Drybench Patent.

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

Each patent and exclusivity date from July to December 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 January to June 2029

Listed patent expiry (374)

2 Jul 2029 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,846,718, use patent
patent.txt line 6,115
Flags
use code U-1717
Product numbers
001
2 Jul 2029 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,846,718, use patent
patent.txt lines 6,116, 6,160
Flags
use code U-1908
Product numbers
001, 002
2 Jul 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,846,718, use patent
patent.txt lines 12,744, 12,786
Flags
use code U-2375
Product numbers
001, 002
2 Jul 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,846,718, use patent
patent.txt line 12,828
Flags
use code U-3427
Product numbers
003
6 Jul 2029 · NDA 207202 · ARIPIPRAZOLE
US 8,956,288, product and use patent
patent.txt lines 7,077, 7,104, 7,131, 7,158, 7,185, 7,212
Flags
product use code U-2167
Product numbers
001, 002, 003, 004, 005, 006
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
8 Jul 2029 · NDA 202317 · MECHLORETHAMINE HYDROCHLORIDE
US 7,872,050, use patent
patent.txt line 3,042
Flags
use code U-1427
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
13 Jul 2029 · NDA 212950 · FOSTEMSAVIR TROMETHAMINE
US 8,168,615, product patent
patent.txt line 14,514
Flags
product
Product numbers
001
14 Jul 2029 · NDA 212489 · OPICAPONE
US 8,524,746, use patent
patent.txt lines 14,089, 14,100
Flags
use code U-3869
Product numbers
001, 002
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
22 Jul 2029 · NDA 216956 · ETRASIMOD ARGININE
US 9,126,932, use patent
patent.txt line 19,082
Flags
use code U-3732
Product numbers
001
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
24 Jul 2029 · NDA 205266 · SONIDEGIB PHOSPHATE
US 8,178,563, substance and use patent
patent.txt line 5,280
Flags
substance use code U-1722
Product numbers
001
24 Jul 2029 · NDA 206843 · DACLATASVIR DIHYDROCHLORIDE
US 8,329,159, substance patent
patent.txt lines 6,824, 6,832
Flags
substance
Product numbers
001, 002
24 Jul 2029 · NDA 208261 · ELBASVIR; GRAZOPREVIR
US 7,973,040, substance and product and use patent
patent.txt line 8,424
Flags
substance product use code U-1813
Product numbers
001
26 Jul 2029 · NDA 207202 · ARIPIPRAZOLE
US 10,441,194, product patent
patent.txt lines 7,062, 7,089, 7,116, 7,143, 7,170, 7,197
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
26 Jul 2029 · NDA 213969 · LONAFARNIB
US 7,838,531, use patent
patent.txt lines 15,345–15,346
Flags
use code U-3070
Product numbers
001, 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 211651 · TALAZOPARIB TOSYLATE
US 10,780,088, use patent
patent.txt lines 12,933, 12,944, 12,955, 12,961
Flags
use code U-3651
Product numbers
001, 003, 005, 006
27 Jul 2029 · NDA 211651 · TALAZOPARIB TOSYLATE
US 8,420,650, substance and product patent
patent.txt lines 12,935, 12,940, 12,946, 12,951, 12,957, 12,963
Flags
substance product
Product numbers
001, 002, 003, 004, 005, 006
27 Jul 2029 · NDA 211651 · TALAZOPARIB TOSYLATE
US 9,820,985, use patent
patent.txt lines 12,937, 12,942, 12,948, 12,953, 12,959, 12,965
Flags
use code U-2437
Product numbers
001, 002, 003, 004, 005, 006
27 Jul 2029 · NDA 217439 · TALAZOPARIB TOSYLATE
US 10,780,088, use patent
patent.txt lines 19,946, 19,952, 19,958, 19,964, 19,970, 19,976
Flags
use code U-3651
Product numbers
001, 002, 003, 004, 005, 006
27 Jul 2029 · NDA 217439 · TALAZOPARIB TOSYLATE
US 8,420,650, substance and product patent
patent.txt lines 19,948, 19,954, 19,960, 19,966, 19,972, 19,978
Flags
substance product
Product numbers
001, 002, 003, 004, 005, 006
27 Jul 2029 · NDA 217439 · TALAZOPARIB TOSYLATE
US 9,820,985, use patent
patent.txt lines 19,950, 19,956, 19,962, 19,968, 19,974, 19,980
Flags
use code U-2437
Product numbers
001, 002, 003, 004, 005, 006
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
30 Jul 2029 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 10,076,615, use patent
patent.txt line 6,271
Flags
use code U-2010
Product numbers
001
30 Jul 2029 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 10,076,615, use patent
patent.txt line 6,272
Flags
use code U-2011
Product numbers
001
30 Jul 2029 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 10,076,615, use patent
patent.txt line 6,273
Flags
use code U-2404
Product numbers
001
31 Jul 2029 · NDA 207975 · HYDROCODONE BITARTRATE
US 8,445,018, product patent
patent.txt lines 7,874, 7,877, 7,880, 7,883, 7,886
Flags
product
Product numbers
001, 002, 003, 004, 005
31 Jul 2029 · NDA 214793 · PIFLUFOLASTAT F-18
US 12,070,513, substance and product and use patent
patent.txt line 16,194
Flags
substance product use code U-3130
Product numbers
001
31 Jul 2029 · NDA 214793 · PIFLUFOLASTAT F-18
US 9,861,713, substance and product and use patent
patent.txt line 16,197
Flags
substance product use code U-3130
Product numbers
001
31 Jul 2029 · NDA 220089 · PIFLUFOLASTAT F-18
US 12,070,513, substance and product and use patent
patent.txt line 22,093
Flags
substance product use code U-3317
Product numbers
001
31 Jul 2029 · NDA 220089 · PIFLUFOLASTAT F-18
US 9,861,713, substance and product and use patent
patent.txt line 22,096
Flags
substance product use code U-3317
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
2 Aug 2029 · NDA 211488 · LEUPROLIDE MESYLATE
US 9,572,857, product patent
patent.txt line 12,877
Flags
product
Product numbers
001
2 Aug 2029 · NDA 219745 · LEUPROLIDE MESYLATE
US 9,572,857, product patent
patent.txt line 21,877
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
7 Aug 2029 · NDA 210875 · APOMORPHINE HYDROCHLORIDE
US 10,821,074, product patent
patent.txt lines 12,316, 12,328, 12,340, 12,352, 12,364
Flags
product
Product numbers
001, 002, 003, 004, 005
7 Aug 2029 · NDA 211109 · ERAVACYCLINE DIHYDROCHLORIDE
US 8,796,245, use patent
patent.txt lines 12,474, 12,478
Flags
use code U-2380
Product numbers
001, 002
9 Aug 2029 · NDA 210872 · ISOPROPYL ALCOHOL
US 8,389,583, use patent
patent.txt line 12,270
Flags
use code U-1397
Product numbers
001
11 Aug 2029 · NDA 214927 · ARIMOCLOMOL CITRATE
US 9,289,472, use patent
patent.txt lines 16,339, 16,343, 16,347, 16,351
Flags
use code U-4021
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 202860 · NITRIC OXIDE
US 10,926,054, product patent
patent.txt line 3,410
Flags
product
Product numbers
001
13 Aug 2029 · NDA 202860 · NITRIC OXIDE
US 8,944,049, product patent
patent.txt line 3,419
Flags
product
Product numbers
001
13 Aug 2029 · NDA 202860 · NITRIC OXIDE
US 9,604,028, use patent
patent.txt line 3,420
Flags
use code U-2793
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 206038 · IVACAFTOR; LUMACAFTOR
US 10,646,481, product patent
patent.txt lines 6,084, 6,132
Flags
product
Product numbers
001, 002
13 Aug 2029 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 11,564,916, use patent
patent.txt lines 6,088, 6,136
Flags
use code U-3529
Product numbers
001, 002
13 Aug 2029 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 12,458,635, product and use patent
patent.txt lines 6,092, 6,140
Flags
product use code U-4338
Product numbers
001, 002
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
13 Aug 2029 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 10,646,481, product patent
patent.txt lines 11,424, 11,457
Flags
product
Product numbers
001, 002
13 Aug 2029 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 11,564,916, use patent
patent.txt lines 11,425, 11,458
Flags
use code U-3527
Product numbers
001, 002
13 Aug 2029 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 12,458,635, product and use patent
patent.txt lines 11,429, 11,461
Flags
product use code U-4336
Product numbers
001, 002
13 Aug 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 10,646,481, product patent
patent.txt lines 12,718, 12,760, 12,802
Flags
product
Product numbers
001, 002, 003
13 Aug 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 11,564,916, use patent
patent.txt lines 12,720, 12,762, 12,804
Flags
use code U-3526
Product numbers
001, 002, 003
13 Aug 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 12,458,635, product and use patent
patent.txt lines 12,724, 12,766, 12,808
Flags
product use code U-4335
Product numbers
001, 002, 003
13 Aug 2029 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,646,481, product patent
patent.txt lines 13,664, 13,738
Flags
product
Product numbers
001, 002
13 Aug 2029 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,564,916, use patent
patent.txt lines 13,683, 13,755
Flags
use code U-3525
Product numbers
001, 002
13 Aug 2029 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,564,916, use patent
patent.txt lines 13,684, 13,756
Flags
use code U-4063
Product numbers
001, 002
13 Aug 2029 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,564,916, use patent
patent.txt lines 13,685, 13,757
Flags
use code U-4491
Product numbers
001, 002
13 Aug 2029 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 12,458,635, product and use patent
patent.txt lines 13,694, 13,766
Flags
product use code U-4330
Product numbers
001, 002
13 Aug 2029 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 12,458,635, product and use patent
patent.txt lines 13,695, 13,767
Flags
product use code U-4486
Product numbers
001, 002
13 Aug 2029 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 10,646,481, product patent
patent.txt lines 20,072, 20,145
Flags
product
Product numbers
001, 002
13 Aug 2029 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,564,916, use patent
patent.txt lines 20,092, 20,165
Flags
use code U-3585
Product numbers
001, 002
13 Aug 2029 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,564,916, use patent
patent.txt lines 20,093, 20,166
Flags
use code U-4055
Product numbers
001, 002
13 Aug 2029 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 11,564,916, use patent
patent.txt lines 20,094, 20,167
Flags
use code U-4485
Product numbers
001, 002
13 Aug 2029 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 12,458,635, product and use patent
patent.txt lines 20,106, 20,181
Flags
product use code U-4333
Product numbers
001, 002
13 Aug 2029 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 12,458,635, product and use patent
patent.txt lines 20,107, 20,182
Flags
product use code U-4493
Product numbers
001, 002
13 Aug 2029 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 10,646,481, product patent
patent.txt lines 21,190, 21,236
Flags
product
Product numbers
001, 002
13 Aug 2029 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 11,564,916, use patent
patent.txt lines 21,192, 21,238
Flags
use code U-4095
Product numbers
001, 002
13 Aug 2029 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 11,564,916, use patent
patent.txt lines 21,193, 21,239
Flags
use code U-4466
Product numbers
001, 002
14 Aug 2029 · NDA 208171 · FERRIC DERISOMALTOSE
US 8,815,301, substance and product and use patent
patent.txt lines 8,285, 8,290, 8,295
Flags
substance product use code U-2734
Product numbers
001, 002, 003
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
15 Aug 2029 · NDA 216993 · QUIZARTINIB DIHYDROCHLORIDE
US 7,968,543, product and use patent
patent.txt lines 19,126, 19,137
Flags
product use code U-3661
Product numbers
001, 002
15 Aug 2029 · NDA 216993 · QUIZARTINIB DIHYDROCHLORIDE
US 8,865,710, product patent
patent.txt lines 19,131, 19,142
Flags
product
Product numbers
001, 002
17 Aug 2029 · NDA 207988 · LESINURAD
US 8,084,483, use patent
patent.txt line 7,922
Flags
use code U-1801
Product numbers
001
17 Aug 2029 · NDA 209203 · ALLOPURINOL; LESINURAD
US 8,084,483, use patent
patent.txt lines 9,860, 9,868
Flags
use code U-2104
Product numbers
001, 002
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
19 Aug 2029 · NDA 207202 · ARIPIPRAZOLE
US 8,945,005, product and use patent
patent.txt lines 7,076, 7,103, 7,130, 7,157, 7,184, 7,211
Flags
product use code U-2167
Product numbers
001, 002, 003, 004, 005, 006
19 Aug 2029 · NDA 214927 · ARIMOCLOMOL CITRATE
US 11,045,460, use patent
patent.txt lines 16,337, 16,341, 16,345, 16,349
Flags
use code U-4021
Product numbers
001, 002, 003, 004
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
21 Aug 2029 · NDA 219616 · AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
US 7,928,109, substance and product patent
patent.txt line 21,800
Flags
substance product
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
25 Aug 2029 · NDA 214622 · INFIGRATINIB PHOSPHATE
US 8,552,002, substance and product patent
patent.txt lines 15,894, 15,898
Flags
substance product
Product numbers
001, 002
29 Aug 2029 · NDA 206334 · ORITAVANCIN DIPHOSPHATE
US 12,514,899, use patent
patent.txt line 6,490
Flags
use code U-4398
Product numbers
001
29 Aug 2029 · NDA 206334 · ORITAVANCIN DIPHOSPHATE
US 8,420,592, use patent
patent.txt line 6,491
Flags
use code U-1570
Product numbers
001
29 Aug 2029 · NDA 214155 · ORITAVANCIN DIPHOSPHATE
US 12,514,899, use patent
patent.txt line 15,572
Flags
use code U-4398
Product numbers
001
29 Aug 2029 · NDA 214155 · ORITAVANCIN DIPHOSPHATE
US 8,420,592, use patent
patent.txt line 15,573
Flags
use code U-3101
Product numbers
001
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
5 Sep 2029 · NDA 205123 · SIMEPREVIR SODIUM
US 8,148,399, substance and product and use patent
patent.txt line 5,262
Flags
substance product use code U-1467
Product numbers
001
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
10 Sep 2029 · NDA 206619 · DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
US 8,642,538, substance and product and use patent
patent.txt line 6,606
Flags
substance product use code U-1638
Product numbers
001
10 Sep 2029 · NDA 207931 · OMBITASVIR; PARITAPREVIR; RITONAVIR
US 8,642,538, substance and product and use patent
patent.txt line 7,650
Flags
substance product use code U-1638
Product numbers
001
10 Sep 2029 · NDA 208624 · DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
US 8,642,538, substance and product and use patent
patent.txt line 9,002
Flags
substance product use code U-1638
Product numbers
001
10 Sep 2029 · NDA 212526 · ALPELISIB
US 8,476,268, substance and product patent
patent.txt lines 14,148, 14,150, 14,152
Flags
substance product
Product numbers
001, 002, 003
10 Sep 2029 · NDA 215039 · ALPELISIB
US 8,476,268, substance and product patent
patent.txt lines 16,448, 16,452, 16,456
Flags
substance product
Product numbers
001, 002, 003
10 Sep 2029 · NDA 218466 · ALPELISIB
US 8,476,268, substance and product patent
patent.txt line 21,091
Flags
substance product
Product numbers
001
12 Sep 2029 · NDA 206185 · LATANOPROST
US 9,629,852, product patent
patent.txt line 6,430
Flags
product
Product numbers
001
14 Sep 2029 · NDA 021225 · LEVONORGESTREL
US 11,850,182, product and use patent
patent.txt line 505
Flags
product use code U-3819
Product numbers
001
14 Sep 2029 · NDA 203159 · LEVONORGESTREL
US 11,850,182, product and use patent
patent.txt line 3,648
Flags
product use code U-3819
Product numbers
001
14 Sep 2029 · NDA 208224 · LEVONORGESTREL
US 11,850,182, product and use patent
patent.txt line 8,356
Flags
product use code U-3819
Product numbers
001
15 Sep 2029 · NDA 205266 · SONIDEGIB PHOSPHATE
US 8,063,043, substance and product patent
patent.txt line 5,279
Flags
substance product
Product numbers
001
15 Sep 2029 · NDA 207202 · ARIPIPRAZOLE
US 9,433,371, product patent
patent.txt lines 7,086, 7,113, 7,140, 7,167, 7,194, 7,221
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
16 Sep 2029 · NDA 021225 · LEVONORGESTREL
US 10,561,524, use patent
patent.txt line 504
Flags
use code U-2948
Product numbers
001
16 Sep 2029 · NDA 203159 · LEVONORGESTREL
US 10,561,524, use patent
patent.txt line 3,646
Flags
use code U-2948
Product numbers
001
16 Sep 2029 · NDA 208224 · LEVONORGESTREL
US 10,561,524, use patent
patent.txt line 8,354
Flags
use code U-2948
Product numbers
001
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
21 Sep 2029 · NDA 202860 · NITRIC OXIDE
US 11,511,252, product patent
patent.txt line 3,412
Flags
product
Product numbers
001
21 Sep 2029 · NDA 217686 · APROCITENTAN
US 8,324,232, substance and product and use patent
patent.txt line 20,333
Flags
substance product use code U-3878
Product numbers
001
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
23 Sep 2029 · NDA 208610 · DELAFLOXACIN MEGLUMINE
US 8,871,938, substance patent
patent.txt line 8,911
Flags
substance
Product numbers
001
23 Sep 2029 · NDA 208611 · DELAFLOXACIN MEGLUMINE
US 8,871,938, substance patent
patent.txt line 8,921
Flags
substance
Product numbers
001
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
29 Sep 2029 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 9,192,606, product and use patent
patent.txt lines 6,122, 6,166
Flags
product use code U-1912
Product numbers
001, 002
29 Sep 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,192,606, product and use patent
patent.txt lines 12,750, 12,792
Flags
product use code U-2397
Product numbers
001, 002
29 Sep 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,192,606, product and use patent
patent.txt line 12,834
Flags
product use code U-3428
Product numbers
003
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 022348 · IBUPROFEN
US 8,735,452, use patent
patent.txt lines 1,726, 1,734
Flags
use code U-981
Product numbers
002, 003
30 Sep 2029 · NDA 022348 · IBUPROFEN
US 8,871,810, use patent
patent.txt lines 1,727, 1,735
Flags
use code U-981
Product numbers
002, 003
30 Sep 2029 · NDA 022348 · IBUPROFEN
US 9,114,068, use patent
patent.txt line 1,729
Flags
use code U-1735
Product numbers
002
30 Sep 2029 · NDA 022348 · IBUPROFEN
US 9,138,404, use patent
patent.txt line 1,730
Flags
use code U-1756
Product numbers
002
30 Sep 2029 · NDA 022348 · IBUPROFEN
US 9,295,639, use patent
patent.txt line 1,731
Flags
use code U-1756
Product numbers
002
30 Sep 2029 · NDA 022348 · IBUPROFEN
US 9,649,284, use patent
patent.txt line 1,732
Flags
use code U-2018
Product numbers
002
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
8 Oct 2029 · NDA 202570 · CRIZOTINIB
US 7,858,643, substance and product patent
patent.txt lines 3,103, 3,108
Flags
substance product
Product numbers
001, 002
8 Oct 2029 · NDA 217581 · CRIZOTINIB
US 7,858,643, substance and product patent
patent.txt lines 20,013, 20,018, 20,023
Flags
substance product
Product numbers
001, 002, 003
9 Oct 2029 · NDA 206500 · ROLAPITANT HYDROCHLORIDE
US 8,361,500, product patent
patent.txt line 6,587
Flags
product
Product numbers
001
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
13 Oct 2029 · NDA 215092 · OMIDENEPAG ISOPROPYL
US 8,648,097, substance and product patent
patent.txt line 16,472
Flags
substance product
Product numbers
001
13 Oct 2029 · NDA 215092 · OMIDENEPAG ISOPROPYL
US 8,685,986, product patent
patent.txt line 16,473
Flags
product
Product numbers
001
13 Oct 2029 · NDA 219491 · ZOLIFLODACIN
US 9,040,528, use patent
patent.txt line 21,785
Flags
use code U-4369
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
20 Oct 2029 · NDA 210922 · PATISIRAN SODIUM
US 10,240,152, substance and product and use patent
patent.txt line 12,394
Flags
substance product use code U-2378
Product numbers
001
20 Oct 2029 · NDA 210922 · PATISIRAN SODIUM
US 8,741,866, use patent
patent.txt line 12,402
Flags
use code U-2378
Product numbers
001
20 Oct 2029 · NDA 210922 · PATISIRAN SODIUM
US 9,234,196, product and use patent
patent.txt line 12,405
Flags
product use code U-2378
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
21 Oct 2029 · NDA 211710 · LAROTRECTINIB SULFATE
US 10,005,783, use patent
patent.txt line 13,069
Flags
use code U-2472
Product numbers
001
21 Oct 2029 · NDA 211710 · LAROTRECTINIB SULFATE
US 10,047,097, use patent
patent.txt line 13,071
Flags
use code U-2474
Product numbers
001
21 Oct 2029 · NDA 211710 · LAROTRECTINIB SULFATE
US 10,774,085, use patent
patent.txt line 13,075
Flags
use code U-2470
Product numbers
001
21 Oct 2029 · NDA 211710 · LAROTRECTINIB SULFATE
US 8,865,698, use patent
patent.txt line 13,082
Flags
use code U-2469
Product numbers
001
21 Oct 2029 · NDA 211710 · LAROTRECTINIB SULFATE
US 9,127,013, substance and product patent
patent.txt line 13,083
Flags
substance product
Product numbers
001
21 Oct 2029 · NDA 211710 · LAROTRECTINIB SULFATE
US 9,447,104, use patent
patent.txt line 13,084
Flags
use code U-2470
Product numbers
001
21 Oct 2029 · NDA 211710 · LAROTRECTINIB SULFATE
US 9,676,783, use patent
patent.txt line 13,085
Flags
use code U-2469
Product numbers
001
22 Oct 2029 · NDA 022114 · LIDOCAINE HYDROCHLORIDE
US 8,540,665, use patent
patent.txt line 1,081
Flags
use code U-1438
Product numbers
001
22 Oct 2029 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 8,550,073, product patent
patent.txt line 6,281
Flags
product
Product numbers
001
22 Oct 2029 · NDA 209936 · COPANLISIB DIHYDROCHLORIDE
US RE46856, substance and product and use patent
patent.txt line 11,063
Flags
substance product use code U-2124
Product numbers
001
26 Oct 2029 · NDA 208030 · DEFERIPRONE
US 8,703,156, product and use patent
patent.txt lines 8,010–8,011
Flags
product use code U-3083
Product numbers
001, 002
30 Oct 2029 · NDA 214096 · TEPOTINIB HYDROCHLORIDE
US 8,329,692, substance and product patent
patent.txt line 15,527
Flags
substance product
Product numbers
001
2 Nov 2029 · NDA 201739 · EPINEPHRINE
US 8,021,344, product patent
patent.txt lines 2,562, 2,571, 2,580
Flags
product
Product numbers
001, 002, 003
2 Nov 2029 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 8,021,344, product patent
patent.txt line 5,879
Flags
product
Product numbers
001
2 Nov 2029 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 8,021,344, product patent
patent.txt line 10,903
Flags
product
Product numbers
001
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
6 Nov 2029 · NDA 202570 · CRIZOTINIB
US 8,217,057, substance and product patent
patent.txt lines 3,104, 3,109
Flags
substance product
Product numbers
001, 002
6 Nov 2029 · NDA 217581 · CRIZOTINIB
US 8,217,057, substance patent
patent.txt lines 20,014, 20,019, 20,024
Flags
substance
Product numbers
001, 002, 003
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
10 Nov 2029 · NDA 206192 · COBIMETINIB FUMARATE
US 7,803,839, substance and product patent
patent.txt line 6,441
Flags
substance product
Product numbers
001
13 Nov 2029 · NDA 022308 · BESIFLOXACIN HYDROCHLORIDE
US 8,937,062, use patent
patent.txt line 1,619
Flags
use code U-80
Product numbers
001
16 Nov 2029 · NDA 213498 · PONESIMOD
US RE43728, substance and product patent
patent.txt lines 15,073, 15,079
Flags
substance product
Product numbers
001, 010
19 Nov 2029 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
US 8,377,453, product and use patent
patent.txt line 4,222
Flags
product use code U-1499
Product numbers
001
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 021610 · OXYMORPHONE HYDROCHLORIDE
US 8,871,779, substance patent
patent.txt lines 640, 642, 644, 646, 648, 650, 652
Flags
substance
Product numbers
001, 002, 003, 004, 005, 006, 007
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
23 Nov 2029 · NDA 022524 · ONDANSETRON
US 8,580,830, product patent
patent.txt lines 2,036, 2,038
Flags
product
Product numbers
001, 002
26 Nov 2029 · NDA 218764 · NERANDOMILAST
US 8,754,073, substance and product and use patent
patent.txt lines 21,283, 21,290
Flags
substance product use code U-4298
Product numbers
001, 002
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
3 Dec 2029 · NDA 216718 · OMAVELOXOLONE
US 8,124,799, substance patent
patent.txt line 18,927
Flags
substance
Product numbers
001
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
5 Dec 2029 · NDA 207202 · ARIPIPRAZOLE
US 8,718,193, product patent
patent.txt lines 7,073, 7,100, 7,127, 7,154, 7,181, 7,208
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
7 Dec 2029 · NDA 209521 · SARECYCLINE HYDROCHLORIDE
US 8,513,223, use patent
patent.txt lines 10,590, 10,595, 10,600
Flags
use code U-2406
Product numbers
001, 002, 003
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
11 Dec 2029 · NDA 207986 · CIPROFLOXACIN
US 9,233,068, product patent
patent.txt line 7,919
Flags
product
Product numbers
001
12 Dec 2029 · NDA 212194 · GIVOSIRAN SODIUM
US 8,106,022, substance and product and use patent
patent.txt line 13,618
Flags
substance product use code U-2672
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 214103 · LUMASIRAN SODIUM
US 8,106,022, substance and product and use patent
patent.txt line 15,547
Flags
substance product use code U-2995
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
15 Dec 2029 · NDA 207202 · ARIPIPRAZOLE
US 9,149,577, product patent
patent.txt lines 7,082, 7,109, 7,136, 7,163, 7,190, 7,217
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
15 Dec 2029 · NDA 208945 · OZENOXACIN
US 9,399,014, use patent
patent.txt line 9,649
Flags
use code U-805
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
16 Dec 2029 · NDA 210874 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
US 7,919,598, substance patent
patent.txt lines 12,277, 12,287, 12,297, 12,307
Flags
substance
Product numbers
001, 002, 003, 004
17 Dec 2029 · NDA 022048 · TRIAMCINOLONE ACETONIDE
US 8,128,960, product patent
patent.txt line 973
Flags
product
Product numbers
001
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
21 Dec 2029 · NDA 022545 · ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
US 8,613,949, product patent
patent.txt lines 2,076–2,079
Flags
product
Product numbers
001, 002, 003, 004
22 Dec 2029 · NDA 207988 · LESINURAD
US 8,357,713, product and use patent
patent.txt line 7,925
Flags
product use code U-1801
Product numbers
001
22 Dec 2029 · NDA 207988 · LESINURAD
US 8,357,713, product and use patent
patent.txt line 7,926
Flags
product use code U-1802
Product numbers
001
22 Dec 2029 · NDA 207988 · LESINURAD
US 8,357,713, product and use patent
patent.txt line 7,927
Flags
product use code U-1803
Product numbers
001
22 Dec 2029 · NDA 209203 · ALLOPURINOL; LESINURAD
US 8,357,713, product and use patent
patent.txt lines 9,862, 9,870
Flags
product use code U-2104
Product numbers
001, 002
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
23 Dec 2029 · NDA 211710 · LAROTRECTINIB SULFATE
US 8,513,263, substance and product patent
patent.txt line 13,081
Flags
substance product
Product numbers
001
28 Dec 2029 · NDA 208610 · DELAFLOXACIN MEGLUMINE
US RE46617, substance patent
patent.txt line 8,912
Flags
substance
Product numbers
001
28 Dec 2029 · NDA 208611 · DELAFLOXACIN MEGLUMINE
US RE46617, substance patent
patent.txt line 8,925
Flags
substance
Product numbers
001
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
30 Dec 2029 · NDA 211801 · TENAPANOR HYDROCHLORIDE
US 12,016,856, substance and product patent
patent.txt line 13,183
Flags
substance product
Product numbers
001
30 Dec 2029 · NDA 211801 · TENAPANOR HYDROCHLORIDE
US 8,969,377, substance and product patent
patent.txt line 13,186
Flags
substance product
Product numbers
001
30 Dec 2029 · NDA 211801 · TENAPANOR HYDROCHLORIDE
US 9,408,840, use patent
patent.txt line 13,188
Flags
use code U-2626
Product numbers
001
30 Dec 2029 · NDA 213931 · TENAPANOR HYDROCHLORIDE
US 12,016,856, substance and product patent
patent.txt lines 15,307, 15,315, 15,323
Flags
substance product
Product numbers
001, 002, 003
30 Dec 2029 · NDA 213931 · TENAPANOR HYDROCHLORIDE
US 8,969,377, substance and product patent
patent.txt lines 15,310, 15,318, 15,326
Flags
substance product
Product numbers
001, 002, 003
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 (58)

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
11 Sep 2029 · NDA 203045 · RALTEGRAVIR POTASSIUM
US 7,754,731 with pediatric exclusivity, as listed
patent.txt lines 3,600, 3,602
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
11 Sep 2029 · NDA 205786 · RALTEGRAVIR POTASSIUM
US 7,754,731 with pediatric exclusivity, as listed
patent.txt line 5,869
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
11 Sep 2029 · NDA 206510 · LAMIVUDINE; RALTEGRAVIR POTASSIUM
US 7,754,731 with pediatric exclusivity, as listed
patent.txt line 6,590
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
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
26 Sep 2029 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 7,964,580 with pediatric exclusivity, as listed
patent.txt lines 5,912, 5,945
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,633,309 with pediatric exclusivity, as listed
patent.txt lines 5,924, 5,957
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,889,159 with pediatric exclusivity, as listed
patent.txt lines 5,932, 5,965
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 7,964,580 with pediatric exclusivity, as listed
patent.txt lines 8,487, 8,517
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,633,309 with pediatric exclusivity, as listed
patent.txt lines 8,497, 8,527
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,889,159 with pediatric exclusivity, as listed
patent.txt lines 8,501, 8,531
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 7,964,580 with pediatric exclusivity, as listed
patent.txt line 9,819
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
26 Sep 2029 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,633,309 with pediatric exclusivity, as listed
patent.txt line 9,834
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
26 Sep 2029 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,889,159 with pediatric exclusivity, as listed
patent.txt line 9,840
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
26 Sep 2029 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 7,964,580 with pediatric exclusivity, as listed
patent.txt lines 13,985, 14,016
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,633,309 with pediatric exclusivity, as listed
patent.txt lines 13,997, 14,028
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,889,159 with pediatric exclusivity, as listed
patent.txt lines 14,005, 14,036
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 212480 · SOFOSBUVIR
US 7,964,580 with pediatric exclusivity, as listed
patent.txt lines 14,053, 14,069
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 212480 · SOFOSBUVIR
US 8,633,309 with pediatric exclusivity, as listed
patent.txt lines 14,061, 14,077
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 212480 · SOFOSBUVIR
US 8,889,159 with pediatric exclusivity, as listed
patent.txt lines 14,063, 14,079
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 7,964,580 with pediatric exclusivity, as listed
patent.txt lines 15,580, 15,608
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,633,309 with pediatric exclusivity, as listed
patent.txt lines 15,590, 15,618
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Sep 2029 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,889,159 with pediatric exclusivity, as listed
patent.txt lines 15,594, 15,622
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 Oct 2029 · NDA 209401 · CYTARABINE; DAUNORUBICIN
US 8,092,828 with pediatric exclusivity, as listed
patent.txt line 10,337
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
18 Oct 2029 · NDA 218490 · MACITENTAN; TADALAFIL
US 8,268,847 with pediatric exclusivity, as listed
patent.txt lines 21,096, 21,102
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
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 (67)

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
7 Jul 2029 · NDA 211746 · MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE
NPP exclusivity
exclusivity.txt line 1,000
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
14 Jul 2029 · NDA 202570 · CRIZOTINIB
ODE-407 exclusivity
exclusivity.txt lines 277, 279
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
14 Jul 2029 · NDA 206709 · STIRIPENTOL
ODE-403 exclusivity
exclusivity.txt lines 560–561
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
14 Jul 2029 · NDA 207223 · STIRIPENTOL
ODE-403 exclusivity
exclusivity.txt lines 582–583
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
16 Jul 2029 · NDA 212819 · CILASTATIN SODIUM; IMIPENEM; RELEBACTAM
GAIN exclusivity
exclusivity.txt line 1,120
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
23 Jul 2029 · NDA 205598 · MACIMORELIN ACETATE
M-14 exclusivity
exclusivity.txt line 512
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
24 Jul 2029 · NDA 219962 · ACETAMINOPHEN; NAPROXEN SODIUM
NP exclusivity
exclusivity.txt line 2,365
Definition
New product (to be checked against FDA's list)
Product numbers
001
25 Jul 2029 · NDA 217900 · DEURUXOLITINIB PHOSPHATE
NCE exclusivity
exclusivity.txt line 2,025
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
28 Jul 2029 · NDA 219990 · ETHINYL ESTRADIOL; NORELGESTROMIN
NP exclusivity
exclusivity.txt line 2,367
Definition
New product (to be checked against FDA's list)
Product numbers
001
31 Jul 2029 · NDA 215833 · LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
I-996 exclusivity
exclusivity.txt line 1,611
Definition
New indication (to be checked against FDA's list)
Product numbers
001
6 Aug 2029 · NDA 218784 · VORASIDENIB
NCE exclusivity
exclusivity.txt lines 2,191, 2,193
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
9 Aug 2029 · NDA 216490 · PALOPEGTERIPARATIDE
NCE exclusivity
exclusivity.txt lines 1,761, 1,763, 1,765
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
14 Aug 2029 · NDA 212862 · PRETOMANID
GAIN exclusivity
exclusivity.txt line 1,123
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
14 Aug 2029 · NDA 217899 · SELADELPAR LYSINE
NCE exclusivity
exclusivity.txt line 2,023
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
19 Aug 2029 · NDA 211672 · LEFAMULIN ACETATE
GAIN exclusivity
exclusivity.txt line 979
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
19 Aug 2029 · NDA 211673 · LEFAMULIN ACETATE
GAIN exclusivity
exclusivity.txt line 981
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
19 Aug 2029 · NDA 219008 · LAZERTINIB MESYLATE
NCE exclusivity
exclusivity.txt lines 2,225–2,226
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
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
24 Aug 2029 · NDA 217003 · IBRUTINIB
ODE-405 exclusivity
exclusivity.txt line 1,832
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
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
27 Aug 2029 · NDA 215974 · LENACAPAVIR SODIUM
I-999 exclusivity
exclusivity.txt line 1,680
Definition
New indication (to be checked against FDA's list)
Product numbers
001
27 Aug 2029 · NDA 221104 · BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM
NP exclusivity
exclusivity.txt line 2,419
Definition
New product (to be checked against FDA's list)
Product numbers
001
27 Aug 2029 · NDA 221443 · BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM
NP exclusivity
exclusivity.txt line 2,421
Definition
New product (to be checked against FDA's list)
Product numbers
001
2 Sep 2029 · NDA 211358 · IVACAFTOR; LUMACAFTOR
ODE-408 exclusivity
exclusivity.txt lines 953, 957, 961
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
11 Sep 2029 · NDA 217759 · LENIOLISIB PHOSPHATE
NPP exclusivity
exclusivity.txt line 1,929
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
11 Sep 2029 · NDA 217759 · LENIOLISIB PHOSPHATE
NS exclusivity
exclusivity.txt lines 1,932, 1,935
Definition
New strength (to be checked against FDA's list)
Product numbers
002, 003
14 Sep 2029 · NDA 022231 · TERLIPRESSIN ACETATE
ODE-406 exclusivity
exclusivity.txt line 175
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
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
20 Sep 2029 · NDA 214927 · ARIMOCLOMOL CITRATE
NCE exclusivity
exclusivity.txt lines 1,416, 1,418, 1,420, 1,422
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
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
21 Sep 2029 · NDA 218160 · SELPERCATINIB
ODE* exclusivity
exclusivity.txt lines 2,047–2,048, 2,067–2,068, 2,087–2,088, 2,107–2,108
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
24 Sep 2029 · NDA 219132 · LEVACETYLLEUCINE
NCE exclusivity
exclusivity.txt line 2,253
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
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
26 Sep 2029 · NDA 216158 · TROSPIUM CHLORIDE; XANOMELINE TARTRATE
NCE exclusivity
exclusivity.txt lines 1,731–1,733
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
27 Sep 2029 · NDA 215168 · FLURPIRIDAZ F-18
NCE exclusivity
exclusivity.txt line 1,487
Definition
New chemical entity (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
29 Sep 2029 · NDA 216660 · SODIUM PHENYLBUTYRATE; TAURURSODIOL
ODE-411 exclusivity
exclusivity.txt line 1,776
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
30 Sep 2029 · NDA 214801 · FUTIBATINIB
ODE-410 exclusivity
exclusivity.txt line 1,405
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
30 Sep 2029 · NDA 214801 · FUTIBATINIB
ODE* exclusivity
exclusivity.txt line 1,407
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
002
6 Oct 2029 · NDA 214103 · LUMASIRAN SODIUM
ODE-415 exclusivity
exclusivity.txt line 1,305
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
10 Oct 2029 · NDA 219249 · INAVOLISIB
NCE exclusivity
exclusivity.txt lines 2,264–2,265
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
25 Oct 2029 · NDA 213972 · PROBENECID; SULOPENEM ETZADROXIL
NCE exclusivity
exclusivity.txt line 1,282
Definition
New chemical entity (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
28 Oct 2029 · NDA 206192 · COBIMETINIB FUMARATE
ODE-416 exclusivity
exclusivity.txt line 553
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
12 Nov 2029 · NDA 206829 · CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
PED exclusivity
exclusivity.txt line 563
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
14 Nov 2029 · NDA 209445 · CEFIDEROCOL SULFATE TOSYLATE
GAIN exclusivity
exclusivity.txt line 784
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
15 Nov 2029 · NDA 218944 · REVUMENIB CITRATE
NCE exclusivity
exclusivity.txt lines 2,213, 2,217, 2,221
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
17 Nov 2029 · NDA 215910 · PHENOBARBITAL SODIUM
ODE-414 exclusivity
exclusivity.txt line 1,674
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
22 Nov 2029 · NDA 216540 · ACORAMIDIS HYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 1,767
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
22 Nov 2029 · NDA 217202 · LANDIOLOL HYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 1,860
Definition
New chemical entity (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
27 Nov 2029 · NDA 216016 · IOMEPROL
NCE exclusivity
exclusivity.txt lines 1,686–1,698
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013
27 Nov 2029 · NDA 216017 · IOMEPROL
NCE exclusivity
exclusivity.txt lines 1,699–1,711
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013
1 Dec 2029 · NDA 215814 · OLUTASIDENIB
ODE-413 exclusivity
exclusivity.txt line 1,608
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
7 Dec 2029 · NDA 215650 · CLINDAMYCIN PHOSPHATE
GAIN exclusivity
exclusivity.txt line 1,603
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
12 Dec 2029 · NDA 216340 · ADAGRASIB
ODE-352 exclusivity
exclusivity.txt line 1,749
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
13 Dec 2029 · NDA 218808 · CRINECERFONT
NCE exclusivity
exclusivity.txt lines 2,202, 2,204, 2,206
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
13 Dec 2029 · NDA 218820 · CRINECERFONT
NCE exclusivity
exclusivity.txt line 2,208
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
18 Dec 2029 · NDA 218171 · ENSARTINIB HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 2,119–2,120
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
20 Dec 2029 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
NCE exclusivity
exclusivity.txt lines 2,179, 2,182
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002