSIROLIMUS
US 8,026,276 with pediatric exclusivity, as listed
patent.txt line 1,046
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
27 Jul 2026 · NDA 022225 · SUGAMMADEX SODIUM
US RE44733 with pediatric exclusivity, as listed
patent.txt lines 1,352, 1,354
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
19 Aug 2026 · NDA 021985 · ALISKIREN HEMIFUMARATE
US 8,617,595 with pediatric exclusivity, as listed
patent.txt lines 865, 867
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
21 Aug 2026 · NDA 021660 · PACLITAXEL
US 7,758,891 with pediatric exclusivity, as listed
patent.txt line 659
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
21 Aug 2026 · NDA 021660 · PACLITAXEL
US 8,268,348 with pediatric exclusivity, as listed
patent.txt line 663
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
21 Aug 2026 · NDA 021660 · PACLITAXEL
US 9,101,543 with pediatric exclusivity, as listed
patent.txt line 665
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
22 Aug 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,361,649 with pediatric exclusivity, as listed
patent.txt lines 6,410, 6,418
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
22 Aug 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,361,650 with pediatric exclusivity, as listed
patent.txt lines 6,412, 6,420
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
22 Aug 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,879,842 with pediatric exclusivity, as listed
patent.txt lines 6,416, 6,424
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
24 Aug 2026 · NDA 202236 · AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
US 8,168,620 with pediatric exclusivity, as listed
patent.txt line 2,956
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
28 Sep 2026 · NDA 021986 · DASATINIB
US 7,491,725 with pediatric exclusivity, as listed
patent.txt lines 869, 871, 873, 875, 877, 879
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006
6 Oct 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358 with pediatric exclusivity, as listed
patent.txt lines 1,090, 1,098, 1,106
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
6 Oct 2026 · NDA 022117 · ASENAPINE MALEATE
US 8,022,228 with pediatric exclusivity, as listed
patent.txt lines 1,096, 1,104, 1,109
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
11 Oct 2026 · NDA 202343 · SIMVASTATIN; SITAGLIPTIN PHOSPHATE
US 7,326,708 with pediatric exclusivity, as listed
patent.txt lines 3,071, 3,073, 3,075, 3,077, 3,079, 3,081
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006
12 Oct 2026 · NDA 205422 · BREXPIPRAZOLE
US 8,349,840 with pediatric exclusivity, as listed
patent.txt lines 5,309, 5,322, 5,335, 5,348, 5,361, 5,372
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006
12 Oct 2026 · NDA 205422 · BREXPIPRAZOLE
US 8,618,109 with pediatric exclusivity, as listed
patent.txt lines 5,311, 5,324, 5,337, 5,350, 5,363, 5,374
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006
12 Oct 2026 · NDA 205422 · BREXPIPRAZOLE
US 9,839,637 with pediatric exclusivity, as listed
patent.txt lines 5,314, 5,327, 5,340, 5,353, 5,366, 5,377
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006
26 Nov 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 8,729,085 with pediatric exclusivity, as listed
patent.txt lines 2,245, 2,256, 2,267, 2,278, 2,289
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
26 Nov 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 8,883,794 with pediatric exclusivity, as listed
patent.txt lines 2,247, 2,258, 2,269, 2,280, 2,291
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
26 Nov 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 9,907,794 with pediatric exclusivity, as listed
patent.txt lines 2,254, 2,265, 2,276, 2,287, 2,298
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
7 Dec 2026 · NDA 022020 · PANTOPRAZOLE SODIUM
US 7,544,370 with pediatric exclusivity, as listed
patent.txt line 910
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
17 Dec 2026 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 7,144,884 with pediatric exclusivity, as listed
patent.txt lines 4,698, 4,718, 4,738, 4,758
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004

Non-patent exclusivity (146)

14 Jan 2026 · NDA 208692 · CABOZANTINIB S-MALATE
ODE-227 exclusivity
exclusivity.txt lines 738, 741, 744
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
18 Jan 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
PED exclusivity
exclusivity.txt line 1,520
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
19 Jan 2026 · NDA 213217 · ZANUBRUTINIB
I-817 exclusivity
exclusivity.txt line 1,161
Definition
New indication (to be checked against FDA's list)
Product numbers
001
19 Jan 2026 · NDA 214377 · VERICIGUAT
NCE exclusivity
exclusivity.txt lines 1,323, 1,325, 1,327
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
19 Jan 2026 · NDA 218785 · ZANUBRUTINIB
I-817 exclusivity
exclusivity.txt line 2,195
Definition
New indication (to be checked against FDA's list)
Product numbers
001
22 Jan 2026 · NDA 213716 · VOCLOSPORIN
NCE exclusivity
exclusivity.txt line 1,246
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
27 Jan 2026 · NDA 214846 · ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
M-289 exclusivity
exclusivity.txt line 1,410
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
9 Feb 2026 · NDA 213871 · ABROCITINIB
NPP exclusivity
exclusivity.txt lines 1,271, 1,273, 1,275
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003
12 Feb 2026 · NDA 214200 · TRILACICLIB DIHYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 1,315
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
15 Feb 2026 · NDA 206947 · LENVATINIB MESYLATE
PED exclusivity
exclusivity.txt lines 566, 570
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
22 Feb 2026 · NDA 207981 · TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
ODE-229 exclusivity
exclusivity.txt lines 676–677
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
24 Feb 2026 · NDA 205552 · IBRUTINIB
PED exclusivity
exclusivity.txt lines 504, 508
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
24 Feb 2026 · NDA 210563 · IBRUTINIB
PED exclusivity
exclusivity.txt lines 891, 895, 899, 903
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
10 Mar 2026 · NDA 212904 · TIVOZANIB HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 1,130–1,131
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
13 Mar 2026 · NDA 201532 · ERIBULIN MESYLATE
PED exclusivity
exclusivity.txt line 224
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
13 Mar 2026 · NDA 214662 · MARALIXIBAT CHLORIDE
NPP exclusivity
exclusivity.txt line 1,349
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
16 Mar 2026 · NDA 202806 · DABRAFENIB MESYLATE
I-908 exclusivity
exclusivity.txt lines 286, 290
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
16 Mar 2026 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
I-908 exclusivity
exclusivity.txt lines 368, 372, 376
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
24 Mar 2026 · NDA 204168 · LEVOMILNACIPRAN HYDROCHLORIDE
M-304 exclusivity
exclusivity.txt lines 380–383
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
28 Mar 2026 · NDA 214028 · PILOCARPINE HYDROCHLORIDE
D-187 exclusivity
exclusivity.txt line 1,294
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001
2 Apr 2026 · NDA 211964 · VILOXAZINE HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 1,005–1,007
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
3 Apr 2026 · NDA 207695 · CRISABOROLE
D-191 exclusivity
exclusivity.txt line 623
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001
17 Apr 2026 · NDA 215206 · ATOGEPANT
I-909 exclusivity
exclusivity.txt lines 1,491, 1,493, 1,495
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
20 Apr 2026 · NDA 212028 · LEMBOREXANT
M-293 exclusivity
exclusivity.txt lines 1,018–1,019
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
22 Apr 2026 · NDA 214787 · REMDESIVIR
PED exclusivity
exclusivity.txt lines 1,394, 1,400
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
26 Apr 2026 · NDA 021196 · SODIUM OXYBATE
PED exclusivity
exclusivity.txt line 118
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
28 Apr 2026 · NDA 022253 · LACOSAMIDE
D-188 exclusivity
exclusivity.txt lines 176–179
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
28 Apr 2026 · NDA 022254 · LACOSAMIDE
D-188 exclusivity
exclusivity.txt line 180
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001
28 Apr 2026 · NDA 022255 · LACOSAMIDE
D-188 exclusivity
exclusivity.txt line 181
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001
29 Apr 2026 · NDA 207925 · IVACAFTOR
ODE-236 exclusivity
exclusivity.txt lines 627, 633, 639
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
1 May 2026 · NDA 214755 · SODIUM OXYBATE
NP exclusivity
exclusivity.txt lines 1,370, 1,373, 1,376, 1,379
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
2 May 2026 · NDA 211192 · IVOSIDENIB
ODE-242 exclusivity
exclusivity.txt line 943
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
3 May 2026 · NDA 207925 · IVACAFTOR
NPP exclusivity
exclusivity.txt lines 645, 651
Definition
New patient population (to be checked against FDA's list)
Product numbers
004, 005
3 May 2026 · NDA 211996 · TAFAMIDIS MEGLUMINE
ODE-237 exclusivity
exclusivity.txt line 1,014
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
3 May 2026 · NDA 212161 · TAFAMIDIS
ODE-237 exclusivity
exclusivity.txt line 1,027
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
8 May 2026 · NDA 202293 · DAPAGLIFLOZIN
M-298 exclusivity
exclusivity.txt lines 267, 271
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
10 May 2026 · NDA 205422 · BREXPIPRAZOLE
I-913 exclusivity
exclusivity.txt lines 450, 455, 460, 465, 470, 475
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
12 May 2026 · NDA 021323 · ESCITALOPRAM OXALATE
NPP exclusivity
exclusivity.txt lines 119–121
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003
13 May 2026 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
NPP exclusivity
exclusivity.txt line 384
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
13 May 2026 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
NS exclusivity
exclusivity.txt line 386
Definition
New strength (to be checked against FDA's list)
Product numbers
003
15 May 2026 · NDA 208573 · VENETOCLAX
ODE-239 exclusivity
exclusivity.txt lines 718–720
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
16 May 2026 · NDA 203441 · TEDUGLUTIDE
ODE-240 exclusivity
exclusivity.txt line 322
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
17 May 2026 · NDA 211321 · MIDAZOLAM
ODE-243 exclusivity
exclusivity.txt line 951
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
18 May 2026 · NDA 211675 · UPADACITINIB
I-919 exclusivity
exclusivity.txt lines 983, 989, 993
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
22 May 2026 · NDA 217470 · NALMEFENE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 1,882
Definition
New product (to be checked against FDA's list)
Product numbers
001
24 May 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
ODE-238 exclusivity
exclusivity.txt lines 238, 244, 250, 256, 262
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
28 May 2026 · NDA 021880 · LENALIDOMIDE
ODE-241 exclusivity
exclusivity.txt lines 133, 135, 137, 139, 141, 143
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
28 May 2026 · NDA 021880 · LENALIDOMIDE
ODE-245 exclusivity
exclusivity.txt lines 134, 136, 138, 140, 142, 144
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
28 May 2026 · NDA 213378 · OLANZAPINE; SAMIDORPHAN L-MALATE
NCE exclusivity
exclusivity.txt lines 1,214–1,217
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
31 May 2026 · NDA 203565 · FERRIC CARBOXYMALTOSE
I-915 exclusivity
exclusivity.txt lines 336–339
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
31 May 2026 · NDA 208558 · OLAPARIB
I-914 exclusivity
exclusivity.txt lines 712, 715
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
5 Jun 2026 · NDA 209939 · LETERMOVIR
I-916 exclusivity
exclusivity.txt lines 819, 825
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
5 Jun 2026 · NDA 209940 · LETERMOVIR
I-916 exclusivity
exclusivity.txt lines 831, 837
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
5 Jun 2026 · NDA 211580 · INDOCYANINE GREEN
I-911 exclusivity
exclusivity.txt line 965
Definition
New indication (to be checked against FDA's list)
Product numbers
001
12 Jun 2026 · NDA 202811 · LINACLOTIDE
I-921 exclusivity
exclusivity.txt lines 294, 297
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 003
15 Jun 2026 · NDA 205551 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
M-294 exclusivity
exclusivity.txt line 500
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
15 Jun 2026 · NDA 214998 · MAVACAMTEN
M-297 exclusivity
exclusivity.txt lines 1,446, 1,449, 1,452, 1,455
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
15 Jun 2026 · NDA 215344 · MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE
NP exclusivity
exclusivity.txt line 1,533
Definition
New product (to be checked against FDA's list)
Product numbers
001
15 Jun 2026 · NDA 215413 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
NPP exclusivity
exclusivity.txt line 1,561
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
17 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
ODE-254 exclusivity
exclusivity.txt lines 946–947
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
18 Jun 2026 · NDA 210251 · BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
ODE-256 exclusivity
exclusivity.txt line 861
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
19 Jun 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
PED exclusivity
exclusivity.txt lines 240, 246, 252, 258, 264
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
20 Jun 2026 · NDA 201280 · LINAGLIPTIN
M-295 exclusivity
exclusivity.txt line 215
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
20 Jun 2026 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
M-295 exclusivity
exclusivity.txt lines 217, 219, 221
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
20 Jun 2026 · NDA 204629 · EMPAGLIFLOZIN
NPP exclusivity
exclusivity.txt lines 438, 440
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
20 Jun 2026 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 544, 546, 548, 550
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
20 Jun 2026 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
M-295 exclusivity
exclusivity.txt lines 678, 680
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
20 Jun 2026 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
M-296 exclusivity
exclusivity.txt lines 725, 727, 729, 731
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
21 Jun 2026 · NDA 021986 · DASATINIB
PED exclusivity
exclusivity.txt lines 146, 148, 150, 152, 154, 156
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
28 Jun 2026 · NDA 211843 · TIOPRONIN
ODE* exclusivity
exclusivity.txt lines 1,003–1,004
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
3 Jul 2026 · NDA 022304 · TAPENTADOL HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 185, 187, 189
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003
3 Jul 2026 · NDA 203794 · TAPENTADOL HYDROCHLORIDE
NPP exclusivity
exclusivity.txt line 340
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
9 Jul 2026 · NDA 215341 · FINERENONE
NCE exclusivity
exclusivity.txt lines 1,526, 1,529, 1,531
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
13 Jul 2026 · NDA 214787 · REMDESIVIR
M-301 exclusivity
exclusivity.txt lines 1,391, 1,397
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
16 Jul 2026 · NDA 214783 · BELUMOSUDIL MESYLATE
NCE exclusivity
exclusivity.txt line 1,389
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
19 Jul 2026 · NDA 205437 · APREMILAST
ODE-248 exclusivity
exclusivity.txt lines 484, 490, 496
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
20 Jul 2026 · NDA 205437 · APREMILAST
M-299 exclusivity
exclusivity.txt lines 482, 488, 494
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
21 Jul 2026 · NDA 215256 · SEMAGLUTIDE
D-190 exclusivity
exclusivity.txt line 1,508
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
004
27 Jul 2026 · NDA 022271 · ALOGLIPTIN BENZOATE
M-300 exclusivity
exclusivity.txt lines 182–184
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
27 Jul 2026 · NDA 203414 · ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
M-300 exclusivity
exclusivity.txt lines 319–320
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
2 Aug 2026 · NDA 209939 · LETERMOVIR
D-189 exclusivity
exclusivity.txt lines 818, 824
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001, 002
2 Aug 2026 · NDA 209940 · LETERMOVIR
D-189 exclusivity
exclusivity.txt lines 830, 836
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001, 002
13 Aug 2026 · NDA 215383 · BELZUTIFAN
NCE exclusivity
exclusivity.txt line 1,557
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
14 Aug 2026 · NDA 211150 · PITOLISANT HYDROCHLORIDE
ODE-255 exclusivity
exclusivity.txt lines 933, 938
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
16 Aug 2026 · NDA 212327 · FEDRATINIB HYDROCHLORIDE
ODE-259 exclusivity
exclusivity.txt line 1,064
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
18 Aug 2026 · NDA 209241 · VALBENAZINE TOSYLATE
I-925 exclusivity
exclusivity.txt lines 767, 769, 771
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
18 Aug 2026 · NDA 218390 · VALBENAZINE TOSYLATE
I-925 exclusivity
exclusivity.txt lines 2,152–2,154
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
22 Aug 2026 · NDA 203094 · COBICISTAT
ODE-260 exclusivity
exclusivity.txt line 300
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
23 Aug 2026 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
M-232 exclusivity
exclusivity.txt lines 428, 430, 432, 434
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
23 Aug 2026 · NDA 214916 · DIFELIKEFALIN ACETATE
NCE exclusivity
exclusivity.txt line 1,415
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
28 Aug 2026 · NDA 204671 · SOFOSBUVIR
ODE* exclusivity
exclusivity.txt lines 444–445
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
6 Sep 2026 · NDA 205832 · NINTEDANIB ESYLATE
ODE-261 exclusivity
exclusivity.txt lines 530, 532
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
16 Sep 2026 · NDA 202806 · DABRAFENIB MESYLATE
PED exclusivity
exclusivity.txt lines 288, 292
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
16 Sep 2026 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
PED exclusivity
exclusivity.txt lines 370, 374, 378
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
21 Sep 2026 · NDA 204629 · EMPAGLIFLOZIN
I-922 exclusivity
exclusivity.txt line 437
Definition
New indication (to be checked against FDA's list)
Product numbers
001
25 Sep 2026 · NDA 217064 · PHENTOLAMINE MESYLATE
NP exclusivity
exclusivity.txt line 1,839
Definition
New product (to be checked against FDA's list)
Product numbers
001
26 Sep 2026 · NDA 203341 · BOSUTINIB MONOHYDRATE
I-923 exclusivity
exclusivity.txt lines 307, 311, 315
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
28 Sep 2026 · NDA 215206 · ATOGEPANT
NCE exclusivity
exclusivity.txt lines 1,492, 1,494, 1,496
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
29 Sep 2026 · NDA 214662 · MARALIXIBAT CHLORIDE
NCE exclusivity
exclusivity.txt lines 1,348, 1,353
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
29 Sep 2026 · NDA 219485 · MARALIXIBAT CHLORIDE
NCE exclusivity
exclusivity.txt lines 2,290, 2,292, 2,294, 2,296
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
2 Oct 2026 · NDA 205739 · PATIROMER SORBITEX CALCIUM
NPP exclusivity
exclusivity.txt lines 526–528
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003
2 Oct 2026 · NDA 205739 · PATIROMER SORBITEX CALCIUM
NS exclusivity
exclusivity.txt line 529
Definition
New strength (to be checked against FDA's list)
Product numbers
004
3 Oct 2026 · NDA 213535 · RISDIPLAM
M-270 exclusivity
exclusivity.txt line 1,229
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
3 Oct 2026 · NDA 219285 · RISDIPLAM
M-270 exclusivity
exclusivity.txt line 2,266
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
5 Oct 2026 · NDA 215985 · ROFLUMILAST
NPP exclusivity
exclusivity.txt line 1,683
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
7 Oct 2026 · NDA 214487 · AVACOPAN
NCE exclusivity
exclusivity.txt line 1,335
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
11 Oct 2026 · NDA 210496 · ENCORAFENIB
I-928 exclusivity
exclusivity.txt lines 880, 884
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
11 Oct 2026 · NDA 210498 · BINIMETINIB
I-928 exclusivity
exclusivity.txt line 888
Definition
New indication (to be checked against FDA's list)
Product numbers
001
18 Oct 2026 · NDA 203496 · TREPROSTINIL DIOLAMINE
ODE-272 exclusivity
exclusivity.txt lines 331–335
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
18 Oct 2026 · NDA 206316 · EDOXABAN TOSYLATE
M-14 exclusivity
exclusivity.txt lines 556–558
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
20 Oct 2026 · NDA 210365 · CANNABIDIOL
M-270 exclusivity
exclusivity.txt line 873
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
20 Oct 2026 · NDA 214938 · VOSORITIDE
NPP exclusivity
exclusivity.txt lines 1,425, 1,429, 1,433
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003
20 Oct 2026 · NDA 216632 · ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
NP exclusivity
exclusivity.txt line 1,774
Definition
New product (to be checked against FDA's list)
Product numbers
001
24 Oct 2026 · NDA 211192 · IVOSIDENIB
I-924 exclusivity
exclusivity.txt line 942
Definition
New indication (to be checked against FDA's list)
Product numbers
001
29 Oct 2026 · NDA 207925 · IVACAFTOR
PED exclusivity
exclusivity.txt lines 631, 637, 643
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
29 Oct 2026 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 1,538, 1,546, 1,552
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
3 Nov 2026 · NDA 207925 · IVACAFTOR
PED exclusivity
exclusivity.txt lines 648, 654
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
004, 005
8 Nov 2026 · NDA 202293 · DAPAGLIFLOZIN
PED exclusivity
exclusivity.txt lines 270, 274
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
8 Nov 2026 · NDA 217806 · TIRZEPATIDE
NP exclusivity
exclusivity.txt lines 1,945, 1,949, 1,953, 1,957, 1,961, 1,965
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
9 Nov 2026 · NDA 022496 · BUPIVACAINE
I-929 exclusivity
exclusivity.txt lines 199–200
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
10 Nov 2026 · NDA 205422 · BREXPIPRAZOLE
PED exclusivity
exclusivity.txt lines 453, 458, 463, 468, 473, 478
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
13 Nov 2026 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
PED exclusivity
exclusivity.txt lines 385, 387
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 003
14 Nov 2026 · NDA 213217 · ZANUBRUTINIB
ODE-276 exclusivity
exclusivity.txt line 1,164
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
14 Nov 2026 · NDA 218785 · ZANUBRUTINIB
ODE* exclusivity
exclusivity.txt line 2,200
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
17 Nov 2026 · NDA 203415 · ENZALUTAMIDE
I-926 exclusivity
exclusivity.txt line 321
Definition
New indication (to be checked against FDA's list)
Product numbers
001
17 Nov 2026 · NDA 213674 · ENZALUTAMIDE
I-926 exclusivity
exclusivity.txt lines 1,241–1,242
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
19 Nov 2026 · NDA 214938 · VOSORITIDE
NCE exclusivity
exclusivity.txt lines 1,424, 1,428, 1,432
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
21 Nov 2026 · NDA 210259 · ACALABRUTINIB
ODE-274 exclusivity
exclusivity.txt line 870
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
23 Nov 2026 · NDA 215596 · MARIBAVIR
NCE exclusivity
exclusivity.txt line 1,601
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
24 Nov 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
PED exclusivity
exclusivity.txt lines 242, 248, 254, 260, 266
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
25 Nov 2026 · NDA 213137 · VOXELOTOR
ODE-281 exclusivity
exclusivity.txt line 1,155
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
25 Nov 2026 · NDA 216157 · VOXELOTOR
ODE* exclusivity
exclusivity.txt line 1,729
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
8 Dec 2026 · NDA 207500 · ISAVUCONAZONIUM SULFATE
NPP exclusivity
exclusivity.txt lines 592, 603
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
8 Dec 2026 · NDA 207501 · ISAVUCONAZONIUM SULFATE
NPP exclusivity
exclusivity.txt line 613
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
14 Dec 2026 · NDA 215383 · BELZUTIFAN
I-931 exclusivity
exclusivity.txt line 1,554
Definition
New indication (to be checked against FDA's list)
Product numbers
001
15 Dec 2026 · NDA 205551 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
PED exclusivity
exclusivity.txt line 501
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
15 Dec 2026 · NDA 215413 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
PED exclusivity
exclusivity.txt line 1,562
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
20 Dec 2026 · NDA 201280 · LINAGLIPTIN
PED exclusivity
exclusivity.txt line 216
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
20 Dec 2026 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 218, 220, 222
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
20 Dec 2026 · NDA 204629 · EMPAGLIFLOZIN
PED exclusivity
exclusivity.txt lines 439, 441
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
20 Dec 2026 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 545, 547, 549, 551
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
20 Dec 2026 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 679, 681
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
20 Dec 2026 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 726, 728, 730, 732
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
22 Dec 2026 · NDA 214012 · INCLISIRAN SODIUM
NCE exclusivity
exclusivity.txt line 1,289
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
27 Dec 2026 · NDA 208558 · OLAPARIB
ODE-283 exclusivity
exclusivity.txt lines 713, 716
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
30 Dec 2026 · NDA 214133 · LEVOKETOCONAZOLE
NCE* exclusivity
exclusivity.txt line 1,308
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001