Drybench Patent.

Patent and exclusivity dates from January to June 2029 for NDAs, as FDA's Orange Book lists them

Each patent and exclusivity date from January to June 2029 that FDA's Orange Book lists for an NDA, as captured on 14 October 2026. That capture lists a patent or exclusivity for 1,411 NDAs. Each entry is named by its rule and linked to its NDA page. A date here belongs to one patent or one exclusivity on the products named; the same NDA may have other listed dates, earlier or later, so no date here stands for a product.

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

Orange Book captured: 14 October 2026

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

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

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

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

Listed dates, 2029 July to December 2029

Listed patent expiry (362)

5 Jan 2029 · NDA 211155 · DUVELISIB
US 9,216,982, use patent
patent.txt lines 12,493, 12,501
Flags
use code U-2412
Product numbers
001, 002
5 Jan 2029 · NDA 211155 · DUVELISIB
US 9,216,982, use patent
patent.txt lines 12,494, 12,502
Flags
use code U-2413
Product numbers
001, 002
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
8 Jan 2029 · NDA 208088 · TESTOSTERONE UNDECANOATE
US 11,304,960, product and use patent
patent.txt line 8,209
Flags
product use code U-1500
Product numbers
001
8 Jan 2029 · NDA 208088 · TESTOSTERONE UNDECANOATE
US 8,778,922, product and use patent
patent.txt line 8,219
Flags
product use code U-1500
Product numbers
001
8 Jan 2029 · NDA 208088 · TESTOSTERONE UNDECANOATE
US 8,865,695, use patent
patent.txt line 8,220
Flags
use code U-1500
Product numbers
001
17 Jan 2029 · NDA 208712 · PACRITINIB CITRATE
US 8,153,632, substance and product and use patent
patent.txt line 9,261
Flags
substance product use code U-3331
Product numbers
001
17 Jan 2029 · NDA 208712 · PACRITINIB CITRATE
US 8,153,632, substance and product and use patent
patent.txt line 9,262
Flags
substance product use code U-3332
Product numbers
001
18 Jan 2029 · NDA 206500 · ROLAPITANT HYDROCHLORIDE
US 8,470,842, use patent
patent.txt line 6,589
Flags
use code U-1741
Product numbers
001
18 Jan 2029 · NDA 208399 · ROLAPITANT HYDROCHLORIDE
US 8,470,842, use patent
patent.txt line 8,570
Flags
use code U-1741
Product numbers
001
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
18 Jan 2029 · NDA 219104 · LETERMOVIR
US RE46791, substance and product patent
patent.txt lines 21,496–21,497
Flags
substance product
Product numbers
001, 002
28 Jan 2029 · NDA 202860 · NITRIC OXIDE
US 9,701,538, product patent
patent.txt line 3,421
Flags
product
Product numbers
001
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
30 Jan 2029 · NDA 202207 · TECHNETIUM TC-99M TILMANOCEPT
US 9,439,985, product patent
patent.txt line 2,946
Flags
product
Product numbers
001
30 Jan 2029 · NDA 214373 · BEXAGLIFLOZIN
US 7,838,499, substance and product and use patent
patent.txt line 15,730
Flags
substance product use code U-2214
Product numbers
001
1 Feb 2029 · NDA 022572 · MITOMYCIN
US 7,806,265, product patent
patent.txt line 2,101
Flags
product
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 204654 · ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
US 7,704,984, use patent
patent.txt line 4,944
Flags
use code U-1
Product numbers
001
2 Feb 2029 · NDA 206488 · ETEPLIRSEN
US RE47769, product patent
patent.txt lines 6,564, 6,571
Flags
product
Product numbers
001, 002
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 021842 · METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
US 9,320,714, product patent
patent.txt lines 740, 742
Flags
product
Product numbers
001, 002
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
3 Feb 2029 · NDA 201110 · PROGESTERONE
US 10,537,584, product patent
patent.txt line 2,322
Flags
product
Product numbers
001
3 Feb 2029 · NDA 201110 · PROGESTERONE
US 10,548,904, use patent
patent.txt line 2,323
Flags
use code U-2810
Product numbers
001
3 Feb 2029 · NDA 209184 · LEVODOPA
US RE43711, use patent
patent.txt line 9,811
Flags
use code U-2484
Product numbers
001
5 Feb 2029 · NDA 021821 · TIGECYCLINE
US 7,879,828, product patent
patent.txt line 703
Flags
product
Product numbers
001
9 Feb 2029 · NDA 218171 · ENSARTINIB HYDROCHLORIDE
US 8,551,995, substance patent
patent.txt lines 20,865, 20,869
Flags
substance
Product numbers
001, 002
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
12 Feb 2029 · NDA 218230 · GEPOTIDACIN MESYLATE
US 8,389,524, substance and product and use patent
patent.txt line 20,922
Flags
substance product use code U-4166
Product numbers
001
14 Feb 2029 · NDA 213312 · SIROLIMUS
US 8,911,786, product and use patent
patent.txt line 14,883
Flags
product use code U-3259
Product numbers
001
16 Feb 2029 · NDA 213026 · CASIMERSEN
US RE48960, substance and product and use patent
patent.txt line 14,575
Flags
substance product use code U-3087
Product numbers
001
16 Feb 2029 · NDA 213026 · CASIMERSEN
US RE48960, substance and product and use patent
patent.txt line 14,576
Flags
substance product use code U-3088
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
26 Feb 2029 · NDA 208437 · GLYCOPYRROLATE
US 10,940,110, product and use patent
patent.txt line 8,624
Flags
product use code U-1773
Product numbers
001
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 207202 · ARIPIPRAZOLE
US 9,060,708, product patent
patent.txt lines 7,079, 7,106, 7,133, 7,160, 7,187, 7,214
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
5 Mar 2029 · NDA 207202 · ARIPIPRAZOLE
US 9,258,035, product patent
patent.txt lines 7,083, 7,110, 7,137, 7,164, 7,191, 7,218
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
5 Mar 2029 · NDA 209816 · OMADACYCLINE TOSYLATE
US 10,124,014, use patent
patent.txt line 10,825
Flags
use code U-2449
Product numbers
001
5 Mar 2029 · NDA 209816 · OMADACYCLINE TOSYLATE
US 9,724,358, use patent
patent.txt line 10,831
Flags
use code U-1569
Product numbers
001
5 Mar 2029 · NDA 209817 · OMADACYCLINE TOSYLATE
US 10,124,014, use patent
patent.txt line 10,832
Flags
use code U-2449
Product numbers
001
5 Mar 2029 · NDA 209817 · OMADACYCLINE TOSYLATE
US 9,265,740, product patent
patent.txt line 10,835
Flags
product
Product numbers
001
5 Mar 2029 · NDA 209817 · OMADACYCLINE TOSYLATE
US 9,724,358, use patent
patent.txt line 10,836
Flags
use code U-1569
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 022048 · TRIAMCINOLONE ACETONIDE
US 8,211,880, use patent
patent.txt line 974
Flags
use code U-1257
Product numbers
001
10 Mar 2029 · NDA 022048 · TRIAMCINOLONE ACETONIDE
US 8,211,880, use patent
patent.txt line 975
Flags
use code U-1258
Product numbers
001
10 Mar 2029 · NDA 204824 · METHOTREXATE
US 10,709,844, product patent
patent.txt lines 5,061, 5,076, 5,091, 5,106, 5,121, 5,136, 5,151, 5,166
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
10 Mar 2029 · NDA 204824 · METHOTREXATE
US 11,684,723, product patent
patent.txt lines 5,064, 5,079, 5,094, 5,109, 5,124, 5,139, 5,154, 5,169
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
10 Mar 2029 · NDA 204824 · METHOTREXATE
US 9,867,949, product patent
patent.txt lines 5,075, 5,090, 5,105, 5,120, 5,135, 5,150, 5,165, 5,180
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
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
10 Mar 2029 · NDA 208056 · DEXLANSOPRAZOLE
US 9,241,910, product patent
patent.txt line 8,048
Flags
product
Product numbers
001
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 203045 · RALTEGRAVIR POTASSIUM
US 7,754,731, substance and product and use patent
patent.txt lines 3,601, 3,603
Flags
substance product use code U-257
Product numbers
001, 002
11 Mar 2029 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
US 8,372,432, product and use patent
patent.txt line 4,221
Flags
product use code U-1499
Product numbers
001
11 Mar 2029 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
US 8,394,408, product patent
patent.txt line 4,223
Flags
product
Product numbers
001
11 Mar 2029 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
US 8,668,929, use patent
patent.txt line 4,226
Flags
use code U-1499
Product numbers
001
11 Mar 2029 · NDA 204061 · ETHINYL ESTRADIOL; LEVONORGESTREL
US 8,415,332, product patent
patent.txt line 4,252
Flags
product
Product numbers
001
11 Mar 2029 · NDA 205786 · RALTEGRAVIR POTASSIUM
US 7,754,731, substance and product and use patent
patent.txt line 5,870
Flags
substance product use code U-257
Product numbers
001
11 Mar 2029 · NDA 206510 · LAMIVUDINE; RALTEGRAVIR POTASSIUM
US 7,754,731, substance and product and use patent
patent.txt line 6,591
Flags
substance product use code U-1663
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 202450 · ACLIDINIUM BROMIDE
US 10,085,974, product and use patent
patent.txt line 3,094
Flags
product use code U-2513
Product numbers
001
13 Mar 2029 · NDA 202450 · ACLIDINIUM BROMIDE
US 11,000,517, product and use patent
patent.txt line 3,095
Flags
product use code U-2513
Product numbers
001
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 206030 · CARBAMAZEPINE
US 7,635,773, product patent
patent.txt line 6,071
Flags
product
Product numbers
001
13 Mar 2029 · NDA 206030 · CARBAMAZEPINE
US 8,410,077, product patent
patent.txt line 6,072
Flags
product
Product numbers
001
13 Mar 2029 · NDA 206030 · CARBAMAZEPINE
US 9,750,822, product patent
patent.txt line 6,077
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 208611 · DELAFLOXACIN MEGLUMINE
US 7,635,773, product patent
patent.txt line 8,916
Flags
product
Product numbers
001
13 Mar 2029 · NDA 208611 · DELAFLOXACIN MEGLUMINE
US 8,410,077, product patent
patent.txt line 8,920
Flags
product
Product numbers
001
13 Mar 2029 · NDA 208611 · DELAFLOXACIN MEGLUMINE
US 9,200,088, product patent
patent.txt line 8,922
Flags
product
Product numbers
001
13 Mar 2029 · NDA 208611 · DELAFLOXACIN MEGLUMINE
US 9,750,822, product patent
patent.txt line 8,924
Flags
product
Product numbers
001
13 Mar 2029 · NDA 210595 · ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
US 10,085,974, product and use patent
patent.txt line 12,035
Flags
product use code U-2513
Product numbers
001
13 Mar 2029 · NDA 210595 · ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
US 11,000,517, product and use patent
patent.txt line 12,036
Flags
product use code U-2513
Product numbers
001
13 Mar 2029 · NDA 210864 · FOSPHENYTOIN SODIUM
US 7,635,773, product patent
patent.txt lines 12,249, 12,254
Flags
product
Product numbers
001, 002
13 Mar 2029 · NDA 210864 · FOSPHENYTOIN SODIUM
US 8,410,077, product patent
patent.txt lines 12,250, 12,255
Flags
product
Product numbers
001, 002
13 Mar 2029 · NDA 210864 · FOSPHENYTOIN SODIUM
US 9,200,088, product patent
patent.txt lines 12,251, 12,256
Flags
product
Product numbers
001, 002
13 Mar 2029 · NDA 210864 · FOSPHENYTOIN SODIUM
US 9,750,822, product patent
patent.txt lines 12,253, 12,258
Flags
product
Product numbers
001, 002
13 Mar 2029 · NDA 211371 · BREXANOLONE
US 10,117,951, product patent
patent.txt line 12,856
Flags
product
Product numbers
001
13 Mar 2029 · NDA 211371 · BREXANOLONE
US 7,635,773, product patent
patent.txt line 12,860
Flags
product
Product numbers
001
13 Mar 2029 · NDA 211371 · BREXANOLONE
US 8,410,077, product patent
patent.txt line 12,861
Flags
product
Product numbers
001
13 Mar 2029 · NDA 211371 · BREXANOLONE
US 9,200,088, product patent
patent.txt line 12,862
Flags
product
Product numbers
001
13 Mar 2029 · NDA 211371 · BREXANOLONE
US 9,750,822, product patent
patent.txt line 12,863
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
18 Mar 2029 · NDA 204677 · FLORBETABEN F-18
US 7,807,135, substance and product and use patent
patent.txt line 4,979
Flags
substance product use code U-1497
Product numbers
001
19 Mar 2029 · NDA 204384 · BEDAQUILINE FUMARATE
US 8,546,428, substance and product and use patent
patent.txt lines 4,657, 4,659
Flags
substance product use code U-1321
Product numbers
001, 002
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
25 Mar 2029 · NDA 208171 · FERRIC DERISOMALTOSE
US 10,414,831, substance and product patent
patent.txt lines 8,281, 8,286, 8,291
Flags
substance product
Product numbers
001, 002, 003
25 Mar 2029 · NDA 208171 · FERRIC DERISOMALTOSE
US 11,851,504, substance and product patent
patent.txt lines 8,283, 8,288, 8,293
Flags
substance product
Product numbers
001, 002, 003
25 Mar 2029 · NDA 208171 · FERRIC DERISOMALTOSE
US 12,030,962, substance and product patent
patent.txt lines 8,284, 8,289, 8,294
Flags
substance product
Product numbers
001, 002, 003
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 205834 · LEDIPASVIR; SOFOSBUVIR
US 7,964,580, substance and product and use patent
patent.txt lines 5,913, 5,946
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,633,309, substance and product and use patent
patent.txt lines 5,925, 5,958
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,889,159, product and use patent
patent.txt lines 5,933, 5,966
Flags
product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 7,964,580, substance and product and use patent
patent.txt lines 8,488, 8,518
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,633,309, substance and product and use patent
patent.txt lines 8,498, 8,528
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,889,159, product and use patent
patent.txt lines 8,502, 8,532
Flags
product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 7,964,580, substance and product and use patent
patent.txt line 9,820
Flags
substance product use code U-2039
Product numbers
001
26 Mar 2029 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 7,964,580, substance and product and use patent
patent.txt line 9,821
Flags
substance product use code U-2040
Product numbers
001
26 Mar 2029 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,633,309, substance and product and use patent
patent.txt line 9,835
Flags
substance product use code U-2039
Product numbers
001
26 Mar 2029 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,633,309, substance and product and use patent
patent.txt line 9,836
Flags
substance product use code U-2040
Product numbers
001
26 Mar 2029 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,889,159, substance and product and use patent
patent.txt line 9,841
Flags
substance product use code U-2039
Product numbers
001
26 Mar 2029 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,889,159, substance and product and use patent
patent.txt line 9,842
Flags
substance product use code U-2040
Product numbers
001
26 Mar 2029 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 7,964,580, substance and product and use patent
patent.txt lines 13,986, 14,017
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,633,309, substance and product and use patent
patent.txt lines 13,998, 14,029
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,889,159, product and use patent
patent.txt lines 14,006, 14,037
Flags
product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 212480 · SOFOSBUVIR
US 7,964,580, substance and product and use patent
patent.txt lines 14,054, 14,070
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 212480 · SOFOSBUVIR
US 8,633,309, substance and product and use patent
patent.txt lines 14,062, 14,078
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 212480 · SOFOSBUVIR
US 8,889,159, product and use patent
patent.txt lines 14,064, 14,080
Flags
product use code U-1470
Product numbers
001, 002
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
26 Mar 2029 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 7,964,580, substance and product and use patent
patent.txt lines 15,581, 15,609
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,633,309, substance and product and use patent
patent.txt lines 15,591, 15,619
Flags
substance product use code U-1470
Product numbers
001, 002
26 Mar 2029 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,889,159, product and use patent
patent.txt lines 15,595, 15,623
Flags
product use code U-1470
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
27 Mar 2029 · NDA 212801 · OSILODROSTAT PHOSPHATE
US 8,314,097, substance and product patent
patent.txt line 14,426
Flags
substance product
Product numbers
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 022556 · CARBINOXAMINE MALEATE
US 8,062,667, product patent
patent.txt line 2,084
Flags
product
Product numbers
001
29 Mar 2029 · NDA 202100 · METHYLPHENIDATE HYDROCHLORIDE
US 8,062,667, product patent
patent.txt line 2,749
Flags
product
Product numbers
001
29 Mar 2029 · NDA 206089 · TESTOSTERONE UNDECANOATE
US 8,241,664, product and use patent
patent.txt lines 6,245, 6,256, 6,267
Flags
product use code U-2506
Product numbers
001, 002, 003
29 Mar 2029 · NDA 207768 · CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX
US 8,062,667, product patent
patent.txt line 7,413
Flags
product
Product numbers
001
29 Mar 2029 · NDA 208147 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 8,062,667, product patent
patent.txt line 8,275
Flags
product
Product numbers
001
29 Mar 2029 · NDA 217645 · CLONIDINE HYDROCHLORIDE
US 8,062,667, product patent
patent.txt line 20,061
Flags
product
Product numbers
001
1 Apr 2029 · NDA 209401 · CYTARABINE; DAUNORUBICIN
US 8,092,828, use patent
patent.txt line 10,338
Flags
use code U-3147
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 207202 · ARIPIPRAZOLE
US 8,674,825, product and use patent
patent.txt lines 7,072, 7,099, 7,126, 7,153, 7,180, 7,207
Flags
product use code U-2170
Product numbers
001, 002, 003, 004, 005, 006
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
9 Apr 2029 · NDA 214018 · FOSDENOPTERIN HYDROBROMIDE
US 7,504,095, product and use patent
patent.txt line 15,451
Flags
product use code U-3092
Product numbers
001
10 Apr 2029 · NDA 201739 · EPINEPHRINE
US 8,226,610, product patent
patent.txt lines 2,564, 2,573, 2,582
Flags
product
Product numbers
001, 002, 003
10 Apr 2029 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 8,226,610, product patent
patent.txt line 5,881
Flags
product
Product numbers
001
10 Apr 2029 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 8,226,610, product patent
patent.txt line 10,905
Flags
product
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
15 Apr 2029 · NDA 210922 · PATISIRAN SODIUM
US 11,141,378, product patent
patent.txt line 12,396
Flags
product
Product numbers
001
15 Apr 2029 · NDA 210922 · PATISIRAN SODIUM
US 8,058,069, product patent
patent.txt line 12,397
Flags
product
Product numbers
001
15 Apr 2029 · NDA 210922 · PATISIRAN SODIUM
US 8,492,359, product patent
patent.txt line 12,400
Flags
product
Product numbers
001
15 Apr 2029 · NDA 210922 · PATISIRAN SODIUM
US 8,822,668, product and use patent
patent.txt line 12,404
Flags
product use code U-2378
Product numbers
001
15 Apr 2029 · NDA 210922 · PATISIRAN SODIUM
US 9,364,435, product and use patent
patent.txt line 12,406
Flags
product use code U-2378
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
17 Apr 2029 · NDA 206317 · FERRIC PYROPHOSPHATE CITRATE
US 7,816,404, product and use patent
patent.txt line 6,469
Flags
product use code U-1656
Product numbers
001
17 Apr 2029 · NDA 208551 · FERRIC PYROPHOSPHATE CITRATE
US 7,816,404, use patent
patent.txt line 8,671
Flags
use code U-1656
Product numbers
001
17 Apr 2029 · NDA 212860 · FERRIC PYROPHOSPHATE CITRATE
US 7,816,404, substance and use patent
patent.txt line 14,473
Flags
substance use code U-2801
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
18 Apr 2029 · NDA 218490 · MACITENTAN; TADALAFIL
US 8,268,847, product and use patent
patent.txt lines 21,097, 21,103
Flags
product use code U-3882
Product numbers
001, 002
20 Apr 2029 · NDA 216718 · OMAVELOXOLONE
US 11,091,430, use patent
patent.txt line 18,924
Flags
use code U-3552
Product numbers
001
20 Apr 2029 · NDA 216718 · OMAVELOXOLONE
US 11,919,838, use patent
patent.txt line 18,925
Flags
use code U-3862
Product numbers
001
20 Apr 2029 · NDA 216718 · OMAVELOXOLONE
US 11,919,838, use patent
patent.txt line 18,926
Flags
use code U-3863
Product numbers
001
20 Apr 2029 · NDA 216718 · OMAVELOXOLONE
US 8,440,854, product patent
patent.txt line 18,928
Flags
product
Product numbers
001
20 Apr 2029 · NDA 216718 · OMAVELOXOLONE
US 9,670,147, substance patent
patent.txt line 18,930
Flags
substance
Product numbers
001
21 Apr 2029 · NDA 202278 · SUMATRIPTAN SUCCINATE
US 8,366,600, use patent
patent.txt line 2,968
Flags
use code U-1327
Product numbers
001
21 Apr 2029 · NDA 207986 · CIPROFLOXACIN
US 11,369,566, product patent
patent.txt line 7,915
Flags
product
Product numbers
001
21 Apr 2029 · NDA 207986 · CIPROFLOXACIN
US 9,205,048, use patent
patent.txt line 7,917
Flags
use code U-1793
Product numbers
001
21 Apr 2029 · NDA 207986 · CIPROFLOXACIN
US 9,603,796, substance and product and use patent
patent.txt line 7,920
Flags
substance product use code U-2252
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 208447 · NIRAPARIB TOSYLATE
US 8,436,185, substance patent
patent.txt line 8,636
Flags
substance
Product numbers
001
24 Apr 2029 · NDA 211911 · BIMATOPROST
US 7,799,336, product patent
patent.txt line 13,224
Flags
product
Product numbers
001
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
24 Apr 2029 · NDA 216793 · ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
US 8,436,185, substance and product patent
patent.txt lines 18,969, 18,993
Flags
substance product
Product numbers
001, 002
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
29 Apr 2029 · NDA 207988 · LESINURAD
US 8,546,437, use patent
patent.txt line 7,929
Flags
use code U-1803
Product numbers
001
29 Apr 2029 · NDA 209203 · ALLOPURINOL; LESINURAD
US 8,546,437, use patent
patent.txt lines 9,864, 9,872
Flags
use code U-2104
Product numbers
001, 002
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 209899 · OZANIMOD HYDROCHLORIDE
US 8,796,318, substance and product patent
patent.txt lines 11,004, 11,010, 11,016
Flags
substance product
Product numbers
001, 002, 003
14 May 2029 · NDA 209899 · OZANIMOD HYDROCHLORIDE
US 9,382,217, use patent
patent.txt lines 11,005, 11,011, 11,017
Flags
use code U-2774
Product numbers
001, 002, 003
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
17 May 2029 · NDA 206619 · DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
US 8,188,104, substance and product and use patent
patent.txt line 6,601
Flags
substance product use code U-1636
Product numbers
001
17 May 2029 · NDA 208624 · DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
US 8,188,104, substance and product and use patent
patent.txt line 8,997
Flags
substance product use code U-1636
Product numbers
001
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 209511 · BUPIVACAINE HYDROCHLORIDE
US RE47826, use patent
patent.txt line 10,588
Flags
use code U-2949
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
21 May 2029 · NDA 022517 · DESMOPRESSIN ACETATE
US 10,137,167, use patent
patent.txt line 2,028
Flags
use code U-2327
Product numbers
002
21 May 2029 · NDA 022517 · DESMOPRESSIN ACETATE
US 11,020,448, use patent
patent.txt line 2,025
Flags
use code U-2327
Product numbers
001
21 May 2029 · NDA 022517 · DESMOPRESSIN ACETATE
US 11,963,995, use patent
patent.txt lines 2,026, 2,029
Flags
use code U-2327
Product numbers
001, 002
21 May 2029 · NDA 022572 · MITOMYCIN
US 9,649,428, use patent
patent.txt line 2,105
Flags
use code U-2095
Product numbers
001
21 May 2029 · NDA 208772 · BRIGATINIB
US 9,273,077, use patent
patent.txt lines 9,317, 9,321, 9,325
Flags
use code U-2837
Product numbers
001, 002, 003
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
28 May 2029 · NDA 215239 · VAMOROLONE
US 10,857,161, product and use patent
patent.txt line 16,590
Flags
product use code U-3747
Product numbers
001
28 May 2029 · NDA 215239 · VAMOROLONE
US 11,833,159, product patent
patent.txt line 16,594
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
2 Jun 2029 · NDA 214965 · CYCLOSPORINE
US 9,132,071, product patent
patent.txt line 16,400
Flags
product
Product numbers
001
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 213972 · PROBENECID; SULOPENEM ETZADROXIL
US 7,795,243, substance and product and use patent
patent.txt line 15,351
Flags
substance product use code U-4026
Product numbers
001
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 022426 · ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
US 8,637,079, product patent
patent.txt lines 1,881, 1,883, 1,885, 1,887, 1,889, 1,891
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
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
18 Jun 2029 · NDA 218171 · ENSARTINIB HYDROCHLORIDE
US 9,296,724, substance and use patent
patent.txt lines 20,867, 20,871
Flags
substance use code U-4099
Product numbers
001, 002
20 Jun 2029 · NDA 202429 · VEMURAFENIB
US 7,863,288, substance and product patent
patent.txt line 3,088
Flags
substance product
Product numbers
001
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
26 Jun 2029 · NDA 214927 · ARIMOCLOMOL CITRATE
US 9,884,058, use patent
patent.txt lines 16,340, 16,344, 16,348, 16,352
Flags
use code U-4021
Product numbers
001, 002, 003, 004
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
30 Jun 2029 · NDA 022437 · TRIPTORELIN PAMOATE
US 10,166,181, product patent
patent.txt line 1,909
Flags
product
Product numbers
001
30 Jun 2029 · NDA 208956 · TRIPTORELIN PAMOATE
US 10,166,181, product patent
patent.txt line 9,650
Flags
product
Product numbers
001

Pediatric exclusivity, as listed (36)

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
13 May 2029 · NDA 205109 · FERRIC OXYHYDROXIDE
US 10,682,376 with pediatric exclusivity, as listed
patent.txt line 5,217
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
13 May 2029 · NDA 205109 · FERRIC OXYHYDROXIDE
US 10,695,367 with pediatric exclusivity, as listed
patent.txt line 5,219
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
13 May 2029 · NDA 205109 · FERRIC OXYHYDROXIDE
US 10,925,896 with pediatric exclusivity, as listed
patent.txt line 5,221
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
13 May 2029 · NDA 205109 · FERRIC OXYHYDROXIDE
US 10,925,897 with pediatric exclusivity, as listed
patent.txt line 5,223
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
13 May 2029 · NDA 205109 · FERRIC OXYHYDROXIDE
US 10,933,090 with pediatric exclusivity, as listed
patent.txt line 5,225
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
13 May 2029 · NDA 205109 · FERRIC OXYHYDROXIDE
US 11,013,761 with pediatric exclusivity, as listed
patent.txt line 5,227
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
13 May 2029 · NDA 205109 · FERRIC OXYHYDROXIDE
US 11,013,762 with pediatric exclusivity, as listed
patent.txt line 5,229
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
4 Jun 2029 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 10,076,513 with pediatric exclusivity, as listed
patent.txt line 6,079
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
4 Jun 2029 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 10,597,384 with pediatric exclusivity, as listed
patent.txt lines 6,081, 6,129
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Jun 2029 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 11,052,075 with pediatric exclusivity, as listed
patent.txt lines 6,085, 6,133
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Jun 2029 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 12,065,432 with pediatric exclusivity, as listed
patent.txt lines 6,089, 6,137
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Jun 2029 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,653,103 with pediatric exclusivity, as listed
patent.txt lines 6,104, 6,151
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Jun 2029 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 9,150,552 with pediatric exclusivity, as listed
patent.txt lines 6,119, 6,163
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Jun 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 10,597,384 with pediatric exclusivity, as listed
patent.txt lines 12,715, 12,757, 12,799
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
4 Jun 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 12,065,432 with pediatric exclusivity, as listed
patent.txt lines 12,721, 12,763, 12,805
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
4 Jun 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,653,103 with pediatric exclusivity, as listed
patent.txt lines 12,735, 12,777, 12,819
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
4 Jun 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,150,552 with pediatric exclusivity, as listed
patent.txt lines 12,747, 12,789, 12,831
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
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

Non-patent exclusivity (81)

5 Jan 2029 · NDA 217424 · BERDAZIMER SODIUM
NCE exclusivity
exclusivity.txt line 1,877
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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
27 Jan 2029 · NDA 214770 · POSACONAZOLE
I-984 exclusivity
exclusivity.txt line 1,388
Definition
New indication (to be checked against FDA's list)
Product numbers
001
28 Jan 2029 · NDA 220142 · BRIMONIDINE TARTRATE; CARBACHOL
NP exclusivity
exclusivity.txt line 2,376
Definition
New product (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
13 Feb 2029 · NDA 217202 · LANDIOLOL HYDROCHLORIDE
NPP exclusivity
exclusivity.txt line 1,861
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
20 Feb 2029 · NDA 216986 · GADOPICLENOL
NPP exclusivity
exclusivity.txt lines 1,814, 1,816, 1,818, 1,820, 1,822, 1,824, 1,826
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006, 007
22 Feb 2029 · NDA 216165 · CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
NCE exclusivity
exclusivity.txt line 1,735
Definition
New chemical entity (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
25 Feb 2029 · NDA 203858 · LOMITAPIDE MESYLATE
NPP exclusivity
exclusivity.txt lines 342–346
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
25 Feb 2029 · NDA 203858 · LOMITAPIDE MESYLATE
NS exclusivity
exclusivity.txt line 347
Definition
New strength (to be checked against FDA's list)
Product numbers
007
28 Feb 2029 · NDA 208712 · PACRITINIB CITRATE
ODE-397 exclusivity
exclusivity.txt line 753
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
6 Mar 2029 · NDA 214958 · DEUCRAVACITINIB
I-986 exclusivity
exclusivity.txt line 1,436
Definition
New indication (to be checked against FDA's list)
Product numbers
001
14 Mar 2029 · NDA 217785 · RESMETIROM
NCE exclusivity
exclusivity.txt lines 1,939–1,941
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
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 213793 · SETMELANOTIDE ACETATE
I-987 exclusivity
exclusivity.txt line 1,264
Definition
New indication (to be checked against FDA's list)
Product numbers
001
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
21 Mar 2029 · NDA 217865 · GIVINOSTAT HYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 2,021
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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 213478 · SIROLIMUS
ODE-391 exclusivity
exclusivity.txt line 1,226
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
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
22 Mar 2029 · NDA 217686 · APROCITENTAN
NCE exclusivity
exclusivity.txt line 1,917
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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 206976 · DICLOFENAC EPOLAMINE
NPP exclusivity
exclusivity.txt line 572
Definition
New patient population (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
27 Mar 2029 · NDA 215192 · VADADUSTAT
NCE exclusivity
exclusivity.txt lines 1,488–1,490
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
29 Mar 2029 · NDA 218037 · DANICOPAN
NCE exclusivity
exclusivity.txt lines 2,034, 2,036
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
3 Apr 2029 · NDA 218275 · CEFTOBIPROLE MEDOCARIL SODIUM
NCE exclusivity
exclusivity.txt line 2,136
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
5 Apr 2029 · NDA 215039 · ALPELISIB
ODE-396 exclusivity
exclusivity.txt lines 1,465–1,467
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
13 Apr 2029 · NDA 216403 · SPARSENTAN
I-989 exclusivity
exclusivity.txt lines 1,753, 1,757
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
17 Apr 2029 · NDA 214511 · PEGULICIANINE ACETATE
NCE exclusivity
exclusivity.txt line 1,337
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
23 Apr 2029 · NDA 217700 · TOVORAFENIB
NCE exclusivity
exclusivity.txt line 1,918
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
23 Apr 2029 · NDA 218033 · TOVORAFENIB
NCE exclusivity
exclusivity.txt line 2,032
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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
26 Apr 2029 · NDA 218709 · MAVORIXAFOR
NCE exclusivity
exclusivity.txt line 2,176
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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
27 Apr 2029 · NDA 212122 · BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
NS exclusivity
exclusivity.txt line 1,025
Definition
New strength (to be checked against FDA's list)
Product numbers
002
27 Apr 2029 · NDA 216579 · BUDESONIDE; FORMOTEROL FUMARATE
I-988 exclusivity
exclusivity.txt line 1,770
Definition
New indication (to be checked against FDA's list)
Product numbers
001
27 Apr 2029 · NDA 216579 · BUDESONIDE; FORMOTEROL FUMARATE
NS exclusivity
exclusivity.txt line 1,771
Definition
New strength (to be checked against FDA's list)
Product numbers
002
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 206829 · CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
NPP exclusivity
exclusivity.txt line 562
Definition
New patient population (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
13 May 2029 · NDA 209816 · OMADACYCLINE TOSYLATE
M-320 exclusivity
exclusivity.txt line 804
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
13 May 2029 · NDA 209817 · OMADACYCLINE TOSYLATE
M-320 exclusivity
exclusivity.txt line 807
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
13 May 2029 · NDA 212576 · CEDAZURIDINE; DECITABINE
I-990 exclusivity
exclusivity.txt line 1,085
Definition
New indication (to be checked against FDA's list)
Product numbers
001
14 May 2029 · NDA 219622 · BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
NP exclusivity
exclusivity.txt lines 2,303–2,304
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002
20 May 2029 · NDA 050794 · AZACITIDINE
ODE-399 exclusivity
exclusivity.txt line 211
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
1 Jun 2029 · NDA 215904 · GANAXOLONE
ODE-395 exclusivity
exclusivity.txt line 1,673
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
10 Jun 2029 · NDA 218860 · ELAFIBRANOR
NCE exclusivity
exclusivity.txt line 2,210
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
11 Jun 2029 · NDA 219776 · BEROTRALSTAT DIHYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 2,324, 2,326, 2,328, 2,330
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
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
12 Jun 2029 · NDA 218197 · CAPIVASERTIB
I-991 exclusivity
exclusivity.txt lines 2,121, 2,123
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002
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
16 Jun 2029 · NDA 213793 · SETMELANOTIDE ACETATE
ODE-402 exclusivity
exclusivity.txt line 1,267
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
18 Jun 2029 · NDA 214231 · DASIGLUCAGON HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 1,317, 1,319
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
20 Jun 2029 · NDA 217347 · SOFPIRONIUM BROMIDE
NCE exclusivity
exclusivity.txt line 1,865
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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
24 Jun 2029 · NDA 218614 · OLEZARSEN SODIUM
I-992 exclusivity
exclusivity.txt line 2,172
Definition
New indication (to be checked against FDA's list)
Product numbers
001
24 Jun 2029 · NDA 218614 · OLEZARSEN SODIUM
NS exclusivity
exclusivity.txt line 2,174
Definition
New strength (to be checked against FDA's list)
Product numbers
002
26 Jun 2029 · NDA 217389 · ENSIFENTRINE
NCE exclusivity
exclusivity.txt line 1,872
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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