Drybench Patent.

Patent and exclusivity dates from July to December 2030 for NDAs, as FDA's Orange Book lists them

Each patent and exclusivity date from July to December 2030 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, 2030 January to June 2030

Listed patent expiry (366)

1 Jul 2030 · NDA 208653 · ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
US 8,748,413, substance and product patent
patent.txt lines 9,022, 9,027, 9,032
Flags
substance product
Product numbers
001, 002, 003
1 Jul 2030 · NDA 208653 · ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
US 8,828,978, product patent
patent.txt lines 9,023, 9,028, 9,033
Flags
product
Product numbers
001, 002, 003
1 Jul 2030 · NDA 208653 · ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
US 9,132,125, substance and product and use patent
patent.txt lines 9,024, 9,029, 9,034
Flags
substance product use code U-2249
Product numbers
001, 002, 003
1 Jul 2030 · NDA 208653 · ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
US 9,549,923, substance and product patent
patent.txt lines 9,025, 9,030, 9,035
Flags
substance product
Product numbers
001, 002, 003
2 Jul 2030 · NDA 206307 · FINAFLOXACIN
US 9,119,859, use patent
patent.txt line 6,460
Flags
use code U-1679
Product numbers
001
2 Jul 2030 · NDA 206307 · FINAFLOXACIN
US 9,993,483, product patent
patent.txt line 6,462
Flags
product
Product numbers
001
4 Jul 2030 · NDA 203752 · ESTRADIOL
US 8,231,906, substance and product patent
patent.txt lines 4,125, 4,128, 4,131, 4,134, 4,137
Flags
substance product
Product numbers
001, 002, 003, 004, 005
5 Jul 2030 · NDA 201292 · AFATINIB DIMALEATE
US 10,004,743, product patent
patent.txt lines 2,399, 2,409, 2,419
Flags
product
Product numbers
001, 002, 003
6 Jul 2030 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 11,576,894, product patent
patent.txt lines 4,506, 4,517, 4,528, 4,539
Flags
product
Product numbers
001, 002, 003, 004
7 Jul 2030 · NDA 201444 · SODIUM NITRITE; SODIUM THIOSULFATE
US 10,479,686, product and use patent
patent.txt line 2,430
Flags
product use code U-3390
Product numbers
001
7 Jul 2030 · NDA 201444 · SODIUM NITRITE; SODIUM THIOSULFATE
US 9,345,724, substance and product and use patent
patent.txt line 2,435
Flags
substance product use code U-2015
Product numbers
001
7 Jul 2030 · NDA 201444 · SODIUM NITRITE; SODIUM THIOSULFATE
US 9,585,912, substance and product patent
patent.txt line 2,436
Flags
substance product
Product numbers
001
7 Jul 2030 · NDA 203923 · SODIUM THIOSULFATE
US 10,479,686, product and use patent
patent.txt line 4,181
Flags
product use code U-3390
Product numbers
001
7 Jul 2030 · NDA 203923 · SODIUM THIOSULFATE
US 9,345,724, substance and product and use patent
patent.txt line 4,185
Flags
substance product use code U-2015
Product numbers
001
7 Jul 2030 · NDA 203923 · SODIUM THIOSULFATE
US 9,585,912, substance and product patent
patent.txt line 4,186
Flags
substance product
Product numbers
001
7 Jul 2030 · NDA 211280 · LASMIDITAN SUCCINATE
US 12,257,246, use patent
patent.txt lines 12,665, 12,669, 12,672
Flags
use code U-2718
Product numbers
001, 002, 003
8 Jul 2030 · NDA 203567 · EFINACONAZOLE
US 10,105,444, product patent
patent.txt line 4,087
Flags
product
Product numbers
001
8 Jul 2030 · NDA 203567 · EFINACONAZOLE
US 8,039,494, use patent
patent.txt line 4,098
Flags
use code U-281
Product numbers
001
8 Jul 2030 · NDA 203567 · EFINACONAZOLE
US 9,861,698, product patent
patent.txt line 4,103
Flags
product
Product numbers
001
13 Jul 2030 · NDA 022524 · ONDANSETRON
US 9,095,577, product patent
patent.txt lines 2,037, 2,039
Flags
product
Product numbers
001, 002
14 Jul 2030 · NDA 202860 · NITRIC OXIDE
US 8,607,785, product patent
patent.txt line 3,418
Flags
product
Product numbers
001
14 Jul 2030 · NDA 208144 · BRIMONIDINE TARTRATE
US 8,293,742, use patent
patent.txt line 8,271
Flags
use code U-2222
Product numbers
001
14 Jul 2030 · NDA 208144 · BRIMONIDINE TARTRATE
US 9,259,425, use patent
patent.txt line 8,272
Flags
use code U-2222
Product numbers
001
14 Jul 2030 · NDA 210598 · REVEFENACIN
US 10,550,081, substance patent
patent.txt line 12,037
Flags
substance
Product numbers
001
14 Jul 2030 · NDA 210598 · REVEFENACIN
US 11,008,289, use patent
patent.txt line 12,038
Flags
use code U-2440
Product numbers
001
14 Jul 2030 · NDA 210598 · REVEFENACIN
US 11,691,948, product patent
patent.txt line 12,040
Flags
product
Product numbers
001
14 Jul 2030 · NDA 210598 · REVEFENACIN
US 11,858,898, substance and product and use patent
patent.txt line 12,041
Flags
substance product use code U-2440
Product numbers
001
14 Jul 2030 · NDA 210598 · REVEFENACIN
US 9,765,028, substance patent
patent.txt line 12,046
Flags
substance
Product numbers
001
14 Jul 2030 · NDA 218424 · BRIMONIDINE TARTRATE
US 8,293,742, use patent
patent.txt line 21,083
Flags
use code U-2222
Product numbers
001
14 Jul 2030 · NDA 218424 · BRIMONIDINE TARTRATE
US 9,259,425, use patent
patent.txt line 21,084
Flags
use code U-2222
Product numbers
001
17 Jul 2030 · NDA 022532 · DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US 11,617,751, product and use patent
patent.txt line 2,052
Flags
product use code U-1
Product numbers
001
17 Jul 2030 · NDA 022532 · DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US 11,617,751, product and use patent
patent.txt line 2,053
Flags
product use code U-3572
Product numbers
001
17 Jul 2030 · NDA 022532 · DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US 11,617,751, product and use patent
patent.txt line 2,054
Flags
product use code U-3573
Product numbers
001
17 Jul 2030 · NDA 022532 · DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US 11,617,751, product and use patent
patent.txt line 2,055
Flags
product use code U-3574
Product numbers
001
17 Jul 2030 · NDA 022574 · DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US 11,617,751, product and use patent
patent.txt line 2,106
Flags
product use code U-1
Product numbers
001
17 Jul 2030 · NDA 022574 · DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US 11,617,751, product and use patent
patent.txt line 2,107
Flags
product use code U-3572
Product numbers
001
18 Jul 2030 · NDA 210361 · GLYCOPYRRONIUM TOSYLATE
US 9,744,105, product and use patent
patent.txt line 11,318
Flags
product use code U-2398
Product numbers
001
21 Jul 2030 · NDA 205874 · FERRIC CITRATE
US 10,300,039, use patent
patent.txt line 5,996
Flags
use code U-2549
Product numbers
001
21 Jul 2030 · NDA 205874 · FERRIC CITRATE
US 9,387,191, product patent
patent.txt line 5,998
Flags
product
Product numbers
001
21 Jul 2030 · NDA 216158 · TROSPIUM CHLORIDE; XANOMELINE TARTRATE
US 10,238,643, product patent
patent.txt lines 18,377, 18,388, 18,399
Flags
product
Product numbers
001, 002, 003
21 Jul 2030 · NDA 216158 · TROSPIUM CHLORIDE; XANOMELINE TARTRATE
US 10,265,311, use patent
patent.txt lines 18,378, 18,389, 18,400
Flags
use code U-3513
Product numbers
001, 002, 003
21 Jul 2030 · NDA 216158 · TROSPIUM CHLORIDE; XANOMELINE TARTRATE
US 10,369,143, use patent
patent.txt lines 18,379, 18,390, 18,401
Flags
use code U-3513
Product numbers
001, 002, 003
21 Jul 2030 · NDA 216158 · TROSPIUM CHLORIDE; XANOMELINE TARTRATE
US 10,369,144, product and use patent
patent.txt lines 18,380, 18,391, 18,402
Flags
product use code U-3513
Product numbers
001, 002, 003
21 Jul 2030 · NDA 216158 · TROSPIUM CHLORIDE; XANOMELINE TARTRATE
US 10,695,339, use patent
patent.txt lines 18,381, 18,392, 18,403
Flags
use code U-3513
Product numbers
001, 002, 003
24 Jul 2030 · NDA 022192 · ILOPERIDONE
US 10,563,259, use patent
patent.txt lines 1,143, 1,157, 1,171, 1,185, 1,199, 1,213, 1,227
Flags
use code U-4562
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Jul 2030 · NDA 022192 · ILOPERIDONE
US 10,563,259, use patent
patent.txt lines 1,144, 1,158, 1,172, 1,186, 1,200, 1,214, 1,228
Flags
use code U-4563
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Jul 2030 · NDA 220358 · MILSAPERIDONE
US 10,563,259, use patent
patent.txt lines 22,138, 22,158, 22,178, 22,198, 22,218, 22,238, 22,258
Flags
use code U-4436
Product numbers
001, 002, 003, 004, 005, 006, 007
24 Jul 2030 · NDA 220358 · MILSAPERIDONE
US 10,563,259, use patent
patent.txt lines 22,139, 22,159, 22,179, 22,199, 22,219, 22,239, 22,259
Flags
use code U-4437
Product numbers
001, 002, 003, 004, 005, 006, 007
25 Jul 2030 · NDA 213433 · CLASCOTERONE
US 8,785,427, product patent
patent.txt line 15,010
Flags
product
Product numbers
001
27 Jul 2030 · NDA 202429 · VEMURAFENIB
US 8,741,920, substance and product patent
patent.txt line 3,092
Flags
substance product
Product numbers
001
27 Jul 2030 · NDA 213973 · RIPRETINIB
US 8,188,113, substance and product patent
patent.txt line 15,391
Flags
substance product
Product numbers
001
28 Jul 2030 · NDA 021529 · ETONOGESTREL
US 9,757,552, product and use patent
patent.txt lines 623, 627
Flags
product use code U-1
Product numbers
001, 002
28 Jul 2030 · NDA 211349 · GILTERITINIB FUMARATE
US 9,487,491, use patent
patent.txt line 12,714
Flags
use code U-2456
Product numbers
001
29 Jul 2030 · NDA 208325 · ETELCALCETIDE
US 8,377,880, substance and product patent
patent.txt lines 8,462, 8,470, 8,478
Flags
substance product
Product numbers
001, 002, 003
29 Jul 2030 · NDA 208325 · ETELCALCETIDE
US 9,278,995, substance patent
patent.txt lines 8,464, 8,472, 8,480
Flags
substance
Product numbers
001, 002, 003
29 Jul 2030 · NDA 208325 · ETELCALCETIDE
US 9,701,712, substance and product and use patent
patent.txt lines 8,465, 8,473, 8,481
Flags
substance product use code U-2014
Product numbers
001, 002, 003
1 Aug 2030 · NDA 207947 · SELEXIPAG
US 8,791,122, substance and product patent
patent.txt lines 7,701, 7,713, 7,725, 7,737, 7,749, 7,761, 7,773, 7,785, 7,797, 7,809
Flags
substance product
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 010, 011
1 Aug 2030 · NDA 214275 · SELEXIPAG
US 8,791,122, substance and product patent
patent.txt line 15,661
Flags
substance product
Product numbers
001
2 Aug 2030 · NDA 201373 · FEXOFENADINE HYDROCHLORIDE
US 8,933,097, product patent
patent.txt lines 2,428–2,429
Flags
product
Product numbers
001, 002
9 Aug 2030 · NDA 020947 · DICLOFENAC SODIUM
US 8,546,450, use patent
patent.txt line 384
Flags
use code U-1435
Product numbers
001
9 Aug 2030 · NDA 020947 · DICLOFENAC SODIUM
US 8,546,450, use patent
patent.txt line 385
Flags
use code U-1436
Product numbers
001
9 Aug 2030 · NDA 204623 · DICLOFENAC SODIUM
US 8,546,450, use patent
patent.txt line 4,858
Flags
use code U-1435
Product numbers
001
9 Aug 2030 · NDA 204623 · DICLOFENAC SODIUM
US 8,546,450, use patent
patent.txt line 4,859
Flags
use code U-1436
Product numbers
001
11 Aug 2030 · NDA 215151 · VONOPRAZAN FUMARATE
US 9,186,411, product patent
patent.txt lines 16,499, 16,501
Flags
product
Product numbers
001, 002
11 Aug 2030 · NDA 215152 · AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE
US 9,186,411, product patent
patent.txt line 16,503
Flags
product
Product numbers
001
11 Aug 2030 · NDA 215153 · AMOXICILLIN; VONOPRAZAN FUMARATE
US 9,186,411, product patent
patent.txt line 16,505
Flags
product
Product numbers
001
18 Aug 2030 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 8,899,229, product patent
patent.txt line 6,283
Flags
product
Product numbers
001
18 Aug 2030 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
US 7,795,447, substance patent
patent.txt lines 20,266, 20,295, 20,324
Flags
substance
Product numbers
001, 002, 003
20 Aug 2030 · NDA 217424 · BERDAZIMER SODIUM
US 10,376,538, product patent
patent.txt line 19,931
Flags
product
Product numbers
001
20 Aug 2030 · NDA 217424 · BERDAZIMER SODIUM
US 9,737,561, use patent
patent.txt line 19,942
Flags
use code U-3802
Product numbers
001
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 10,005,761, use patent
patent.txt lines 11,503, 11,513
Flags
use code U-2335
Product numbers
001, 002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 10,005,761, use patent
patent.txt line 11,514
Flags
use code U-2802
Product numbers
002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 10,005,761, use patent
patent.txt line 11,515
Flags
use code U-2803
Product numbers
002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 10,005,761, use patent
patent.txt line 11,516
Flags
use code U-3738
Product numbers
002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 10,005,761, use patent
patent.txt line 11,517
Flags
use code U-4051
Product numbers
002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 10,005,761, use patent
patent.txt line 11,518
Flags
use code U-4440
Product numbers
002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 9,593,099, substance patent
patent.txt lines 11,508, 11,539
Flags
substance
Product numbers
001, 002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 9,593,100, product patent
patent.txt lines 11,509, 11,540
Flags
product
Product numbers
001, 002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 9,850,229, use patent
patent.txt lines 11,511, 11,542
Flags
use code U-2337
Product numbers
001, 002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 9,850,230, use patent
patent.txt lines 11,512, 11,543
Flags
use code U-2334
Product numbers
001, 002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 9,850,230, use patent
patent.txt line 11,544
Flags
use code U-2802
Product numbers
002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 9,850,230, use patent
patent.txt line 11,545
Flags
use code U-2803
Product numbers
002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 9,850,230, use patent
patent.txt line 11,546
Flags
use code U-3738
Product numbers
002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 9,850,230, use patent
patent.txt line 11,547
Flags
use code U-4051
Product numbers
002
27 Aug 2030 · NDA 210496 · ENCORAFENIB
US 9,850,230, use patent
patent.txt line 11,548
Flags
use code U-4440
Product numbers
002
27 Aug 2030 · NDA 210498 · BINIMETINIB
US 10,005,761, use patent
patent.txt line 11,550
Flags
use code U-2331
Product numbers
001
27 Aug 2030 · NDA 210498 · BINIMETINIB
US 10,005,761, use patent
patent.txt line 11,551
Flags
use code U-3737
Product numbers
001
27 Aug 2030 · NDA 210498 · BINIMETINIB
US 9,850,229, use patent
patent.txt line 11,557
Flags
use code U-2333
Product numbers
001
28 Aug 2030 · NDA 214900 · IBREXAFUNGERP CITRATE
US 8,188,085, substance and product and use patent
patent.txt line 16,305
Flags
substance product use code U-3159
Product numbers
001
31 Aug 2030 · NDA 022192 · ILOPERIDONE
US 8,652,776, use patent
patent.txt lines 1,150, 1,164, 1,178, 1,192, 1,206, 1,220, 1,234
Flags
use code U-1685
Product numbers
001, 002, 003, 004, 005, 006, 007
31 Aug 2030 · NDA 208079 · BETAMETHASONE DIPROPIONATE
US 10,179,137, product and use patent
patent.txt line 8,100
Flags
product use code U-1858
Product numbers
001
31 Aug 2030 · NDA 208079 · BETAMETHASONE DIPROPIONATE
US 9,364,485, product and use patent
patent.txt line 8,102
Flags
product use code U-1858
Product numbers
001
31 Aug 2030 · NDA 208079 · BETAMETHASONE DIPROPIONATE
US 9,433,630, product and use patent
patent.txt line 8,103
Flags
product use code U-1858
Product numbers
001
31 Aug 2030 · NDA 208079 · BETAMETHASONE DIPROPIONATE
US 9,439,911, product and use patent
patent.txt line 8,104
Flags
product use code U-1858
Product numbers
001
31 Aug 2030 · NDA 208079 · BETAMETHASONE DIPROPIONATE
US 9,655,907, product and use patent
patent.txt line 8,105
Flags
product use code U-1858
Product numbers
001
31 Aug 2030 · NDA 208079 · BETAMETHASONE DIPROPIONATE
US 9,775,851, product and use patent
patent.txt line 8,106
Flags
product use code U-1858
Product numbers
001
31 Aug 2030 · NDA 208079 · BETAMETHASONE DIPROPIONATE
US 9,877,974, product and use patent
patent.txt line 8,107
Flags
product use code U-1858
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 10,064,875, product and use patent
patent.txt line 10,420
Flags
product use code U-1408
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 10,064,875, product and use patent
patent.txt line 10,421
Flags
product use code U-1858
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 10,064,875, product and use patent
patent.txt line 10,422
Flags
product use code U-193
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 10,064,875, product and use patent
patent.txt line 10,423
Flags
product use code U-742
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 10,064,875, product and use patent
patent.txt line 10,424
Flags
product use code U-88
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 10,588,914, product and use patent
patent.txt line 10,425
Flags
product use code U-2771
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 11,179,465, product and use patent
patent.txt line 10,426
Flags
product use code U-1858
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 9,956,231, product and use patent
patent.txt line 10,428
Flags
product use code U-1408
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 9,956,231, product and use patent
patent.txt line 10,429
Flags
product use code U-1761
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 9,956,231, product and use patent
patent.txt line 10,430
Flags
product use code U-1858
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 9,956,231, product and use patent
patent.txt line 10,431
Flags
product use code U-193
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 9,956,231, product and use patent
patent.txt line 10,432
Flags
product use code U-742
Product numbers
001
31 Aug 2030 · NDA 209483 · CLOBETASOL PROPIONATE
US 9,956,231, product and use patent
patent.txt line 10,433
Flags
product use code U-88
Product numbers
001
31 Aug 2030 · NDA 211210 · MELOXICAM
US 8,545,879, product patent
patent.txt lines 12,541–12,542
Flags
product
Product numbers
001, 002
1 Sep 2030 · NDA 214511 · PEGULICIANINE ACETATE
US 11,592,396, substance patent
patent.txt line 15,830
Flags
substance
Product numbers
001
2 Sep 2030 · NDA 021164 · GEPIRONE HYDROCHLORIDE
US 7,538,116, use patent
patent.txt lines 485–488
Flags
use code U-3699
Product numbers
001, 002, 003, 004
7 Sep 2030 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 8,513,299, use patent
patent.txt lines 942, 958
Flags
use code U-620
Product numbers
001, 002
7 Sep 2030 · NDA 208010 · CALCIFEDIOL
US 11,801,253, product and use patent
patent.txt line 7,953
Flags
product use code U-3721
Product numbers
001
7 Sep 2030 · NDA 208010 · CALCIFEDIOL
US 11,801,253, product and use patent
patent.txt line 7,954
Flags
product use code U-3722
Product numbers
001
7 Sep 2030 · NDA 208010 · CALCIFEDIOL
US 11,801,253, product and use patent
patent.txt line 7,955
Flags
product use code U-3723
Product numbers
001
13 Sep 2030 · NDA 204671 · SOFOSBUVIR
US 9,284,342, substance and product and use patent
patent.txt lines 4,960, 4,978
Flags
substance product use code U-1470
Product numbers
001, 002
13 Sep 2030 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 9,284,342, substance and product and use patent
patent.txt lines 5,937, 5,970
Flags
substance product use code U-1470
Product numbers
001, 002
13 Sep 2030 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 9,284,342, substance and product and use patent
patent.txt lines 8,510, 8,540
Flags
substance product use code U-1470
Product numbers
001, 002
13 Sep 2030 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 9,284,342, substance and product and use patent
patent.txt line 9,855
Flags
substance product use code U-2039
Product numbers
001
13 Sep 2030 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 9,284,342, substance and product and use patent
patent.txt line 9,856
Flags
substance product use code U-2040
Product numbers
001
13 Sep 2030 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 9,284,342, substance and product and use patent
patent.txt lines 14,010, 14,041
Flags
substance product use code U-1470
Product numbers
001, 002
13 Sep 2030 · NDA 212480 · SOFOSBUVIR
US 9,284,342, substance and product and use patent
patent.txt lines 14,068, 14,084
Flags
substance product use code U-1470
Product numbers
001, 002
13 Sep 2030 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 9,284,342, substance and product and use patent
patent.txt lines 15,603, 15,631
Flags
substance product use code U-1470
Product numbers
001, 002
14 Sep 2030 · NDA 022348 · IBUPROFEN
US 9,012,508, use patent
patent.txt lines 1,728, 1,736
Flags
use code U-981
Product numbers
002, 003
14 Sep 2030 · NDA 202992 · TERIFLUNOMIDE
US 8,802,735, product patent
patent.txt lines 3,591, 3,597
Flags
product
Product numbers
001, 002
15 Sep 2030 · NDA 207202 · ARIPIPRAZOLE
US 11,464,423, product patent
patent.txt lines 7,065, 7,092, 7,119, 7,146, 7,173, 7,200
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
20 Sep 2030 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,507,534, substance and product patent
patent.txt lines 6,103, 6,150
Flags
substance product
Product numbers
001, 002
20 Sep 2030 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,716,338, product and use patent
patent.txt line 6,107
Flags
product use code U-1718
Product numbers
001
20 Sep 2030 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,716,338, product and use patent
patent.txt lines 6,108, 6,154
Flags
product use code U-1910
Product numbers
001, 002
20 Sep 2030 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,507,534, substance and product patent
patent.txt lines 12,734, 12,776, 12,818
Flags
substance product
Product numbers
001, 002, 003
20 Sep 2030 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,716,338, product and use patent
patent.txt lines 12,738, 12,780
Flags
product use code U-2396
Product numbers
001, 002
20 Sep 2030 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,716,338, product and use patent
patent.txt line 12,822
Flags
product use code U-3426
Product numbers
003
21 Sep 2030 · NDA 200327 · CEFTAROLINE FOSAMIL
US 9,629,861, product patent
patent.txt lines 2,217, 2,219
Flags
product
Product numbers
001, 002
21 Sep 2030 · NDA 214793 · PIFLUFOLASTAT F-18
US 8,778,305, substance and product and use patent
patent.txt line 16,196
Flags
substance product use code U-3130
Product numbers
001
21 Sep 2030 · NDA 220089 · PIFLUFOLASTAT F-18
US 8,778,305, substance and product and use patent
patent.txt line 22,095
Flags
substance product use code U-3317
Product numbers
001
22 Sep 2030 · NDA 022192 · ILOPERIDONE
US 12,606,869, use patent
patent.txt lines 1,147, 1,161, 1,175, 1,189, 1,203, 1,217, 1,231
Flags
use code U-4504
Product numbers
001, 002, 003, 004, 005, 006, 007
22 Sep 2030 · NDA 022192 · ILOPERIDONE
US 12,606,869, use patent
patent.txt lines 1,148, 1,162, 1,176, 1,190, 1,204, 1,218, 1,232
Flags
use code U-4505
Product numbers
001, 002, 003, 004, 005, 006, 007
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 10,045,958, use patent
patent.txt line 3,690
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 10,045,959, use patent
patent.txt line 3,691
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 10,183,002, use patent
patent.txt line 3,692
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 10,183,003, use patent
patent.txt line 3,693
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 10,183,004, use patent
patent.txt line 3,694
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 10,183,005, use patent
patent.txt line 3,695
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 10,183,006, use patent
patent.txt line 3,696
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 10,668,040, use patent
patent.txt line 3,697
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 8,642,012, use patent
patent.txt line 3,698
Flags
use code U-1383
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 9,254,278, use patent
patent.txt line 3,699
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 9,326,966, use patent
patent.txt line 3,700
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 9,561,197, use patent
patent.txt line 3,701
Flags
use code U-1383
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 9,962,359, use patent
patent.txt line 3,702
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 203284 · GLYCEROL PHENYLBUTYRATE
US 9,999,608, use patent
patent.txt line 3,703
Flags
use code U-1816
Product numbers
001
22 Sep 2030 · NDA 220358 · MILSAPERIDONE
US 12,606,869, use patent
patent.txt lines 22,144, 22,164, 22,184, 22,204, 22,224, 22,244, 22,264
Flags
use code U-4506
Product numbers
001, 002, 003, 004, 005, 006, 007
22 Sep 2030 · NDA 220358 · MILSAPERIDONE
US 12,606,869, use patent
patent.txt lines 22,145, 22,165, 22,185, 22,205, 22,225, 22,245, 22,265
Flags
use code U-4507
Product numbers
001, 002, 003, 004, 005, 006, 007
23 Sep 2030 · NDA 209816 · OMADACYCLINE TOSYLATE
US 8,383,610, substance patent
patent.txt line 10,828
Flags
substance
Product numbers
001
27 Sep 2030 · NDA 219249 · INAVOLISIB
US 8,242,104, substance and product patent
patent.txt lines 21,562, 21,569
Flags
substance product
Product numbers
001, 002
27 Sep 2030 · NDA 219249 · INAVOLISIB
US 8,343,955, use patent
patent.txt lines 21,563, 21,570
Flags
use code U-4024
Product numbers
001, 002
30 Sep 2030 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 10,610,489, product patent
patent.txt lines 6,293, 6,324, 6,355, 6,384
Flags
product
Product numbers
001, 002, 003, 004
1 Oct 2030 · NDA 212379 · MINOCYCLINE HYDROCHLORIDE
US 10,086,080, use patent
patent.txt line 13,954
Flags
use code U-2647
Product numbers
001
1 Oct 2030 · NDA 212379 · MINOCYCLINE HYDROCHLORIDE
US 10,137,200, use patent
patent.txt line 13,955
Flags
use code U-2647
Product numbers
001
1 Oct 2030 · NDA 212379 · MINOCYCLINE HYDROCHLORIDE
US 10,213,512, product and use patent
patent.txt line 13,956
Flags
product use code U-2647
Product numbers
001
1 Oct 2030 · NDA 212379 · MINOCYCLINE HYDROCHLORIDE
US 10,265,404, product patent
patent.txt line 13,957
Flags
product
Product numbers
001
1 Oct 2030 · NDA 212379 · MINOCYCLINE HYDROCHLORIDE
US 10,517,882, use patent
patent.txt line 13,959
Flags
use code U-2647
Product numbers
001
1 Oct 2030 · NDA 212379 · MINOCYCLINE HYDROCHLORIDE
US 10,821,187, use patent
patent.txt line 13,960
Flags
use code U-2647
Product numbers
001
1 Oct 2030 · NDA 212379 · MINOCYCLINE HYDROCHLORIDE
US 8,865,139, product and use patent
patent.txt line 13,962
Flags
product use code U-2647
Product numbers
001
1 Oct 2030 · NDA 212379 · MINOCYCLINE HYDROCHLORIDE
US 8,945,516, product patent
patent.txt line 13,963
Flags
product
Product numbers
001
1 Oct 2030 · NDA 212379 · MINOCYCLINE HYDROCHLORIDE
US 8,992,896, product and use patent
patent.txt line 13,964
Flags
product use code U-2647
Product numbers
001
1 Oct 2030 · NDA 212379 · MINOCYCLINE HYDROCHLORIDE
US 9,675,700, product and use patent
patent.txt line 13,965
Flags
product use code U-2647
Product numbers
001
1 Oct 2030 · NDA 213690 · MINOCYCLINE HYDROCHLORIDE
US 10,213,512, product and use patent
patent.txt line 15,197
Flags
product use code U-1631
Product numbers
001
1 Oct 2030 · NDA 213690 · MINOCYCLINE HYDROCHLORIDE
US 10,265,404, product patent
patent.txt line 15,198
Flags
product
Product numbers
001
1 Oct 2030 · NDA 213690 · MINOCYCLINE HYDROCHLORIDE
US 10,322,186, use patent
patent.txt line 15,199
Flags
use code U-1631
Product numbers
001
1 Oct 2030 · NDA 213690 · MINOCYCLINE HYDROCHLORIDE
US 10,946,101, use patent
patent.txt line 15,200
Flags
use code U-1631
Product numbers
001
1 Oct 2030 · NDA 213690 · MINOCYCLINE HYDROCHLORIDE
US 12,138,311, use patent
patent.txt line 15,201
Flags
use code U-1631
Product numbers
001
1 Oct 2030 · NDA 213690 · MINOCYCLINE HYDROCHLORIDE
US 12,661,407, use patent
patent.txt line 15,202
Flags
use code U-1631
Product numbers
001
1 Oct 2030 · NDA 213690 · MINOCYCLINE HYDROCHLORIDE
US 8,865,139, product and use patent
patent.txt line 15,203
Flags
product use code U-1631
Product numbers
001
1 Oct 2030 · NDA 213690 · MINOCYCLINE HYDROCHLORIDE
US 8,945,516, product patent
patent.txt line 15,204
Flags
product
Product numbers
001
1 Oct 2030 · NDA 213690 · MINOCYCLINE HYDROCHLORIDE
US 8,992,896, product and use patent
patent.txt line 15,205
Flags
product use code U-1631
Product numbers
001
1 Oct 2030 · NDA 213690 · MINOCYCLINE HYDROCHLORIDE
US 9,675,700, product and use patent
patent.txt line 15,206
Flags
product use code U-1631
Product numbers
001
4 Oct 2030 · NDA 206947 · LENVATINIB MESYLATE
US 12,508,313, product patent
patent.txt lines 6,888, 6,909
Flags
product
Product numbers
001, 002
4 Oct 2030 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,895,033, product and use patent
patent.txt line 9,893
Flags
product use code U-2589
Product numbers
001
4 Oct 2030 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,895,033, product and use patent
patent.txt line 9,894
Flags
product use code U-2590
Product numbers
001
4 Oct 2030 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,895,033, product and use patent
patent.txt line 9,895
Flags
product use code U-2597
Product numbers
001
4 Oct 2030 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,895,033, product and use patent
patent.txt line 9,896
Flags
product use code U-2601
Product numbers
001
4 Oct 2030 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,895,033, product and use patent
patent.txt line 9,897
Flags
product use code U-2602
Product numbers
001
4 Oct 2030 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,895,033, product and use patent
patent.txt line 9,898
Flags
product use code U-3188
Product numbers
001
4 Oct 2030 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,895,033, product and use patent
patent.txt line 9,899
Flags
product use code U-3189
Product numbers
001
4 Oct 2030 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,895,033, product and use patent
patent.txt line 9,900
Flags
product use code U-3190
Product numbers
001
7 Oct 2030 · NDA 216203 · SOTAGLIFLOZIN
US 8,217,156, substance and product patent
patent.txt lines 18,466, 18,469
Flags
substance product
Product numbers
001, 002
8 Oct 2030 · NDA 021821 · TIGECYCLINE
US 8,372,995, product patent
patent.txt line 704
Flags
product
Product numbers
001
8 Oct 2030 · NDA 203756 · CABOZANTINIB S-MALATE
US 8,877,776, substance and product and use patent
patent.txt lines 4,147, 4,155
Flags
substance product use code U-1617
Product numbers
001, 002
8 Oct 2030 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 8,835,455, product patent
patent.txt line 6,579
Flags
product
Product numbers
001
8 Oct 2030 · NDA 208692 · CABOZANTINIB S-MALATE
US 8,877,776, substance and product and use patent
patent.txt lines 9,195, 9,215, 9,235
Flags
substance product use code U-3225
Product numbers
001, 002, 003
8 Oct 2030 · NDA 217906 · AVIBACTAM SODIUM; AZTREONAM
US 8,835,455, product patent
patent.txt line 20,774
Flags
product
Product numbers
001
11 Oct 2030 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 8,746,242, product patent
patent.txt lines 4,436, 4,446, 4,454
Flags
product
Product numbers
001, 002, 003
11 Oct 2030 · NDA 209482 · FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 8,746,242, product patent
patent.txt lines 10,411, 10,418
Flags
product
Product numbers
001, 002
15 Oct 2030 · NDA 202806 · DABRAFENIB MESYLATE
US 8,703,781, substance and product and use patent
patent.txt lines 3,263, 3,287
Flags
substance product use code U-1713
Product numbers
001, 002
15 Oct 2030 · NDA 202806 · DABRAFENIB MESYLATE
US 8,703,781, substance and product and use patent
patent.txt lines 3,264, 3,288
Flags
substance product use code U-2032
Product numbers
001, 002
15 Oct 2030 · NDA 202806 · DABRAFENIB MESYLATE
US 8,703,781, substance and product and use patent
patent.txt lines 3,265, 3,289
Flags
substance product use code U-2296
Product numbers
001, 002
15 Oct 2030 · NDA 202806 · DABRAFENIB MESYLATE
US 8,703,781, substance and product and use patent
patent.txt lines 3,266, 3,290
Flags
substance product use code U-2298
Product numbers
001, 002
15 Oct 2030 · NDA 202806 · DABRAFENIB MESYLATE
US 8,952,018, use patent
patent.txt lines 3,268, 3,292
Flags
use code U-2027
Product numbers
001, 002
15 Oct 2030 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,703,781, substance and product and use patent
patent.txt lines 4,278, 4,298, 4,318
Flags
substance product use code U-1712
Product numbers
001, 002, 003
15 Oct 2030 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,703,781, substance and product and use patent
patent.txt lines 4,279, 4,299, 4,319
Flags
substance product use code U-2020
Product numbers
001, 002, 003
15 Oct 2030 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,703,781, substance and product and use patent
patent.txt lines 4,280, 4,300, 4,320
Flags
substance product use code U-2037
Product numbers
001, 002, 003
15 Oct 2030 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,703,781, substance and product and use patent
patent.txt lines 4,281, 4,301, 4,321
Flags
substance product use code U-2302
Product numbers
001, 002, 003
15 Oct 2030 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,703,781, substance and product and use patent
patent.txt lines 4,282, 4,302, 4,322
Flags
substance product use code U-2305
Product numbers
001, 002, 003
15 Oct 2030 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,952,018, use patent
patent.txt lines 4,284, 4,304, 4,324
Flags
use code U-2020
Product numbers
001, 002, 003
15 Oct 2030 · NDA 212279 · AIR POLYMER-TYPE A
US 9,034,300, product and use patent
patent.txt line 13,795
Flags
product use code U-2663
Product numbers
001
15 Oct 2030 · NDA 217513 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,703,781, substance and product and use patent
patent.txt line 19,991
Flags
substance product use code U-3564
Product numbers
001
15 Oct 2030 · NDA 217514 · DABRAFENIB MESYLATE
US 8,703,781, substance and product and use patent
patent.txt line 19,999
Flags
substance product use code U-3565
Product numbers
001
16 Oct 2030 · NDA 021747 · ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
US 8,733,341, product patent
patent.txt line 697
Flags
product delist requested
Product numbers
001
16 Oct 2030 · NDA 021936 · TIOTROPIUM BROMIDE
US 8,733,341, product patent
patent.txt line 813
Flags
product delist requested
Product numbers
001
16 Oct 2030 · NDA 206756 · OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
US 8,733,341, product patent
patent.txt line 6,761
Flags
product delist requested
Product numbers
001
17 Oct 2030 · NDA 218010 · TRAVOPROST
US 10,206,813, product patent
patent.txt line 20,780
Flags
product
Product numbers
001
17 Oct 2030 · NDA 218010 · TRAVOPROST
US 11,426,306, product patent
patent.txt line 20,781
Flags
product
Product numbers
001
21 Oct 2030 · NDA 022145 · RALTEGRAVIR POTASSIUM
US 9,649,311, product patent
patent.txt line 1,122
Flags
product
Product numbers
002
21 Oct 2030 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 9,649,456, product and use patent
patent.txt line 6,285
Flags
product use code U-1719
Product numbers
001
21 Oct 2030 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 9,649,456, product and use patent
patent.txt line 6,286
Flags
product use code U-2010
Product numbers
001
21 Oct 2030 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 9,649,456, product and use patent
patent.txt line 6,287
Flags
product use code U-2011
Product numbers
001
21 Oct 2030 · NDA 208073 · LIFITEGRAST
US 9,353,088, product patent
patent.txt line 8,091
Flags
product
Product numbers
001
21 Oct 2030 · NDA 208073 · LIFITEGRAST
US 9,890,141, substance patent
patent.txt line 8,093
Flags
substance
Product numbers
001
21 Oct 2030 · NDA 209805 · ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
US 9,308,204, product patent
patent.txt lines 10,805, 10,810
Flags
product
Product numbers
001, 002
21 Oct 2030 · NDA 209805 · ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
US 9,439,901, use patent
patent.txt lines 10,806, 10,811
Flags
use code U-2214
Product numbers
001, 002
21 Oct 2030 · NDA 209806 · ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 9,308,204, product patent
patent.txt lines 10,813, 10,816, 10,819, 10,822
Flags
product
Product numbers
001, 002, 003, 004
21 Oct 2030 · NDA 209806 · ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 9,439,902, use patent
patent.txt lines 10,814, 10,817, 10,820, 10,823
Flags
use code U-2214
Product numbers
001, 002, 003, 004
21 Oct 2030 · NDA 210922 · PATISIRAN SODIUM
US 8,802,644, product and use patent
patent.txt line 12,403
Flags
product use code U-2378
Product numbers
001
22 Oct 2030 · NDA 209128 · SUFENTANIL CITRATE
US 8,202,535, use patent
patent.txt line 9,792
Flags
use code U-1351
Product numbers
001
22 Oct 2030 · NDA 209128 · SUFENTANIL CITRATE
US 8,865,743, use patent
patent.txt line 9,802
Flags
use code U-1351
Product numbers
001
24 Oct 2030 · NDA 203567 · EFINACONAZOLE
US 8,486,978, product patent
patent.txt line 4,099
Flags
product
Product numbers
001
24 Oct 2030 · NDA 203567 · EFINACONAZOLE
US 9,302,009, product patent
patent.txt line 4,100
Flags
product
Product numbers
001
24 Oct 2030 · NDA 209816 · OMADACYCLINE TOSYLATE
US 9,265,740, product and use patent
patent.txt line 10,829
Flags
product use code U-1569
Product numbers
001
26 Oct 2030 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,436,190, product patent
patent.txt lines 1,362, 1,379
Flags
product
Product numbers
001, 002
26 Oct 2030 · NDA 207533 · ARIPIPRAZOLE LAUROXIL
US 8,431,576, substance patent
patent.txt lines 7,286, 7,303, 7,321, 7,339
Flags
substance
Product numbers
001, 002, 003, 004
26 Oct 2030 · NDA 209830 · ARIPIPRAZOLE LAUROXIL
US 8,431,576, substance patent
patent.txt line 10,893
Flags
substance
Product numbers
001
27 Oct 2030 · NDA 201023 · CABAZITAXEL
US 10,583,110, use patent
patent.txt line 2,313
Flags
use code U-2753
Product numbers
001
27 Oct 2030 · NDA 201023 · CABAZITAXEL
US 10,716,777, use patent
patent.txt line 2,315
Flags
use code U-2856
Product numbers
001
27 Oct 2030 · NDA 201023 · CABAZITAXEL
US 12,453,712, use patent
patent.txt line 2,317
Flags
use code U-4334
Product numbers
001
27 Oct 2030 · NDA 201023 · CABAZITAXEL
US 8,927,592, use patent
patent.txt line 2,321
Flags
use code U-3200
Product numbers
001
27 Oct 2030 · NDA 212099 · DAROLUTAMIDE
US 10,711,013, substance and product patent
patent.txt line 13,534
Flags
substance product
Product numbers
001
27 Oct 2030 · NDA 212099 · DAROLUTAMIDE
US 11,046,713, substance patent
patent.txt line 13,539
Flags
substance
Product numbers
001
27 Oct 2030 · NDA 212099 · DAROLUTAMIDE
US 9,657,003, substance and product and use patent
patent.txt line 13,546
Flags
substance product use code U-4208
Product numbers
001
27 Oct 2030 · NDA 212099 · DAROLUTAMIDE
US 9,657,003, substance and product and use patent
patent.txt line 13,547
Flags
substance product use code U-4209
Product numbers
001
27 Oct 2030 · NDA 212099 · DAROLUTAMIDE
US 9,657,003, substance and product and use patent
patent.txt line 13,548
Flags
substance product use code U-4210
Product numbers
001
28 Oct 2030 · NDA 022192 · ILOPERIDONE
US 8,999,638, use patent
patent.txt lines 1,151, 1,165, 1,179, 1,193, 1,207, 1,221, 1,235
Flags
use code U-1674
Product numbers
001, 002, 003, 004, 005, 006, 007
28 Oct 2030 · NDA 220358 · MILSAPERIDONE
US 8,999,638, use patent
patent.txt lines 22,146, 22,166, 22,186, 22,206, 22,226, 22,246, 22,266
Flags
use code U-4436
Product numbers
001, 002, 003, 004, 005, 006, 007
28 Oct 2030 · NDA 220358 · MILSAPERIDONE
US 8,999,638, use patent
patent.txt lines 22,147, 22,167, 22,187, 22,207, 22,227, 22,247, 22,267
Flags
use code U-4437
Product numbers
001, 002, 003, 004, 005, 006, 007
30 Oct 2030 · NDA 204251 · BRIMONIDINE TARTRATE; BRINZOLAMIDE
US 9,044,484, product patent
patent.txt line 4,423
Flags
product
Product numbers
001
30 Oct 2030 · NDA 208437 · GLYCOPYRROLATE
US 9,789,270, product patent
patent.txt line 8,629
Flags
product
Product numbers
001
4 Nov 2030 · NDA 201688 · TOBRAMYCIN
US 10,207,066, product and use patent
patent.txt line 2,548
Flags
product use code U-909
Product numbers
001
4 Nov 2030 · NDA 207202 · ARIPIPRAZOLE
US 9,941,931, product patent
patent.txt lines 7,088, 7,115, 7,142, 7,169, 7,196, 7,223
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
5 Nov 2030 · NDA 208051 · NERATINIB MALEATE
US 8,790,708, product and use patent
patent.txt line 8,022
Flags
product use code U-2043
Product numbers
001
5 Nov 2030 · NDA 208051 · NERATINIB MALEATE
US 8,790,708, product and use patent
patent.txt line 8,023
Flags
product use code U-3047
Product numbers
001
5 Nov 2030 · NDA 208051 · NERATINIB MALEATE
US 8,790,708, product and use patent
patent.txt line 8,024
Flags
product use code U-3097
Product numbers
001
6 Nov 2030 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
US 9,586,978, use patent
patent.txt line 10,319
Flags
use code U-2141
Product numbers
001
6 Nov 2030 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
US 9,586,978, use patent
patent.txt line 10,320
Flags
use code U-3237
Product numbers
001
6 Nov 2030 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
US 9,586,978, use patent
patent.txt line 10,321
Flags
use code U-4206
Product numbers
001
6 Nov 2030 · NDA 215110 · GLECAPREVIR; PIBRENTASVIR
US 9,586,978, use patent
patent.txt line 16,493
Flags
use code U-3238
Product numbers
001
6 Nov 2030 · NDA 215110 · GLECAPREVIR; PIBRENTASVIR
US 9,586,978, use patent
patent.txt line 16,494
Flags
use code U-4206
Product numbers
001
7 Nov 2030 · NDA 022308 · BESIFLOXACIN HYDROCHLORIDE
US 8,415,342, use patent
patent.txt line 1,616
Flags
use code U-80
Product numbers
001
10 Nov 2030 · NDA 204958 · CANGRELOR
US 9,427,448, use patent
patent.txt line 5,185
Flags
use code U-1926
Product numbers
001
10 Nov 2030 · NDA 208254 · NETARSUDIL MESYLATE
US 8,394,826, substance and product and use patent
patent.txt line 8,402
Flags
substance product use code U-1524
Product numbers
001
10 Nov 2030 · NDA 208259 · LATANOPROST; NETARSUDIL DIMESYLATE
US 8,394,826, substance and product and use patent
patent.txt line 8,418
Flags
substance product use code U-1524
Product numbers
001
10 Nov 2030 · NDA 210922 · PATISIRAN SODIUM
US 8,158,601, product and use patent
patent.txt line 12,398
Flags
product use code U-2378
Product numbers
001
12 Nov 2030 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 9,616,028, product patent
patent.txt lines 5,719, 5,729, 5,739, 5,749, 5,759
Flags
product
Product numbers
001, 002, 003, 004, 005
12 Nov 2030 · NDA 208073 · LIFITEGRAST
US 8,927,574, product patent
patent.txt line 8,089
Flags
product
Product numbers
001
12 Nov 2030 · NDA 210874 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
US 9,616,028, product patent
patent.txt lines 12,283, 12,293, 12,303, 12,313
Flags
product
Product numbers
001, 002, 003, 004
12 Nov 2030 · NDA 213026 · CASIMERSEN
US 10,287,586, substance and product patent
patent.txt line 14,570
Flags
substance product
Product numbers
001
12 Nov 2030 · NDA 213026 · CASIMERSEN
US 10,781,450, use patent
patent.txt line 14,571
Flags
use code U-3089
Product numbers
001
12 Nov 2030 · NDA 213026 · CASIMERSEN
US 9,228,187, substance and product patent
patent.txt line 14,572
Flags
substance product
Product numbers
001
12 Nov 2030 · NDA 213026 · CASIMERSEN
US 9,758,783, use patent
patent.txt line 14,573
Flags
use code U-3088
Product numbers
001
12 Nov 2030 · NDA 213026 · CASIMERSEN
US 9,758,783, use patent
patent.txt line 14,574
Flags
use code U-3089
Product numbers
001
15 Nov 2030 · NDA 209899 · OZANIMOD HYDROCHLORIDE
US 10,239,846, use patent
patent.txt lines 11,000, 11,006, 11,012
Flags
use code U-3740
Product numbers
001, 002, 003
17 Nov 2030 · NDA 207202 · ARIPIPRAZOLE
US 8,961,412, product patent
patent.txt lines 7,078, 7,105, 7,132, 7,159, 7,186, 7,213
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
18 Nov 2030 · NDA 205718 · NETUPITANT; PALONOSETRON HYDROCHLORIDE
US 11,559,523, product and use patent
patent.txt line 5,816
Flags
product use code U-3522
Product numbers
001
18 Nov 2030 · NDA 205718 · NETUPITANT; PALONOSETRON HYDROCHLORIDE
US 12,042,494, product and use patent
patent.txt line 5,817
Flags
product use code U-3522
Product numbers
001
18 Nov 2030 · NDA 205718 · NETUPITANT; PALONOSETRON HYDROCHLORIDE
US 8,623,826, use patent
patent.txt line 5,818
Flags
use code U-2293
Product numbers
001
18 Nov 2030 · NDA 205718 · NETUPITANT; PALONOSETRON HYDROCHLORIDE
US 8,951,969, product patent
patent.txt line 5,819
Flags
product
Product numbers
001
18 Nov 2030 · NDA 205718 · NETUPITANT; PALONOSETRON HYDROCHLORIDE
US 9,186,357, use patent
patent.txt line 5,820
Flags
use code U-2293
Product numbers
001
18 Nov 2030 · NDA 205718 · NETUPITANT; PALONOSETRON HYDROCHLORIDE
US 9,943,515, use patent
patent.txt line 5,822
Flags
use code U-2293
Product numbers
001
18 Nov 2030 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
US 9,186,357, use patent
patent.txt lines 11,488, 11,500
Flags
use code U-2301
Product numbers
001, 002
19 Nov 2030 · NDA 202278 · SUMATRIPTAN SUCCINATE
US 8,983,594, product and use patent
patent.txt line 2,971
Flags
product use code U-1328
Product numbers
001
20 Nov 2030 · NDA 208051 · NERATINIB MALEATE
US 8,518,446, product and use patent
patent.txt line 8,018
Flags
product use code U-2043
Product numbers
001
20 Nov 2030 · NDA 208051 · NERATINIB MALEATE
US 8,518,446, product and use patent
patent.txt line 8,019
Flags
product use code U-3047
Product numbers
001
20 Nov 2030 · NDA 208051 · NERATINIB MALEATE
US 8,518,446, product and use patent
patent.txt line 8,020
Flags
product use code U-3097
Product numbers
001
20 Nov 2030 · NDA 209360 · ANGIOTENSIN II ACETATE
US 9,572,856, use patent
patent.txt line 10,205
Flags
use code U-2221
Product numbers
002
23 Nov 2030 · NDA 021572 · DAPTOMYCIN
US 9,138,456, product patent
patent.txt line 638
Flags
product
Product numbers
003
24 Nov 2030 · NDA 205494 · ELIGLUSTAT TARTRATE
US 11,458,119, substance and product patent
patent.txt line 5,455
Flags
substance product
Product numbers
001
24 Nov 2030 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,263,122, product patent
patent.txt lines 10,043, 10,057
Flags
product
Product numbers
001, 002
24 Nov 2030 · NDA 209531 · NUSINERSEN SODIUM
US 8,980,853, use patent
patent.txt lines 10,619, 10,627, 10,634
Flags
use code U-1941
Product numbers
001, 002, 003
24 Nov 2030 · NDA 215064 · BIRCH TRITERPENES
US 9,352,041, use patent
patent.txt line 16,461
Flags
use code U-3811
Product numbers
001
24 Nov 2030 · NDA 215064 · BIRCH TRITERPENES
US 9,827,214, use patent
patent.txt line 16,462
Flags
use code U-3811
Product numbers
001
25 Nov 2030 · NDA 207202 · ARIPIPRAZOLE
US 8,258,962, product patent
patent.txt lines 7,069, 7,096, 7,123, 7,150, 7,177, 7,204
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
29 Nov 2030 · NDA 203975 · UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 11,090,294, use patent
patent.txt line 4,187
Flags
use code U-3203
Product numbers
001
29 Nov 2030 · NDA 203975 · UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 12,396,986, product patent
patent.txt line 4,188
Flags
product
Product numbers
001
29 Nov 2030 · NDA 203975 · UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 9,750,726, product patent
patent.txt line 4,192
Flags
product
Product numbers
001
29 Nov 2030 · NDA 209482 · FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 11,090,294, use patent
patent.txt line 10,405
Flags
use code U-3202
Product numbers
001
29 Nov 2030 · NDA 209482 · FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 12,396,986, product patent
patent.txt lines 10,406, 10,413
Flags
product
Product numbers
001, 002
29 Nov 2030 · NDA 209482 · FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 9,750,726, product patent
patent.txt lines 10,412, 10,419
Flags
product
Product numbers
001, 002
30 Nov 2030 · NDA 208088 · TESTOSTERONE UNDECANOATE
US 10,226,473, use patent
patent.txt line 8,207
Flags
use code U-1500
Product numbers
001
30 Nov 2030 · NDA 208088 · TESTOSTERONE UNDECANOATE
US 10,716,794, use patent
patent.txt line 8,208
Flags
use code U-1500
Product numbers
001
30 Nov 2030 · NDA 208088 · TESTOSTERONE UNDECANOATE
US 11,311,555, use patent
patent.txt line 8,210
Flags
use code U-1500
Product numbers
001
30 Nov 2030 · NDA 208088 · TESTOSTERONE UNDECANOATE
US 11,364,249, use patent
patent.txt line 8,211
Flags
use code U-1500
Product numbers
001
30 Nov 2030 · NDA 208088 · TESTOSTERONE UNDECANOATE
US 11,433,083, use patent
patent.txt line 8,212
Flags
use code U-1500
Product numbers
001
30 Nov 2030 · NDA 208088 · TESTOSTERONE UNDECANOATE
US 9,943,527, use patent
patent.txt line 8,221
Flags
use code U-1500
Product numbers
001
30 Nov 2030 · NDA 208088 · TESTOSTERONE UNDECANOATE
US 9,949,985, use patent
patent.txt line 8,222
Flags
use code U-1500
Product numbers
001
30 Nov 2030 · NDA 209884 · SIPONIMOD
US 8,492,441, use patent
patent.txt lines 10,989, 10,994, 10,999
Flags
use code U-2511
Product numbers
001, 002, 003
1 Dec 2030 · NDA 203491 · NEPAFENAC
US 9,662,398, product patent
patent.txt line 3,945
Flags
product
Product numbers
001
1 Dec 2030 · NDA 204734 · LANTHANUM CARBONATE
US 8,980,327, product patent
patent.txt lines 4,988, 4,990
Flags
product
Product numbers
001, 002
1 Dec 2030 · NDA 204734 · LANTHANUM CARBONATE
US 9,023,397, product patent
patent.txt lines 4,989, 4,991
Flags
product
Product numbers
001, 002
2 Dec 2030 · NDA 207997 · MIDOSTAURIN
US 8,575,146, use patent
patent.txt line 7,933
Flags
use code U-2008
Product numbers
001
2 Dec 2030 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 11,197,835, use patent
patent.txt lines 9,620, 9,637
Flags
use code U-2106
Product numbers
001, 002
2 Dec 2030 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 8,741,343, use patent
patent.txt lines 9,626, 9,643
Flags
use code U-2106
Product numbers
001, 002
2 Dec 2030 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 9,867,791, use patent
patent.txt lines 9,627, 9,644
Flags
use code U-2106
Product numbers
001, 002
2 Dec 2030 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 9,867,792, use patent
patent.txt lines 9,628, 9,645
Flags
use code U-2106
Product numbers
001, 002
2 Dec 2030 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 9,867,793, use patent
patent.txt lines 9,629, 9,646
Flags
use code U-2106
Product numbers
001, 002
2 Dec 2030 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 9,877,933, use patent
patent.txt lines 9,630, 9,647
Flags
use code U-2224
Product numbers
001, 002
3 Dec 2030 · NDA 211616 · BEMPEDOIC ACID
US 7,335,799, substance patent
patent.txt line 12,897
Flags
substance
Product numbers
001
3 Dec 2030 · NDA 211617 · BEMPEDOIC ACID; EZETIMIBE
US 7,335,799, substance patent
patent.txt line 12,907
Flags
substance
Product numbers
001
6 Dec 2030 · NDA 022318 · SEVELAMER CARBONATE
US 9,095,509, product patent
patent.txt lines 1,644–1,645
Flags
product
Product numbers
001, 002
6 Dec 2030 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 8,978,647, product patent
patent.txt line 6,284
Flags
product
Product numbers
001
10 Dec 2030 · NDA 208090 · OXYCODONE
US 10,004,729, product and use patent
patent.txt lines 8,223, 8,231, 8,239, 8,247, 8,255
Flags
product use code U-1556
Product numbers
001, 002, 003, 004, 005
10 Dec 2030 · NDA 208090 · OXYCODONE
US 10,668,060, product and use patent
patent.txt lines 8,226, 8,234, 8,242, 8,250, 8,258
Flags
product use code U-1556
Product numbers
001, 002, 003, 004, 005
10 Dec 2030 · NDA 208090 · OXYCODONE
US 9,682,075, product and use patent
patent.txt lines 8,228, 8,236, 8,244, 8,252, 8,260
Flags
product use code U-1556
Product numbers
001, 002, 003, 004, 005
11 Dec 2030 · NDA 204671 · SOFOSBUVIR
US 8,618,076, substance and product and use patent
patent.txt lines 4,952, 4,970
Flags
substance product use code U-1470
Product numbers
001, 002
11 Dec 2030 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,618,076, substance and product and use patent
patent.txt lines 5,923, 5,956
Flags
substance product use code U-1470
Product numbers
001, 002
11 Dec 2030 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,993,600, product patent
patent.txt lines 6,118, 6,162
Flags
product
Product numbers
001, 002
11 Dec 2030 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,618,076, substance and product and use patent
patent.txt lines 8,496, 8,526
Flags
substance product use code U-1470
Product numbers
001, 002
11 Dec 2030 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,618,076, substance and product and use patent
patent.txt line 9,832
Flags
substance product use code U-2039
Product numbers
001
11 Dec 2030 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,618,076, substance and product and use patent
patent.txt line 9,833
Flags
substance product use code U-2040
Product numbers
001
11 Dec 2030 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,993,600, product patent
patent.txt lines 12,746, 12,788, 12,830
Flags
product
Product numbers
001, 002, 003
11 Dec 2030 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,618,076, substance and product and use patent
patent.txt lines 13,996, 14,027
Flags
substance product use code U-1470
Product numbers
001, 002
11 Dec 2030 · NDA 212480 · SOFOSBUVIR
US 8,618,076, substance and product and use patent
patent.txt lines 14,060, 14,076
Flags
substance product use code U-1470
Product numbers
001, 002
11 Dec 2030 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,618,076, substance and product and use patent
patent.txt lines 15,589, 15,617
Flags
substance product use code U-1470
Product numbers
001, 002
12 Dec 2030 · NDA 220442 · ENSITRELVIR
US 9,150,546, substance and product patent
patent.txt line 22,289
Flags
substance product
Product numbers
001
13 Dec 2030 · NDA 217469 · CYCLOSPORINE
US 8,614,178, product patent
patent.txt line 19,985
Flags
product
Product numbers
001
14 Dec 2030 · NDA 202324 · AXITINIB
US 8,791,140, substance patent
patent.txt lines 3,055, 3,064
Flags
substance
Product numbers
001, 002
17 Dec 2030 · NDA 022192 · ILOPERIDONE
US 9,074,255, use patent
patent.txt lines 1,154, 1,168, 1,182, 1,196, 1,210, 1,224, 1,238
Flags
use code U-1674
Product numbers
001, 002, 003, 004, 005, 006, 007
17 Dec 2030 · NDA 205718 · NETUPITANT; PALONOSETRON HYDROCHLORIDE
US 10,828,297, use patent
patent.txt line 5,814
Flags
use code U-2293
Product numbers
001
17 Dec 2030 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
US 10,828,297, use patent
patent.txt lines 11,482, 11,494
Flags
use code U-2301
Product numbers
001, 002
17 Dec 2030 · NDA 219683 · GEMCITABINE HYDROCHLORIDE
US 12,576,253, product patent
patent.txt line 21,861
Flags
product
Product numbers
001
17 Dec 2030 · NDA 220358 · MILSAPERIDONE
US 9,074,255, use patent
patent.txt lines 22,152, 22,172, 22,192, 22,212, 22,232, 22,252, 22,272
Flags
use code U-4436
Product numbers
001, 002, 003, 004, 005, 006, 007
17 Dec 2030 · NDA 220358 · MILSAPERIDONE
US 9,074,255, use patent
patent.txt lines 22,153, 22,173, 22,193, 22,213, 22,233, 22,253, 22,273
Flags
use code U-4437
Product numbers
001, 002, 003, 004, 005, 006, 007
18 Dec 2030 · NDA 207202 · ARIPIPRAZOLE
US 8,547,248, product and use patent
patent.txt lines 7,071, 7,098, 7,125, 7,152, 7,179, 7,206
Flags
product use code U-2167
Product numbers
001, 002, 003, 004, 005, 006
20 Dec 2030 · NDA 206089 · TESTOSTERONE UNDECANOATE
US 8,492,369, product and use patent
patent.txt lines 6,246, 6,257, 6,268
Flags
product use code U-2506
Product numbers
001, 002, 003
21 Dec 2030 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
US 8,597,681, product patent
patent.txt line 4,224
Flags
product
Product numbers
001
21 Dec 2030 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
US 8,980,319, product patent
patent.txt line 4,228
Flags
product
Product numbers
001
22 Dec 2030 · NDA 021829 · ROTIGOTINE
US 10,130,589, product patent
patent.txt lines 708, 713, 718, 723, 728, 733
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
22 Dec 2030 · NDA 021829 · ROTIGOTINE
US 10,350,174, product patent
patent.txt lines 709, 714, 719, 724, 729, 734
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
23 Dec 2030 · NDA 209531 · NUSINERSEN SODIUM
US 8,361,977, substance and product patent
patent.txt lines 10,618, 10,626, 10,633
Flags
substance product
Product numbers
001, 002, 003
23 Dec 2030 · NDA 219622 · BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
US 10,159,645, product and use patent
patent.txt lines 21,802, 21,808
Flags
product use code U-4538
Product numbers
001, 002
23 Dec 2030 · NDA 219622 · BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
US 10,806,701, product patent
patent.txt lines 21,804, 21,810
Flags
product
Product numbers
001, 002
23 Dec 2030 · NDA 219622 · BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
US 11,389,401, product patent
patent.txt lines 21,805, 21,811
Flags
product
Product numbers
001, 002
23 Dec 2030 · NDA 219622 · BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
US 11,590,074, use patent
patent.txt lines 21,806, 21,812
Flags
use code U-4538
Product numbers
001, 002
23 Dec 2030 · NDA 219622 · BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
US 12,357,568, product and use patent
patent.txt lines 21,807, 21,813
Flags
product use code U-4538
Product numbers
001, 002
28 Dec 2030 · NDA 208383 · BETRIXABAN
US 8,987,463, product patent
patent.txt lines 8,558, 8,564
Flags
product
Product numbers
001, 002
28 Dec 2030 · NDA 213189 · TIRBANIBULIN
US 7,300,931, substance and product patent
patent.txt line 14,725
Flags
substance product
Product numbers
001
29 Dec 2030 · NDA 208051 · NERATINIB MALEATE
US 7,399,865, substance and product patent
patent.txt line 8,017
Flags
substance product
Product numbers
001
30 Dec 2030 · NDA 214902 · BENZOYL PEROXIDE; TRETINOIN
US 10,653,899, product and use patent
patent.txt line 16,307
Flags
product use code U-3194
Product numbers
001
30 Dec 2030 · NDA 214902 · BENZOYL PEROXIDE; TRETINOIN
US 11,071,878, product patent
patent.txt line 16,308
Flags
product
Product numbers
001
30 Dec 2030 · NDA 214902 · BENZOYL PEROXIDE; TRETINOIN
US 12,070,629, product and use patent
patent.txt line 16,310
Flags
product use code U-3987
Product numbers
001
31 Dec 2030 · NDA 021964 · METHYLNALTREXONE BROMIDE
US 8,247,425, use patent
patent.txt lines 833, 840, 847
Flags
use code U-1185
Product numbers
001, 002, 003
31 Dec 2030 · NDA 205435 · TEDIZOLID PHOSPHATE
US 8,426,389, substance and product and use patent
patent.txt line 5,387
Flags
substance product use code U-282
Product numbers
001
31 Dec 2030 · NDA 205436 · TEDIZOLID PHOSPHATE
US 8,426,389, substance and product and use patent
patent.txt line 5,394
Flags
substance product use code U-282
Product numbers
001
31 Dec 2030 · NDA 213953 · TESTOSTERONE UNDECANOATE
US 10,576,089, product and use patent
patent.txt lines 15,327, 15,333, 15,339
Flags
product use code U-2506
Product numbers
001, 002, 003
31 Dec 2030 · NDA 213953 · TESTOSTERONE UNDECANOATE
US 10,576,090, product patent
patent.txt lines 15,328, 15,334, 15,340
Flags
product
Product numbers
001, 002, 003
31 Dec 2030 · NDA 213953 · TESTOSTERONE UNDECANOATE
US 11,590,146, product patent
patent.txt lines 15,329, 15,335, 15,341
Flags
product
Product numbers
001, 002, 003

Pediatric exclusivity, as listed (48)

18 Jul 2030 · NDA 202293 · DAPAGLIFLOZIN
US 8,721,615 with pediatric exclusivity, as listed
patent.txt lines 2,999, 3,037
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
20 Jul 2030 · NDA 202806 · DABRAFENIB MESYLATE
US 7,994,185 with pediatric exclusivity, as listed
patent.txt lines 3,252, 3,276
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
20 Jul 2030 · NDA 202806 · DABRAFENIB MESYLATE
US 8,415,345 with pediatric exclusivity, as listed
patent.txt lines 3,257, 3,281
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
20 Jul 2030 · NDA 207695 · CRISABOROLE
US 8,168,614 with pediatric exclusivity, as listed
patent.txt line 7,407
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
20 Jul 2030 · NDA 217514 · DABRAFENIB MESYLATE
US 7,994,185 with pediatric exclusivity, as listed
patent.txt line 19,994
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
20 Jul 2030 · NDA 217514 · DABRAFENIB MESYLATE
US 8,415,345 with pediatric exclusivity, as listed
patent.txt line 19,996
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
23 Jul 2030 · NDA 205109 · FERRIC OXYHYDROXIDE
US 9,561,251 with pediatric exclusivity, as listed
patent.txt line 5,235
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
11 Aug 2030 · NDA 204629 · EMPAGLIFLOZIN
US 12,115,179 with pediatric exclusivity, as listed
patent.txt lines 4,887, 4,918
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
11 Aug 2030 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 12,115,179 with pediatric exclusivity, as listed
patent.txt lines 6,182, 6,214
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
11 Aug 2030 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 12,115,179 with pediatric exclusivity, as listed
patent.txt lines 6,302, 6,333, 6,362, 6,391
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
11 Aug 2030 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 12,115,179 with pediatric exclusivity, as listed
patent.txt lines 9,049, 9,081, 9,111, 9,141
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
11 Aug 2030 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 12,115,179 with pediatric exclusivity, as listed
patent.txt lines 14,237, 14,267, 14,297, 14,326
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
8 Sep 2030 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 8,534,281 with pediatric exclusivity, as listed
patent.txt lines 4,433, 4,443, 4,451
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
8 Sep 2030 · NDA 209482 · FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 8,534,281 with pediatric exclusivity, as listed
patent.txt lines 10,408, 10,415
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
15 Sep 2030 · NDA 208694 · CETIRIZINE HYDROCHLORIDE
US 8,829,005 with pediatric exclusivity, as listed
patent.txt line 9,237
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
17 Sep 2030 · NDA 022287 · DEXLANSOPRAZOLE
US 8,173,158 with pediatric exclusivity, as listed
patent.txt lines 1,555, 1,569
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
17 Oct 2030 · NDA 022433 · TICAGRELOR
US 8,425,934 with pediatric exclusivity, as listed
patent.txt lines 1,900, 1,905
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
29 Oct 2030 · NDA 207318 · PIMAVANSERIN TARTRATE
US 7,601,740 with pediatric exclusivity, as listed
patent.txt lines 7,232, 7,241
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
29 Oct 2030 · NDA 210793 · PIMAVANSERIN TARTRATE
US 7,601,740 with pediatric exclusivity, as listed
patent.txt line 12,146
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
30 Oct 2030 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 8,633,219 with pediatric exclusivity, as listed
patent.txt line 3,637
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
30 Oct 2030 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,633,219 with pediatric exclusivity, as listed
patent.txt line 7,354
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
12 Nov 2030 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,088,368 with pediatric exclusivity, as listed
patent.txt lines 5,914, 5,947
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
12 Nov 2030 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,273,341 with pediatric exclusivity, as listed
patent.txt lines 5,916, 5,949
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
12 Nov 2030 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,822,430 with pediatric exclusivity, as listed
patent.txt lines 5,928, 5,961
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
12 Nov 2030 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,841,278 with pediatric exclusivity, as listed
patent.txt lines 5,930, 5,963
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
12 Nov 2030 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 9,511,056 with pediatric exclusivity, as listed
patent.txt line 5,940
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
12 Nov 2030 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 9,511,056 with pediatric exclusivity, as listed
patent.txt line 5,973
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002
12 Nov 2030 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,088,368 with pediatric exclusivity, as listed
patent.txt lines 13,987, 14,018
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
12 Nov 2030 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,273,341 with pediatric exclusivity, as listed
patent.txt lines 13,989, 14,020
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
12 Nov 2030 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,822,430 with pediatric exclusivity, as listed
patent.txt lines 14,001, 14,032
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
12 Nov 2030 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,841,278 with pediatric exclusivity, as listed
patent.txt lines 14,003, 14,034
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
12 Nov 2030 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 9,511,056 with pediatric exclusivity, as listed
patent.txt lines 14,013, 14,044
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
19 Nov 2030 · NDA 204026 · POMALIDOMIDE
US 10,555,939 with pediatric exclusivity, as listed
patent.txt lines 4,196, 4,202, 4,208, 4,214
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
19 Nov 2030 · NDA 204026 · POMALIDOMIDE
US 9,993,467 with pediatric exclusivity, as listed
patent.txt lines 4,200, 4,206, 4,212, 4,218
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
21 Nov 2030 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 9,155,705 with pediatric exclusivity, as listed
patent.txt lines 2,358, 2,376, 2,394
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
21 Nov 2030 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 9,155,705 with pediatric exclusivity, as listed
patent.txt lines 7,982, 8,001
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
25 Nov 2030 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,685,980 with pediatric exclusivity, as listed
patent.txt line 9,700
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
25 Nov 2030 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 8,685,980 with pediatric exclusivity, as listed
patent.txt line 11,045
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
26 Nov 2030 · NDA 202293 · DAPAGLIFLOZIN
US 8,685,934 with pediatric exclusivity, as listed
patent.txt lines 2,995, 3,033
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
26 Nov 2030 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,685,934 with pediatric exclusivity, as listed
patent.txt lines 5,716, 5,726, 5,736, 5,746, 5,756
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
4 Dec 2030 · NDA 201280 · LINAGLIPTIN
US 8,846,695 with pediatric exclusivity, as listed
patent.txt line 2,336
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
4 Dec 2030 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,846,695 with pediatric exclusivity, as listed
patent.txt lines 2,354, 2,372, 2,390
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
10 Dec 2030 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
US 10,028,937 with pediatric exclusivity, as listed
patent.txt line 10,294
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
10 Dec 2030 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
US 10,039,754 with pediatric exclusivity, as listed
patent.txt line 10,298
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
10 Dec 2030 · NDA 215110 · GLECAPREVIR; PIBRENTASVIR
US 10,028,937 with pediatric exclusivity, as listed
patent.txt line 16,476
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
10 Dec 2030 · NDA 215110 · GLECAPREVIR; PIBRENTASVIR
US 10,039,754 with pediatric exclusivity, as listed
patent.txt line 16,479
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
25 Dec 2030 · NDA 207947 · SELEXIPAG
US 9,284,280 with pediatric exclusivity, as listed
patent.txt lines 7,704, 7,716, 7,728, 7,740, 7,752, 7,764, 7,776, 7,788, 7,800, 7,812
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 010, 011
25 Dec 2030 · NDA 214275 · SELEXIPAG
US 9,284,280 with pediatric exclusivity, as listed
patent.txt line 15,664
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001

Non-patent exclusivity (60)

2 Jul 2030 · NDA 219839 · SUNVOZERTINIB
NCE exclusivity
exclusivity.txt lines 2,334–2,335
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
3 Jul 2030 · NDA 219301 · SEBETRALSTAT
NCE exclusivity
exclusivity.txt line 2,267
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
20 Jul 2030 · NDA 216993 · QUIZARTINIB DIHYDROCHLORIDE
ODE-437 exclusivity
exclusivity.txt lines 1,828, 1,830
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
23 Jul 2030 · NDA 219155 · DELGOCITINIB
NCE exclusivity
exclusivity.txt line 2,255
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
28 Jul 2030 · NDA 219666 · SEPIAPTERIN
NCE exclusivity
exclusivity.txt lines 2,311, 2,313
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
31 Jul 2030 · NDA 218585 · ACECLIDINE HYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 2,169
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
6 Aug 2030 · NDA 219876 · DORDAVIPRONE HYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 2,338
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
8 Aug 2030 · NDA 219042 · ZONGERTINIB
NCE exclusivity
exclusivity.txt line 2,236
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
12 Aug 2030 · NDA 217673 · BRENSOCATIB
NCE exclusivity
exclusivity.txt lines 1,909–1,910
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
14 Aug 2030 · NDA 201848 · MELPHALAN HYDROCHLORIDE
ODE-438 exclusivity
exclusivity.txt line 227
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
16 Aug 2030 · NDA 215559 · PALOVAROTENE
ODE-439 exclusivity
exclusivity.txt lines 1,592, 1,594, 1,596, 1,598, 1,600
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
18 Aug 2030 · NDA 209241 · VALBENAZINE TOSYLATE
ODE-440 exclusivity
exclusivity.txt lines 768, 770, 772
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
29 Aug 2030 · NDA 219685 · RILZABRUTINIB
NCE exclusivity
exclusivity.txt line 2,316
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
8 Sep 2030 · NDA 217159 · MOTIXAFORTIDE ACETATE
ODE-442 exclusivity
exclusivity.txt line 1,841
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
10 Sep 2030 · NDA 217026 · TROFINETIDE
PED exclusivity
exclusivity.txt line 1,838
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
10 Sep 2030 · NDA 219884 · TROFINETIDE
PED exclusivity
exclusivity.txt lines 2,345, 2,349, 2,353
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
15 Sep 2030 · NDA 216873 · MOMELOTINIB DIHYDROCHLORIDE
ODE-441 exclusivity
exclusivity.txt lines 1,798, 1,800, 1,802
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
16 Sep 2030 · NDA 202806 · DABRAFENIB MESYLATE
PED exclusivity
exclusivity.txt lines 289, 293
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
16 Sep 2030 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
PED exclusivity
exclusivity.txt lines 371, 375, 379
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
16 Sep 2030 · NDA 217513 · TRAMETINIB DIMETHYL SULFOXIDE
PED exclusivity
exclusivity.txt line 1,886
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
16 Sep 2030 · NDA 217514 · DABRAFENIB MESYLATE
PED exclusivity
exclusivity.txt line 1,890
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
19 Sep 2030 · NDA 215244 · ELAMIPRETIDE HYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 1,500
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
25 Sep 2030 · NDA 218881 · IMLUNESTRANT TOSYLATE
NCE exclusivity
exclusivity.txt line 2,212
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
25 Sep 2030 · NDA 219070 · PALTUSOTINE HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 2,237, 2,239
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
26 Sep 2030 · NDA 203341 · BOSUTINIB MONOHYDRATE
ODE-444 exclusivity
exclusivity.txt lines 308, 312, 316
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
26 Sep 2030 · NDA 217729 · BOSUTINIB MONOHYDRATE
ODE-444 exclusivity
exclusivity.txt lines 1,921, 1,925
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
28 Sep 2030 · NDA 207356 · AMIKACIN SULFATE
GAIN exclusivity
exclusivity.txt line 588
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001
29 Sep 2030 · NDA 215842 · NEDOSIRAN SODIUM
ODE-443 exclusivity
exclusivity.txt lines 1,615, 1,619, 1,623
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
30 Sep 2030 · NDA 218436 · REMIBRUTINIB
NCE exclusivity
exclusivity.txt line 2,155
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
7 Oct 2030 · NDA 218764 · NERANDOMILAST
NCE exclusivity
exclusivity.txt lines 2,186, 2,189
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
11 Oct 2030 · NDA 210496 · ENCORAFENIB
ODE-445 exclusivity
exclusivity.txt lines 883, 887
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
17 Oct 2030 · NDA 216834 · ZILUCOPLAN SODIUM
ODE-446 exclusivity
exclusivity.txt lines 1,792, 1,794, 1,796
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
20 Oct 2030 · NDA 212725 · ENTRECTINIB
ODE-448 exclusivity
exclusivity.txt lines 1,109, 1,113
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
20 Oct 2030 · NDA 214938 · VOSORITIDE
ODE-449 exclusivity
exclusivity.txt lines 1,427, 1,431, 1,435
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
20 Oct 2030 · NDA 218550 · ENTRECTINIB
ODE-448 exclusivity
exclusivity.txt line 2,167
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
24 Oct 2030 · NDA 211192 · IVOSIDENIB
ODE-447 exclusivity
exclusivity.txt line 945
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
24 Oct 2030 · NDA 219469 · ELINZANETANT
NCE exclusivity
exclusivity.txt line 2,287
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
26 Oct 2030 · NDA 215239 · VAMOROLONE
ODE-450 exclusivity
exclusivity.txt line 1,499
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
3 Nov 2030 · NDA 207925 · IVACAFTOR
PED exclusivity
exclusivity.txt lines 649, 655
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
004, 005
3 Nov 2030 · NDA 219792 · DOXECITINE; DOXRIBTIMINE
NCE exclusivity
exclusivity.txt line 2,331
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
13 Nov 2030 · NDA 220305 · ZIFTOMENIB
NCE exclusivity
exclusivity.txt line 2,383
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
15 Nov 2030 · NDA 218213 · REPOTRECTINIB
ODE-455 exclusivity
exclusivity.txt line 2,127
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
15 Nov 2030 · NDA 218213 · REPOTRECTINIB
ODE* exclusivity
exclusivity.txt line 2,130
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
002
19 Nov 2030 · NDA 219972 · SEVABERTINIB
NCE exclusivity
exclusivity.txt line 2,366
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
27 Nov 2030 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
ODE-452 exclusivity
exclusivity.txt line 1,912
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
27 Nov 2030 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
ODE* exclusivity
exclusivity.txt lines 1,914, 1,916
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
002, 003
1 Dec 2030 · NDA 216059 · PIRTOBRUTINIB
ODE-451 exclusivity
exclusivity.txt lines 1,716, 1,721
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
5 Dec 2030 · NDA 218276 · IPTACOPAN HYDROCHLORIDE
ODE-456 exclusivity
exclusivity.txt line 2,140
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
8 Dec 2030 · NDA 207500 · ISAVUCONAZONIUM SULFATE
ODE-454 exclusivity
exclusivity.txt lines 594, 605
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
8 Dec 2030 · NDA 207500 · ISAVUCONAZONIUM SULFATE
ODE-458 exclusivity
exclusivity.txt lines 595, 606
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
8 Dec 2030 · NDA 207501 · ISAVUCONAZONIUM SULFATE
ODE-453 exclusivity
exclusivity.txt line 615
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
8 Dec 2030 · NDA 207501 · ISAVUCONAZONIUM SULFATE
ODE-459 exclusivity
exclusivity.txt line 616
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
12 Dec 2030 · NDA 218571 · ETRIPAMIL
NCE exclusivity
exclusivity.txt line 2,168
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
12 Dec 2030 · NDA 219491 · ZOLIFLODACIN
NCE exclusivity
exclusivity.txt line 2,300
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
13 Dec 2030 · NDA 215500 · EFLORNITHINE HYDROCHLORIDE
ODE-462 exclusivity
exclusivity.txt line 1,586
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
18 Dec 2030 · NDA 215064 · BIRCH TRITERPENES
ODE-460 exclusivity
exclusivity.txt line 1,471
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
19 Dec 2030 · NDA 219083 · AFICAMTEN
NCE exclusivity
exclusivity.txt lines 2,241–2,244
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
20 Dec 2030 · NDA 215935 · BUDESONIDE
ODE-464 exclusivity
exclusivity.txt line 1,676
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
21 Dec 2030 · NDA 217388 · EPLONTERSEN SODIUM
ODE-461 exclusivity
exclusivity.txt line 1,871
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
30 Dec 2030 · NDA 220152 · TRADIPITANT
NCE exclusivity
exclusivity.txt line 2,378
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001