Drybench Patent.

Patent and exclusivity dates from January to June 2031 for NDAs, as FDA's Orange Book lists them

Each patent and exclusivity date from January to June 2031 that FDA's Orange Book lists for an NDA, as captured on 14 October 2026. That capture lists a patent or exclusivity for 1,411 NDAs. Each entry is named by its rule and linked to its NDA page. A date here belongs to one patent or one exclusivity on the products named; the same NDA may have other listed dates, earlier or later, so no date here stands for a product.

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

Orange Book captured: 14 October 2026

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

This page covers every NDA whose Orange Book capture lists a patent or exclusivity. It does not cover ANDAs or any BLA. NCE exclusivity dates are here as FDA lists them; NCE-1 dates, computed from them, are on the NCE-1 calendar.

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

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

Listed dates, 2031 July to December 2031

Listed patent expiry (458)

6 Jan 2031 · NDA 020845 · NITRIC OXIDE
US 8,291,904, product and use patent
patent.txt lines 199, 221
Flags
product use code U-1226
Product numbers
002, 003
6 Jan 2031 · NDA 020845 · NITRIC OXIDE
US 8,573,209, product patent
patent.txt lines 205, 227
Flags
product
Product numbers
002, 003
6 Jan 2031 · NDA 020845 · NITRIC OXIDE
US 8,573,210, product and use patent
patent.txt lines 207, 229
Flags
product use code U-1453
Product numbers
002, 003
6 Jan 2031 · NDA 020845 · NITRIC OXIDE
US 8,776,794, product and use patent
patent.txt lines 209, 231
Flags
product use code U-1226
Product numbers
002, 003
6 Jan 2031 · NDA 020845 · NITRIC OXIDE
US 8,776,795, product and use patent
patent.txt lines 211, 233
Flags
product use code U-1226
Product numbers
002, 003
6 Jan 2031 · NDA 020845 · NITRIC OXIDE
US 9,265,911, product and use patent
patent.txt line 239
Flags
product use code U-1824
Product numbers
003
6 Jan 2031 · NDA 020845 · NITRIC OXIDE
US 9,295,802, product and use patent
patent.txt line 243
Flags
product use code U-1226
Product numbers
003
6 Jan 2031 · NDA 020845 · NITRIC OXIDE
US 9,408,993, product and use patent
patent.txt line 245
Flags
product use code U-1824
Product numbers
003
9 Jan 2031 · NDA 022308 · BESIFLOXACIN HYDROCHLORIDE
US 8,481,526, substance patent
patent.txt line 1,617
Flags
substance
Product numbers
001
10 Jan 2031 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 11,033,543, use patent
patent.txt line 2,202
Flags
use code U-1583
Product numbers
001
13 Jan 2031 · NDA 212801 · OSILODROSTAT PHOSPHATE
US 8,609,862, use patent
patent.txt lines 14,415, 14,421
Flags
use code U-4529
Product numbers
001, 002
13 Jan 2031 · NDA 212801 · OSILODROSTAT PHOSPHATE
US 8,609,862, use patent
patent.txt line 14,427
Flags
use code U-2770
Product numbers
003
13 Jan 2031 · NDA 212801 · OSILODROSTAT PHOSPHATE
US 9,434,754, substance patent
patent.txt lines 14,417, 14,423, 14,429
Flags
substance
Product numbers
001, 002, 003
14 Jan 2031 · NDA 021717 · LIDOCAINE; TETRACAINE
US 10,350,180, product patent
patent.txt line 684
Flags
product
Product numbers
001
14 Jan 2031 · NDA 021717 · LIDOCAINE; TETRACAINE
US 10,603,293, product patent
patent.txt line 685
Flags
product
Product numbers
001
14 Jan 2031 · NDA 021717 · LIDOCAINE; TETRACAINE
US 10,751,305, product patent
patent.txt line 686
Flags
product
Product numbers
001
14 Jan 2031 · NDA 021717 · LIDOCAINE; TETRACAINE
US 12,558,328, use patent
patent.txt line 687
Flags
use code U-4421
Product numbers
001
15 Jan 2031 · NDA 211675 · UPADACITINIB
US 8,962,629, substance and use patent
patent.txt line 13,015
Flags
substance use code U-3255
Product numbers
001
15 Jan 2031 · NDA 211675 · UPADACITINIB
US 8,962,629, substance and use patent
patent.txt line 13,016
Flags
substance use code U-3275
Product numbers
001
15 Jan 2031 · NDA 211675 · UPADACITINIB
US 8,962,629, substance and use patent
patent.txt line 13,018
Flags
substance use code U-3371
Product numbers
001
15 Jan 2031 · NDA 211675 · UPADACITINIB
US 8,962,629, substance and use patent
patent.txt line 13,020
Flags
substance use code U-3945
Product numbers
001
15 Jan 2031 · NDA 211675 · UPADACITINIB
US 8,962,629, substance and use patent
patent.txt line 13,021
Flags
substance use code U-3946
Product numbers
001
15 Jan 2031 · NDA 211675 · UPADACITINIB
US 8,962,629, substance and use patent
patent.txt lines 13,017, 13,046, 13,065
Flags
substance use code U-3341
Product numbers
001, 002, 003
15 Jan 2031 · NDA 211675 · UPADACITINIB
US 8,962,629, substance and use patent
patent.txt lines 13,019, 13,047, 13,066
Flags
substance use code U-3624
Product numbers
001, 002, 003
15 Jan 2031 · NDA 218347 · UPADACITINIB
US 8,962,629, substance and use patent
patent.txt line 20,976
Flags
substance use code U-3945
Product numbers
001
15 Jan 2031 · NDA 218347 · UPADACITINIB
US 8,962,629, substance and use patent
patent.txt line 20,977
Flags
substance use code U-3946
Product numbers
001
16 Jan 2031 · NDA 022192 · ILOPERIDONE
US 9,072,742, use patent
patent.txt lines 1,152, 1,166, 1,180, 1,194, 1,208, 1,222, 1,236
Flags
use code U-1674
Product numbers
001, 002, 003, 004, 005, 006, 007
16 Jan 2031 · NDA 220358 · MILSAPERIDONE
US 9,072,742, use patent
patent.txt lines 22,148, 22,168, 22,188, 22,208, 22,228, 22,248, 22,268
Flags
use code U-4436
Product numbers
001, 002, 003, 004, 005, 006, 007
16 Jan 2031 · NDA 220358 · MILSAPERIDONE
US 9,072,742, use patent
patent.txt lines 22,149, 22,169, 22,189, 22,209, 22,229, 22,249, 22,269
Flags
use code U-4437
Product numbers
001, 002, 003, 004, 005, 006, 007
19 Jan 2031 · NDA 208379 · PITAVASTATIN MAGNESIUM
US 8,829,186, substance and product patent
patent.txt lines 8,551–8,553
Flags
substance product
Product numbers
001, 002, 003
20 Jan 2031 · NDA 022512 · DABIGATRAN ETEXILATE MESYLATE
US 9,034,822, use patent
patent.txt lines 2,016, 2,020, 2,024
Flags
use code U-1759
Product numbers
001, 002, 003
20 Jan 2031 · NDA 211728 · MITOMYCIN
US 12,268,745, use patent
patent.txt line 13,133
Flags
use code U-4172
Product numbers
001
20 Jan 2031 · NDA 211728 · MITOMYCIN
US 9,040,074, product patent
patent.txt line 13,134
Flags
product
Product numbers
001
20 Jan 2031 · NDA 211728 · MITOMYCIN
US 9,950,069, product patent
patent.txt line 13,135
Flags
product
Product numbers
001
20 Jan 2031 · NDA 215793 · MITOMYCIN
US 10,039,832, use patent
patent.txt line 17,512
Flags
use code U-4256
Product numbers
001
20 Jan 2031 · NDA 215793 · MITOMYCIN
US 12,440,568, use patent
patent.txt line 17,513
Flags
use code U-4256
Product numbers
001
20 Jan 2031 · NDA 215793 · MITOMYCIN
US 9,040,074, product and use patent
patent.txt line 17,515
Flags
product use code U-4256
Product numbers
001
20 Jan 2031 · NDA 215793 · MITOMYCIN
US 9,950,069, product and use patent
patent.txt line 17,516
Flags
product use code U-4256
Product numbers
001
22 Jan 2031 · NDA 203496 · TREPROSTINIL DIOLAMINE
US 8,349,892, product patent
patent.txt lines 3,948, 3,957, 3,966, 3,975, 3,984
Flags
product
Product numbers
001, 002, 003, 004, 005
24 Jan 2031 · NDA 210192 · DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
US 10,426,780, substance and product and use patent
patent.txt line 11,204
Flags
substance product use code U-257
Product numbers
001
24 Jan 2031 · NDA 211994 · DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 11,234,985, product and use patent
patent.txt line 13,375
Flags
product use code U-257
Product numbers
001
26 Jan 2031 · NDA 022264 · PALIPERIDONE PALMITATE
US 9,439,906, use patent
patent.txt lines 1,420, 1,422, 1,424, 1,426, 1,428
Flags
use code U-2757
Product numbers
001, 002, 003, 004, 005
26 Jan 2031 · NDA 022264 · PALIPERIDONE PALMITATE
US 9,439,906, use patent
patent.txt lines 1,421, 1,423, 1,425, 1,427, 1,429
Flags
use code U-2758
Product numbers
001, 002, 003, 004, 005
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 10,010,533, product patent
patent.txt line 5,663
Flags
product
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 11,103,483, product and use patent
patent.txt line 5,664
Flags
product use code U-1971
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 11,103,483, product and use patent
patent.txt line 5,665
Flags
product use code U-1972
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 11,844,783, use patent
patent.txt line 5,666
Flags
use code U-1542
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 11,844,783, use patent
patent.txt line 5,667
Flags
use code U-1971
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 11,844,783, use patent
patent.txt line 5,668
Flags
use code U-1972
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 11,872,214, product patent
patent.txt line 5,669
Flags
product
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 12,138,248, product patent
patent.txt line 5,670
Flags
product
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 12,350,257, product and use patent
patent.txt line 5,671
Flags
product use code U-1542
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 12,350,257, product and use patent
patent.txt line 5,672
Flags
product use code U-1971
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 12,350,257, product and use patent
patent.txt line 5,673
Flags
product use code U-1972
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 9,265,831, product patent
patent.txt line 5,678
Flags
product
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 9,572,796, product and use patent
patent.txt line 5,679
Flags
product use code U-1971
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 9,572,796, product and use patent
patent.txt line 5,680
Flags
product use code U-1972
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 9,572,797, use patent
patent.txt line 5,681
Flags
use code U-1971
Product numbers
001
28 Jan 2031 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 9,572,797, use patent
patent.txt line 5,682
Flags
use code U-1972
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 10,010,533, product patent
patent.txt line 8,298
Flags
product
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 11,103,483, product and use patent
patent.txt line 8,301
Flags
product use code U-1971
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 11,103,483, product and use patent
patent.txt line 8,302
Flags
product use code U-1972
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 11,844,783, use patent
patent.txt line 8,303
Flags
use code U-1542
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 11,844,783, use patent
patent.txt line 8,304
Flags
use code U-1971
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 11,844,783, use patent
patent.txt line 8,305
Flags
use code U-1972
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 11,872,214, product patent
patent.txt line 8,306
Flags
product
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 12,138,248, product patent
patent.txt line 8,307
Flags
product
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 12,350,257, product and use patent
patent.txt line 8,308
Flags
product use code U-1542
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 12,350,257, product and use patent
patent.txt line 8,309
Flags
product use code U-1971
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 12,350,257, product and use patent
patent.txt line 8,310
Flags
product use code U-1972
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 9,265,831, product patent
patent.txt line 8,316
Flags
product
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 9,572,796, product and use patent
patent.txt line 8,317
Flags
product use code U-1971
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 9,572,796, product and use patent
patent.txt line 8,318
Flags
product use code U-1972
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 9,572,797, use patent
patent.txt line 8,319
Flags
use code U-1971
Product numbers
001
28 Jan 2031 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 9,572,797, use patent
patent.txt line 8,320
Flags
use code U-1972
Product numbers
001
31 Jan 2031 · NDA 205494 · ELIGLUSTAT TARTRATE
US 10,888,547, use patent
patent.txt line 5,453
Flags
use code U-3042
Product numbers
001
31 Jan 2031 · NDA 205494 · ELIGLUSTAT TARTRATE
US 10,888,547, use patent
patent.txt line 5,454
Flags
use code U-3043
Product numbers
001
3 Feb 2031 · NDA 214487 · AVACOPAN
US 8,445,515, substance and product patent
patent.txt line 15,813
Flags
substance product
Product numbers
001
4 Feb 2031 · NDA 212887 · CABOTEGRAVIR SODIUM
US 8,410,103, substance and product and use patent
patent.txt line 14,475
Flags
substance product use code U-3348
Product numbers
001
4 Feb 2031 · NDA 212888 · CABOTEGRAVIR; RILPIVIRINE
US 8,410,103, substance and product and use patent
patent.txt lines 14,484, 14,494
Flags
substance product use code U-3348
Product numbers
001, 002
4 Feb 2031 · NDA 215499 · CABOTEGRAVIR
US 8,410,103, substance and product patent
patent.txt line 17,411
Flags
substance product
Product numbers
001
5 Feb 2031 · NDA 020263 · LEUPROLIDE ACETATE
US 8,921,326, product patent
patent.txt line 181
Flags
product
Product numbers
009
5 Feb 2031 · NDA 020517 · LEUPROLIDE ACETATE
US 8,921,326, product and use patent
patent.txt line 184
Flags
product use code U-1666
Product numbers
003
7 Feb 2031 · NDA 208325 · ETELCALCETIDE
US 8,999,932, substance and product and use patent
patent.txt lines 8,463, 8,471, 8,479
Flags
substance product use code U-2014
Product numbers
001, 002, 003
10 Feb 2031 · NDA 022192 · ILOPERIDONE
US 9,074,256, use patent
patent.txt lines 1,155, 1,169, 1,183, 1,197, 1,211, 1,225, 1,239
Flags
use code U-1674
Product numbers
001, 002, 003, 004, 005, 006, 007
10 Feb 2031 · NDA 200327 · CEFTAROLINE FOSAMIL
US 8,247,400, product and use patent
patent.txt lines 2,216, 2,218
Flags
product use code U-282
Product numbers
001, 002
10 Feb 2031 · NDA 209115 · RUCAPARIB CAMSYLATE
US 10,278,974, product patent
patent.txt lines 9,732, 9,751, 9,770
Flags
product
Product numbers
001, 002, 003
10 Feb 2031 · NDA 209115 · RUCAPARIB CAMSYLATE
US 8,754,072, substance and product patent
patent.txt lines 9,739, 9,758, 9,777
Flags
substance product
Product numbers
001, 002, 003
10 Feb 2031 · NDA 209115 · RUCAPARIB CAMSYLATE
US 9,045,487, substance and product patent
patent.txt lines 9,743, 9,762, 9,781
Flags
substance product
Product numbers
001, 002, 003
10 Feb 2031 · NDA 209115 · RUCAPARIB CAMSYLATE
US 9,861,638, use patent
patent.txt lines 9,744, 9,763, 9,782
Flags
use code U-2012
Product numbers
001, 002, 003
10 Feb 2031 · NDA 209115 · RUCAPARIB CAMSYLATE
US 9,861,638, use patent
patent.txt lines 9,745, 9,764, 9,783
Flags
use code U-2273
Product numbers
001, 002, 003
10 Feb 2031 · NDA 220358 · MILSAPERIDONE
US 9,074,256, use patent
patent.txt lines 22,154, 22,174, 22,194, 22,214, 22,234, 22,254, 22,274
Flags
use code U-4436
Product numbers
001, 002, 003, 004, 005, 006, 007
10 Feb 2031 · NDA 220358 · MILSAPERIDONE
US 9,074,256, use patent
patent.txt lines 22,155, 22,175, 22,195, 22,215, 22,235, 22,255, 22,275
Flags
use code U-4437
Product numbers
001, 002, 003, 004, 005, 006, 007
10 Feb 2031 · NDA 221075 · IBERDOMIDE HYDROCHLORIDE
US 9,828,361, substance and product patent
patent.txt lines 22,410, 22,417
Flags
substance product
Product numbers
001, 002
14 Feb 2031 · NDA 208798 · FLUTICASONE PROPIONATE
US 10,195,375, product patent
patent.txt lines 9,464, 9,468, 9,472, 9,476, 9,486, 9,496, 9,506, 9,510
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
14 Feb 2031 · NDA 208799 · FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
US 10,195,375, product patent
patent.txt lines 9,520, 9,528, 9,534, 9,540, 9,554, 9,566
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
14 Feb 2031 · NDA 218010 · TRAVOPROST
US 12,201,555, substance and product patent
patent.txt line 20,782
Flags
substance product
Product numbers
001
15 Feb 2031 · NDA 202100 · METHYLPHENIDATE HYDROCHLORIDE
US 8,287,903, product patent
patent.txt line 2,750
Flags
product
Product numbers
001
15 Feb 2031 · NDA 202100 · METHYLPHENIDATE HYDROCHLORIDE
US 8,465,765, product and use patent
patent.txt line 2,751
Flags
product use code U-1415
Product numbers
001
15 Feb 2031 · NDA 202100 · METHYLPHENIDATE HYDROCHLORIDE
US 8,563,033, product and use patent
patent.txt line 2,752
Flags
product use code U-1415
Product numbers
001
15 Feb 2031 · NDA 202100 · METHYLPHENIDATE HYDROCHLORIDE
US 8,778,390, product and use patent
patent.txt line 2,753
Flags
product use code U-1543
Product numbers
001
15 Feb 2031 · NDA 202100 · METHYLPHENIDATE HYDROCHLORIDE
US 8,956,649, product and use patent
patent.txt line 2,754
Flags
product use code U-1665
Product numbers
001
15 Feb 2031 · NDA 202100 · METHYLPHENIDATE HYDROCHLORIDE
US 9,040,083, product patent
patent.txt line 2,755
Flags
product
Product numbers
001
15 Feb 2031 · NDA 207960 · METHYLPHENIDATE HYDROCHLORIDE
US 8,287,903, product patent
patent.txt lines 7,841, 7,851, 7,861
Flags
product
Product numbers
001, 002, 003
16 Feb 2031 · NDA 203085 · REGORAFENIB
US 8,637,553, substance and product patent
patent.txt line 3,605
Flags
substance product
Product numbers
001
17 Feb 2031 · NDA 202811 · LINACLOTIDE
US 8,933,030, product and use patent
patent.txt line 3,342
Flags
product use code U-4345
Product numbers
001
17 Feb 2031 · NDA 202811 · LINACLOTIDE
US 8,933,030, product patent
patent.txt line 3,356
Flags
product
Product numbers
002
17 Feb 2031 · NDA 202811 · LINACLOTIDE
US 8,933,030, product and use patent
patent.txt line 3,370
Flags
product use code U-1516
Product numbers
003
17 Feb 2031 · NDA 202811 · LINACLOTIDE
US 8,933,030, product and use patent
patent.txt line 3,371
Flags
product use code U-3644
Product numbers
003
17 Feb 2031 · NDA 202811 · LINACLOTIDE
US 8,933,030, product and use patent
patent.txt line 3,372
Flags
product use code U-4566
Product numbers
003
22 Feb 2031 · NDA 208653 · ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
US 8,461,137, substance and product patent
patent.txt lines 9,021, 9,026, 9,031
Flags
substance product
Product numbers
001, 002, 003
24 Feb 2031 · NDA 022335 · TECHNETIUM TC-99M LABELED CARBON
US 7,722,856, use patent
patent.txt line 1,720
Flags
use code U-4442
Product numbers
001
24 Feb 2031 · NDA 202155 · APIXABAN
US 9,326,945, product patent
patent.txt lines 2,788, 2,796, 2,800
Flags
product
Product numbers
001, 002, 003
24 Feb 2031 · NDA 208854 · NALDEMEDINE TOSYLATE
US RE46365, substance and product patent
patent.txt line 9,582
Flags
substance product
Product numbers
001
25 Feb 2031 · NDA 021997 · ZOLPIDEM TARTRATE
US 9,265,720, use patent
patent.txt lines 896, 898
Flags
use code U-674
Product numbers
001, 002
25 Feb 2031 · NDA 050790 · CYCLOSPORINE
US 8,292,129, product patent
patent.txt line 2,140
Flags
product delist requested
Product numbers
002
26 Feb 2031 · NDA 216993 · QUIZARTINIB DIHYDROCHLORIDE
US 8,357,690, use patent
patent.txt lines 19,128, 19,139
Flags
use code U-3661
Product numbers
001, 002
27 Feb 2031 · NDA 208794 · TELOTRISTAT ETIPRATE
US 8,193,204, substance patent
patent.txt line 9,461
Flags
substance
Product numbers
001
28 Feb 2031 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 10,322,239, use patent
patent.txt line 5,873
Flags
use code U-1907
Product numbers
001
28 Feb 2031 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 8,939,943, product patent
patent.txt line 5,885
Flags
product
Product numbers
001
28 Feb 2031 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 9,022,022, product patent
patent.txt line 5,886
Flags
product
Product numbers
001
28 Feb 2031 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 9,474,869, product and use patent
patent.txt line 5,889
Flags
product use code U-1907
Product numbers
001
28 Feb 2031 · NDA 208794 · TELOTRISTAT ETIPRATE
US 7,709,493, substance and use patent
patent.txt line 9,459
Flags
substance use code U-1979
Product numbers
001
28 Feb 2031 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 10,322,239, use patent
patent.txt line 10,897
Flags
use code U-1907
Product numbers
001
28 Feb 2031 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 8,939,943, product patent
patent.txt line 10,909
Flags
product
Product numbers
001
28 Feb 2031 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 9,022,022, product patent
patent.txt line 10,910
Flags
product
Product numbers
001
28 Feb 2031 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 9,474,869, product and use patent
patent.txt line 10,913
Flags
product use code U-1907
Product numbers
001
28 Feb 2031 · NDA 215457 · NALOXONE HYDROCHLORIDE
US 10,322,239, use patent
patent.txt line 17,289
Flags
use code U-1907
Product numbers
001
28 Feb 2031 · NDA 215457 · NALOXONE HYDROCHLORIDE
US 8,939,943, product patent
patent.txt line 17,290
Flags
product
Product numbers
001
28 Feb 2031 · NDA 215457 · NALOXONE HYDROCHLORIDE
US 9,022,022, product patent
patent.txt line 17,291
Flags
product
Product numbers
001
28 Feb 2031 · NDA 215457 · NALOXONE HYDROCHLORIDE
US 9,474,869, product and use patent
patent.txt line 17,292
Flags
product use code U-1907
Product numbers
001
28 Feb 2031 · NDA 215457 · NALOXONE HYDROCHLORIDE
US 9,814,838, product patent
patent.txt line 17,293
Flags
product
Product numbers
001
2 Mar 2031 · NDA 204168 · LEVOMILNACIPRAN HYDROCHLORIDE
US 8,481,598, use patent
patent.txt lines 4,337, 4,340, 4,343, 4,346
Flags
use code U-839
Product numbers
001, 002, 003, 004
5 Mar 2031 · NDA 201280 · LINAGLIPTIN
US 8,853,156, product and use patent
patent.txt line 2,339
Flags
product use code U-1642
Product numbers
001
10 Mar 2031 · NDA 208271 · METHYLNALTREXONE BROMIDE
US 10,307,417, product patent
patent.txt line 8,428
Flags
product
Product numbers
001
10 Mar 2031 · NDA 208271 · METHYLNALTREXONE BROMIDE
US 10,376,505, product patent
patent.txt line 8,429
Flags
product
Product numbers
001
10 Mar 2031 · NDA 208271 · METHYLNALTREXONE BROMIDE
US 8,524,276, product patent
patent.txt line 8,431
Flags
product
Product numbers
001
10 Mar 2031 · NDA 208271 · METHYLNALTREXONE BROMIDE
US 8,956,651, product patent
patent.txt line 8,432
Flags
product
Product numbers
001
10 Mar 2031 · NDA 208271 · METHYLNALTREXONE BROMIDE
US 9,314,461, product patent
patent.txt line 8,434
Flags
product
Product numbers
001
10 Mar 2031 · NDA 209510 · AMISULPRIDE
US 10,525,033, product patent
patent.txt lines 10,555, 10,571
Flags
product
Product numbers
001, 002
10 Mar 2031 · NDA 209510 · AMISULPRIDE
US 12,194,022, use patent
patent.txt lines 10,560, 10,576
Flags
use code U-1744
Product numbers
001, 002
10 Mar 2031 · NDA 209510 · AMISULPRIDE
US 12,194,022, use patent
patent.txt lines 10,561, 10,577
Flags
use code U-3467
Product numbers
001, 002
10 Mar 2031 · NDA 209510 · AMISULPRIDE
US 9,545,426, use patent
patent.txt lines 10,567, 10,583
Flags
use code U-1744
Product numbers
001, 002
10 Mar 2031 · NDA 209510 · AMISULPRIDE
US 9,545,426, use patent
patent.txt lines 10,568, 10,584
Flags
use code U-2754
Product numbers
001, 002
10 Mar 2031 · NDA 209510 · AMISULPRIDE
US 9,889,118, use patent
patent.txt lines 10,569, 10,585
Flags
use code U-1744
Product numbers
001, 002
10 Mar 2031 · NDA 209510 · AMISULPRIDE
US 9,889,118, use patent
patent.txt lines 10,570, 10,586
Flags
use code U-2754
Product numbers
001, 002
13 Mar 2031 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,415,355, substance and product patent
patent.txt line 9,699
Flags
substance product
Product numbers
001
13 Mar 2031 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 8,415,355, substance and product patent
patent.txt line 11,044
Flags
substance product
Product numbers
001
17 Mar 2031 · NDA 208294 · FORMOTEROL FUMARATE; GLYCOPYRROLATE
US 8,815,258, use patent
patent.txt line 8,446
Flags
use code U-2889
Product numbers
001
17 Mar 2031 · NDA 212122 · BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
US 8,815,258, use patent
patent.txt line 13,587
Flags
use code U-2889
Product numbers
001
17 Mar 2031 · NDA 212122 · BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
US 8,815,258, use patent
patent.txt line 13,596
Flags
use code U-4503
Product numbers
002
18 Mar 2031 · NDA 209816 · OMADACYCLINE TOSYLATE
US 9,314,475, product patent
patent.txt line 10,830
Flags
product
Product numbers
001
19 Mar 2031 · NDA 208470 · PRASTERONE
US 8,268,806, product patent
patent.txt line 8,667
Flags
product
Product numbers
001
21 Mar 2031 · NDA 207145 · SAFINAMIDE MESYLATE
US 8,283,380, use patent
patent.txt lines 7,050, 7,053
Flags
use code U-1993
Product numbers
001, 002
23 Mar 2031 · NDA 208627 · TECOVIRIMAT
US 12,433,868, product patent
patent.txt line 9,013
Flags
product
Product numbers
001
23 Mar 2031 · NDA 208627 · TECOVIRIMAT
US 9,339,466, substance and product patent
patent.txt line 9,016
Flags
substance product
Product numbers
001
25 Mar 2031 · NDA 204708 · BRIMONIDINE TARTRATE
US 8,513,247, product and use patent
patent.txt line 4,984
Flags
product use code U-1428
Product numbers
001
25 Mar 2031 · NDA 204708 · BRIMONIDINE TARTRATE
US 8,513,249, product and use patent
patent.txt line 4,985
Flags
product use code U-1428
Product numbers
001
25 Mar 2031 · NDA 204708 · BRIMONIDINE TARTRATE
US 9,861,631, use patent
patent.txt line 4,986
Flags
use code U-1428
Product numbers
001
25 Mar 2031 · NDA 204708 · BRIMONIDINE TARTRATE
US 9,861,632, use patent
patent.txt line 4,987
Flags
use code U-1428
Product numbers
001
25 Mar 2031 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 10,081,621, product and use patent
patent.txt lines 11,418, 11,451
Flags
product use code U-3024
Product numbers
001, 002
25 Mar 2031 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 10,081,621, product and use patent
patent.txt lines 11,419, 11,452
Flags
product use code U-3025
Product numbers
001, 002
25 Mar 2031 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 11,578,062, product and use patent
patent.txt lines 11,426, 11,459
Flags
product use code U-3545
Product numbers
001, 002
25 Mar 2031 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,081,621, product and use patent
patent.txt line 13,656
Flags
product use code U-3032
Product numbers
001
25 Mar 2031 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,081,621, product and use patent
patent.txt lines 13,657, 13,732
Flags
product use code U-3157
Product numbers
001, 002
25 Mar 2031 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,081,621, product and use patent
patent.txt lines 13,658, 13,733
Flags
product use code U-4075
Product numbers
001, 002
25 Mar 2031 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,081,621, product and use patent
patent.txt lines 13,659, 13,734
Flags
product use code U-4480
Product numbers
001, 002
25 Mar 2031 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,578,062, product and use patent
patent.txt lines 13,686, 13,758
Flags
product use code U-3544
Product numbers
001, 002
25 Mar 2031 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,578,062, product and use patent
patent.txt lines 13,687, 13,759
Flags
product use code U-4054
Product numbers
001, 002
25 Mar 2031 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,578,062, product and use patent
patent.txt lines 13,688, 13,760
Flags
product use code U-4490
Product numbers
001, 002
25 Mar 2031 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,081,621, product and use patent
patent.txt lines 20,063, 20,136
Flags
product use code U-3600
Product numbers
001, 002
25 Mar 2031 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,081,621, product and use patent
patent.txt lines 20,064, 20,137
Flags
product use code U-4065
Product numbers
001, 002
25 Mar 2031 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,081,621, product and use patent
patent.txt lines 20,065, 20,138
Flags
product use code U-4481
Product numbers
001, 002
25 Mar 2031 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,578,062, product and use patent
patent.txt lines 20,095, 20,168
Flags
product use code U-3584
Product numbers
001, 002
25 Mar 2031 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,578,062, product and use patent
patent.txt lines 20,096, 20,169
Flags
product use code U-4054
Product numbers
001, 002
25 Mar 2031 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,578,062, product and use patent
patent.txt lines 20,097, 20,170
Flags
product use code U-4488
Product numbers
001, 002
25 Mar 2031 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 10,081,621, product and use patent
patent.txt lines 21,186, 21,230
Flags
product use code U-4087
Product numbers
001, 002
25 Mar 2031 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 10,081,621, product and use patent
patent.txt lines 21,187, 21,231
Flags
product use code U-4468
Product numbers
001, 002
25 Mar 2031 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 11,578,062, product and use patent
patent.txt lines 21,194, 21,240
Flags
product use code U-4096
Product numbers
001, 002
25 Mar 2031 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 11,578,062, product and use patent
patent.txt lines 21,195, 21,241
Flags
product use code U-4465
Product numbers
001, 002
26 Mar 2031 · NDA 022204 · OXYBUTYNIN CHLORIDE
US 8,920,392, use patent
patent.txt line 1,341
Flags
use code U-1644
Product numbers
001
27 Mar 2031 · NDA 208447 · NIRAPARIB TOSYLATE
US 8,071,623, substance and product patent
patent.txt line 8,634
Flags
substance product
Product numbers
001
27 Mar 2031 · NDA 214876 · NIRAPARIB TOSYLATE
US 8,071,623, substance and product patent
patent.txt lines 16,278, 16,287, 16,296
Flags
substance product
Product numbers
001, 002, 003
27 Mar 2031 · NDA 216793 · ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
US 8,071,623, substance and product patent
patent.txt lines 18,966, 18,990
Flags
substance product
Product numbers
001, 002
29 Mar 2031 · NDA 201444 · SODIUM NITRITE; SODIUM THIOSULFATE
US 8,496,973, substance and product and use patent
patent.txt line 2,433
Flags
substance product use code U-1419
Product numbers
001
29 Mar 2031 · NDA 203923 · SODIUM THIOSULFATE
US 8,496,973, substance and product and use patent
patent.txt line 4,184
Flags
substance product use code U-1419
Product numbers
001
29 Mar 2031 · NDA 208383 · BETRIXABAN
US 8,404,724, product and use patent
patent.txt lines 8,555, 8,561
Flags
product use code U-2034
Product numbers
001, 002
29 Mar 2031 · NDA 212320 · FERRIC MALTOL
US 9,248,148, use patent
patent.txt line 13,947
Flags
use code U-2603
Product numbers
001
3 Apr 2031 · NDA 208082 · DEUTETRABENAZINE
US 8,524,733, substance and product patent
patent.txt lines 8,133, 8,165, 8,197
Flags
substance product
Product numbers
001, 002, 003
3 Apr 2031 · NDA 216354 · DEUTETRABENAZINE
US 8,524,733, substance and product patent
patent.txt lines 18,550, 18,580, 18,610, 18,640, 18,670, 18,700, 18,730, 18,760
Flags
substance product
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
4 Apr 2031 · NDA 209022 · FLUTICASONE PROPIONATE
US 12,083,270, use patent
patent.txt line 9,652
Flags
use code U-2133
Product numbers
001
4 Apr 2031 · NDA 216578 · FEZOLINETANT
US 8,871,761, substance patent
patent.txt line 18,865
Flags
substance
Product numbers
001
8 Apr 2031 · NDA 203085 · REGORAFENIB
US 9,458,107, product patent
patent.txt line 3,607
Flags
product
Product numbers
001
10 Apr 2031 · NDA 206619 · DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
US 8,420,596, substance and product patent
patent.txt line 6,602
Flags
substance product
Product numbers
001
10 Apr 2031 · NDA 206619 · DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
US 9,044,480, use patent
patent.txt line 6,612
Flags
use code U-1638
Product numbers
001
10 Apr 2031 · NDA 207931 · OMBITASVIR; PARITAPREVIR; RITONAVIR
US 8,420,596, substance and product patent
patent.txt line 7,649
Flags
substance product
Product numbers
001
10 Apr 2031 · NDA 207931 · OMBITASVIR; PARITAPREVIR; RITONAVIR
US 9,044,480, use patent
patent.txt line 7,654
Flags
use code U-1638
Product numbers
001
10 Apr 2031 · NDA 208624 · DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
US 8,420,596, substance and product patent
patent.txt line 8,998
Flags
substance product
Product numbers
001
10 Apr 2031 · NDA 208624 · DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
US 9,044,480, use patent
patent.txt line 9,008
Flags
use code U-1638
Product numbers
001
11 Apr 2031 · NDA 209241 · VALBENAZINE TOSYLATE
US 8,039,627, substance and product patent
patent.txt lines 9,952, 9,985, 10,018
Flags
substance product
Product numbers
001, 002, 003
11 Apr 2031 · NDA 218390 · VALBENAZINE TOSYLATE
US 8,039,627, substance and product patent
patent.txt lines 21,010, 21,043, 21,076
Flags
substance product
Product numbers
001, 002, 003
22 Apr 2031 · NDA 215888 · OTESECONAZOLE
US 8,236,962, substance and product patent
patent.txt line 18,076
Flags
substance product
Product numbers
001
22 Apr 2031 · NDA 215888 · OTESECONAZOLE
US 8,754,227, use patent
patent.txt line 18,077
Flags
use code U-3366
Product numbers
001
28 Apr 2031 · NDA 208743 · ABALOPARATIDE
US 7,803,770, use patent
patent.txt line 9,297
Flags
use code U-2009
Product numbers
001
28 Apr 2031 · NDA 208743 · ABALOPARATIDE
US RE49444, use patent
patent.txt line 9,301
Flags
use code U-2009
Product numbers
001
28 Apr 2031 · NDA 208743 · ABALOPARATIDE
US RE49444, use patent
patent.txt line 9,302
Flags
use code U-3543
Product numbers
001
28 Apr 2031 · NDA 208772 · BRIGATINIB
US 9,012,462, substance patent
patent.txt lines 9,316, 9,320, 9,324
Flags
substance
Product numbers
001, 002, 003
28 Apr 2031 · NDA 212018 · ERDAFITINIB
US 9,464,071, use patent
patent.txt lines 13,398, 13,416, 13,434
Flags
use code U-3805
Product numbers
001, 002, 003
29 Apr 2031 · NDA 211172 · INOTERSEN SODIUM
US 8,697,860, product patent
patent.txt line 12,507
Flags
product
Product numbers
001
29 Apr 2031 · NDA 211172 · INOTERSEN SODIUM
US 9,061,044, substance patent
patent.txt line 12,508
Flags
substance
Product numbers
001
29 Apr 2031 · NDA 211172 · INOTERSEN SODIUM
US 9,399,774, use patent
patent.txt line 12,509
Flags
use code U-2430
Product numbers
001
30 Apr 2031 · NDA 216490 · PALOPEGTERIPARATIDE
US 8,906,847, substance and product and use patent
patent.txt lines 18,832, 18,841, 18,850
Flags
substance product use code U-3982
Product numbers
001, 002, 003
30 Apr 2031 · NDA 219164 · NAVEPEGRITIDE
US 8,906,847, substance and product and use patent
patent.txt lines 21,522, 21,534, 21,546
Flags
substance product use code U-4425
Product numbers
001, 002, 003
2 May 2031 · NDA 215168 · FLURPIRIDAZ F-18
US 9,603,951, use patent
patent.txt line 16,511
Flags
use code U-4011
Product numbers
001
4 May 2031 · NDA 208261 · ELBASVIR; GRAZOPREVIR
US 8,871,759, substance and product and use patent
patent.txt line 8,425
Flags
substance product use code U-1813
Product numbers
001
5 May 2031 · NDA 210854 · BALOXAVIR MARBOXIL
US 8,927,710, product patent
patent.txt lines 12,190, 12,201, 12,212
Flags
product
Product numbers
001, 002, 003
5 May 2031 · NDA 214410 · BALOXAVIR MARBOXIL
US 8,927,710, product patent
patent.txt lines 15,762, 15,773, 15,784
Flags
product
Product numbers
001, 002, 003
5 May 2031 · NDA 216540 · ACORAMIDIS HYDROCHLORIDE
US 10,398,681, product patent
patent.txt line 18,851
Flags
product
Product numbers
001
5 May 2031 · NDA 216540 · ACORAMIDIS HYDROCHLORIDE
US 10,842,777, use patent
patent.txt line 18,853
Flags
use code U-4046
Product numbers
001
5 May 2031 · NDA 216540 · ACORAMIDIS HYDROCHLORIDE
US 8,877,795, product patent
patent.txt line 18,860
Flags
product
Product numbers
001
5 May 2031 · NDA 216540 · ACORAMIDIS HYDROCHLORIDE
US 9,169,214, product and use patent
patent.txt line 18,861
Flags
product use code U-4046
Product numbers
001
5 May 2031 · NDA 216540 · ACORAMIDIS HYDROCHLORIDE
US 9,642,838, substance and product patent
patent.txt line 18,862
Flags
substance product
Product numbers
001
5 May 2031 · NDA 216540 · ACORAMIDIS HYDROCHLORIDE
US 9,913,826, use patent
patent.txt line 18,863
Flags
use code U-4046
Product numbers
001
10 May 2031 · NDA 207962 · LIDOCAINE
US 10,765,640, product patent
patent.txt line 7,866
Flags
product
Product numbers
001
10 May 2031 · NDA 207962 · LIDOCAINE
US 10,765,749, product patent
patent.txt line 7,867
Flags
product
Product numbers
001
10 May 2031 · NDA 207962 · LIDOCAINE
US 11,278,623, product patent
patent.txt line 7,868
Flags
product
Product numbers
001
10 May 2031 · NDA 207962 · LIDOCAINE
US 11,786,455, product and use patent
patent.txt line 7,869
Flags
product use code U-2267
Product numbers
001
10 May 2031 · NDA 207962 · LIDOCAINE
US 11,793,766, use patent
patent.txt line 7,870
Flags
use code U-2267
Product numbers
001
10 May 2031 · NDA 207962 · LIDOCAINE
US 9,283,174, product patent
patent.txt line 7,871
Flags
product
Product numbers
001
10 May 2031 · NDA 207962 · LIDOCAINE
US 9,925,264, product and use patent
patent.txt line 7,872
Flags
product use code U-2267
Product numbers
001
10 May 2031 · NDA 207962 · LIDOCAINE
US 9,931,403, product patent
patent.txt line 7,873
Flags
product
Product numbers
001
12 May 2031 · NDA 050444 · MINOCYCLINE HYDROCHLORIDE
US 12,161,656, product patent
patent.txt line 2,137
Flags
product
Product numbers
001
12 May 2031 · NDA 050444 · MINOCYCLINE HYDROCHLORIDE
US 9,084,802, use patent
patent.txt line 2,138
Flags
use code U-282
Product numbers
001
12 May 2031 · NDA 050444 · MINOCYCLINE HYDROCHLORIDE
US 9,278,105, use patent
patent.txt line 2,139
Flags
use code U-282
Product numbers
001
18 May 2031 · NDA 020911 · BECLOMETHASONE DIPROPIONATE
US 9,463,289, product patent
patent.txt lines 379, 381
Flags
product delist requested
Product numbers
001, 002
18 May 2031 · NDA 020911 · BECLOMETHASONE DIPROPIONATE
US 9,808,587, product patent
patent.txt lines 380, 382
Flags
product delist requested
Product numbers
001, 002
18 May 2031 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 10,022,509, product patent
patent.txt lines 7,440, 7,455
Flags
product delist requested
Product numbers
001, 002
18 May 2031 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 10,022,510, product patent
patent.txt lines 7,441, 7,456
Flags
product delist requested
Product numbers
001, 002
18 May 2031 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 10,086,156, product patent
patent.txt lines 7,442, 7,457
Flags
product delist requested
Product numbers
001, 002
18 May 2031 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 10,695,512, product patent
patent.txt lines 7,444, 7,459
Flags
product delist requested
Product numbers
001, 002
18 May 2031 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 11,395,889, product patent
patent.txt lines 7,447, 7,462
Flags
product delist requested
Product numbers
001, 002
18 May 2031 · NDA 209529 · SOLIFENACIN SUCCINATE
US 9,918,970, product patent
patent.txt line 10,604
Flags
product
Product numbers
001
19 May 2031 · NDA 214377 · VERICIGUAT
US 10,736,896, substance and product patent
patent.txt lines 15,736, 15,742, 15,748
Flags
substance product
Product numbers
001, 002, 003
19 May 2031 · NDA 214377 · VERICIGUAT
US 11,439,642, use patent
patent.txt lines 15,737, 15,743, 15,749
Flags
use code U-3062
Product numbers
001, 002, 003
19 May 2031 · NDA 214377 · VERICIGUAT
US 8,420,656, substance and product patent
patent.txt lines 15,738, 15,744, 15,750
Flags
substance product
Product numbers
001, 002, 003
19 May 2031 · NDA 214377 · VERICIGUAT
US 8,921,377, use patent
patent.txt lines 15,739, 15,745, 15,751
Flags
use code U-3062
Product numbers
001, 002, 003
19 May 2031 · NDA 214377 · VERICIGUAT
US 9,993,476, use patent
patent.txt lines 15,741, 15,747, 15,753
Flags
use code U-3062
Product numbers
001, 002, 003
20 May 2031 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 10,758,543, product patent
patent.txt line 16,738
Flags
product
Product numbers
001
20 May 2031 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 10,869,870, use patent
patent.txt line 16,740
Flags
use code U-3229
Product numbers
001
20 May 2031 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 10,869,870, use patent
patent.txt line 16,741
Flags
use code U-3404
Product numbers
001
20 May 2031 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 11,219,624, product and use patent
patent.txt line 16,743
Flags
product use code U-3229
Product numbers
001
20 May 2031 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 11,571,425, product patent
patent.txt line 16,745
Flags
product
Product numbers
001
20 May 2031 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 11,590,136, use patent
patent.txt line 16,746
Flags
use code U-3229
Product numbers
001
20 May 2031 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 11,590,136, use patent
patent.txt line 16,747
Flags
use code U-3404
Product numbers
001
20 May 2031 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 12,226,419, product patent
patent.txt line 16,751
Flags
product
Product numbers
001
20 May 2031 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 12,544,381, product patent
patent.txt line 16,753
Flags
product
Product numbers
001
20 May 2031 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 12,564,593, product patent
patent.txt line 16,754
Flags
product
Product numbers
001
23 May 2031 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 9,259,423, use patent
patent.txt lines 2,250, 2,261, 2,272, 2,283, 2,294
Flags
use code U-1822
Product numbers
001, 002, 003, 004, 005
23 May 2031 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 9,827,242, use patent
patent.txt lines 2,252, 2,263, 2,274, 2,285, 2,296
Flags
use code U-2199
Product numbers
001, 002, 003, 004, 005
23 May 2031 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 9,827,242, use patent
patent.txt lines 2,253, 2,264, 2,275, 2,286, 2,297
Flags
use code U-2201
Product numbers
001, 002, 003, 004, 005
23 May 2031 · NDA 211672 · LEFAMULIN ACETATE
US 9,120,727, substance and product patent
patent.txt line 12,968
Flags
substance product
Product numbers
001
24 May 2031 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 10,143,972, use patent
patent.txt line 5,871
Flags
use code U-2476
Product numbers
001
24 May 2031 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 10,143,792, use patent
patent.txt line 10,895
Flags
use code U-2476
Product numbers
001
24 May 2031 · NDA 215457 · NALOXONE HYDROCHLORIDE
US 10,143,792, use patent
patent.txt line 17,288
Flags
use code U-2476
Product numbers
001
26 May 2031 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,260,053, use patent
patent.txt line 15,925
Flags
use code U-3290
Product numbers
001
26 May 2031 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,260,053, use patent
patent.txt line 15,926
Flags
use code U-3974
Product numbers
001
26 May 2031 · NDA 219485 · MARALIXIBAT CHLORIDE
US 11,260,053, use patent
patent.txt lines 21,750, 21,759, 21,768, 21,777
Flags
use code U-4187
Product numbers
001, 002, 003, 004
27 May 2031 · NDA 204824 · METHOTREXATE
US 8,814,834, product patent
patent.txt lines 5,070, 5,085, 5,100, 5,115, 5,130, 5,145, 5,160, 5,175
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
29 May 2031 · NDA 208434 · ALECTINIB HYDROCHLORIDE
US 9,126,931, substance patent
patent.txt line 8,618
Flags
substance
Product numbers
001
31 May 2031 · NDA 214835 · RISPERIDONE
US 10,058,504, product patent
patent.txt lines 16,208, 16,222
Flags
product
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 10,085,936, product patent
patent.txt lines 16,209, 16,223
Flags
product
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 10,182,982, use patent
patent.txt lines 16,210, 16,224
Flags
use code U-3943
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 10,195,138, use patent
patent.txt lines 16,211, 16,225
Flags
use code U-3943
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 10,335,366, product patent
patent.txt lines 16,212, 16,226
Flags
product
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 10,463,607, product patent
patent.txt lines 16,213, 16,227
Flags
product
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 10,881,605, product patent
patent.txt lines 16,214, 16,228
Flags
product
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 11,007,139, use patent
patent.txt lines 16,215, 16,229
Flags
use code U-3942
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 11,173,110, use patent
patent.txt lines 16,216, 16,230
Flags
use code U-3941
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 11,241,377, use patent
patent.txt lines 16,217, 16,231
Flags
use code U-3939
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 11,752,092, use patent
patent.txt lines 16,218, 16,232
Flags
use code U-3941
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 11,752,093, product patent
patent.txt lines 16,219, 16,233
Flags
product
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 11,752,094, use patent
patent.txt lines 16,220, 16,234
Flags
use code U-3942
Product numbers
001, 002
31 May 2031 · NDA 214835 · RISPERIDONE
US 11,759,416, use patent
patent.txt lines 16,221, 16,235
Flags
use code U-3939
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,004,746, use patent
patent.txt lines 5,468, 5,567
Flags
use code U-1684
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,004,746, use patent
patent.txt lines 5,469, 5,568
Flags
use code U-1946
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,004,746, use patent
patent.txt lines 5,470, 5,569
Flags
use code U-2241
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,004,746, use patent
patent.txt lines 5,471, 5,570
Flags
use code U-2242
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,016,435, use patent
patent.txt lines 5,473, 5,572
Flags
use code U-1650
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 5,485, 5,584
Flags
use code U-1650
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 5,486, 5,585
Flags
use code U-1684
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 5,487, 5,586
Flags
use code U-1946
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 5,488, 5,587
Flags
use code U-2241
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 5,489, 5,588
Flags
use code U-2242
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 5,490, 5,589
Flags
use code U-2665
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 5,491, 5,590
Flags
use code U-3422
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,751,342, use patent
patent.txt lines 5,495, 5,594
Flags
use code U-1491
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,751,342, use patent
patent.txt lines 5,496, 5,595
Flags
use code U-1946
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,751,342, use patent
patent.txt lines 5,497, 5,596
Flags
use code U-2943
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 10,751,342, use patent
patent.txt lines 5,498, 5,597
Flags
use code U-2944
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 11,672,803, use patent
patent.txt lines 5,503, 5,600
Flags
use code U-1684
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 11,672,803, use patent
patent.txt lines 5,504, 5,601
Flags
use code U-1946
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 11,672,803, use patent
patent.txt lines 5,505, 5,602
Flags
use code U-2241
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 11,672,803, use patent
patent.txt lines 5,506, 5,603
Flags
use code U-2242
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 8,999,999, use patent
patent.txt line 5,541
Flags
use code U-1683
Product numbers
001
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 8,999,999, use patent
patent.txt line 5,542
Flags
use code U-1684
Product numbers
001
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 8,999,999, use patent
patent.txt line 5,638
Flags
use code U-1491
Product numbers
002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 8,999,999, use patent
patent.txt line 5,639
Flags
use code U-1946
Product numbers
002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 8,999,999, use patent
patent.txt line 5,640
Flags
use code U-2228
Product numbers
002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 9,125,889, use patent
patent.txt line 5,544
Flags
use code U-1745
Product numbers
001
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 9,125,889, use patent
patent.txt line 5,642
Flags
use code U-1650
Product numbers
002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 9,801,881, use patent
patent.txt lines 5,563, 5,660
Flags
use code U-1491
Product numbers
001, 002
3 Jun 2031 · NDA 205552 · IBRUTINIB
US 9,801,883, use patent
patent.txt lines 5,565, 5,662
Flags
use code U-2159
Product numbers
001, 002
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,004,746, use patent
patent.txt lines 11,588, 11,694, 11,798, 11,902
Flags
use code U-1684
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,004,746, use patent
patent.txt lines 11,589, 11,695, 11,799, 11,903
Flags
use code U-1946
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,004,746, use patent
patent.txt lines 11,590, 11,696, 11,800, 11,904
Flags
use code U-2241
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,004,746, use patent
patent.txt lines 11,591, 11,697, 11,801, 11,905
Flags
use code U-2242
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,016,435, use patent
patent.txt lines 11,595, 11,701, 11,805, 11,909
Flags
use code U-1650
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 11,611, 11,717, 11,821
Flags
use code U-3422
Product numbers
001, 002, 003
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 11,605, 11,711, 11,815, 11,920
Flags
use code U-1650
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 11,606, 11,712, 11,816, 11,921
Flags
use code U-1684
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 11,607, 11,713, 11,817, 11,922
Flags
use code U-1946
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 11,608, 11,714, 11,818, 11,924
Flags
use code U-2241
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 11,609, 11,715, 11,819, 11,925
Flags
use code U-2242
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,478,439, use patent
patent.txt lines 11,610, 11,716, 11,820, 11,926
Flags
use code U-2665
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,478,439, use patent
patent.txt line 11,919
Flags
use code U-1456
Product numbers
004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,478,439, use patent
patent.txt line 11,923
Flags
use code U-1947
Product numbers
004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,653,696, use patent
patent.txt line 11,928
Flags
use code U-1456
Product numbers
004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,751,342, use patent
patent.txt lines 11,615, 11,721, 11,825, 11,932
Flags
use code U-1491
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,751,342, use patent
patent.txt lines 11,616, 11,722, 11,826, 11,933
Flags
use code U-1946
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,751,342, use patent
patent.txt lines 11,617, 11,723, 11,827, 11,934
Flags
use code U-2943
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 10,751,342, use patent
patent.txt lines 11,618, 11,724, 11,828, 11,935
Flags
use code U-2944
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 11,672,803, use patent
patent.txt lines 11,625, 11,729, 11,833
Flags
use code U-1684
Product numbers
001, 002, 003
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 11,672,803, use patent
patent.txt lines 11,626, 11,730, 11,834
Flags
use code U-1946
Product numbers
001, 002, 003
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 11,672,803, use patent
patent.txt lines 11,627, 11,731, 11,835
Flags
use code U-2241
Product numbers
001, 002, 003
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 11,672,803, use patent
patent.txt lines 11,628, 11,732, 11,836
Flags
use code U-2242
Product numbers
001, 002, 003
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 8,754,090, use patent
patent.txt line 11,972
Flags
use code U-1456
Product numbers
004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 8,999,999, use patent
patent.txt lines 11,669, 11,773, 11,877, 11,986
Flags
use code U-1491
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 8,999,999, use patent
patent.txt lines 11,670, 11,774, 11,878, 11,987
Flags
use code U-1946
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 8,999,999, use patent
patent.txt lines 11,671, 11,775, 11,879, 11,988
Flags
use code U-2241
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 8,999,999, use patent
patent.txt lines 11,672, 11,776, 11,880, 11,989
Flags
use code U-2242
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 9,125,889, use patent
patent.txt lines 11,674, 11,778, 11,882, 11,991
Flags
use code U-1650
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 9,801,881, use patent
patent.txt lines 11,688, 11,792, 11,896, 12,004
Flags
use code U-1491
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 9,801,881, use patent
patent.txt lines 11,689, 11,793, 11,897, 12,005
Flags
use code U-2242
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 9,801,883, use patent
patent.txt lines 11,691, 11,795, 11,899, 12,007
Flags
use code U-2159
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 9,801,883, use patent
patent.txt lines 11,692, 11,796, 11,900, 12,008
Flags
use code U-2243
Product numbers
001, 002, 003, 004
3 Jun 2031 · NDA 210563 · IBRUTINIB
US 9,814,721, use patent
patent.txt line 12,010
Flags
use code U-1947
Product numbers
004
3 Jun 2031 · NDA 213426 · CELECOXIB; TRAMADOL HYDROCHLORIDE
US 8,846,744, product patent
patent.txt line 15,004
Flags
product
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,004,746, use patent
patent.txt line 19,147
Flags
use code U-3846
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,004,746, use patent
patent.txt line 19,148
Flags
use code U-3847
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,004,746, use patent
patent.txt line 19,149
Flags
use code U-3848
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,004,746, use patent
patent.txt line 19,150
Flags
use code U-3849
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,016,435, use patent
patent.txt line 19,151
Flags
use code U-3845
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,478,439, use patent
patent.txt line 19,158
Flags
use code U-2666
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,478,439, use patent
patent.txt line 19,159
Flags
use code U-2970
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,478,439, use patent
patent.txt line 19,160
Flags
use code U-3422
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,478,439, use patent
patent.txt line 19,161
Flags
use code U-3842
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,478,439, use patent
patent.txt line 19,162
Flags
use code U-3843
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,478,439, use patent
patent.txt line 19,163
Flags
use code U-3844
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,478,439, use patent
patent.txt line 19,164
Flags
use code U-3845
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,751,342, use patent
patent.txt line 19,166
Flags
use code U-2666
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,751,342, use patent
patent.txt line 19,167
Flags
use code U-3842
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,751,342, use patent
patent.txt line 19,168
Flags
use code U-3843
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 10,751,342, use patent
patent.txt line 19,169
Flags
use code U-3844
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 11,672,803, use patent
patent.txt line 19,172
Flags
use code U-2666
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 11,672,803, use patent
patent.txt line 19,173
Flags
use code U-3842
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 11,672,803, use patent
patent.txt line 19,174
Flags
use code U-3843
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 11,672,803, use patent
patent.txt line 19,175
Flags
use code U-3844
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 8,999,999, use patent
patent.txt line 19,213
Flags
use code U-2666
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 8,999,999, use patent
patent.txt line 19,214
Flags
use code U-3842
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 8,999,999, use patent
patent.txt line 19,215
Flags
use code U-3843
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 8,999,999, use patent
patent.txt line 19,216
Flags
use code U-3844
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 9,125,889, use patent
patent.txt line 19,217
Flags
use code U-3845
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 9,801,881, use patent
patent.txt line 19,227
Flags
use code U-3846
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 9,801,881, use patent
patent.txt line 19,228
Flags
use code U-3847
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 9,801,883, use patent
patent.txt line 19,229
Flags
use code U-2666
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 9,801,883, use patent
patent.txt line 19,230
Flags
use code U-3842
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 9,801,883, use patent
patent.txt line 19,231
Flags
use code U-3843
Product numbers
001
3 Jun 2031 · NDA 217003 · IBRUTINIB
US 9,801,883, use patent
patent.txt line 19,232
Flags
use code U-3844
Product numbers
001
5 Jun 2031 · NDA 213591 · CAPMATINIB HYDROCHLORIDE
US 8,420,645, substance and product patent
patent.txt lines 15,142, 15,149
Flags
substance product
Product numbers
001, 002
5 Jun 2031 · NDA 221075 · IBERDOMIDE HYDROCHLORIDE
US 8,518,972, substance and product patent
patent.txt lines 22,407, 22,414
Flags
substance product
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 10,198,218, use patent
patent.txt lines 10,837, 10,861
Flags
use code U-2489
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 10,592,168, use patent
patent.txt lines 10,839, 10,863
Flags
use code U-2489
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,272,044, use patent
patent.txt lines 10,847, 10,872
Flags
use code U-2176
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,272,044, use patent
patent.txt lines 10,848, 10,873
Flags
use code U-2177
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,272,044, use patent
patent.txt lines 10,849, 10,874
Flags
use code U-2178
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,272,044, use patent
patent.txt lines 10,850, 10,875
Flags
use code U-2209
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,498,432, product and use patent
patent.txt lines 10,851, 10,876
Flags
product use code U-2179
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,782,402, product and use patent
patent.txt lines 10,852, 10,877
Flags
product use code U-2176
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,782,402, product and use patent
patent.txt lines 10,853, 10,878
Flags
product use code U-2180
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,782,402, product and use patent
patent.txt lines 10,854, 10,879
Flags
product use code U-2207
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,782,402, product and use patent
patent.txt lines 10,855, 10,880
Flags
product use code U-2208
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,827,241, product and use patent
patent.txt lines 10,856, 10,881
Flags
product use code U-2174
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,827,241, product and use patent
patent.txt lines 10,857, 10,882
Flags
product use code U-2181
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,827,241, product and use patent
patent.txt lines 10,858, 10,883
Flags
product use code U-2206
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,827,241, product and use patent
patent.txt lines 10,859, 10,884
Flags
product use code U-2210
Product numbers
001, 002
6 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 9,827,241, product and use patent
patent.txt lines 10,860, 10,885
Flags
product use code U-2211
Product numbers
001, 002
7 Jun 2031 · NDA 021035 · LEVETIRACETAM
US 8,802,142, product patent
patent.txt lines 400, 402, 404, 406
Flags
product
Product numbers
001, 002, 003, 004
9 Jun 2031 · NDA 206619 · DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
US 8,686,026, product patent
patent.txt line 6,609
Flags
product
Product numbers
001
9 Jun 2031 · NDA 207931 · OMBITASVIR; PARITAPREVIR; RITONAVIR
US 8,686,026, product patent
patent.txt line 7,651
Flags
product
Product numbers
001
9 Jun 2031 · NDA 208624 · DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
US 8,686,026, product patent
patent.txt line 9,005
Flags
product
Product numbers
001
10 Jun 2031 · NDA 207589 · BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
US 10,130,640, product patent
patent.txt line 7,365
Flags
product
Product numbers
001
10 Jun 2031 · NDA 207589 · BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
US 10,617,698, product patent
patent.txt line 7,366
Flags
product
Product numbers
001
10 Jun 2031 · NDA 207589 · BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
US 10,660,908, product and use patent
patent.txt line 7,367
Flags
product use code U-2627
Product numbers
001
10 Jun 2031 · NDA 207589 · BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
US 10,682,364, product patent
patent.txt line 7,368
Flags
product
Product numbers
001
10 Jun 2031 · NDA 207589 · BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
US 10,688,108, use patent
patent.txt line 7,369
Flags
use code U-2627
Product numbers
001
10 Jun 2031 · NDA 207589 · BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
US 10,716,799, product patent
patent.txt line 7,370
Flags
product
Product numbers
001
10 Jun 2031 · NDA 207589 · BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
US 9,119,781, product and use patent
patent.txt line 7,372
Flags
product use code U-1761
Product numbers
001
10 Jun 2031 · NDA 207589 · BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
US 9,119,781, product and use patent
patent.txt line 7,373
Flags
product use code U-2627
Product numbers
001
10 Jun 2031 · NDA 207589 · BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
US 9,566,286, product patent
patent.txt line 7,374
Flags
product
Product numbers
001
11 Jun 2031 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 8,440,715, use patent
patent.txt lines 12,596, 12,635
Flags
use code U-2548
Product numbers
001, 002
13 Jun 2031 · NDA 204708 · BRIMONIDINE TARTRATE
US 10,201,517, product patent
patent.txt line 4,981
Flags
product
Product numbers
001
13 Jun 2031 · NDA 204708 · BRIMONIDINE TARTRATE
US 8,053,427, product and use patent
patent.txt line 4,982
Flags
product use code U-1428
Product numbers
001
13 Jun 2031 · NDA 204708 · BRIMONIDINE TARTRATE
US 8,163,725, product patent
patent.txt line 4,983
Flags
product
Product numbers
001
13 Jun 2031 · NDA 206843 · DACLATASVIR DIHYDROCHLORIDE
US 8,629,171, substance and product and use patent
patent.txt lines 6,825, 6,833
Flags
substance product use code U-1724
Product numbers
001, 002
13 Jun 2031 · NDA 214373 · BEXAGLIFLOZIN
US 10,981,942, substance and product patent
patent.txt line 15,728
Flags
substance product
Product numbers
001
19 Jun 2031 · NDA 208610 · DELAFLOXACIN MEGLUMINE
US 7,728,143, substance patent
patent.txt line 8,908
Flags
substance
Product numbers
001
19 Jun 2031 · NDA 208611 · DELAFLOXACIN MEGLUMINE
US 7,728,143, substance patent
patent.txt line 8,917
Flags
substance
Product numbers
001
21 Jun 2031 · NDA 204026 · POMALIDOMIDE
US 8,828,427, substance and product patent
patent.txt lines 4,199, 4,205, 4,211, 4,217
Flags
substance product
Product numbers
001, 002, 003, 004
23 Jun 2031 · NDA 022205 · BALSALAZIDE DISODIUM
US 8,497,256, use patent
patent.txt line 1,345
Flags
use code U-1229
Product numbers
001
24 Jun 2031 · NDA 205596 · POSACONAZOLE
US 9,358,297, product and use patent
patent.txt line 5,690
Flags
product use code U-3160
Product numbers
001
24 Jun 2031 · NDA 205596 · POSACONAZOLE
US 9,358,297, product and use patent
patent.txt line 5,691
Flags
product use code U-3171
Product numbers
001
24 Jun 2031 · NDA 205596 · POSACONAZOLE
US 9,358,297, product and use patent
patent.txt line 5,692
Flags
product use code U-4415
Product numbers
001
24 Jun 2031 · NDA 205596 · POSACONAZOLE
US 9,358,297, product and use patent
patent.txt line 5,693
Flags
product use code U-4416
Product numbers
001
25 Jun 2031 · NDA 209819 · BUPRENORPHINE
US 10,558,394, product patent
patent.txt lines 10,838, 10,862
Flags
product
Product numbers
001, 002
27 Jun 2031 · NDA 208573 · VENETOCLAX
US 8,546,399, substance and product patent
patent.txt lines 8,867, 8,881, 8,895
Flags
substance product
Product numbers
001, 002, 003
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 10,179,140, use patent
patent.txt line 12,841
Flags
use code U-2553
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 10,603,281, use patent
patent.txt line 12,842
Flags
use code U-2553
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 10,849,857, product and use patent
patent.txt line 12,843
Flags
product use code U-2553
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 10,987,364, product patent
patent.txt line 12,844
Flags
product
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 11,123,299, product patent
patent.txt line 12,845
Flags
product
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 11,291,632, product patent
patent.txt line 12,846
Flags
product
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 11,291,633, product patent
patent.txt line 12,847
Flags
product
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 11,351,122, product patent
patent.txt line 12,848
Flags
product
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 11,413,249, use patent
patent.txt line 12,849
Flags
use code U-2553
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 11,478,487, product patent
patent.txt line 12,850
Flags
product
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 11,504,334, product patent
patent.txt line 12,851
Flags
product
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 11,951,213, use patent
patent.txt line 12,852
Flags
use code U-2553
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 12,090,231, use patent
patent.txt line 12,853
Flags
use code U-2553
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 12,280,151, product patent
patent.txt line 12,854
Flags
product
Product numbers
001
28 Jun 2031 · NDA 211367 · DROSPIRENONE
US 9,603,860, use patent
patent.txt line 12,855
Flags
use code U-2553
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 10,179,140, use patent
patent.txt line 18,476
Flags
use code U-2553
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 10,603,281, use patent
patent.txt line 18,477
Flags
use code U-2553
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 10,849,857, product and use patent
patent.txt line 18,478
Flags
product use code U-2553
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 10,987,364, product patent
patent.txt line 18,479
Flags
product
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 11,123,299, product patent
patent.txt line 18,480
Flags
product
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 11,291,632, product patent
patent.txt line 18,481
Flags
product
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 11,291,633, product patent
patent.txt line 18,482
Flags
product
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 11,351,122, product patent
patent.txt line 18,483
Flags
product
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 11,413,249, use patent
patent.txt line 18,484
Flags
use code U-2553
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 11,439,598, product patent
patent.txt line 18,485
Flags
product
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 11,478,487, product patent
patent.txt line 18,486
Flags
product
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 11,504,334, product patent
patent.txt line 18,487
Flags
product
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 11,951,213, use patent
patent.txt line 18,488
Flags
use code U-2553
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 12,090,231, use patent
patent.txt line 18,489
Flags
use code U-2553
Product numbers
001
28 Jun 2031 · NDA 216285 · DROSPIRENONE
US 9,603,860, use patent
patent.txt line 18,490
Flags
use code U-2553
Product numbers
001
30 Jun 2031 · NDA 022425 · DRONEDARONE HYDROCHLORIDE
US 8,602,215, use patent
patent.txt line 1,877
Flags
use code U-1473
Product numbers
001
30 Jun 2031 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 8,722,684, substance and product patent
patent.txt lines 4,701, 4,721, 4,741, 4,761
Flags
substance product
Product numbers
001, 002, 003, 004
30 Jun 2031 · NDA 215168 · FLURPIRIDAZ F-18
US 8,936,777, use patent
patent.txt line 16,509
Flags
use code U-4011
Product numbers
001

Pediatric exclusivity, as listed (47)

5 Jan 2031 · NDA 201292 · AFATINIB DIMALEATE
US 10,004,743 with pediatric exclusivity, as listed
patent.txt lines 2,398, 2,408, 2,418
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
1 Feb 2031 · NDA 207947 · SELEXIPAG
US 8,791,122 with pediatric exclusivity, as listed
patent.txt lines 7,700, 7,712, 7,724, 7,736, 7,748, 7,760, 7,772, 7,784, 7,796, 7,808
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 010, 011
1 Feb 2031 · NDA 214275 · SELEXIPAG
US 8,791,122 with pediatric exclusivity, as listed
patent.txt line 15,660
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
13 Mar 2031 · NDA 204671 · SOFOSBUVIR
US 9,284,342 with pediatric exclusivity, as listed
patent.txt lines 4,959, 4,977
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
13 Mar 2031 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 9,284,342 with pediatric exclusivity, as listed
patent.txt lines 5,936, 5,969
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
13 Mar 2031 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 9,284,342 with pediatric exclusivity, as listed
patent.txt lines 8,509, 8,539
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
13 Mar 2031 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 9,284,342 with pediatric exclusivity, as listed
patent.txt line 9,854
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
13 Mar 2031 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 9,284,342 with pediatric exclusivity, as listed
patent.txt lines 14,009, 14,040
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
13 Mar 2031 · NDA 212480 · SOFOSBUVIR
US 9,284,342 with pediatric exclusivity, as listed
patent.txt lines 14,067, 14,083
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
13 Mar 2031 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 9,284,342 with pediatric exclusivity, as listed
patent.txt lines 15,602, 15,630
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
14 Mar 2031 · NDA 202992 · TERIFLUNOMIDE
US 8,802,735 with pediatric exclusivity, as listed
patent.txt lines 3,590, 3,596
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
20 Mar 2031 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,507,534 with pediatric exclusivity, as listed
patent.txt lines 6,102, 6,149
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
20 Mar 2031 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,716,338 with pediatric exclusivity, as listed
patent.txt lines 6,106, 6,153
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
20 Mar 2031 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,507,534 with pediatric exclusivity, as listed
patent.txt lines 12,733, 12,775, 12,817
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
20 Mar 2031 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,716,338 with pediatric exclusivity, as listed
patent.txt lines 12,737, 12,779, 12,821
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
30 Mar 2031 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 10,610,489 with pediatric exclusivity, as listed
patent.txt lines 6,292, 6,323, 6,354, 6,383
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
4 Apr 2031 · NDA 206947 · LENVATINIB MESYLATE
US 12,508,313 with pediatric exclusivity, as listed
patent.txt lines 6,887, 6,908
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Apr 2031 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,895,033 with pediatric exclusivity, as listed
patent.txt line 9,892
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
11 Apr 2031 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 8,746,242 with pediatric exclusivity, as listed
patent.txt lines 4,435, 4,445, 4,453
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
11 Apr 2031 · NDA 209482 · FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 8,746,242 with pediatric exclusivity, as listed
patent.txt lines 10,410, 10,417
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
15 Apr 2031 · NDA 202806 · DABRAFENIB MESYLATE
US 8,703,781 with pediatric exclusivity, as listed
patent.txt lines 3,262, 3,286
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
15 Apr 2031 · NDA 202806 · DABRAFENIB MESYLATE
US 8,952,018 with pediatric exclusivity, as listed
patent.txt lines 3,267, 3,291
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
15 Apr 2031 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,703,781 with pediatric exclusivity, as listed
patent.txt lines 4,277, 4,297, 4,317
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
15 Apr 2031 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,952,018 with pediatric exclusivity, as listed
patent.txt lines 4,283, 4,303, 4,323
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
15 Apr 2031 · NDA 217513 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,703,781 with pediatric exclusivity, as listed
patent.txt line 19,990
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
15 Apr 2031 · NDA 217514 · DABRAFENIB MESYLATE
US 8,703,781 with pediatric exclusivity, as listed
patent.txt line 19,998
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
16 Apr 2031 · NDA 021936 · TIOTROPIUM BROMIDE
US 8,733,341 with pediatric exclusivity, as listed
patent.txt line 812
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
21 Apr 2031 · NDA 022145 · RALTEGRAVIR POTASSIUM
US 9,649,311 with pediatric exclusivity, as listed
patent.txt line 1,121
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
002
26 Apr 2031 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,436,190 with pediatric exclusivity, as listed
patent.txt lines 1,361, 1,378
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
27 Apr 2031 · NDA 201023 · CABAZITAXEL
US 10,583,110 with pediatric exclusivity, as listed
patent.txt line 2,312
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
27 Apr 2031 · NDA 201023 · CABAZITAXEL
US 10,716,777 with pediatric exclusivity, as listed
patent.txt line 2,314
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
27 Apr 2031 · NDA 201023 · CABAZITAXEL
US 12,453,712 with pediatric exclusivity, as listed
patent.txt line 2,316
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
27 Apr 2031 · NDA 201023 · CABAZITAXEL
US 8,927,592 with pediatric exclusivity, as listed
patent.txt line 2,320
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
6 May 2031 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
US 9,586,978 with pediatric exclusivity, as listed
patent.txt line 10,318
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
6 May 2031 · NDA 215110 · GLECAPREVIR; PIBRENTASVIR
US 9,586,978 with pediatric exclusivity, as listed
patent.txt line 16,492
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
12 May 2031 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 9,616,028 with pediatric exclusivity, as listed
patent.txt lines 5,718, 5,728, 5,738, 5,748, 5,758
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
12 May 2031 · NDA 210874 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
US 9,616,028 with pediatric exclusivity, as listed
patent.txt lines 12,282, 12,292, 12,302, 12,312
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
11 Jun 2031 · NDA 204671 · SOFOSBUVIR
US 8,618,076 with pediatric exclusivity, as listed
patent.txt lines 4,951, 4,969
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
11 Jun 2031 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,618,076 with pediatric exclusivity, as listed
patent.txt lines 5,922, 5,955
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
11 Jun 2031 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,993,600 with pediatric exclusivity, as listed
patent.txt lines 6,117, 6,161
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
11 Jun 2031 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,618,076 with pediatric exclusivity, as listed
patent.txt lines 8,495, 8,525
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
11 Jun 2031 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,618,076 with pediatric exclusivity, as listed
patent.txt line 9,831
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
11 Jun 2031 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,993,600 with pediatric exclusivity, as listed
patent.txt lines 12,745, 12,787, 12,829
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
11 Jun 2031 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,618,076 with pediatric exclusivity, as listed
patent.txt lines 13,995, 14,026
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
11 Jun 2031 · NDA 212480 · SOFOSBUVIR
US 8,618,076 with pediatric exclusivity, as listed
patent.txt lines 14,059, 14,075
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
11 Jun 2031 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,618,076 with pediatric exclusivity, as listed
patent.txt lines 15,588, 15,616
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
14 Jun 2031 · NDA 202324 · AXITINIB
US 8,791,140 with pediatric exclusivity, as listed
patent.txt lines 3,054, 3,063
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002

Non-patent exclusivity (49)

12 Jan 2031 · NDA 211241 · COPPER HISTIDINATE
NCE exclusivity
exclusivity.txt line 948
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
9 Feb 2031 · NDA 213976 · BUDESONIDE
ODE-466 exclusivity
exclusivity.txt line 1,285
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
12 Feb 2031 · NDA 219474 · DIFAMILAST
NCE exclusivity
exclusivity.txt line 2,288
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
13 Feb 2031 · NDA 207793 · IRINOTECAN HYDROCHLORIDE
ODE-463 exclusivity
exclusivity.txt line 625
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
13 Feb 2031 · NDA 217933 · ILOPROST
ODE-465 exclusivity
exclusivity.txt line 2,030
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
20 Feb 2031 · NDA 220358 · MILSAPERIDONE
NCE exclusivity
exclusivity.txt lines 2,384–2,390
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006, 007
23 Feb 2031 · NDA 210251 · BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
ODE-468 exclusivity
exclusivity.txt lines 862, 866
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
27 Feb 2031 · NDA 219164 · NAVEPEGRITIDE
NCE exclusivity
exclusivity.txt lines 2,256, 2,258, 2,260
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
7 Mar 2031 · NDA 213217 · ZANUBRUTINIB
ODE-467 exclusivity
exclusivity.txt line 1,167
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
7 Mar 2031 · NDA 218785 · ZANUBRUTINIB
ODE* exclusivity
exclusivity.txt line 2,199
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
13 Mar 2031 · NDA 214662 · MARALIXIBAT CHLORIDE
ODE-471 exclusivity
exclusivity.txt line 1,352
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
13 Mar 2031 · NDA 214662 · MARALIXIBAT CHLORIDE
ODE* exclusivity
exclusivity.txt line 1,355
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
002
17 Mar 2031 · NDA 220149 · ICOTROKINRA HYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 2,377
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
17 Mar 2031 · NDA 220295 · LINERIXIBAT
NCE exclusivity
exclusivity.txt line 2,381
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
19 Mar 2031 · NDA 203469 · PONATINIB HYDROCHLORIDE
ODE-472 exclusivity
exclusivity.txt lines 324, 326, 328, 330
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
21 Mar 2031 · NDA 217865 · GIVINOSTAT HYDROCHLORIDE
ODE-473 exclusivity
exclusivity.txt line 2,022
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
22 Mar 2031 · NDA 218490 · MACITENTAN; TADALAFIL
ODE-475 exclusivity
exclusivity.txt lines 2,157, 2,161
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
25 Mar 2031 · NDA 220641 · RELACORILANT
NCE exclusivity
exclusivity.txt line 2,400
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
26 Mar 2031 · NDA 203341 · BOSUTINIB MONOHYDRATE
PED exclusivity
exclusivity.txt lines 310, 314, 318
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
26 Mar 2031 · NDA 217729 · BOSUTINIB MONOHYDRATE
PED exclusivity
exclusivity.txt lines 1,923, 1,927
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
29 Mar 2031 · NDA 218037 · DANICOPAN
ODE-476 exclusivity
exclusivity.txt lines 2,035, 2,037
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
1 Apr 2031 · NDA 220934 · ORFORGLIPRON CALCIUM
NCE exclusivity
exclusivity.txt lines 2,410–2,415
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
4 Apr 2031 · NDA 216593 · HYDROXYUREA
ODE-470 exclusivity
exclusivity.txt line 1,773
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
18 Apr 2031 · NDA 208434 · ALECTINIB HYDROCHLORIDE
ODE-477 exclusivity
exclusivity.txt line 708
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
20 Apr 2031 · NDA 216964 · DORAVIRINE; ISLATRAVIR
NCE exclusivity
exclusivity.txt line 1,810
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
23 Apr 2031 · NDA 208700 · LUTETIUM LU-177 DOTATATE
ODE-479 exclusivity
exclusivity.txt line 748
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
23 Apr 2031 · NDA 217700 · TOVORAFENIB
ODE-478 exclusivity
exclusivity.txt line 1,919
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
23 Apr 2031 · NDA 218033 · TOVORAFENIB
ODE-478 exclusivity
exclusivity.txt line 2,033
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
26 Apr 2031 · NDA 211675 · UPADACITINIB
ODE-481 exclusivity
exclusivity.txt lines 987, 992, 996
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
26 Apr 2031 · NDA 218347 · UPADACITINIB
ODE-481 exclusivity
exclusivity.txt line 2,151
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
26 Apr 2031 · NDA 218709 · MAVORIXAFOR
ODE-480 exclusivity
exclusivity.txt line 2,177
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
1 May 2031 · NDA 219835 · VEPDEGESTRANT
NCE exclusivity
exclusivity.txt lines 2,332–2,333
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
13 May 2031 · NDA 220711 · SONROTOCLAX
NCE exclusivity
exclusivity.txt lines 2,401–2,404
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
15 May 2031 · NDA 219878 · BAXDROSTAT
NCE exclusivity
exclusivity.txt lines 2,340–2,341
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
29 May 2031 · NDA 213246 · SELPERCATINIB
ODE-484 exclusivity
exclusivity.txt lines 1,177, 1,199
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
29 May 2031 · NDA 213246 · SELPERCATINIB
ODE-485 exclusivity
exclusivity.txt lines 1,178, 1,200
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
29 May 2031 · NDA 213246 · SELPERCATINIB
ODE-487 exclusivity
exclusivity.txt lines 1,179, 1,201
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
29 May 2031 · NDA 218160 · SELPERCATINIB
ODE* exclusivity
exclusivity.txt lines 2,041–2,043, 2,061–2,063, 2,081–2,083, 2,101–2,103
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
29 May 2031 · NDA 220442 · ENSITRELVIR
NCE exclusivity
exclusivity.txt line 2,392
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
29 May 2031 · NDA 220787 · CEFEPIME HYDROCHLORIDE; ZIDEBACTAM
NCE exclusivity
exclusivity.txt line 2,406
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
1 Jun 2031 · NDA 214900 · IBREXAFUNGERP CITRATE
GAIN exclusivity
exclusivity.txt line 1,411
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
6 Jun 2031 · NDA 217779 · IMETELSTAT SODIUM
ODE-482 exclusivity
exclusivity.txt lines 1,937–1,938
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
8 Jun 2031 · NDA 207500 · ISAVUCONAZONIUM SULFATE
PED exclusivity
exclusivity.txt lines 598–599, 608–609
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
8 Jun 2031 · NDA 207501 · ISAVUCONAZONIUM SULFATE
PED exclusivity
exclusivity.txt lines 619–620
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
10 Jun 2031 · NDA 218860 · ELAFIBRANOR
ODE-486 exclusivity
exclusivity.txt line 2,211
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
12 Jun 2031 · NDA 219627 · GADOQUATRANE
NCE exclusivity
exclusivity.txt lines 2,305–2,310
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
13 Jun 2031 · NDA 218213 · REPOTRECTINIB
ODE-483 exclusivity
exclusivity.txt lines 2,128, 2,131
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
17 Jun 2031 · NDA 215960 · TEBIPENEM PIVOXIL HYDROBROMIDE
NCE exclusivity
exclusivity.txt line 1,678
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
21 Jun 2031 · NDA 211150 · PITOLISANT HYDROCHLORIDE
ODE-489 exclusivity
exclusivity.txt lines 935, 940
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002