Drybench Patent.

Patent and exclusivity dates in 2029 for NDAs on FDA's Paragraph IV list, as FDA lists them

Each patent and exclusivity date in 2029 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 (430)

7 Jan 2029 · NDA 022115 · LAMOTRIGINE
US 8,637,512, product patent
patent.txt lines 1,084–1,089
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
18 Jan 2029 · NDA 209939 · LETERMOVIR
US RE46791, substance and product patent
patent.txt lines 11,064–11,065
Flags
substance product
Product numbers
001, 002
18 Jan 2029 · NDA 209940 · LETERMOVIR
US RE46791, substance and product patent
patent.txt lines 11,067, 11,069
Flags
substance product
Product numbers
001, 002
28 Jan 2029 · NDA 214621 · RELUGOLIX
US 7,300,935, substance patent
patent.txt line 15,890
Flags
substance
Product numbers
001
28 Jan 2029 · NDA 214846 · ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
US 7,300,935, substance patent
patent.txt line 16,242
Flags
substance
Product numbers
001
2 Feb 2029 · NDA 022501 · ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
US 7,704,984, use patent
patent.txt line 2,001
Flags
use code U-1090
Product numbers
001
2 Feb 2029 · NDA 213189 · TIRBANIBULIN
US 7,851,470, substance and product and use patent
patent.txt line 14,726
Flags
substance product use code U-3015
Product numbers
001
3 Feb 2029 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 8,088,786, product patent
patent.txt line 2,207
Flags
product
Product numbers
001
10 Feb 2029 · NDA 022201 · DEGARELIX ACETATE
US 10,729,739, use patent
patent.txt lines 1,315, 1,324
Flags
use code U-1978
Product numbers
001, 002
10 Feb 2029 · NDA 022201 · DEGARELIX ACETATE
US 10,973,870, use patent
patent.txt lines 1,316, 1,325
Flags
use code U-1978
Product numbers
001, 002
10 Feb 2029 · NDA 022201 · DEGARELIX ACETATE
US 9,579,359, use patent
patent.txt lines 1,322, 1,331
Flags
use code U-1978
Product numbers
001, 002
10 Feb 2029 · NDA 022352 · COLCHICINE
US 7,601,758, use patent
patent.txt line 1,741
Flags
use code U-1007
Product numbers
001
11 Feb 2029 · NDA 211580 · INDOCYANINE GREEN
US 8,647,605, use patent
patent.txt line 12,889
Flags
use code U-2464
Product numbers
001
11 Feb 2029 · NDA 211580 · INDOCYANINE GREEN
US 8,647,605, use patent
patent.txt line 12,890
Flags
use code U-2468
Product numbers
001
12 Feb 2029 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,813,921, use patent
patent.txt line 8,937
Flags
use code U-2371
Product numbers
001
12 Feb 2029 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 8,592,362, use patent
patent.txt line 8,986
Flags
use code U-2371 delist requested
Product numbers
001
12 Feb 2029 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 9,095,584, use patent
patent.txt line 8,988
Flags
use code U-2371
Product numbers
001
17 Feb 2029 · NDA 022352 · COLCHICINE
US 7,820,681, use patent
patent.txt line 1,743
Flags
use code U-1020
Product numbers
001
17 Feb 2029 · NDA 022352 · COLCHICINE
US 7,906,519, use patent
patent.txt line 1,744
Flags
use code U-1116
Product numbers
001
17 Feb 2029 · NDA 022352 · COLCHICINE
US 7,915,269, use patent
patent.txt line 1,745
Flags
use code U-1007
Product numbers
001
17 Feb 2029 · NDA 022352 · COLCHICINE
US 8,440,721, use patent
patent.txt line 1,756
Flags
use code U-1007
Product numbers
001
17 Feb 2029 · NDA 022352 · COLCHICINE
US 8,440,722, use patent
patent.txt line 1,757
Flags
use code U-1020
Product numbers
001
20 Feb 2029 · NDA 022201 · DEGARELIX ACETATE
US 12,514,898, use patent
patent.txt lines 1,319, 1,328
Flags
use code U-1978
Product numbers
001, 002
20 Feb 2029 · NDA 022201 · DEGARELIX ACETATE
US 12,533,387, use patent
patent.txt lines 1,320, 1,329
Flags
use code U-4417
Product numbers
001, 002
20 Feb 2029 · NDA 022474 · ULIPRISTAL ACETATE
US 8,735,380, product patent
patent.txt line 1,924
Flags
product
Product numbers
001
21 Feb 2029 · NDA 207795 · LATANOPROSTENE BUNOD
US 8,058,467, substance and use patent
patent.txt line 7,432
Flags
substance use code U-2144
Product numbers
001
24 Feb 2029 · NDA 022202 · DICLOFENAC POTASSIUM
US 7,662,858, use patent
patent.txt line 1,332
Flags
use code U-1035
Product numbers
001
24 Feb 2029 · NDA 022202 · DICLOFENAC POTASSIUM
US 7,884,095, use patent
patent.txt line 1,333
Flags
use code U-1111
Product numbers
001
24 Feb 2029 · NDA 022202 · DICLOFENAC POTASSIUM
US 7,939,518, use patent
patent.txt line 1,334
Flags
use code U-980
Product numbers
001
24 Feb 2029 · NDA 022202 · DICLOFENAC POTASSIUM
US 8,110,606, use patent
patent.txt line 1,335
Flags
use code U-980
Product numbers
001
24 Feb 2029 · NDA 022202 · DICLOFENAC POTASSIUM
US 8,623,920, use patent
patent.txt line 1,336
Flags
use code U-1482
Product numbers
001
24 Feb 2029 · NDA 022202 · DICLOFENAC POTASSIUM
US 9,561,200, use patent
patent.txt line 1,337
Flags
use code U-1482
Product numbers
001
26 Feb 2029 · NDA 021361 · RIFAXIMIN
US 10,456,384, use patent
patent.txt line 567
Flags
use code U-2643
Product numbers
002
26 Feb 2029 · NDA 021361 · RIFAXIMIN
US 10,456,384, use patent
patent.txt line 568
Flags
use code U-2644
Product numbers
002
26 Feb 2029 · NDA 021361 · RIFAXIMIN
US 10,765,667, use patent
patent.txt line 572
Flags
use code U-2643
Product numbers
002
26 Feb 2029 · NDA 021361 · RIFAXIMIN
US 10,765,667, use patent
patent.txt line 573
Flags
use code U-2644
Product numbers
002
26 Feb 2029 · NDA 021361 · RIFAXIMIN
US 11,564,912, use patent
patent.txt line 574
Flags
use code U-3511
Product numbers
002
26 Feb 2029 · NDA 021361 · RIFAXIMIN
US 11,564,912, use patent
patent.txt line 575
Flags
use code U-3512
Product numbers
002
26 Feb 2029 · NDA 021361 · RIFAXIMIN
US 11,779,571, use patent
patent.txt line 576
Flags
use code U-3706
Product numbers
002
26 Feb 2029 · NDA 204042 · CANAGLIFLOZIN
US 7,943,582, substance and product and use patent
patent.txt lines 4,233, 4,243
Flags
substance product use code U-2441
Product numbers
001, 002
26 Feb 2029 · NDA 204042 · CANAGLIFLOZIN
US 7,943,582, substance and product and use patent
patent.txt lines 4,234, 4,244
Flags
substance product use code U-2632
Product numbers
001, 002
26 Feb 2029 · NDA 204042 · CANAGLIFLOZIN
US 7,943,582, substance and product and use patent
patent.txt lines 4,235, 4,245
Flags
substance product use code U-493
Product numbers
001, 002
26 Feb 2029 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 11,116,721, product and use patent
patent.txt line 4,426
Flags
product use code U-1401
Product numbers
001
26 Feb 2029 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 11,116,721, product and use patent
patent.txt lines 4,427, 4,438
Flags
product use code U-1691
Product numbers
001, 002
26 Feb 2029 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 11,116,721, product and use patent
patent.txt lines 4,428, 4,439, 4,448
Flags
product use code U-3623
Product numbers
001, 002, 003
26 Feb 2029 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,582, substance and product and use patent
patent.txt lines 4,508, 4,519, 4,530, 4,541
Flags
substance product use code U-2441
Product numbers
001, 002, 003, 004
26 Feb 2029 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,582, substance and product and use patent
patent.txt lines 4,509, 4,520, 4,531, 4,542
Flags
substance product use code U-2632
Product numbers
001, 002, 003, 004
26 Feb 2029 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,582, substance and product and use patent
patent.txt lines 4,510, 4,521, 4,532, 4,543
Flags
substance product use code U-493
Product numbers
001, 002, 003, 004
26 Feb 2029 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,582, substance and product and use patent
patent.txt lines 6,000, 6,010, 6,020, 6,030
Flags
substance product use code U-2441
Product numbers
001, 002, 003, 004
26 Feb 2029 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,582, substance and product and use patent
patent.txt lines 6,001, 6,011, 6,021, 6,031
Flags
substance product use code U-2632
Product numbers
001, 002, 003, 004
26 Feb 2029 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,582, substance and product and use patent
patent.txt lines 6,002, 6,012, 6,022, 6,032
Flags
substance product use code U-493
Product numbers
001, 002, 003, 004
28 Feb 2029 · NDA 207071 · AZELAIC ACID
US 9,211,259, use patent
patent.txt line 7,007
Flags
use code U-1796
Product numbers
001
5 Mar 2029 · NDA 206911 · BROMFENAC SODIUM
US RE50218, product and use patent
patent.txt line 6,845
Flags
product use code U-1834
Product numbers
001
5 Mar 2029 · NDA 216665 · DIAZOXIDE CHOLINE
US 7,799,777, substance patent
patent.txt lines 18,899, 18,905, 18,911
Flags
substance
Product numbers
001, 002, 003
10 Mar 2029 · NDA 207924 · BARICITINIB
US 8,420,629, use patent
patent.txt lines 7,477, 7,483
Flags
use code U-247
Product numbers
001, 002
11 Mar 2029 · NDA 022145 · RALTEGRAVIR POTASSIUM
US 7,754,731, substance and product and use patent
patent.txt lines 1,114, 1,119
Flags
substance product use code U-257
Product numbers
001, 002
11 Mar 2029 · NDA 204061 · ETHINYL ESTRADIOL; LEVONORGESTREL
US 8,415,332, product patent
patent.txt line 4,252
Flags
product
Product numbers
001
12 Mar 2029 · NDA 018705 · NITROGLYCERIN
US 7,872,049, product and use patent
patent.txt line 140
Flags
product use code U-2223
Product numbers
002
12 Mar 2029 · NDA 201152 · NEVIRAPINE
US 8,460,704, use patent
patent.txt line 2,325
Flags
use code U-1409
Product numbers
001
12 Mar 2029 · NDA 209080 · RILUZOLE
US 8,765,150, product and use patent
patent.txt line 9,655
Flags
product use code U-2401
Product numbers
001
12 Mar 2029 · NDA 209500 · LUMATEPERONE TOSYLATE
US 9,199,995, use patent
patent.txt lines 10,461, 10,493, 10,523
Flags
use code U-2713
Product numbers
001, 002, 003
12 Mar 2029 · NDA 209500 · LUMATEPERONE TOSYLATE
US 9,199,995, use patent
patent.txt lines 10,462, 10,494, 10,524
Flags
use code U-4343
Product numbers
001, 002, 003
12 Mar 2029 · NDA 209500 · LUMATEPERONE TOSYLATE
US 9,586,960, substance and product patent
patent.txt line 10,463
Flags
substance product
Product numbers
001
12 Mar 2029 · NDA 209500 · LUMATEPERONE TOSYLATE
US RE48825, substance and product patent
patent.txt line 10,466
Flags
substance product
Product numbers
001
12 Mar 2029 · NDA 209500 · LUMATEPERONE TOSYLATE
US RE48825, substance patent
patent.txt lines 10,497, 10,527
Flags
substance
Product numbers
002, 003
13 Mar 2029 · NDA 018207 · TRAZODONE HYDROCHLORIDE
US 8,133,893, substance and product patent
patent.txt lines 133–136
Flags
substance product
Product numbers
001, 002, 003, 004
13 Mar 2029 · NDA 022325 · AMIODARONE HYDROCHLORIDE
US 10,117,951, product patent
patent.txt lines 1,692, 1,698
Flags
product
Product numbers
002, 003
13 Mar 2029 · NDA 022325 · AMIODARONE HYDROCHLORIDE
US 7,635,773, product patent
patent.txt lines 1,691, 1,693, 1,699
Flags
product
Product numbers
001, 002, 003
13 Mar 2029 · NDA 022325 · AMIODARONE HYDROCHLORIDE
US 8,410,077, product patent
patent.txt lines 1,694, 1,700
Flags
product
Product numbers
002, 003
13 Mar 2029 · NDA 022325 · AMIODARONE HYDROCHLORIDE
US 9,200,088, product patent
patent.txt lines 1,695, 1,701
Flags
product
Product numbers
002, 003
13 Mar 2029 · NDA 022325 · AMIODARONE HYDROCHLORIDE
US 9,750,822, product patent
patent.txt lines 1,697, 1,703
Flags
product
Product numbers
002, 003
13 Mar 2029 · NDA 022411 · TRAZODONE HYDROCHLORIDE
US 8,133,893, substance and product patent
patent.txt lines 1,812, 1,814
Flags
substance product
Product numbers
001, 002
13 Mar 2029 · NDA 204822 · TRAVOPROST
US 9,144,561, product patent
patent.txt line 5,060
Flags
product
Product numbers
001
13 Mar 2029 · NDA 205596 · POSACONAZOLE
US 10,117,951, product patent
patent.txt line 5,683
Flags
product
Product numbers
001
13 Mar 2029 · NDA 205596 · POSACONAZOLE
US 8,410,077, product patent
patent.txt line 5,684
Flags
product
Product numbers
001
13 Mar 2029 · NDA 205596 · POSACONAZOLE
US 9,750,822, product patent
patent.txt line 5,695
Flags
product
Product numbers
001
13 Mar 2029 · NDA 207155 · MELPHALAN HYDROCHLORIDE
US 8,410,077, product patent
patent.txt line 7,059
Flags
product
Product numbers
001
13 Mar 2029 · NDA 207155 · MELPHALAN HYDROCHLORIDE
US 9,200,088, product patent
patent.txt line 7,060
Flags
product
Product numbers
001
13 Mar 2029 · NDA 218637 · TRAZODONE HYDROCHLORIDE
US 8,133,893, substance and product patent
patent.txt line 21,150
Flags
substance product
Product numbers
001
14 Mar 2029 · NDA 202088 · PHENTERMINE HYDROCHLORIDE
US 8,440,170, product patent
patent.txt lines 2,745–2,747
Flags
product
Product numbers
001, 002, 003
24 Mar 2029 · NDA 022525 · MEMANTINE HYDROCHLORIDE
US 8,039,009, use patent
patent.txt lines 2,041, 2,043, 2,045, 2,047
Flags
use code U-539
Product numbers
001, 002, 003, 004
24 Mar 2029 · NDA 206439 · DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US 8,039,009, use patent
patent.txt lines 6,548, 6,551, 6,554, 6,557
Flags
use code U-1641
Product numbers
001, 002, 003, 004
26 Mar 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,445,524, substance and product and use patent
patent.txt lines 1,364, 1,381
Flags
substance product use code U-1402
Product numbers
001, 002
26 Mar 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,445,524, substance patent
patent.txt lines 1,398, 1,404
Flags
substance
Product numbers
003, 004
26 Mar 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,669,279, product and use patent
patent.txt lines 1,368, 1,385
Flags
product use code U-1402
Product numbers
001, 002
26 Mar 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,883,836, product and use patent
patent.txt lines 1,372, 1,389
Flags
product use code U-1402
Product numbers
001, 002
26 Mar 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 9,533,955, product and use patent
patent.txt lines 1,376, 1,393
Flags
product use code U-1949
Product numbers
001, 002
26 Mar 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 9,533,955, product and use patent
patent.txt lines 1,377, 1,394
Flags
product use code U-1952
Product numbers
001, 002
26 Mar 2029 · NDA 204671 · SOFOSBUVIR
US 7,964,580, substance and product and use patent
patent.txt lines 4,946, 4,964
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 204671 · SOFOSBUVIR
US 8,633,309, substance and product and use patent
patent.txt lines 4,954, 4,972
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 204671 · SOFOSBUVIR
US 8,889,159, product and use patent
patent.txt lines 4,956, 4,974
Flags
product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 204671 · SOFOSBUVIR
US 9,549,941, use patent
patent.txt line 4,962
Flags
use code U-1958
Product numbers
001
26 Mar 2029 · NDA 213756 · SELUMETINIB SULFATE
US 11,813,246, product patent
patent.txt lines 15,254, 15,262
Flags
product
Product numbers
001, 002
26 Mar 2029 · NDA 213756 · SELUMETINIB SULFATE
US 12,220,403, product patent
patent.txt lines 15,255, 15,263
Flags
product
Product numbers
001, 002
26 Mar 2029 · NDA 213756 · SELUMETINIB SULFATE
US 12,318,367, product patent
patent.txt lines 15,256, 15,264
Flags
product
Product numbers
001, 002
26 Mar 2029 · NDA 213756 · SELUMETINIB SULFATE
US 12,364,684, use patent
patent.txt lines 15,257, 15,265
Flags
use code U-4357
Product numbers
001, 002
27 Mar 2029 · NDA 211635 · DIAZEPAM
US 11,241,414, product patent
patent.txt lines 12,908, 12,916, 12,924
Flags
product
Product numbers
001, 002, 003
27 Mar 2029 · NDA 211635 · DIAZEPAM
US 11,793,786, product patent
patent.txt lines 12,909, 12,917, 12,925
Flags
product
Product numbers
001, 002, 003
27 Mar 2029 · NDA 211635 · DIAZEPAM
US 12,268,664, product patent
patent.txt lines 12,910, 12,918, 12,926
Flags
product
Product numbers
001, 002, 003
27 Mar 2029 · NDA 211635 · DIAZEPAM
US 12,521,400, product patent
patent.txt lines 12,913, 12,921, 12,929
Flags
product
Product numbers
001, 002, 003
27 Mar 2029 · NDA 211635 · DIAZEPAM
US 8,895,546, product patent
patent.txt lines 12,915, 12,923, 12,931
Flags
product
Product numbers
001, 002, 003
29 Mar 2029 · NDA 021272 · TREPROSTINIL
US 7,999,007, product and use patent
patent.txt lines 509, 514, 519, 524, 529, 534, 539, 544
Flags
product use code U-1437
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
29 Mar 2029 · NDA 202100 · METHYLPHENIDATE HYDROCHLORIDE
US 8,062,667, product patent
patent.txt line 2,749
Flags
product
Product numbers
001
2 Apr 2029 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 10,022,379, use patent
patent.txt lines 2,345, 2,363, 2,381
Flags
use code U-2339
Product numbers
001, 002, 003
2 Apr 2029 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 10,973,827, product patent
patent.txt lines 2,347, 2,365, 2,383
Flags
product
Product numbers
001, 002, 003
2 Apr 2029 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 12,678,442, product patent
patent.txt lines 2,351, 2,369, 2,387
Flags
product
Product numbers
001, 002, 003
2 Apr 2029 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 9,415,016, product patent
patent.txt lines 2,361, 2,379, 2,397
Flags
product
Product numbers
001, 002, 003
2 Apr 2029 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 10,022,379, use patent
patent.txt lines 7,973, 7,992
Flags
use code U-2339
Product numbers
001, 002
2 Apr 2029 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 12,678,442, product patent
patent.txt lines 7,977, 7,996
Flags
product
Product numbers
001, 002
2 Apr 2029 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 9,415,016, product patent
patent.txt lines 7,987, 8,006
Flags
product
Product numbers
001, 002
2 Apr 2029 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 10,022,379, product and use patent
patent.txt lines 14,225, 14,255, 14,285, 14,315
Flags
product use code U-2732
Product numbers
001, 002, 003, 004
2 Apr 2029 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 12,678,442, product patent
patent.txt lines 14,242, 14,272, 14,302, 14,331
Flags
product
Product numbers
001, 002, 003, 004
2 Apr 2029 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 9,415,016, product patent
patent.txt lines 14,252, 14,282, 14,312, 14,341
Flags
product
Product numbers
001, 002, 003, 004
2 Apr 2029 · NDA 213006 · VIBEGRON
US 8,653,260, substance patent
patent.txt line 14,569
Flags
substance
Product numbers
001
6 Apr 2029 · NDA 204516 · PAROXETINE MESYLATE
US 8,658,663, substance and product and use patent
patent.txt line 4,823
Flags
substance product use code U-904
Product numbers
001
9 Apr 2029 · NDA 211580 · INDOCYANINE GREEN
US 8,406,860, use patent
patent.txt line 12,888
Flags
use code U-2463
Product numbers
001
15 Apr 2029 · NDA 208073 · LIFITEGRAST
US 8,367,701, product and use patent
patent.txt line 8,087
Flags
product use code U-1880
Product numbers
001
15 Apr 2029 · NDA 208073 · LIFITEGRAST
US 9,447,077, use patent
patent.txt line 8,092
Flags
use code U-1900
Product numbers
001
16 Apr 2029 · NDA 022425 · DRONEDARONE HYDROCHLORIDE
US 8,410,167, use patent
patent.txt line 1,875
Flags
use code U-1387
Product numbers
001
16 Apr 2029 · NDA 022425 · DRONEDARONE HYDROCHLORIDE
US 8,410,167, use patent
patent.txt line 1,876
Flags
use code U-1388
Product numbers
001
16 Apr 2029 · NDA 022425 · DRONEDARONE HYDROCHLORIDE
US 9,107,900, use patent
patent.txt line 1,878
Flags
use code U-1726
Product numbers
001
16 Apr 2029 · NDA 022425 · DRONEDARONE HYDROCHLORIDE
US 9,107,900, use patent
patent.txt line 1,879
Flags
use code U-1728
Product numbers
001
18 Apr 2029 · NDA 204410 · MACITENTAN
US 8,268,847, use patent
patent.txt line 4,671
Flags
use code U-1446
Product numbers
001
22 Apr 2029 · NDA 022535 · PIRFENIDONE
US 7,566,729, use patent
patent.txt line 2,057
Flags
use code U-1600
Product numbers
001
22 Apr 2029 · NDA 022535 · PIRFENIDONE
US 7,635,707, use patent
patent.txt line 2,058
Flags
use code U-1609
Product numbers
001
22 Apr 2029 · NDA 022535 · PIRFENIDONE
US 8,592,462, use patent
patent.txt line 2,070
Flags
use code U-1609
Product numbers
001
22 Apr 2029 · NDA 022535 · PIRFENIDONE
US 8,609,701, use patent
patent.txt line 2,071
Flags
use code U-1610
Product numbers
001
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 7,566,729, use patent
patent.txt lines 9,328, 9,414
Flags
use code U-2077
Product numbers
001, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 7,566,729, use patent
patent.txt lines 9,329, 9,415
Flags
use code U-2078
Product numbers
001, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 7,566,729, use patent
patent.txt line 9,371
Flags
use code U-2269
Product numbers
002
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 7,566,729, use patent
patent.txt line 9,372
Flags
use code U-2270
Product numbers
002
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 7,635,707, use patent
patent.txt lines 9,330, 9,373, 9,416
Flags
use code U-2072
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 7,635,707, use patent
patent.txt lines 9,331, 9,374, 9,417
Flags
use code U-2073
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 7,635,707, use patent
patent.txt lines 9,332, 9,375, 9,418
Flags
use code U-2074
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 7,635,707, use patent
patent.txt lines 9,333, 9,376, 9,419
Flags
use code U-2075
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 7,635,707, use patent
patent.txt lines 9,334, 9,377, 9,420
Flags
use code U-2076
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 7,635,707, use patent
patent.txt lines 9,335, 9,378, 9,421
Flags
use code U-2083
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,592,462, use patent
patent.txt lines 9,349, 9,392, 9,435
Flags
use code U-2055
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,592,462, use patent
patent.txt lines 9,350, 9,393, 9,436
Flags
use code U-2056
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,592,462, use patent
patent.txt lines 9,351, 9,394, 9,437
Flags
use code U-2057
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,592,462, use patent
patent.txt lines 9,352, 9,395, 9,438
Flags
use code U-2058
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,592,462, use patent
patent.txt lines 9,353, 9,396, 9,439
Flags
use code U-2059
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,592,462, use patent
patent.txt lines 9,354, 9,397, 9,440
Flags
use code U-2060
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,592,462, use patent
patent.txt lines 9,355, 9,398, 9,441
Flags
use code U-2061
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,592,462, use patent
patent.txt lines 9,356, 9,399, 9,442
Flags
use code U-2062
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,592,462, use patent
patent.txt lines 9,357, 9,400, 9,443
Flags
use code U-2063
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,609,701, use patent
patent.txt lines 9,358, 9,401, 9,444
Flags
use code U-2064
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,609,701, use patent
patent.txt lines 9,359, 9,402, 9,445
Flags
use code U-2065
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,609,701, use patent
patent.txt lines 9,360, 9,403, 9,446
Flags
use code U-2066
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,609,701, use patent
patent.txt lines 9,361, 9,404, 9,447
Flags
use code U-2067
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,609,701, use patent
patent.txt lines 9,362, 9,405, 9,448
Flags
use code U-2068
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,609,701, use patent
patent.txt lines 9,363, 9,406, 9,449
Flags
use code U-2069
Product numbers
001, 002, 003
22 Apr 2029 · NDA 208780 · PIRFENIDONE
US 8,609,701, use patent
patent.txt lines 9,364, 9,407, 9,450
Flags
use code U-2070
Product numbers
001, 002, 003
22 Apr 2029 · NDA 214787 · REMDESIVIR
US 8,318,682, substance and product patent
patent.txt lines 16,153, 16,185
Flags
substance product
Product numbers
001, 002
22 Apr 2029 · NDA 214787 · REMDESIVIR
US RE46762, substance and product patent
patent.txt lines 16,159, 16,191
Flags
substance product
Product numbers
001, 002
24 Apr 2029 · NDA 214876 · NIRAPARIB TOSYLATE
US 8,436,185, substance patent
patent.txt lines 16,280, 16,289, 16,298
Flags
substance
Product numbers
001, 002, 003
28 Apr 2029 · NDA 021937 · EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 8,598,185, product patent
patent.txt line 816
Flags
product
Product numbers
001
28 Apr 2029 · NDA 213687 · TRIHEPTANOIN
US 8,697,748, product patent
patent.txt line 15,196
Flags
product
Product numbers
001
30 Apr 2029 · NDA 022360 · NICOTINE POLACRILEX
US 8,940,772, product patent
patent.txt lines 1,759, 1,761
Flags
product
Product numbers
001, 002
4 May 2029 · NDA 202806 · DABRAFENIB MESYLATE
US 9,233,956, use patent
patent.txt lines 3,270, 3,294
Flags
use code U-1811
Product numbers
001, 002
4 May 2029 · NDA 202806 · DABRAFENIB MESYLATE
US 9,233,956, use patent
patent.txt lines 3,271, 3,295
Flags
use code U-2031
Product numbers
001, 002
4 May 2029 · NDA 202806 · DABRAFENIB MESYLATE
US 9,233,956, use patent
patent.txt lines 3,272, 3,296
Flags
use code U-2032
Product numbers
001, 002
4 May 2029 · NDA 202806 · DABRAFENIB MESYLATE
US 9,233,956, use patent
patent.txt lines 3,273, 3,297
Flags
use code U-2296
Product numbers
001, 002
7 May 2029 · NDA 215935 · BUDESONIDE
US 8,491,932, product and use patent
patent.txt line 18,099
Flags
product use code U-3269
Product numbers
001
7 May 2029 · NDA 215935 · BUDESONIDE
US 8,491,932, product and use patent
patent.txt line 18,100
Flags
product use code U-3781
Product numbers
001
9 May 2029 · NDA 208073 · LIFITEGRAST
US 8,168,655, use patent
patent.txt line 8,086
Flags
use code U-1880
Product numbers
001
13 May 2029 · NDA 204958 · CANGRELOR
US 9,925,265, use patent
patent.txt line 5,188
Flags
use code U-2260
Product numbers
001
14 May 2029 · NDA 214120 · AZACITIDINE
US 11,571,436, product patent
patent.txt lines 15,550, 15,553
Flags
product
Product numbers
001, 002
14 May 2029 · NDA 214120 · AZACITIDINE
US 12,053,482, use patent
patent.txt lines 15,551, 15,554
Flags
use code U-2950
Product numbers
001, 002
15 May 2029 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
US 8,580,298, product patent
patent.txt lines 2,109, 2,115, 2,121, 2,127
Flags
product
Product numbers
001, 002, 003, 004
19 May 2029 · NDA 204822 · TRAVOPROST
US 8,754,123, product patent
patent.txt line 5,059
Flags
product
Product numbers
001
20 May 2029 · NDA 213591 · CAPMATINIB HYDROCHLORIDE
US 8,901,123, use patent
patent.txt lines 15,144, 15,151
Flags
use code U-2813
Product numbers
001, 002
24 May 2029 · NDA 203414 · ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
US 8,900,638, product patent
patent.txt lines 3,854, 3,856
Flags
product
Product numbers
001, 002
27 May 2029 · NDA 206940 · ELUXADOLINE
US 7,741,356, substance and product patent
patent.txt lines 6,853, 6,867
Flags
substance product
Product numbers
001, 002
27 May 2029 · NDA 209500 · LUMATEPERONE TOSYLATE
US 10,117,867, use patent
patent.txt lines 10,434, 10,470, 10,501
Flags
use code U-3271
Product numbers
001, 002, 003
27 May 2029 · NDA 209500 · LUMATEPERONE TOSYLATE
US 9,168,258, product patent
patent.txt line 10,492
Flags
product
Product numbers
002
27 May 2029 · NDA 209500 · LUMATEPERONE TOSYLATE
US 9,616,061, product patent
patent.txt lines 10,464, 10,495, 10,525
Flags
product
Product numbers
001, 002, 003
28 May 2029 · NDA 202514 · TAFLUPROST
US 10,864,159, product and use patent
patent.txt line 3,096
Flags
product use code U-778
Product numbers
001
28 May 2029 · NDA 202514 · TAFLUPROST
US 9,999,593, product patent
patent.txt line 3,097
Flags
product
Product numbers
001
29 May 2029 · NDA 022428 · MOXIFLOXACIN HYDROCHLORIDE
US 8,450,311, product patent
patent.txt line 1,895
Flags
product
Product numbers
001
29 May 2029 · NDA 022428 · MOXIFLOXACIN HYDROCHLORIDE
US 9,114,168, product patent
patent.txt line 1,896
Flags
product
Product numbers
001
29 May 2029 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 11,324,741, use patent
patent.txt line 2,204
Flags
use code U-1583
Product numbers
001
1 Jun 2029 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 9,532,971, product patent
patent.txt lines 945, 961
Flags
product
Product numbers
001, 002
1 Jun 2029 · NDA 205776 · METHOTREXATE
US 8,664,231, use patent
patent.txt lines 5,859–5,868
Flags
use code U-1442
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 009, 010
3 Jun 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 10,137,142, product and use patent
patent.txt line 2,184
Flags
product use code U-916
Product numbers
002
3 Jun 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 10,220,049, product and use patent
patent.txt lines 2,178, 2,185
Flags
product use code U-916
Product numbers
001, 002
3 Jun 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 10,624,918, use patent
patent.txt line 2,179
Flags
use code U-916
Product numbers
001
3 Jun 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 8,663,699, use patent
patent.txt line 2,181
Flags
use code U-124
Product numbers
001
3 Jun 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 8,895,070, use patent
patent.txt line 2,182
Flags
use code U-124
Product numbers
001
3 Jun 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 9,078,870, product patent
patent.txt line 2,183
Flags
product
Product numbers
001
3 Jun 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 9,504,704, product and use patent
patent.txt line 2,192
Flags
product use code U-124
Product numbers
002
3 Jun 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 9,504,704, product and use patent
patent.txt line 2,193
Flags
product use code U-134
Product numbers
002
3 Jun 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 9,504,704, product and use patent
patent.txt line 2,194
Flags
product use code U-818
Product numbers
002
3 Jun 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 9,504,704, product and use patent
patent.txt line 2,195
Flags
product use code U-916
Product numbers
002
3 Jun 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 9,561,208, product and use patent
patent.txt line 2,196
Flags
product use code U-916
Product numbers
002
3 Jun 2029 · NDA 216632 · ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 10,220,049, product and use patent
patent.txt line 18,875
Flags
product use code U-3713
Product numbers
001
3 Jun 2029 · NDA 216632 · ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 10,624,918, use patent
patent.txt line 18,876
Flags
use code U-3713
Product numbers
001
3 Jun 2029 · NDA 216632 · ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 9,561,208, product and use patent
patent.txt line 18,883
Flags
product use code U-3713
Product numbers
001
4 Jun 2029 · NDA 205832 · NINTEDANIB ESYLATE
US 10,105,323, product patent
patent.txt lines 5,893, 5,901
Flags
product
Product numbers
001, 002
7 Jun 2029 · NDA 205832 · NINTEDANIB ESYLATE
US 9,907,756, product patent
patent.txt lines 5,899, 5,907
Flags
product
Product numbers
001, 002
10 Jun 2029 · NDA 022399 · GABAPENTIN ENACARBIL
US 8,795,725, product and use patent
patent.txt lines 1,777, 1,781
Flags
product use code U-1231
Product numbers
001, 002
10 Jun 2029 · NDA 022399 · GABAPENTIN ENACARBIL
US 8,795,725, product and use patent
patent.txt lines 1,778, 1,782
Flags
product use code U-1247
Product numbers
001, 002
14 Jun 2029 · NDA 022360 · NICOTINE POLACRILEX
US 8,501,164, product patent
patent.txt lines 1,758, 1,760
Flags
product
Product numbers
001, 002
14 Jun 2029 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
US 8,580,299, use patent
patent.txt lines 2,110, 2,116, 2,122, 2,128
Flags
use code U-3399
Product numbers
001, 002, 003, 004
16 Jun 2029 · NDA 022271 · ALOGLIPTIN BENZOATE
US 8,697,125, product patent
patent.txt lines 1,436, 1,438, 1,440
Flags
product
Product numbers
001, 002, 003
16 Jun 2029 · NDA 208462 · IXAZOMIB CITRATE
US 8,859,504, substance and product patent
patent.txt lines 8,642, 8,649, 8,656
Flags
substance product
Product numbers
001, 002, 003
16 Jun 2029 · NDA 208462 · IXAZOMIB CITRATE
US 9,175,017, use patent
patent.txt lines 8,644, 8,651, 8,658
Flags
use code U-2434
Product numbers
001, 002, 003
25 Jun 2029 · NDA 208073 · LIFITEGRAST
US 7,314,938, substance and product patent
patent.txt line 8,084
Flags
substance product
Product numbers
001
29 Jun 2029 · NDA 207695 · CRISABOROLE
US 8,039,451, substance and product patent
patent.txt line 7,406
Flags
substance product
Product numbers
001
30 Jun 2029 · NDA 020845 · NITRIC OXIDE
US 11,931,377, substance and product and use patent
patent.txt lines 217, 248
Flags
substance product use code U-3903
Product numbers
003, 004
30 Jun 2029 · NDA 020845 · NITRIC OXIDE
US 8,282,966, use patent
patent.txt lines 197, 219
Flags
use code U-1286
Product numbers
002, 003
30 Jun 2029 · NDA 020845 · NITRIC OXIDE
US 8,293,284, use patent
patent.txt lines 201, 223
Flags
use code U-1286
Product numbers
002, 003
30 Jun 2029 · NDA 020845 · NITRIC OXIDE
US 8,431,163, use patent
patent.txt lines 203, 225
Flags
use code U-1286
Product numbers
002, 003
30 Jun 2029 · NDA 020845 · NITRIC OXIDE
US 8,795,741, use patent
patent.txt lines 213, 235
Flags
use code U-1286
Product numbers
002, 003
30 Jun 2029 · NDA 020845 · NITRIC OXIDE
US 8,846,112, use patent
patent.txt lines 215, 237
Flags
use code U-1286
Product numbers
002, 003
6 Jul 2029 · NDA 210450 · ELAGOLIX SODIUM
US 7,419,983, substance and product and use patent
patent.txt lines 11,394, 11,400
Flags
substance product use code U-2360
Product numbers
001, 002
6 Jul 2029 · NDA 213388 · ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
US 7,419,983, substance and product patent
patent.txt line 14,974
Flags
substance product
Product numbers
001
10 Jul 2029 · NDA 020947 · DICLOFENAC SODIUM
US 8,217,078, use patent
patent.txt line 383
Flags
use code U-1248
Product numbers
001
10 Jul 2029 · NDA 020947 · DICLOFENAC SODIUM
US 8,618,164, use patent
patent.txt line 386
Flags
use code U-1477
Product numbers
001
10 Jul 2029 · NDA 020947 · DICLOFENAC SODIUM
US 8,741,956, use patent
patent.txt line 387
Flags
use code U-1435
Product numbers
001
10 Jul 2029 · NDA 201655 · OXYMORPHONE HYDROCHLORIDE
US 7,851,482, substance patent
patent.txt lines 2,521, 2,524, 2,527, 2,530, 2,533, 2,536, 2,539
Flags
substance
Product numbers
001, 002, 003, 004, 005, 006, 007
10 Jul 2029 · NDA 204623 · DICLOFENAC SODIUM
US 8,217,078, use patent
patent.txt line 4,856
Flags
use code U-1477
Product numbers
001
10 Jul 2029 · NDA 204623 · DICLOFENAC SODIUM
US 8,618,164, use patent
patent.txt line 4,861
Flags
use code U-1477
Product numbers
001
10 Jul 2029 · NDA 204623 · DICLOFENAC SODIUM
US 8,741,956, use patent
patent.txt line 4,862
Flags
use code U-1435
Product numbers
001
10 Jul 2029 · NDA 204623 · DICLOFENAC SODIUM
US 9,370,501, use patent
patent.txt line 4,872
Flags
use code U-1614
Product numbers
001
10 Jul 2029 · NDA 204623 · DICLOFENAC SODIUM
US 9,375,412, use patent
patent.txt line 4,873
Flags
use code U-1614
Product numbers
001
10 Jul 2029 · NDA 204623 · DICLOFENAC SODIUM
US 9,415,029, use patent
patent.txt line 4,874
Flags
use code U-1614
Product numbers
001
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE47350, use patent
patent.txt line 4,559
Flags
use code U-1750
Product numbers
001
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE47350, use patent
patent.txt lines 4,560, 4,630, 4,647
Flags
use code U-2543
Product numbers
001, 005, 006
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE47350, use patent
patent.txt lines 4,561, 4,631, 4,648
Flags
use code U-2544
Product numbers
001, 005, 006
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE47350, use patent
patent.txt lines 4,562, 4,632, 4,649
Flags
use code U-2545
Product numbers
001, 005, 006
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE47350, use patent
patent.txt lines 4,563, 4,633, 4,650
Flags
use code U-3503
Product numbers
001, 005, 006
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE49110, use patent
patent.txt lines 4,565, 4,583, 4,599, 4,614, 4,635, 4,652
Flags
use code U-2543
Product numbers
001, 002, 003, 004, 005, 006
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE49110, use patent
patent.txt lines 4,566, 4,584, 4,600, 4,615, 4,636, 4,653
Flags
use code U-2544
Product numbers
001, 002, 003, 004, 005, 006
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE49110, use patent
patent.txt lines 4,567, 4,585, 4,601, 4,616, 4,637, 4,654
Flags
use code U-2545
Product numbers
001, 002, 003, 004, 005, 006
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE49110, use patent
patent.txt lines 4,568, 4,586, 4,638, 4,655
Flags
use code U-3503
Product numbers
001, 002, 005, 006
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE49302, use patent
patent.txt lines 4,570, 4,588, 4,603, 4,618
Flags
use code U-2543
Product numbers
001, 002, 003, 004
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE49302, use patent
patent.txt lines 4,571, 4,589, 4,604, 4,619
Flags
use code U-2544
Product numbers
001, 002, 003, 004
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE49302, use patent
patent.txt lines 4,572, 4,590, 4,605, 4,620
Flags
use code U-2545
Product numbers
001, 002, 003, 004
16 Jul 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US RE49302, use patent
patent.txt lines 4,573, 4,591, 4,606, 4,621
Flags
use code U-3503
Product numbers
001, 002, 003, 004
18 Jul 2029 · NDA 021361 · RIFAXIMIN
US 8,309,569, use patent
patent.txt line 579
Flags
use code U-1707 delist requested
Product numbers
002
18 Jul 2029 · NDA 021361 · RIFAXIMIN
US 8,309,569, use patent
patent.txt line 580
Flags
use code U-1708 delist requested
Product numbers
002
23 Jul 2029 · NDA 210496 · ENCORAFENIB
US 8,946,250, substance and product patent
patent.txt lines 11,505, 11,528
Flags
substance product
Product numbers
001, 002
24 Jul 2029 · NDA 021361 · RIFAXIMIN
US 10,314,828, use patent
patent.txt line 565
Flags
use code U-1481
Product numbers
002
24 Jul 2029 · NDA 021361 · RIFAXIMIN
US 10,335,397, use patent
patent.txt line 566
Flags
use code U-2579
Product numbers
002
24 Jul 2029 · NDA 021361 · RIFAXIMIN
US 10,709,694, use patent
patent.txt line 571
Flags
use code U-2579
Product numbers
002
24 Jul 2029 · NDA 021361 · RIFAXIMIN
US 7,928,115, use patent
patent.txt line 560
Flags
use code U-1121
Product numbers
001
24 Jul 2029 · NDA 021361 · RIFAXIMIN
US 8,829,017, use patent
patent.txt line 586
Flags
use code U-1562
Product numbers
002
24 Jul 2029 · NDA 021361 · RIFAXIMIN
US 8,946,252, use patent
patent.txt line 587
Flags
use code U-1481
Product numbers
002
24 Jul 2029 · NDA 021361 · RIFAXIMIN
US 9,421,195, use patent
patent.txt line 590
Flags
use code U-1481
Product numbers
002
24 Jul 2029 · NDA 021361 · RIFAXIMIN
US 9,629,828, use patent
patent.txt line 591
Flags
use code U-1994
Product numbers
002
27 Jul 2029 · NDA 208144 · BRIMONIDINE TARTRATE
US 11,596,600, use patent
patent.txt line 8,268
Flags
use code U-2222
Product numbers
001
27 Jul 2029 · NDA 208144 · BRIMONIDINE TARTRATE
US 11,833,245, use patent
patent.txt line 8,269
Flags
use code U-2222
Product numbers
001
27 Jul 2029 · NDA 208144 · BRIMONIDINE TARTRATE
US 12,514,857, use patent
patent.txt line 8,270
Flags
use code U-2222
Product numbers
001
27 Jul 2029 · NDA 218424 · BRIMONIDINE TARTRATE
US 11,596,600, use patent
patent.txt line 21,080
Flags
use code U-2222
Product numbers
001
27 Jul 2029 · NDA 218424 · BRIMONIDINE TARTRATE
US 12,311,050, use patent
patent.txt line 21,081
Flags
use code U-2222
Product numbers
001
27 Jul 2029 · NDA 218424 · BRIMONIDINE TARTRATE
US 12,514,857, use patent
patent.txt line 21,082
Flags
use code U-2222
Product numbers
001
1 Aug 2029 · NDA 213976 · BUDESONIDE
US 9,050,368, product patent
patent.txt line 15,404
Flags
product
Product numbers
001
3 Aug 2029 · NDA 213976 · BUDESONIDE
US 8,324,192, use patent
patent.txt line 15,400
Flags
use code U-3820
Product numbers
001
4 Aug 2029 · NDA 208051 · NERATINIB MALEATE
US 9,265,784, use patent
patent.txt line 8,030
Flags
use code U-3047
Product numbers
001
5 Aug 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 8,288,434, product and use patent
patent.txt lines 2,180, 2,187
Flags
product use code U-124
Product numbers
001, 002
5 Aug 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 8,288,434, product and use patent
patent.txt line 2,186
Flags
product use code U-1033
Product numbers
002
5 Aug 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 8,288,434, product and use patent
patent.txt line 2,188
Flags
product use code U-134
Product numbers
002
5 Aug 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 8,288,434, product and use patent
patent.txt line 2,189
Flags
product use code U-818
Product numbers
002
5 Aug 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 8,288,434, product and use patent
patent.txt line 2,190
Flags
product use code U-916
Product numbers
002
5 Aug 2029 · NDA 050819 · BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 8,288,434, product and use patent
patent.txt line 2,191
Flags
product use code U-921
Product numbers
002
5 Aug 2029 · NDA 201280 · LINAGLIPTIN
US 10,034,877, use patent
patent.txt line 2,327
Flags
use code U-2347
Product numbers
001
5 Aug 2029 · NDA 201280 · LINAGLIPTIN
US 9,486,526, use patent
patent.txt line 2,343
Flags
use code U-1915
Product numbers
001
5 Aug 2029 · NDA 216632 · ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 8,288,434, product and use patent
patent.txt line 18,882
Flags
product use code U-3713
Product numbers
001
7 Aug 2029 · NDA 022410 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 11,135,216, product and use patent
patent.txt lines 1,799, 1,802, 1,805, 1,808
Flags
product use code U-3111
Product numbers
001, 002, 003, 004
7 Aug 2029 · NDA 022410 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 9,687,454, product and use patent
patent.txt lines 1,801, 1,804, 1,807, 1,810
Flags
product use code U-1464
Product numbers
001, 002, 003, 004
12 Aug 2029 · NDA 207947 · SELEXIPAG
US 9,173,881, use patent
patent.txt lines 7,703, 7,715, 7,727, 7,739, 7,751, 7,763, 7,775, 7,787, 7,799, 7,811
Flags
use code U-1798
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 010, 011
12 Aug 2029 · NDA 214275 · SELEXIPAG
US 9,173,881, use patent
patent.txt line 15,663
Flags
use code U-1798
Product numbers
001
13 Aug 2029 · NDA 203188 · IVACAFTOR
US 10,646,481, product patent
patent.txt line 3,652
Flags
product
Product numbers
001
13 Aug 2029 · NDA 203188 · IVACAFTOR
US 11,564,916, use patent
patent.txt line 3,654
Flags
use code U-3530
Product numbers
001
13 Aug 2029 · NDA 203188 · IVACAFTOR
US 12,458,635, product and use patent
patent.txt line 3,656
Flags
product use code U-4339
Product numbers
001
13 Aug 2029 · NDA 207925 · IVACAFTOR
US 10,646,481, product patent
patent.txt lines 7,494, 7,527, 7,560, 7,593, 7,621
Flags
product
Product numbers
001, 002, 003, 004, 005
13 Aug 2029 · NDA 207925 · IVACAFTOR
US 11,564,916, use patent
patent.txt lines 7,498, 7,531, 7,564
Flags
use code U-3528
Product numbers
001, 002, 003
13 Aug 2029 · NDA 207925 · IVACAFTOR
US 11,564,916, use patent
patent.txt lines 7,597, 7,625
Flags
use code U-3603
Product numbers
004, 005
13 Aug 2029 · NDA 207925 · IVACAFTOR
US 12,458,635, product and use patent
patent.txt lines 7,504, 7,537, 7,570, 7,603, 7,631
Flags
product use code U-4337
Product numbers
001, 002, 003, 004, 005
15 Aug 2029 · NDA 022427 · KETOROLAC TROMETHAMINE
US 7,842,714, substance and product patent
patent.txt line 1,892
Flags
substance product
Product numbers
001
18 Aug 2029 · NDA 022483 · IMIQUIMOD
US 10,238,645, use patent
patent.txt line 1,929
Flags
use code U-1455
Product numbers
001
18 Aug 2029 · NDA 022483 · IMIQUIMOD
US 10,238,645, use patent
patent.txt line 1,930
Flags
use code U-172
Product numbers
001
18 Aug 2029 · NDA 022483 · IMIQUIMOD
US 8,598,196, use patent
patent.txt line 1,939
Flags
use code U-1455
Product numbers
001
18 Aug 2029 · NDA 022483 · IMIQUIMOD
US 8,598,196, use patent
patent.txt line 1,940
Flags
use code U-172
Product numbers
001
20 Aug 2029 · NDA 022328 · ZOLPIDEM TARTRATE
US 8,242,131, use patent
patent.txt lines 1,705, 1,707
Flags
use code U-1266
Product numbers
001, 002
20 Aug 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 9,416,136, use patent
patent.txt line 9,713
Flags
use code U-1981
Product numbers
001
20 Aug 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 9,416,136, use patent
patent.txt line 9,714
Flags
use code U-2355
Product numbers
001
20 Aug 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 9,416,136, use patent
patent.txt line 9,715
Flags
use code U-2356
Product numbers
001
20 Aug 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 9,416,136, use patent
patent.txt line 9,716
Flags
use code U-3265
Product numbers
001
20 Aug 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 9,416,136, use patent
patent.txt line 9,717
Flags
use code U-3266
Product numbers
001
20 Aug 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 9,416,136, use patent
patent.txt line 9,718
Flags
use code U-3975
Product numbers
001
20 Aug 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 9,416,136, use patent
patent.txt line 9,719
Flags
use code U-3999
Product numbers
001
20 Aug 2029 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 9,416,136, use patent
patent.txt line 11,054
Flags
use code U-2505
Product numbers
001
20 Aug 2029 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 9,416,136, use patent
patent.txt line 11,055
Flags
use code U-3264
Product numbers
001
20 Aug 2029 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 9,416,136, use patent
patent.txt line 11,056
Flags
use code U-3998
Product numbers
001
24 Aug 2029 · NDA 022063 · AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
US 8,846,100, product patent
patent.txt lines 982, 984, 986, 988
Flags
product
Product numbers
001, 002, 003, 004
3 Sep 2029 · NDA 203094 · COBICISTAT
US 8,148,374, substance and product and use patent
patent.txt lines 3,624, 3,628
Flags
substance product use code U-1279
Product numbers
001, 002
3 Sep 2029 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 8,148,374, substance and product and use patent
patent.txt line 3,636
Flags
substance product use code U-1279
Product numbers
001
3 Sep 2029 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 9,891,239, product and use patent
patent.txt line 3,642
Flags
product use code U-257
Product numbers
001
3 Sep 2029 · NDA 205395 · COBICISTAT; DARUNAVIR ETHANOLATE
US 8,148,374, substance and product and use patent
patent.txt line 5,298
Flags
substance product use code U-1279
Product numbers
001
3 Sep 2029 · NDA 205395 · COBICISTAT; DARUNAVIR ETHANOLATE
US 8,148,374, substance and product and use patent
patent.txt line 5,299
Flags
substance product use code U-2939
Product numbers
001
3 Sep 2029 · NDA 205395 · COBICISTAT; DARUNAVIR ETHANOLATE
US 8,148,374, substance and product and use patent
patent.txt lines 5,300, 5,304
Flags
substance product use code U-4162
Product numbers
001, 002
3 Sep 2029 · NDA 206353 · ATAZANAVIR SULFATE; COBICISTAT
US 8,148,374, substance and product and use patent
patent.txt line 6,495
Flags
substance product use code U-1279
Product numbers
001
3 Sep 2029 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,148,374, substance and product and use patent
patent.txt line 7,353
Flags
substance product use code U-1279
Product numbers
001
3 Sep 2029 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 9,891,239, product and use patent
patent.txt line 7,363
Flags
product use code U-257
Product numbers
001
3 Sep 2029 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,148,374, substance and product and use patent
patent.txt line 11,404
Flags
substance product use code U-2353
Product numbers
001
3 Sep 2029 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,148,374, substance and product and use patent
patent.txt line 11,405
Flags
substance product use code U-2364
Product numbers
001
3 Sep 2029 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,148,374, substance and product and use patent
patent.txt line 11,406
Flags
substance product use code U-2365
Product numbers
001
3 Sep 2029 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,148,374, substance and product and use patent
patent.txt line 11,407
Flags
substance product use code U-2766
Product numbers
001
3 Sep 2029 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,148,374, substance and product and use patent
patent.txt line 11,408
Flags
substance product use code U-2767
Product numbers
001
3 Sep 2029 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,148,374, substance and product and use patent
patent.txt line 11,409
Flags
substance product use code U-2768
Product numbers
001
4 Sep 2029 · NDA 211964 · VILOXAZINE HYDROCHLORIDE
US 11,324,753, use patent
patent.txt lines 13,292, 13,298, 13,304
Flags
use code U-727
Product numbers
001, 002, 003
4 Sep 2029 · NDA 211964 · VILOXAZINE HYDROCHLORIDE
US 11,458,143, use patent
patent.txt lines 13,293, 13,299, 13,305
Flags
use code U-727
Product numbers
001, 002, 003
4 Sep 2029 · NDA 211964 · VILOXAZINE HYDROCHLORIDE
US 12,121,523, use patent
patent.txt lines 13,294, 13,300, 13,306
Flags
use code U-727
Product numbers
001, 002, 003
6 Sep 2029 · NDA 214787 · REMDESIVIR
US 8,008,264, substance and product patent
patent.txt lines 16,151, 16,183
Flags
substance product
Product numbers
001, 002
8 Sep 2029 · NDA 022421 · PRAMIPEXOLE DIHYDROCHLORIDE
US 8,679,533, product and use patent
patent.txt lines 1,862, 1,864, 1,866, 1,868, 1,870, 1,872, 1,874
Flags
product use code U-219
Product numbers
001, 002, 003, 004, 005, 006, 007
17 Sep 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US 7,737,142, substance and product and use patent
patent.txt lines 4,551, 4,575, 4,593, 4,608
Flags
substance product use code U-1750
Product numbers
001, 002, 003, 004
17 Sep 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US 7,737,142, substance and product and use patent
patent.txt lines 4,552, 4,576, 4,594, 4,609, 4,623, 4,640
Flags
substance product use code U-2543
Product numbers
001, 002, 003, 004, 005, 006
17 Sep 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US 7,737,142, substance and product and use patent
patent.txt lines 4,553, 4,577, 4,595, 4,610, 4,624, 4,641
Flags
substance product use code U-2544
Product numbers
001, 002, 003, 004, 005, 006
17 Sep 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US 7,737,142, substance and product and use patent
patent.txt lines 4,554, 4,578, 4,625, 4,642
Flags
substance product use code U-2545
Product numbers
001, 002, 005, 006
17 Sep 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US 7,737,142, substance and product and use patent
patent.txt lines 4,555, 4,579, 4,626, 4,643
Flags
substance product use code U-3503
Product numbers
001, 002, 005, 006
17 Sep 2029 · NDA 208232 · OCTREOTIDE ACETATE
US 11,969,471, product patent
patent.txt line 8,365
Flags
product
Product numbers
001
17 Sep 2029 · NDA 208232 · OCTREOTIDE ACETATE
US 11,986,529, use patent
patent.txt line 8,366
Flags
use code U-2857
Product numbers
001
17 Sep 2029 · NDA 208232 · OCTREOTIDE ACETATE
US 8,329,198, product patent
patent.txt line 8,369
Flags
product
Product numbers
001
17 Sep 2029 · NDA 208232 · OCTREOTIDE ACETATE
US 8,535,695, use patent
patent.txt line 8,370
Flags
use code U-2857
Product numbers
001
17 Sep 2029 · NDA 208232 · OCTREOTIDE ACETATE
US 9,265,812, product patent
patent.txt line 8,371
Flags
product
Product numbers
001
17 Sep 2029 · NDA 208232 · OCTREOTIDE ACETATE
US 9,566,246, product patent
patent.txt line 8,372
Flags
product
Product numbers
001
18 Sep 2029 · NDA 022059 · LAPATINIB DITOSYLATE
US 8,821,927, substance and product patent
patent.txt line 981
Flags
substance product
Product numbers
001
19 Sep 2029 · NDA 022256 · MILNACIPRAN HYDROCHLORIDE
US 7,994,220, use patent
patent.txt lines 1,409–1,412
Flags
use code U-819
Product numbers
001, 002, 003, 004
22 Sep 2029 · NDA 207981 · TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
US RE46284, use patent
patent.txt lines 7,898, 7,910
Flags
use code U-1751
Product numbers
001, 002
22 Sep 2029 · NDA 207981 · TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
US RE46284, use patent
patent.txt lines 7,899, 7,911
Flags
use code U-2503
Product numbers
001, 002
22 Sep 2029 · NDA 207981 · TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
US RE46284, use patent
patent.txt lines 7,900, 7,912
Flags
use code U-3656
Product numbers
001, 002
23 Sep 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,344,006, product and use patent
patent.txt lines 1,396, 1,402
Flags
product use code U-1402
Product numbers
003, 004
26 Sep 2029 · NDA 211150 · PITOLISANT HYDROCHLORIDE
US 8,486,947, use patent
patent.txt lines 12,483, 12,488
Flags
use code U-1101
Product numbers
001, 002
26 Sep 2029 · NDA 211150 · PITOLISANT HYDROCHLORIDE
US 8,486,947, use patent
patent.txt lines 12,484, 12,489
Flags
use code U-1102
Product numbers
001, 002
28 Sep 2029 · NDA 202611 · MIRABEGRON
US 10,842,780, product and use patent
patent.txt lines 3,111, 3,124
Flags
product use code U-2996
Product numbers
001, 002
28 Sep 2029 · NDA 202611 · MIRABEGRON
US 10,842,780, product and use patent
patent.txt lines 3,112, 3,125
Flags
product use code U-3670
Product numbers
001, 002
28 Sep 2029 · NDA 202611 · MIRABEGRON
US 11,707,451, use patent
patent.txt lines 3,114, 3,127
Flags
use code U-2996
Product numbers
001, 002
28 Sep 2029 · NDA 202611 · MIRABEGRON
US 11,707,451, use patent
patent.txt lines 3,115, 3,128
Flags
use code U-3670
Product numbers
001, 002
28 Sep 2029 · NDA 202611 · MIRABEGRON
US 12,059,409, product patent
patent.txt lines 3,117, 3,130
Flags
product
Product numbers
001, 002
28 Sep 2029 · NDA 202611 · MIRABEGRON
US 12,097,189, use patent
patent.txt lines 3,119, 3,132
Flags
use code U-2996
Product numbers
001, 002
28 Sep 2029 · NDA 202611 · MIRABEGRON
US 12,097,189, use patent
patent.txt lines 3,120, 3,133
Flags
use code U-3670
Product numbers
001, 002
30 Sep 2029 · NDA 021964 · METHYLNALTREXONE BROMIDE
US 8,420,663, use patent
patent.txt lines 834, 841, 848
Flags
use code U-1185
Product numbers
001, 002, 003
30 Sep 2029 · NDA 021964 · METHYLNALTREXONE BROMIDE
US 8,822,490, product and use patent
patent.txt lines 835, 842, 849
Flags
product use code U-1185
Product numbers
001, 002, 003
30 Sep 2029 · NDA 021964 · METHYLNALTREXONE BROMIDE
US 9,180,125, product and use patent
patent.txt lines 836, 843, 850
Flags
product use code U-1185
Product numbers
001, 002, 003
30 Sep 2029 · NDA 021964 · METHYLNALTREXONE BROMIDE
US 9,492,445, product and use patent
patent.txt lines 837, 844, 851
Flags
product use code U-1185
Product numbers
001, 002, 003
30 Sep 2029 · NDA 208271 · METHYLNALTREXONE BROMIDE
US 8,420,663, use patent
patent.txt line 8,430
Flags
use code U-1185
Product numbers
001
30 Sep 2029 · NDA 208271 · METHYLNALTREXONE BROMIDE
US 9,180,125, product and use patent
patent.txt line 8,433
Flags
product use code U-1185
Product numbers
001
30 Sep 2029 · NDA 208271 · METHYLNALTREXONE BROMIDE
US 9,492,445, product and use patent
patent.txt line 8,435
Flags
product use code U-1185
Product numbers
001
30 Sep 2029 · NDA 208271 · METHYLNALTREXONE BROMIDE
US 9,724,343, product and use patent
patent.txt line 8,436
Flags
product use code U-1185
Product numbers
001
2 Oct 2029 · NDA 021361 · RIFAXIMIN
US 8,642,573, use patent
patent.txt line 582
Flags
use code U-1481
Product numbers
002
2 Oct 2029 · NDA 021361 · RIFAXIMIN
US 8,969,398, use patent
patent.txt line 588
Flags
use code U-1481
Product numbers
002
5 Oct 2029 · NDA 205003 · AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
US 7,846,961, substance and product and use patent
patent.txt lines 5,189–5,191
Flags
substance product use code U-3
Product numbers
001, 002, 003
7 Oct 2029 · NDA 208558 · OLAPARIB
US 11,633,396, product patent
patent.txt lines 8,680, 8,737
Flags
product
Product numbers
001, 002
7 Oct 2029 · NDA 208558 · OLAPARIB
US 11,975,001, product patent
patent.txt lines 8,684, 8,741
Flags
product
Product numbers
001, 002
7 Oct 2029 · NDA 208558 · OLAPARIB
US 12,048,695, product patent
patent.txt lines 8,685, 8,742
Flags
product
Product numbers
001, 002
7 Oct 2029 · NDA 208558 · OLAPARIB
US 12,144,810, product patent
patent.txt lines 8,686, 8,743
Flags
product
Product numbers
001, 002
7 Oct 2029 · NDA 208558 · OLAPARIB
US 12,178,816, product patent
patent.txt lines 8,687, 8,744
Flags
product
Product numbers
001, 002
10 Oct 2029 · NDA 201292 · AFATINIB DIMALEATE
US 8,426,586, substance patent
patent.txt lines 2,401, 2,411, 2,421
Flags
substance
Product numbers
001, 002, 003
10 Oct 2029 · NDA 204822 · TRAVOPROST
US 8,178,582, product patent
patent.txt line 5,057
Flags
product
Product numbers
001
10 Oct 2029 · NDA 204822 · TRAVOPROST
US 8,722,735, product patent
patent.txt line 5,058
Flags
product
Product numbers
001
13 Oct 2029 · NDA 021994 · TRAVOPROST
US 8,268,299, product patent
patent.txt line 887
Flags
product
Product numbers
001
14 Oct 2029 · NDA 204629 · EMPAGLIFLOZIN
US 8,551,957, use patent
patent.txt lines 4,904, 4,935
Flags
use code U-1651
Product numbers
001, 002
14 Oct 2029 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 8,551,957, product and use patent
patent.txt lines 6,198, 6,230
Flags
product use code U-1651
Product numbers
001, 002
14 Oct 2029 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,551,957, product and use patent
patent.txt lines 14,248, 14,278, 14,308, 14,337
Flags
product use code U-2730
Product numbers
001, 002, 003, 004
15 Oct 2029 · NDA 021897 · NALTREXONE
US 7,919,499, use patent
patent.txt line 763
Flags
use code U-1123
Product numbers
001
15 Oct 2029 · NDA 021897 · NALTREXONE
US 7,919,499, use patent
patent.txt line 764
Flags
use code U-1124
Product numbers
001
21 Oct 2029 · NDA 202714 · CARFILZOMIB
US RE47954, use patent
patent.txt lines 3,145, 3,155, 3,165
Flags
use code U-3449
Product numbers
001, 002, 003
21 Oct 2029 · NDA 210861 · LAROTRECTINIB SULFATE
US 10,005,783, use patent
patent.txt lines 12,219, 12,234
Flags
use code U-2472
Product numbers
001, 002
21 Oct 2029 · NDA 210861 · LAROTRECTINIB SULFATE
US 10,047,097, use patent
patent.txt lines 12,220, 12,235
Flags
use code U-2474
Product numbers
001, 002
21 Oct 2029 · NDA 210861 · LAROTRECTINIB SULFATE
US 10,774,085, use patent
patent.txt lines 12,223, 12,238
Flags
use code U-2470
Product numbers
001, 002
21 Oct 2029 · NDA 210861 · LAROTRECTINIB SULFATE
US 8,865,698, use patent
patent.txt lines 12,229, 12,244
Flags
use code U-2469
Product numbers
001, 002
21 Oct 2029 · NDA 210861 · LAROTRECTINIB SULFATE
US 9,127,013, substance and product patent
patent.txt lines 12,230, 12,245
Flags
substance product
Product numbers
001, 002
21 Oct 2029 · NDA 210861 · LAROTRECTINIB SULFATE
US 9,447,104, use patent
patent.txt lines 12,231, 12,246
Flags
use code U-2470
Product numbers
001, 002
21 Oct 2029 · NDA 210861 · LAROTRECTINIB SULFATE
US 9,676,783, use patent
patent.txt lines 12,232, 12,247
Flags
use code U-2469
Product numbers
001, 002
6 Nov 2029 · NDA 022204 · OXYBUTYNIN CHLORIDE
US 10,449,173, product and use patent
patent.txt line 1,340
Flags
product use code U-2637
Product numbers
001
6 Nov 2029 · NDA 022204 · OXYBUTYNIN CHLORIDE
US 9,259,388, use patent
patent.txt line 1,342
Flags
use code U-1644
Product numbers
001
7 Nov 2029 · NDA 022321 · MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
US 8,623,418, use patent
patent.txt lines 1,653, 1,660, 1,667, 1,674, 1,681, 1,688
Flags
use code U-1640
Product numbers
001, 002, 003, 004, 005, 006
20 Nov 2029 · NDA 204569 · SUVOREXANT
US 7,951,797, substance and product and use patent
patent.txt lines 4,829, 4,833, 4,837, 4,841
Flags
substance product use code U-620
Product numbers
001, 002, 003, 004
20 Nov 2029 · NDA 208462 · IXAZOMIB CITRATE
US 7,442,830, substance and product and use patent
patent.txt lines 8,638, 8,645, 8,652
Flags
substance product use code U-2434
Product numbers
001, 002, 003
22 Nov 2029 · NDA 201655 · OXYMORPHONE HYDROCHLORIDE
US 8,871,779, substance patent
patent.txt lines 2,523, 2,526, 2,529, 2,532, 2,535, 2,538, 2,541
Flags
substance
Product numbers
001, 002, 003, 004, 005, 006, 007
1 Dec 2029 · NDA 209500 · LUMATEPERONE TOSYLATE
US 8,648,077, substance and product patent
patent.txt lines 10,460, 10,491, 10,522
Flags
substance product
Product numbers
001, 002, 003
5 Dec 2029 · NDA 206439 · DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US 8,058,291, use patent
patent.txt lines 6,549, 6,552, 6,555, 6,558
Flags
use code U-1641
Product numbers
001, 002, 003, 004
8 Dec 2029 · NDA 204790 · DOLUTEGRAVIR SODIUM
US 9,242,986, substance and product patent
patent.txt lines 5,006, 5,010, 5,014
Flags
substance product
Product numbers
001, 002, 003
8 Dec 2029 · NDA 205551 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 9,242,986, substance and product patent
patent.txt line 5,466
Flags
substance product
Product numbers
001
8 Dec 2029 · NDA 210192 · DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
US 9,242,986, substance and product patent
patent.txt line 11,209
Flags
substance product
Product numbers
001
8 Dec 2029 · NDA 211994 · DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 9,242,986, substance and product patent
patent.txt line 13,379
Flags
substance product
Product numbers
001
8 Dec 2029 · NDA 213983 · DOLUTEGRAVIR SODIUM
US 9,242,986, substance and product patent
patent.txt line 15,421
Flags
substance product
Product numbers
001
8 Dec 2029 · NDA 215413 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 9,242,986, substance and product patent
patent.txt line 16,888
Flags
substance product
Product numbers
001
9 Dec 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,962,630, use patent
patent.txt line 9,703
Flags
use code U-1981
Product numbers
001
9 Dec 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,962,630, use patent
patent.txt line 9,704
Flags
use code U-2355
Product numbers
001
9 Dec 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,962,630, use patent
patent.txt line 9,705
Flags
use code U-2356
Product numbers
001
9 Dec 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,962,630, use patent
patent.txt line 9,706
Flags
use code U-3265
Product numbers
001
9 Dec 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,962,630, use patent
patent.txt line 9,707
Flags
use code U-3266
Product numbers
001
9 Dec 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,962,630, use patent
patent.txt line 9,708
Flags
use code U-3975
Product numbers
001
9 Dec 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,962,630, use patent
patent.txt line 9,709
Flags
use code U-3999
Product numbers
001
9 Dec 2029 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 8,962,630, use patent
patent.txt line 11,048
Flags
use code U-2505
Product numbers
001
9 Dec 2029 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 8,962,630, use patent
patent.txt line 11,049
Flags
use code U-3264
Product numbers
001
9 Dec 2029 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 8,962,630, use patent
patent.txt line 11,050
Flags
use code U-3998
Product numbers
001
10 Dec 2029 · NDA 210361 · GLYCOPYRRONIUM TOSYLATE
US 8,618,160, product and use patent
patent.txt line 11,315
Flags
product use code U-2398
Product numbers
001
11 Dec 2029 · NDA 022483 · IMIQUIMOD
US 10,238,644, use patent
patent.txt line 1,928
Flags
use code U-68
Product numbers
001
11 Dec 2029 · NDA 022483 · IMIQUIMOD
US 11,318,130, use patent
patent.txt line 1,941
Flags
use code U-68
Product numbers
002
11 Dec 2029 · NDA 022483 · IMIQUIMOD
US 8,222,270, use patent
patent.txt line 1,942
Flags
use code U-68
Product numbers
002
11 Dec 2029 · NDA 022483 · IMIQUIMOD
US 8,236,816, use patent
patent.txt line 1,937
Flags
use code U-68
Product numbers
001
11 Dec 2029 · NDA 022483 · IMIQUIMOD
US 8,299,109, use patent
patent.txt line 1,938
Flags
use code U-68
Product numbers
001
12 Dec 2029 · NDA 214012 · INCLISIRAN SODIUM
US 8,106,022, substance and product and use patent
patent.txt line 15,436
Flags
substance product use code U-4249
Product numbers
001
12 Dec 2029 · NDA 214012 · INCLISIRAN SODIUM
US 8,106,022, substance and product and use patent
patent.txt line 15,437
Flags
substance product use code U-4413
Product numbers
001
12 Dec 2029 · NDA 214012 · INCLISIRAN SODIUM
US 8,106,022, substance and product and use patent
patent.txt line 15,438
Flags
substance product use code U-4414
Product numbers
001
12 Dec 2029 · NDA 215515 · VUTRISIRAN SODIUM
US 8,106,022, substance and product and use patent
patent.txt line 17,422
Flags
substance product use code U-3396
Product numbers
001
13 Dec 2029 · NDA 213702 · LURBINECTEDIN
US 7,763,615, substance and product and use patent
patent.txt line 15,210
Flags
substance product use code U-2836
Product numbers
001
13 Dec 2029 · NDA 213702 · LURBINECTEDIN
US 7,763,615, substance and product and use patent
patent.txt line 15,211
Flags
substance product use code U-4299
Product numbers
001
16 Dec 2029 · NDA 202293 · DAPAGLIFLOZIN
US 7,919,598, substance patent
patent.txt lines 2,983, 3,021
Flags
substance
Product numbers
001, 002
16 Dec 2029 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,919,598, substance patent
patent.txt lines 5,713, 5,723, 5,733, 5,743, 5,753
Flags
substance
Product numbers
001, 002, 003, 004, 005
16 Dec 2029 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 7,919,598, substance patent
patent.txt lines 9,660, 9,676
Flags
substance
Product numbers
001, 002
16 Dec 2029 · NDA 209360 · ANGIOTENSIN II ACETATE
US 10,335,451, use patent
patent.txt lines 10,178, 10,193, 10,208
Flags
use code U-2581
Product numbers
001, 002, 003
16 Dec 2029 · NDA 209360 · ANGIOTENSIN II ACETATE
US 10,500,247, use patent
patent.txt lines 10,180, 10,195, 10,210
Flags
use code U-2680
Product numbers
001, 002, 003
16 Dec 2029 · NDA 209360 · ANGIOTENSIN II ACETATE
US 10,500,247, use patent
patent.txt lines 10,181, 10,196, 10,211
Flags
use code U-2681
Product numbers
001, 002, 003
16 Dec 2029 · NDA 209360 · ANGIOTENSIN II ACETATE
US 10,548,943, use patent
patent.txt lines 10,182, 10,197, 10,212
Flags
use code U-2739
Product numbers
001, 002, 003
16 Dec 2029 · NDA 209360 · ANGIOTENSIN II ACETATE
US 10,548,943, use patent
patent.txt lines 10,183, 10,198, 10,213
Flags
use code U-2740
Product numbers
001, 002, 003
16 Dec 2029 · NDA 209360 · ANGIOTENSIN II ACETATE
US 9,867,863, use patent
patent.txt lines 10,191, 10,206, 10,221
Flags
use code U-2231
Product numbers
001, 002, 003
19 Dec 2029 · NDA 201292 · AFATINIB DIMALEATE
US 8,545,884, product patent
patent.txt lines 2,403, 2,413, 2,423
Flags
product
Product numbers
001, 002, 003
22 Dec 2029 · NDA 209388 · METOCLOPRAMIDE HYDROCHLORIDE
US 11,020,361, use patent
patent.txt line 10,287
Flags
use code U-2843
Product numbers
001
22 Dec 2029 · NDA 209388 · METOCLOPRAMIDE HYDROCHLORIDE
US 11,628,150, product and use patent
patent.txt line 10,288
Flags
product use code U-2843
Product numbers
001
22 Dec 2029 · NDA 209388 · METOCLOPRAMIDE HYDROCHLORIDE
US 11,813,231, product and use patent
patent.txt line 10,289
Flags
product use code U-2843
Product numbers
001
22 Dec 2029 · NDA 209388 · METOCLOPRAMIDE HYDROCHLORIDE
US 12,194,008, use patent
patent.txt line 10,290
Flags
use code U-2843
Product numbers
001
22 Dec 2029 · NDA 209388 · METOCLOPRAMIDE HYDROCHLORIDE
US 12,194,009, use patent
patent.txt line 10,291
Flags
use code U-2843
Product numbers
001
23 Dec 2029 · NDA 210861 · LAROTRECTINIB SULFATE
US 8,513,263, substance and product patent
patent.txt lines 12,228, 12,243
Flags
substance product
Product numbers
001, 002
28 Dec 2029 · NDA 209500 · LUMATEPERONE TOSYLATE
US 8,598,119, use patent
patent.txt line 10,459
Flags
use code U-543 delist requested
Product numbers
001
31 Dec 2029 · NDA 208558 · OLAPARIB
US 8,475,842, product patent
patent.txt lines 8,719, 8,776
Flags
product
Product numbers
001, 002

Pediatric exclusivity, as listed (54)

21 Jan 2029 · NDA 022044 · METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
US 8,414,921 with pediatric exclusivity, as listed
patent.txt lines 967, 971
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
27 Jan 2029 · NDA 020873 · BIVALIRUDIN
US 7,582,727 with pediatric exclusivity, as listed
patent.txt line 375
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
27 Jan 2029 · NDA 020873 · BIVALIRUDIN
US 7,598,343 with pediatric exclusivity, as listed
patent.txt line 377
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
1 Feb 2029 · NDA 204629 · EMPAGLIFLOZIN
US 7,579,449 with pediatric exclusivity, as listed
patent.txt lines 4,899, 4,930
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 Feb 2029 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 7,579,449 with pediatric exclusivity, as listed
patent.txt lines 6,193, 6,225
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 Feb 2029 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,579,449 with pediatric exclusivity, as listed
patent.txt lines 6,314, 6,345, 6,374, 6,403
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
1 Feb 2029 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,579,449 with pediatric exclusivity, as listed
patent.txt lines 9,059, 9,091, 9,121, 9,151
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
1 Feb 2029 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 7,579,449 with pediatric exclusivity, as listed
patent.txt lines 14,243, 14,273, 14,303, 14,332
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
19 Feb 2029 · NDA 202293 · DAPAGLIFLOZIN
US 7,851,502 with pediatric exclusivity, as listed
patent.txt lines 2,980, 3,018
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
23 Feb 2029 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,163,904 with pediatric exclusivity, as listed
patent.txt lines 994, 1,008, 1,022
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
22 Mar 2029 · NDA 200533 · TAPENTADOL HYDROCHLORIDE
US 8,536,130 with pediatric exclusivity, as listed
patent.txt lines 2,223, 2,228, 2,233, 2,238, 2,243
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
4 Apr 2029 · NDA 204410 · MACITENTAN
US 8,367,685 with pediatric exclusivity, as listed
patent.txt line 4,672
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
30 Apr 2029 · NDA 202611 · MIRABEGRON
US 8,772,315 with pediatric exclusivity, as listed
patent.txt lines 3,121, 3,134
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
13 May 2029 · NDA 022450 · ACETAMINOPHEN
US 10,383,834 with pediatric exclusivity, as listed
patent.txt line 1,910
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
13 May 2029 · NDA 022450 · ACETAMINOPHEN
US 9,610,265 with pediatric exclusivity, as listed
patent.txt line 1,916
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
13 May 2029 · NDA 022450 · ACETAMINOPHEN
US 9,987,238 with pediatric exclusivity, as listed
patent.txt line 1,918
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
16 Jun 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US 7,943,621 with pediatric exclusivity, as listed
patent.txt lines 4,556, 4,580, 4,596, 4,611
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
20 Jun 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
US 7,943,621 with pediatric exclusivity, as listed
patent.txt lines 4,627, 4,644
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
005, 006
23 Jun 2029 · NDA 205422 · BREXPIPRAZOLE
US RE48059 with pediatric exclusivity, as listed
patent.txt lines 5,318, 5,331, 5,344, 5,357, 5,370, 5,381
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006
26 Aug 2029 · NDA 204042 · CANAGLIFLOZIN
US 7,943,582 with pediatric exclusivity, as listed
patent.txt lines 4,232, 4,242
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Aug 2029 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 11,116,721 with pediatric exclusivity, as listed
patent.txt lines 4,425, 4,437, 4,447
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
26 Aug 2029 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,582 with pediatric exclusivity, as listed
patent.txt lines 4,507, 4,518, 4,529, 4,540
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
26 Aug 2029 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,582 with pediatric exclusivity, as listed
patent.txt lines 5,999, 6,009, 6,019, 6,029
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
11 Sep 2029 · NDA 022145 · RALTEGRAVIR POTASSIUM
US 7,754,731 with pediatric exclusivity, as listed
patent.txt lines 1,113, 1,118
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
24 Sep 2029 · NDA 022525 · MEMANTINE HYDROCHLORIDE
US 8,039,009 with pediatric exclusivity, as listed
patent.txt lines 2,040, 2,042, 2,044, 2,046
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
24 Sep 2029 · NDA 206439 · DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
US 8,039,009 with pediatric exclusivity, as listed
patent.txt lines 6,547, 6,550, 6,553, 6,556
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
26 Sep 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,445,524 with pediatric exclusivity, as listed
patent.txt lines 1,363, 1,380
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,445,524 with pediatric exclusivity, as listed
patent.txt lines 1,397, 1,403
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
003, 004
26 Sep 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,669,279 with pediatric exclusivity, as listed
patent.txt lines 1,367, 1,384
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,883,836 with pediatric exclusivity, as listed
patent.txt lines 1,371, 1,388
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 9,533,955 with pediatric exclusivity, as listed
patent.txt lines 1,375, 1,392
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 204671 · SOFOSBUVIR
US 7,964,580 with pediatric exclusivity, as listed
patent.txt lines 4,945, 4,963
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 204671 · SOFOSBUVIR
US 8,633,309 with pediatric exclusivity, as listed
patent.txt lines 4,953, 4,971
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 204671 · SOFOSBUVIR
US 8,889,159 with pediatric exclusivity, as listed
patent.txt lines 4,955, 4,973
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 204671 · SOFOSBUVIR
US 9,549,941 with pediatric exclusivity, as listed
patent.txt line 4,961
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
2 Oct 2029 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 10,022,379 with pediatric exclusivity, as listed
patent.txt lines 2,344, 2,362, 2,380
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
2 Oct 2029 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 10,973,827 with pediatric exclusivity, as listed
patent.txt lines 2,346, 2,364, 2,382
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
2 Oct 2029 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 9,415,016 with pediatric exclusivity, as listed
patent.txt lines 2,360, 2,378, 2,396
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
2 Oct 2029 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 10,022,379 with pediatric exclusivity, as listed
patent.txt lines 7,972, 7,991
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
2 Oct 2029 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 9,415,016 with pediatric exclusivity, as listed
patent.txt lines 7,986, 8,005
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
2 Oct 2029 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 12,678,442 with pediatric exclusivity, as listed
patent.txt lines 14,241, 14,271, 14,301, 14,330
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
18 Oct 2029 · NDA 204410 · MACITENTAN
US 8,268,847 with pediatric exclusivity, as listed
patent.txt line 4,670
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
22 Oct 2029 · NDA 214787 · REMDESIVIR
US 8,318,682 with pediatric exclusivity, as listed
patent.txt lines 16,152, 16,184
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
22 Oct 2029 · NDA 214787 · REMDESIVIR
US RE46762 with pediatric exclusivity, as listed
patent.txt lines 16,158, 16,190
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Nov 2029 · NDA 202806 · DABRAFENIB MESYLATE
US 9,233,956 with pediatric exclusivity, as listed
patent.txt lines 3,269, 3,293
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Dec 2029 · NDA 205832 · NINTEDANIB ESYLATE
US 10,105,323 with pediatric exclusivity, as listed
patent.txt lines 5,892, 5,900
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
7 Dec 2029 · NDA 205832 · NINTEDANIB ESYLATE
US 9,907,756 with pediatric exclusivity, as listed
patent.txt lines 5,898, 5,906
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
29 Dec 2029 · NDA 207695 · CRISABOROLE
US 8,039,451 with pediatric exclusivity, as listed
patent.txt line 7,405
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
30 Dec 2029 · NDA 020845 · NITRIC OXIDE
US 11,931,377 with pediatric exclusivity, as listed
patent.txt line 216
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
003
30 Dec 2029 · NDA 020845 · NITRIC OXIDE
US 8,282,966 with pediatric exclusivity, as listed
patent.txt lines 196, 218
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
30 Dec 2029 · NDA 020845 · NITRIC OXIDE
US 8,293,284 with pediatric exclusivity, as listed
patent.txt lines 200, 222
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
30 Dec 2029 · NDA 020845 · NITRIC OXIDE
US 8,431,163 with pediatric exclusivity, as listed
patent.txt lines 202, 224
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
30 Dec 2029 · NDA 020845 · NITRIC OXIDE
US 8,795,741 with pediatric exclusivity, as listed
patent.txt lines 212, 234
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003
30 Dec 2029 · NDA 020845 · NITRIC OXIDE
US 8,846,112 with pediatric exclusivity, as listed
patent.txt lines 214, 236
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003

Non-patent exclusivity (52)

7 Jan 2029 · NDA 208215 · EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
ODE-554 exclusivity
exclusivity.txt line 699
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
002
16 Jan 2029 · NDA 021529 · ETONOGESTREL
D-199 exclusivity
exclusivity.txt line 123
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
002
21 Jan 2029 · NDA 214377 · VERICIGUAT
D-198 exclusivity
exclusivity.txt lines 1,322, 1,324, 1,326
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001, 002, 003
27 Jan 2029 · NDA 205053 · POSACONAZOLE
NPP exclusivity
exclusivity.txt line 446
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
27 Jan 2029 · NDA 205596 · POSACONAZOLE
NPP exclusivity
exclusivity.txt line 510
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
12 Feb 2029 · NDA 214012 · INCLISIRAN SODIUM
I-985 exclusivity
exclusivity.txt line 1,288
Definition
New indication (to be checked against FDA's list)
Product numbers
001
12 Feb 2029 · NDA 214012 · INCLISIRAN SODIUM
NPP exclusivity
exclusivity.txt line 1,290
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
17 Feb 2029 · NDA 216196 · MITAPIVAT SULFATE
ODE-392 exclusivity
exclusivity.txt lines 1,737, 1,739, 1,741
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
19 Feb 2029 · NDA 210259 · ACALABRUTINIB
D-200 exclusivity
exclusivity.txt line 868
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001
19 Feb 2029 · NDA 216387 · ACALABRUTINIB MALEATE
D-200 exclusivity
exclusivity.txt line 1,751
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001
24 Feb 2029 · NDA 210496 · ENCORAFENIB
I-997 exclusivity
exclusivity.txt lines 882, 886
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
16 Mar 2029 · NDA 207103 · PALBOCICLIB
PED exclusivity
exclusivity.txt lines 575, 578, 581
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
16 Mar 2029 · NDA 212436 · PALBOCICLIB
PED exclusivity
exclusivity.txt lines 1,067, 1,070, 1,073
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
19 Mar 2029 · NDA 215256 · SEMAGLUTIDE
NS exclusivity
exclusivity.txt line 1,513
Definition
New strength (to be checked against FDA's list)
Product numbers
006
22 Mar 2029 · NDA 202192 · RUXOLITINIB PHOSPHATE
PED exclusivity
exclusivity.txt lines 241, 247, 253, 259, 265
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
22 Mar 2029 · NDA 217180 · RUXOLITINIB PHOSPHATE
PED exclusivity
exclusivity.txt lines 1,845, 1,847, 1,849, 1,851, 1,853
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
23 Mar 2029 · NDA 022068 · NILOTINIB HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 158, 160, 162
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
25 Mar 2029 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
ODE-393 exclusivity
exclusivity.txt line 1,022
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
27 Mar 2029 · NDA 209531 · NUSINERSEN SODIUM
NS exclusivity
exclusivity.txt lines 794–795
Definition
New strength (to be checked against FDA's list)
Product numbers
002, 003
24 Apr 2029 · NDA 209500 · LUMATEPERONE TOSYLATE
M-319 exclusivity
exclusivity.txt lines 789, 791, 793
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
27 Apr 2029 · NDA 207318 · PIMAVANSERIN TARTRATE
M-14 exclusivity
exclusivity.txt lines 584, 586
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
27 Apr 2029 · NDA 210793 · PIMAVANSERIN TARTRATE
M-14 exclusivity
exclusivity.txt line 909
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
28 Apr 2029 · NDA 214998 · MAVACAMTEN
ODE-398 exclusivity
exclusivity.txt lines 1,448, 1,451, 1,454, 1,457
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
28 Apr 2029 · NDA 215760 · TRIENTINE TETRAHYDROCHLORIDE
ODE-401 exclusivity
exclusivity.txt line 1,605
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
30 Apr 2029 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
I-913 exclusivity
exclusivity.txt lines 1,563–1,564
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
4 May 2029 · NDA 202811 · LINACLOTIDE
PED exclusivity
exclusivity.txt line 296
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
12 May 2029 · NDA 215446 · EDARAVONE
ODE-144 exclusivity
exclusivity.txt line 1,566
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
21 May 2029 · NDA 202811 · LINACLOTIDE
NPP exclusivity
exclusivity.txt line 298
Definition
New patient population (to be checked against FDA's list)
Product numbers
003
23 May 2029 · NDA 207947 · SELEXIPAG
NPP exclusivity
exclusivity.txt lines 656, 658, 660, 662, 664, 666, 668, 670
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
23 May 2029 · NDA 207947 · SELEXIPAG
NS exclusivity
exclusivity.txt lines 672, 674
Definition
New strength (to be checked against FDA's list)
Product numbers
010, 011
27 May 2029 · NDA 213535 · RISDIPLAM
ODE-400 exclusivity
exclusivity.txt line 1,231
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
12 Jun 2029 · NDA 215383 · BELZUTIFAN
I-994 exclusivity
exclusivity.txt line 1,556
Definition
New indication (to be checked against FDA's list)
Product numbers
001
13 Jun 2029 · NDA 215515 · VUTRISIRAN SODIUM
ODE-212 exclusivity
exclusivity.txt line 1,589
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
18 Jun 2029 · NDA 204370 · CARIPRAZINE HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 398–399, 402–403, 406–407, 409, 412–413, 416–417
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
24 Jun 2029 · NDA 207103 · PALBOCICLIB
I-995 exclusivity
exclusivity.txt lines 573, 576, 579
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
24 Jun 2029 · NDA 212436 · PALBOCICLIB
I-995 exclusivity
exclusivity.txt lines 1,065, 1,068, 1,071
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
29 Jun 2029 · NDA 215985 · ROFLUMILAST
NPP exclusivity
exclusivity.txt line 1,682
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
1 Jul 2029 · NDA 209092 · RIBOCICLIB SUCCINATE
M-14 exclusivity
exclusivity.txt line 761
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
1 Jul 2029 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
M-14 exclusivity
exclusivity.txt line 815
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
24 Aug 2029 · NDA 205552 · IBRUTINIB
ODE-405 exclusivity
exclusivity.txt lines 503, 507
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
24 Aug 2029 · NDA 210563 · IBRUTINIB
ODE-405 exclusivity
exclusivity.txt lines 890, 894, 898, 902
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
25 Aug 2029 · NDA 213983 · DOLUTEGRAVIR SODIUM
NPP exclusivity
exclusivity.txt line 1,286
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
26 Aug 2029 · NDA 213736 · PEMIGATINIB
ODE-404 exclusivity
exclusivity.txt lines 1,251, 1,253, 1,255
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
16 Sep 2029 · NDA 215341 · FINERENONE
I-998 exclusivity
exclusivity.txt lines 1,525, 1,528, 1,530
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
20 Sep 2029 · NDA 212937 · SODIUM THIOSULFATE
ODE-384 exclusivity
exclusivity.txt line 1,133
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
21 Sep 2029 · NDA 213246 · SELPERCATINIB
ODE-409 exclusivity
exclusivity.txt lines 1,175, 1,197
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
21 Sep 2029 · NDA 213246 · SELPERCATINIB
ODE-412 exclusivity
exclusivity.txt lines 1,176, 1,198
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
25 Sep 2029 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
PED exclusivity
exclusivity.txt line 1,024
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
29 Sep 2029 · NDA 208078 · AMIFAMPRIDINE PHOSPHATE
ODE-553 exclusivity
exclusivity.txt line 694
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
27 Oct 2029 · NDA 207318 · PIMAVANSERIN TARTRATE
PED exclusivity
exclusivity.txt lines 585, 587
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
27 Oct 2029 · NDA 210793 · PIMAVANSERIN TARTRATE
PED exclusivity
exclusivity.txt line 910
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
23 Nov 2029 · NDA 207947 · SELEXIPAG
PED exclusivity
exclusivity.txt lines 657, 659, 661, 663, 665, 667, 669, 671, 673, 675
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 010, 011