Drybench Patent.

Patent and exclusivity dates in 2032 for NDAs on FDA's Paragraph IV list, as FDA lists them

Each patent and exclusivity date in 2032 that FDA's Orange Book lists, as captured on 14 October 2026, for the 607 NDAs that FDA's Paragraph IV list names, as captured on 17 October 2026, and whose Orange Book capture lists a patent or exclusivity. Each entry is named by its rule and linked to its NDA page. A date here belongs to one patent or one exclusivity on the products named; the same NDA may have other listed dates, earlier or later, so no date here stands for a product.

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

Orange Book captured: 14 October 2026
Paragraph IV list captured: 17 October 2026

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

This page covers only NDAs that FDA's Paragraph IV list names and that have Orange Book listings. It does not cover other NDAs or any BLA. NCE exclusivity dates are here as FDA lists them; NCE-1 dates, computed from them, are on the NCE-1 calendar.

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

FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.

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

Listed patent expiry (297)

1 Jan 2032 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 10,561,808, product patent
patent.txt lines 7,443, 7,458
Flags
product delist requested
Product numbers
001, 002
4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 10,016,396, product patent
patent.txt lines 407, 420
Flags
product
Product numbers
002, 003
4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 8,242,158, product patent
patent.txt lines 409, 422, 434
Flags
product
Product numbers
002, 003, 004
4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 8,338,470, product patent
patent.txt lines 411, 424, 436
Flags
product
Product numbers
002, 003, 004
4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 8,455,527, use patent
patent.txt lines 413, 426, 438
Flags
use code U-421
Product numbers
002, 003, 004
4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 8,648,106, product patent
patent.txt lines 415, 428, 440
Flags
product
Product numbers
002, 003, 004
4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 9,320,712, product patent
patent.txt lines 417, 430, 442
Flags
product
Product numbers
002, 003, 004
4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 9,616,049, product patent
patent.txt lines 419, 432, 444
Flags
product
Product numbers
002, 003, 004
4 Jan 2032 · NDA 215596 · MARIBAVIR
US 11,684,632, use patent
patent.txt line 17,471
Flags
use code U-3650
Product numbers
001
5 Jan 2032 · NDA 209884 · SIPONIMOD
US 12,071,402, product patent
patent.txt lines 10,986, 10,991, 10,996
Flags
product
Product numbers
001, 002, 003
13 Jan 2032 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 9,248,123, use patent
patent.txt line 2,213
Flags
use code U-1808
Product numbers
001
28 Jan 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,580,304, product patent
patent.txt lines 4,276, 4,296, 4,316
Flags
product
Product numbers
001, 002, 003
28 Jan 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 9,155,706, product patent
patent.txt lines 4,286, 4,306, 4,326
Flags
product
Product numbers
001, 002, 003
28 Jan 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 9,271,941, product patent
patent.txt lines 4,288, 4,308, 4,328
Flags
product
Product numbers
001, 002, 003
28 Jan 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 9,399,021, product patent
patent.txt lines 4,290, 4,310, 4,330
Flags
product
Product numbers
001, 002, 003
29 Jan 2032 · NDA 208573 · VENETOCLAX
US 8,722,657, substance patent
patent.txt lines 8,868, 8,882, 8,896
Flags
substance
Product numbers
001, 002, 003
1 Feb 2032 · NDA 209637 · SEMAGLUTIDE
US 9,132,239, product patent
patent.txt lines 10,695, 10,713, 10,730, 10,748
Flags
product delist requested
Product numbers
001, 002, 003, 004
10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE
US 10,335,432, use patent
patent.txt line 7,010
Flags
use code U-2312
Product numbers
001
10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE
US 10,398,730, use patent
patent.txt lines 7,011, 7,024
Flags
use code U-2312
Product numbers
001, 002
10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE
US 10,413,569, substance patent
patent.txt lines 7,012, 7,025
Flags
substance
Product numbers
001, 002
10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE
US 11,406,662, substance patent
patent.txt lines 7,014, 7,027
Flags
substance
Product numbers
001, 002
10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE
US 8,808,750, use patent
patent.txt lines 7,017, 7,030
Flags
use code U-2312
Product numbers
001, 002
10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE
US 9,844,567, use patent
patent.txt lines 7,020, 7,033
Flags
use code U-2312
Product numbers
001, 002
10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE
US 9,861,658, use patent
patent.txt lines 7,021, 7,034
Flags
use code U-2312
Product numbers
001, 002
10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE
US 11,298,349, product patent
patent.txt lines 9,187, 9,207, 9,227
Flags
product
Product numbers
001, 002, 003
10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE
US 12,128,039, product and use patent
patent.txt lines 9,188, 9,208, 9,228
Flags
product use code U-1220
Product numbers
001, 002, 003
10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE
US 12,128,039, product and use patent
patent.txt lines 9,189, 9,209, 9,229
Flags
product use code U-1480
Product numbers
001, 002, 003
10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE
US 12,128,039, product and use patent
patent.txt lines 9,190, 9,210, 9,230
Flags
product use code U-2488
Product numbers
001, 002, 003
10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE
US 12,128,039, product and use patent
patent.txt lines 9,191, 9,211, 9,231
Flags
product use code U-3225
Product numbers
001, 002, 003
10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE
US 12,128,039, product and use patent
patent.txt lines 9,192, 9,212, 9,232
Flags
product use code U-4131
Product numbers
001, 002, 003
10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE
US 12,128,039, product and use patent
patent.txt lines 9,193, 9,213, 9,233
Flags
product use code U-4156
Product numbers
001, 002, 003
13 Feb 2032 · NDA 213378 · OLANZAPINE; SAMIDORPHAN L-MALATE
US 8,778,960, use patent
patent.txt lines 14,898, 14,919, 14,940, 14,961
Flags
use code U-3136
Product numbers
001, 002, 003, 004
13 Feb 2032 · NDA 213378 · OLANZAPINE; SAMIDORPHAN L-MALATE
US 8,778,960, use patent
patent.txt lines 14,899, 14,920, 14,941, 14,962
Flags
use code U-3137
Product numbers
001, 002, 003, 004
14 Feb 2032 · NDA 210951 · APALUTAMIDE
US 8,445,507, substance and product and use patent
patent.txt lines 12,440, 12,458
Flags
substance product use code U-2237
Product numbers
001, 002
14 Feb 2032 · NDA 210951 · APALUTAMIDE
US 8,445,507, substance and product and use patent
patent.txt lines 12,441, 12,459
Flags
substance product use code U-2624
Product numbers
001, 002
17 Feb 2032 · NDA 206333 · DEOXYCHOLIC ACID
US 12,161,653, use patent
patent.txt line 6,477
Flags
use code U-1940
Product numbers
001
1 Mar 2032 · NDA 021829 · ROTIGOTINE
US 9,925,150, product patent
patent.txt lines 712, 717, 722, 727, 732, 737
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
1 Mar 2032 · NDA 208745 · PLECANATIDE
US 11,319,346, product patent
patent.txt line 9,305
Flags
product
Product numbers
001
2 Mar 2032 · NDA 021903 · IBUPROFEN LYSINE
US 8,415,337, substance and product patent
patent.txt line 766
Flags
substance product
Product numbers
001
4 Mar 2032 · NDA 021660 · PACLITAXEL
US 9,393,318, use patent
patent.txt line 668
Flags
use code U-1290
Product numbers
001
4 Mar 2032 · NDA 021660 · PACLITAXEL
US 9,597,409, use patent
patent.txt line 672
Flags
use code U-1290
Product numbers
001
4 Mar 2032 · NDA 208434 · ALECTINIB HYDROCHLORIDE
US 9,365,514, product patent
patent.txt line 8,619
Flags
product
Product numbers
001
5 Mar 2032 · NDA 022287 · DEXLANSOPRAZOLE
US 9,233,103, use patent
patent.txt lines 1,563, 1,577
Flags
use code U-1805
Product numbers
001, 002
7 Mar 2032 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 10,596,120, product and use patent
patent.txt lines 9,039, 9,071, 9,103, 9,133
Flags
product use code U-2775
Product numbers
001, 002, 003, 004
7 Mar 2032 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 10,596,120, product and use patent
patent.txt lines 9,040, 9,072, 9,104, 9,134
Flags
product use code U-2792
Product numbers
001, 002, 003, 004
7 Mar 2032 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 10,596,120, product and use patent
patent.txt lines 14,229, 14,259, 14,289, 14,319
Flags
product use code U-2776
Product numbers
001, 002, 003, 004
7 Mar 2032 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 10,596,120, product and use patent
patent.txt lines 14,230, 14,260, 14,290, 14,320
Flags
product use code U-2790
Product numbers
001, 002, 003, 004
7 Mar 2032 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 11,564,886, product and use patent
patent.txt lines 14,233, 14,263, 14,293
Flags
product use code U-3531
Product numbers
001, 002, 003
9 Mar 2032 · NDA 209381 · ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
US 10,780,112, product patent
patent.txt line 10,278
Flags
product
Product numbers
001
9 Mar 2032 · NDA 209381 · ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
US 10,792,306, product and use patent
patent.txt line 10,279
Flags
product use code U-2310
Product numbers
001
9 Mar 2032 · NDA 209381 · ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
US 11,529,368, product and use patent
patent.txt line 10,281
Flags
product use code U-2310
Product numbers
001
21 Mar 2032 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,278,096, use patent
patent.txt lines 4,713, 4,733, 4,753, 4,773
Flags
use code U-2436
Product numbers
001, 002, 003, 004
25 Mar 2032 · NDA 209381 · ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
US 10,646,512, product patent
patent.txt line 10,277
Flags
product
Product numbers
001
30 Mar 2032 · NDA 022145 · RALTEGRAVIR POTASSIUM
US 10,772,888, use patent
patent.txt line 1,117
Flags
use code U-1663
Product numbers
002
30 Mar 2032 · NDA 022527 · FINGOLIMOD HYDROCHLORIDE
US 9,592,208, product and use patent
patent.txt line 2,051
Flags
product use code U-2315
Product numbers
002
31 Mar 2032 · NDA 203491 · NEPAFENAC
US 8,921,337, product patent
patent.txt line 3,944
Flags
product
Product numbers
001
2 Apr 2032 · NDA 204760 · NALOXEGOL OXALATE
US 9,012,469, substance and product patent
patent.txt lines 4,993, 4,995
Flags
substance product
Product numbers
001, 002
6 Apr 2032 · NDA 021539 · ACETYLCYSTEINE
US 8,722,738, use patent
patent.txt line 629
Flags
use code U-1373
Product numbers
001
7 Apr 2032 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 9,061,029, substance and use patent
patent.txt lines 1,006, 1,020, 1,034
Flags
substance use code U-1374
Product numbers
001, 002, 003
7 Apr 2032 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 9,061,029, substance and use patent
patent.txt lines 1,007, 1,021, 1,035
Flags
substance use code U-3231
Product numbers
001, 002, 003
16 Apr 2032 · NDA 050790 · CYCLOSPORINE
US 8,561,859, product patent
patent.txt line 2,141
Flags
product delist requested
Product numbers
002
19 Apr 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE
US 8,802,152, substance patent
patent.txt lines 7,016, 7,029
Flags
substance
Product numbers
001, 002
23 Apr 2032 · NDA 019034 · HYDROMORPHONE HYDROCHLORIDE
US 9,731,082, product patent
patent.txt lines 144, 146, 148, 150, 152, 154, 156
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
27 Apr 2032 · NDA 022201 · DEGARELIX ACETATE
US 10,695,398, use patent
patent.txt lines 1,314, 1,323
Flags
use code U-1895
Product numbers
001, 002
27 Apr 2032 · NDA 022201 · DEGARELIX ACETATE
US 11,766,468, use patent
patent.txt lines 1,317, 1,326
Flags
use code U-1978
Product numbers
001, 002
27 Apr 2032 · NDA 022201 · DEGARELIX ACETATE
US 11,826,397, use patent
patent.txt lines 1,318, 1,327
Flags
use code U-1978
Product numbers
001, 002
27 Apr 2032 · NDA 022201 · DEGARELIX ACETATE
US 9,415,085, use patent
patent.txt lines 1,321, 1,330
Flags
use code U-1895
Product numbers
001, 002
3 May 2032 · NDA 216196 · MITAPIVAT SULFATE
US 10,632,114, use patent
patent.txt lines 18,432, 18,441, 18,450
Flags
use code U-3320
Product numbers
001, 002, 003
3 May 2032 · NDA 216196 · MITAPIVAT SULFATE
US 10,632,114, use patent
patent.txt line 18,459
Flags
use code U-4391
Product numbers
004
3 May 2032 · NDA 216196 · MITAPIVAT SULFATE
US 9,682,080, use patent
patent.txt lines 18,438, 18,447, 18,456
Flags
use code U-3319
Product numbers
001, 002, 003
3 May 2032 · NDA 216196 · MITAPIVAT SULFATE
US 9,682,080, use patent
patent.txt line 18,463
Flags
use code U-4392
Product numbers
004
3 May 2032 · NDA 216196 · MITAPIVAT SULFATE
US 9,980,961, use patent
patent.txt lines 18,439, 18,448, 18,457
Flags
use code U-3319
Product numbers
001, 002, 003
10 May 2032 · NDA 022088 · TEMSIROLIMUS
US 8,791,097, use patent
patent.txt line 1,049
Flags
use code U-1550
Product numbers
001
10 May 2032 · NDA 022088 · TEMSIROLIMUS
US 8,791,097, use patent
patent.txt line 1,050
Flags
use code U-1551
Product numbers
001
19 May 2032 · NDA 206276 · OLOPATADINE HYDROCHLORIDE
US 8,791,154, product and use patent
patent.txt line 6,455
Flags
product use code U-1680
Product numbers
001
19 May 2032 · NDA 206276 · OLOPATADINE HYDROCHLORIDE
US 9,533,053, product patent
patent.txt line 6,456
Flags
product
Product numbers
001
23 May 2032 · NDA 204168 · LEVOMILNACIPRAN HYDROCHLORIDE
US 8,865,937, substance and product patent
patent.txt lines 4,338, 4,341, 4,344, 4,347
Flags
substance product
Product numbers
001, 002, 003, 004
23 May 2032 · NDA 208573 · VENETOCLAX
US 11,369,599, product patent
patent.txt lines 8,864, 8,878, 8,892
Flags
product
Product numbers
001, 002, 003
23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
US 10,208,073, use patent
patent.txt lines 11,479, 11,491
Flags
use code U-2301
Product numbers
001, 002
23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
US 10,717,721, substance patent
patent.txt lines 11,481, 11,493
Flags
substance
Product numbers
001, 002
23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
US 11,312,698, substance and product patent
patent.txt lines 11,483, 11,495
Flags
substance product
Product numbers
001, 002
23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
US 8,426,450, substance and product patent
patent.txt lines 11,486, 11,498
Flags
substance product
Product numbers
001, 002
23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
US 8,895,586, use patent
patent.txt lines 11,487, 11,499
Flags
use code U-2301
Product numbers
001, 002
23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
US 9,403,772, substance and use patent
patent.txt lines 11,489, 11,501
Flags
substance use code U-2301
Product numbers
001, 002
23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
US 9,908,907, substance and product patent
patent.txt lines 11,490, 11,502
Flags
substance product
Product numbers
001, 002
31 May 2032 · NDA 207924 · BARICITINIB
US 8,158,616, substance and product patent
patent.txt lines 7,476, 7,482, 7,488
Flags
substance product
Product numbers
001, 002, 003
4 Jun 2032 · NDA 212327 · FEDRATINIB HYDROCHLORIDE
US 10,391,094, product and use patent
patent.txt line 13,949
Flags
product use code U-2607
Product numbers
001
5 Jun 2032 · NDA 205494 · ELIGLUSTAT TARTRATE
US 12,465,586, use patent
patent.txt line 5,456
Flags
use code U-3042
Product numbers
001
5 Jun 2032 · NDA 205494 · ELIGLUSTAT TARTRATE
US 12,465,586, use patent
patent.txt line 5,457
Flags
use code U-3043
Product numbers
001
13 Jun 2032 · NDA 211635 · DIAZEPAM
US 12,337,061, use patent
patent.txt lines 12,912, 12,920, 12,928
Flags
use code U-4173
Product numbers
001, 002, 003
15 Jun 2032 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 8,969,566, substance patent
patent.txt line 6,580
Flags
substance
Product numbers
001
15 Jun 2032 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 9,284,314, substance patent
patent.txt line 6,581
Flags
substance
Product numbers
001
15 Jun 2032 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 9,695,122, substance patent
patent.txt line 6,582
Flags
substance
Product numbers
001
22 Jun 2032 · NDA 208114 · DEFIBROTIDE SODIUM
US 11,085,043, product patent
patent.txt line 8,263
Flags
product
Product numbers
001
22 Jun 2032 · NDA 208114 · DEFIBROTIDE SODIUM
US 11,236,328, use patent
patent.txt line 8,264
Flags
use code U-3301
Product numbers
001
22 Jun 2032 · NDA 208114 · DEFIBROTIDE SODIUM
US 11,746,348, product patent
patent.txt line 8,265
Flags
product
Product numbers
001
22 Jun 2032 · NDA 208114 · DEFIBROTIDE SODIUM
US 12,529,052, product patent
patent.txt line 8,266
Flags
product
Product numbers
001
22 Jun 2032 · NDA 208114 · DEFIBROTIDE SODIUM
US 12,534,722, product patent
patent.txt line 8,267
Flags
product
Product numbers
001
28 Jun 2032 · NDA 204326 · AMPHETAMINE
US 8,709,491, product patent
patent.txt lines 4,476, 4,481, 4,486, 4,491, 4,496, 4,501
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
28 Jun 2032 · NDA 204326 · AMPHETAMINE
US 9,017,731, product patent
patent.txt lines 4,478, 4,483, 4,488, 4,493, 4,498, 4,503
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
28 Jun 2032 · NDA 204326 · AMPHETAMINE
US 9,265,737, product patent
patent.txt lines 4,479, 4,484, 4,489, 4,494, 4,499, 4,504
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
28 Jun 2032 · NDA 204326 · AMPHETAMINE
US 9,839,619, product patent
patent.txt lines 4,480, 4,485, 4,490, 4,495, 4,500, 4,505
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
28 Jun 2032 · NDA 205223 · METRONIDAZOLE
US 10,238,634, product patent
patent.txt line 5,271
Flags
product
Product numbers
001
28 Jun 2032 · NDA 205223 · METRONIDAZOLE
US 10,596,155, product patent
patent.txt line 5,272
Flags
product
Product numbers
001
28 Jun 2032 · NDA 205223 · METRONIDAZOLE
US 8,946,276, use patent
patent.txt line 5,276
Flags
use code U-1664
Product numbers
001
28 Jun 2032 · NDA 205223 · METRONIDAZOLE
US 9,198,858, use patent
patent.txt line 5,277
Flags
use code U-1664
Product numbers
001
28 Jun 2032 · NDA 205489 · METHYLPHENIDATE
US 9,072,680, product patent
patent.txt lines 5,441, 5,445, 5,449
Flags
product
Product numbers
001, 002, 003
28 Jun 2032 · NDA 205489 · METHYLPHENIDATE
US 9,089,496, product patent
patent.txt lines 5,442, 5,446, 5,450
Flags
product
Product numbers
001, 002, 003
29 Jun 2032 · NDA 208078 · AMIFAMPRIDINE PHOSPHATE
US 11,060,128, use patent
patent.txt line 8,096
Flags
use code U-2956
Product numbers
001
29 Jun 2032 · NDA 208078 · AMIFAMPRIDINE PHOSPHATE
US 11,268,128, use patent
patent.txt line 8,097
Flags
use code U-2956
Product numbers
001
29 Jun 2032 · NDA 208078 · AMIFAMPRIDINE PHOSPHATE
US 11,274,331, use patent
patent.txt line 8,098
Flags
use code U-2956
Product numbers
001
29 Jun 2032 · NDA 208078 · AMIFAMPRIDINE PHOSPHATE
US 11,274,332, use patent
patent.txt line 8,099
Flags
use code U-2956
Product numbers
001
9 Jul 2032 · NDA 203085 · REGORAFENIB
US 9,957,232, substance patent
patent.txt line 3,608
Flags
substance
Product numbers
001
9 Jul 2032 · NDA 208694 · CETIRIZINE HYDROCHLORIDE
US 9,254,286, product patent
patent.txt line 9,240
Flags
product
Product numbers
001
11 Jul 2032 · NDA 210259 · ACALABRUTINIB
US 10,239,883, use patent
patent.txt line 11,246
Flags
use code U-2666
Product numbers
001
11 Jul 2032 · NDA 210259 · ACALABRUTINIB
US 10,239,883, use patent
patent.txt line 11,247
Flags
use code U-2668
Product numbers
001
11 Jul 2032 · NDA 210259 · ACALABRUTINIB
US 9,290,504, substance and product patent
patent.txt line 11,264
Flags
substance product
Product numbers
001
11 Jul 2032 · NDA 210259 · ACALABRUTINIB
US 9,758,524, use patent
patent.txt line 11,265
Flags
use code U-2145
Product numbers
001
11 Jul 2032 · NDA 210259 · ACALABRUTINIB
US 9,758,524, use patent
patent.txt line 11,266
Flags
use code U-4108
Product numbers
001
11 Jul 2032 · NDA 216387 · ACALABRUTINIB MALEATE
US 10,239,883, use patent
patent.txt line 18,765
Flags
use code U-2666
Product numbers
001
11 Jul 2032 · NDA 216387 · ACALABRUTINIB MALEATE
US 10,239,883, use patent
patent.txt line 18,766
Flags
use code U-2668
Product numbers
001
11 Jul 2032 · NDA 216387 · ACALABRUTINIB MALEATE
US 9,290,504, substance and product patent
patent.txt line 18,791
Flags
substance product
Product numbers
001
11 Jul 2032 · NDA 216387 · ACALABRUTINIB MALEATE
US 9,758,524, use patent
patent.txt line 18,792
Flags
use code U-2145
Product numbers
001
11 Jul 2032 · NDA 216387 · ACALABRUTINIB MALEATE
US 9,758,524, use patent
patent.txt line 18,793
Flags
use code U-4108
Product numbers
001
18 Jul 2032 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 8,569,328, product and use patent
patent.txt line 17,080
Flags
product use code U-3419
Product numbers
001
18 Jul 2032 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 8,569,328, product and use patent
patent.txt lines 17,081, 17,158
Flags
product use code U-4516
Product numbers
001, 002
19 Jul 2032 · NDA 211765 · UBROGEPANT
US 8,754,096, substance and product and use patent
patent.txt lines 13,167, 13,179
Flags
substance product use code U-2717
Product numbers
001, 002
25 Jul 2032 · NDA 208065 · OSIMERTINIB MESYLATE
US 11,524,951, substance and product patent
patent.txt lines 8,054, 8,071
Flags
substance product
Product numbers
001, 002
25 Jul 2032 · NDA 208065 · OSIMERTINIB MESYLATE
US 9,732,058, substance and product and use patent
patent.txt lines 8,061, 8,078
Flags
substance product use code U-1777
Product numbers
001, 002
25 Jul 2032 · NDA 208065 · OSIMERTINIB MESYLATE
US 9,732,058, substance and product and use patent
patent.txt lines 8,062, 8,079
Flags
substance product use code U-2289
Product numbers
001, 002
25 Jul 2032 · NDA 208065 · OSIMERTINIB MESYLATE
US 9,732,058, substance and product and use patent
patent.txt lines 8,063, 8,080
Flags
substance product use code U-3016
Product numbers
001, 002
25 Jul 2032 · NDA 208065 · OSIMERTINIB MESYLATE
US 9,732,058, substance and product and use patent
patent.txt lines 8,064, 8,081
Flags
substance product use code U-3823
Product numbers
001, 002
25 Jul 2032 · NDA 208065 · OSIMERTINIB MESYLATE
US 9,732,058, substance and product and use patent
patent.txt lines 8,065, 8,082
Flags
substance product use code U-4010
Product numbers
001, 002
27 Jul 2032 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,771,648, product patent
patent.txt lines 10,046, 10,060
Flags
product
Product numbers
001, 002
27 Jul 2032 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,951,504, use patent
patent.txt lines 10,048, 10,062
Flags
use code U-2294
Product numbers
001, 002
8 Aug 2032 · NDA 208065 · OSIMERTINIB MESYLATE
US 8,946,235, substance and product and use patent
patent.txt lines 8,056, 8,073
Flags
substance product use code U-1777
Product numbers
001, 002
8 Aug 2032 · NDA 208065 · OSIMERTINIB MESYLATE
US 8,946,235, substance and product and use patent
patent.txt lines 8,057, 8,074
Flags
substance product use code U-2289
Product numbers
001, 002
8 Aug 2032 · NDA 208065 · OSIMERTINIB MESYLATE
US 8,946,235, substance and product and use patent
patent.txt lines 8,058, 8,075
Flags
substance product use code U-3016
Product numbers
001, 002
8 Aug 2032 · NDA 208065 · OSIMERTINIB MESYLATE
US 8,946,235, substance and product and use patent
patent.txt lines 8,059, 8,076
Flags
substance product use code U-3823
Product numbers
001, 002
8 Aug 2032 · NDA 208065 · OSIMERTINIB MESYLATE
US 8,946,235, substance and product and use patent
patent.txt lines 8,060, 8,077
Flags
substance product use code U-4010
Product numbers
001, 002
11 Aug 2032 · NDA 209381 · ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
US 9,592,252, product and use patent
patent.txt line 10,285
Flags
product use code U-2310
Product numbers
001
15 Aug 2032 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,754,065, substance and product and use patent
patent.txt line 7,357
Flags
substance product use code U-257
Product numbers
001
15 Aug 2032 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 9,296,769, substance and product and use patent
patent.txt line 7,361
Flags
substance product use code U-257
Product numbers
001
15 Aug 2032 · NDA 208215 · EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,754,065, substance and product and use patent
patent.txt line 8,336
Flags
substance product use code U-1259
Product numbers
001
15 Aug 2032 · NDA 208215 · EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,754,065, substance and product and use patent
patent.txt line 8,338
Flags
substance product use code U-257
Product numbers
001
15 Aug 2032 · NDA 208215 · EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,754,065, substance and product and use patent
patent.txt lines 8,337, 8,345
Flags
substance product use code U-1663
Product numbers
001, 002
15 Aug 2032 · NDA 208215 · EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 9,296,769, substance and product and use patent
patent.txt line 8,340
Flags
substance product use code U-1259
Product numbers
001
15 Aug 2032 · NDA 208215 · EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 9,296,769, substance and product and use patent
patent.txt line 8,342
Flags
substance product use code U-257
Product numbers
001
15 Aug 2032 · NDA 208215 · EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 9,296,769, substance and product and use patent
patent.txt lines 8,341, 8,347
Flags
substance product use code U-1663
Product numbers
001, 002
15 Aug 2032 · NDA 208351 · EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,754,065, substance and product and use patent
patent.txt line 8,544
Flags
substance product use code U-257
Product numbers
001
15 Aug 2032 · NDA 208351 · EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
US 9,296,769, substance and product and use patent
patent.txt line 8,546
Flags
substance product use code U-257
Product numbers
001
15 Aug 2032 · NDA 208464 · TENOFOVIR ALAFENAMIDE FUMARATE
US 8,754,065, substance and product and use patent
patent.txt line 8,660
Flags
substance product use code U-1275
Product numbers
001
15 Aug 2032 · NDA 208464 · TENOFOVIR ALAFENAMIDE FUMARATE
US 8,754,065, substance and product and use patent
patent.txt line 8,661
Flags
substance product use code U-3880
Product numbers
001
15 Aug 2032 · NDA 208464 · TENOFOVIR ALAFENAMIDE FUMARATE
US 8,754,065, substance and product and use patent
patent.txt line 8,662
Flags
substance product use code U-999
Product numbers
001
15 Aug 2032 · NDA 208464 · TENOFOVIR ALAFENAMIDE FUMARATE
US 9,296,769, substance and product and use patent
patent.txt line 8,664
Flags
substance product use code U-1275
Product numbers
001
15 Aug 2032 · NDA 208464 · TENOFOVIR ALAFENAMIDE FUMARATE
US 9,296,769, substance and product and use patent
patent.txt line 8,665
Flags
substance product use code U-3880
Product numbers
001
15 Aug 2032 · NDA 208464 · TENOFOVIR ALAFENAMIDE FUMARATE
US 9,296,769, substance and product and use patent
patent.txt line 8,666
Flags
substance product use code U-999
Product numbers
001
15 Aug 2032 · NDA 210251 · BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,754,065, substance and product and use patent
patent.txt lines 11,216, 11,225
Flags
substance product use code U-257
Product numbers
001, 002
15 Aug 2032 · NDA 210251 · BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 9,296,769, substance and product and use patent
patent.txt lines 11,219, 11,228
Flags
substance product use code U-257
Product numbers
001, 002
15 Aug 2032 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,754,065, substance and product and use patent
patent.txt line 11,410
Flags
substance product use code U-2352
Product numbers
001
15 Aug 2032 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,754,065, substance and product and use patent
patent.txt line 11,411
Flags
substance product use code U-2765
Product numbers
001
15 Aug 2032 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 9,296,769, substance and product and use patent
patent.txt line 11,412
Flags
substance product use code U-2352
Product numbers
001
15 Aug 2032 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 9,296,769, substance and product and use patent
patent.txt line 11,413
Flags
substance product use code U-2765
Product numbers
001
20 Aug 2032 · NDA 205637 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 8,703,177, product patent
patent.txt lines 5,699, 5,703, 5,707
Flags
product
Product numbers
001, 002, 003
20 Aug 2032 · NDA 208745 · PLECANATIDE
US 9,616,097, product patent
patent.txt line 9,311
Flags
product
Product numbers
001
24 Aug 2032 · NDA 022416 · ESLICARBAZEPINE ACETATE
US 9,750,747, use patent
patent.txt lines 1,820, 1,828, 1,836, 1,844
Flags
use code U-2041
Product numbers
001, 002, 003, 004
24 Aug 2032 · NDA 022416 · ESLICARBAZEPINE ACETATE
US 9,750,747, use patent
patent.txt lines 1,821, 1,829, 1,837, 1,845
Flags
use code U-2121
Product numbers
001, 002, 003, 004
29 Aug 2032 · NDA 202231 · LEVOTHYROXINE SODIUM
US 9,168,238, product patent
patent.txt lines 2,948, 2,951, 2,954
Flags
product
Product numbers
001, 002, 003
29 Aug 2032 · NDA 202231 · LEVOTHYROXINE SODIUM
US 9,168,239, product patent
patent.txt lines 2,949, 2,952, 2,955
Flags
product
Product numbers
001, 002, 003
30 Aug 2032 · NDA 210807 · DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
US 8,486,975, substance and product and use patent
patent.txt line 12,157
Flags
substance product use code U-2395
Product numbers
001
30 Aug 2032 · NDA 210807 · DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
US 8,486,975, substance and product and use patent
patent.txt line 12,158
Flags
substance product use code U-2629
Product numbers
001
30 Aug 2032 · NDA 210807 · DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
US 8,486,975, substance and product and use patent
patent.txt line 12,159
Flags
substance product use code U-3307
Product numbers
001
18 Sep 2032 · NDA 204242 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 10,874,661, product patent
patent.txt line 4,380
Flags
product
Product numbers
002
18 Sep 2032 · NDA 204242 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 10,946,010, product patent
patent.txt lines 4,372, 4,381, 4,390, 4,399, 4,408, 4,417
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
18 Sep 2032 · NDA 204242 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 11,020,387, product and use patent
patent.txt lines 4,382, 4,391, 4,400, 4,409
Flags
product use code U-3131
Product numbers
002, 003, 004, 005
18 Sep 2032 · NDA 204242 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 11,020,388, product and use patent
patent.txt lines 4,373, 4,383, 4,392, 4,401, 4,410, 4,418
Flags
product use code U-3131
Product numbers
001, 002, 003, 004, 005, 006
18 Sep 2032 · NDA 204242 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 11,433,066, use patent
patent.txt lines 4,374, 4,384, 4,393, 4,402, 4,411
Flags
use code U-3131
Product numbers
001, 002, 003, 004, 005
18 Sep 2032 · NDA 204242 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 8,940,330, product patent
patent.txt lines 4,377, 4,387, 4,396, 4,405, 4,414, 4,421
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
18 Sep 2032 · NDA 204242 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 9,259,421, product patent
patent.txt lines 4,378, 4,388, 4,397, 4,406, 4,415, 4,422
Flags
product
Product numbers
001, 002, 003, 004, 005, 006
18 Sep 2032 · NDA 204242 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 9,439,900, product patent
patent.txt lines 4,379, 4,389, 4,398, 4,407, 4,416
Flags
product
Product numbers
001, 002, 003, 004, 005
3 Oct 2032 · NDA 202231 · LEVOTHYROXINE SODIUM
US 9,006,289, product patent
patent.txt lines 2,947, 2,950, 2,953
Flags
product
Product numbers
001, 002, 003
6 Oct 2032 · NDA 203094 · COBICISTAT
US 10,039,718, product patent
patent.txt lines 3,622, 3,626
Flags
product
Product numbers
001, 002
6 Oct 2032 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 10,039,718, product patent
patent.txt line 3,630
Flags
product
Product numbers
001
6 Oct 2032 · NDA 205395 · COBICISTAT; DARUNAVIR ETHANOLATE
US 10,039,718, product patent
patent.txt lines 5,295, 5,301
Flags
product
Product numbers
001, 002
6 Oct 2032 · NDA 206353 · ATAZANAVIR SULFATE; COBICISTAT
US 10,039,718, product patent
patent.txt line 6,494
Flags
product
Product numbers
001
6 Oct 2032 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 10,039,718, product patent
patent.txt line 7,347
Flags
product
Product numbers
001
6 Oct 2032 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 10,039,718, product patent
patent.txt line 11,401
Flags
product
Product numbers
001
12 Oct 2032 · NDA 205422 · BREXPIPRAZOLE
US 10,307,419, product patent
patent.txt lines 5,308, 5,321, 5,334, 5,347, 5,360
Flags
product
Product numbers
001, 002, 003, 004, 005
16 Oct 2032 · NDA 050444 · MINOCYCLINE HYDROCHLORIDE
US 11,944,634, product patent
patent.txt line 2,136
Flags
product
Product numbers
001
16 Oct 2032 · NDA 211635 · DIAZEPAM
US 12,324,852, use patent
patent.txt lines 12,911, 12,919, 12,927
Flags
use code U-4173
Product numbers
001, 002, 003
24 Oct 2032 · NDA 210854 · BALOXAVIR MARBOXIL
US 8,987,441, substance and product patent
patent.txt lines 12,191, 12,202, 12,213
Flags
substance product
Product numbers
001, 002, 003
26 Oct 2032 · NDA 214662 · MARALIXIBAT CHLORIDE
US 10,512,657, use patent
patent.txt line 15,921
Flags
use code U-3850
Product numbers
001
26 Oct 2032 · NDA 214662 · MARALIXIBAT CHLORIDE
US 10,512,657, use patent
patent.txt line 15,935
Flags
use code U-3973
Product numbers
002
26 Oct 2032 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,229,661, use patent
patent.txt line 15,924
Flags
use code U-3850
Product numbers
001
26 Oct 2032 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,229,661, use patent
patent.txt line 15,936
Flags
use code U-3973
Product numbers
002
26 Oct 2032 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,376,251, use patent
patent.txt line 15,927
Flags
use code U-3290
Product numbers
001
26 Oct 2032 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,376,251, use patent
patent.txt line 15,928
Flags
use code U-3974
Product numbers
001
26 Oct 2032 · NDA 214662 · MARALIXIBAT CHLORIDE
US 12,350,267, use patent
patent.txt line 15,937
Flags
use code U-3973
Product numbers
002
26 Oct 2032 · NDA 216196 · MITAPIVAT SULFATE
US 9,193,701, use patent
patent.txt lines 18,437, 18,446, 18,455
Flags
use code U-3319
Product numbers
001, 002, 003
26 Oct 2032 · NDA 216196 · MITAPIVAT SULFATE
US 9,193,701, use patent
patent.txt line 18,462
Flags
use code U-4393
Product numbers
004
26 Oct 2032 · NDA 219485 · MARALIXIBAT CHLORIDE
US 10,512,657, use patent
patent.txt lines 21,747, 21,756, 21,765, 21,774
Flags
use code U-4186
Product numbers
001, 002, 003, 004
26 Oct 2032 · NDA 219485 · MARALIXIBAT CHLORIDE
US 11,229,661, use patent
patent.txt lines 21,749, 21,758, 21,767, 21,776
Flags
use code U-4186
Product numbers
001, 002, 003, 004
26 Oct 2032 · NDA 219485 · MARALIXIBAT CHLORIDE
US 11,376,251, use patent
patent.txt lines 21,751, 21,760, 21,769, 21,778
Flags
use code U-4187
Product numbers
001, 002, 003, 004
26 Oct 2032 · NDA 219485 · MARALIXIBAT CHLORIDE
US 12,350,267, use patent
patent.txt lines 21,755, 21,764, 21,773, 21,782
Flags
use code U-3973
Product numbers
001, 002, 003, 004
30 Oct 2032 · NDA 212839 · CENOBAMATE
US 7,598,279, substance patent
patent.txt lines 14,438, 14,440, 14,442, 14,444, 14,446, 14,448
Flags
substance
Product numbers
001, 002, 003, 004, 005, 006
1 Nov 2032 · NDA 205065 · SAPROPTERIN DIHYDROCHLORIDE
US 9,216,178, product patent
patent.txt lines 5,198, 5,200
Flags
product
Product numbers
001, 002
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 8,568,747, product patent
patent.txt line 4,461
Flags
product
Product numbers
001
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 8,778,366, use patent
patent.txt line 4,462
Flags
use code U-1723
Product numbers
001
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 8,778,366, use patent
patent.txt line 4,463
Flags
use code U-185
Product numbers
001
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 8,778,366, use patent
patent.txt line 4,464
Flags
use code U-1892
Product numbers
001
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 8,778,366, use patent
patent.txt line 4,465
Flags
use code U-3
Product numbers
001
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 8,778,366, use patent
patent.txt line 4,466
Flags
use code U-71
Product numbers
001
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 9,855,214, product patent
patent.txt line 4,467
Flags
product
Product numbers
001
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 9,968,553, use patent
patent.txt line 4,468
Flags
use code U-1723
Product numbers
001
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 9,968,553, use patent
patent.txt line 4,469
Flags
use code U-185
Product numbers
001
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 9,968,553, use patent
patent.txt line 4,470
Flags
use code U-1892
Product numbers
001
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 9,968,553, use patent
patent.txt line 4,471
Flags
use code U-3
Product numbers
001
6 Nov 2032 · NDA 204308 · ENALAPRIL MALEATE
US 9,968,553, use patent
patent.txt line 4,472
Flags
use code U-71
Product numbers
001
12 Nov 2032 · NDA 214916 · DIFELIKEFALIN ACETATE
US 7,402,564, substance and product and use patent
patent.txt line 16,328
Flags
substance product use code U-3204
Product numbers
001
15 Nov 2032 · NDA 202107 · MIFEPRISTONE
US 10,842,801, use patent
patent.txt line 2,768
Flags
use code U-1643
Product numbers
001
16 Nov 2032 · NDA 215515 · VUTRISIRAN SODIUM
US 10,570,391, substance and product and use patent
patent.txt line 17,415
Flags
substance product use code U-3396
Product numbers
001
16 Nov 2032 · NDA 215515 · VUTRISIRAN SODIUM
US 9,399,775, substance and product and use patent
patent.txt line 17,425
Flags
substance product use code U-3396
Product numbers
001
18 Nov 2032 · NDA 214787 · REMDESIVIR
US 10,065,958, substance patent
patent.txt lines 16,122, 16,161
Flags
substance
Product numbers
001, 002
19 Nov 2032 · NDA 203168 · BROMFENAC SODIUM
US 10,085,958, product patent
patent.txt line 3,649
Flags
product
Product numbers
001
19 Nov 2032 · NDA 213591 · CAPMATINIB HYDROCHLORIDE
US 7,767,675, substance and product patent
patent.txt lines 15,141, 15,148
Flags
substance product
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,258,630, use patent
patent.txt lines 8,794, 8,826
Flags
use code U-2316
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,258,630, use patent
patent.txt lines 8,795, 8,827
Flags
use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,398,708, use patent
patent.txt lines 8,796, 8,828
Flags
use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,398,708, use patent
patent.txt lines 8,797, 8,829
Flags
use code U-2614
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,471,072, use patent
patent.txt lines 8,798, 8,830
Flags
use code U-2316
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,471,072, use patent
patent.txt lines 8,799, 8,831
Flags
use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,537,581, product and use patent
patent.txt lines 8,800, 8,832
Flags
product use code U-2316
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,537,581, product and use patent
patent.txt lines 8,801, 8,833
Flags
product use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,568,891, use patent
patent.txt lines 8,802, 8,834
Flags
use code U-2316
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,568,891, use patent
patent.txt lines 8,803, 8,835
Flags
use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,668,082, use patent
patent.txt lines 8,804, 8,836
Flags
use code U-2316
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,668,082, use patent
patent.txt lines 8,805, 8,837
Flags
use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,806,697, product patent
patent.txt lines 8,806, 8,838
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,835,487, use patent
patent.txt lines 8,807, 8,839
Flags
use code U-2316
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,835,487, use patent
patent.txt lines 8,808, 8,840
Flags
use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,888,516, use patent
patent.txt lines 8,809, 8,841
Flags
use code U-2316
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 10,888,516, use patent
patent.txt lines 8,810, 8,842
Flags
use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,065,197, product patent
patent.txt lines 8,811, 8,843
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,116,717, product patent
patent.txt lines 8,812, 8,844
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,123,283, product patent
patent.txt lines 8,813, 8,845
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,241,445, use patent
patent.txt lines 8,814, 8,846
Flags
use code U-2316
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,241,445, use patent
patent.txt lines 8,815, 8,847
Flags
use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,246,875, use patent
patent.txt lines 8,816, 8,848
Flags
use code U-2316
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,246,875, use patent
patent.txt lines 8,817, 8,849
Flags
use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,304,959, product patent
patent.txt lines 8,820, 8,852
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,351,182, use patent
patent.txt lines 8,821, 8,853
Flags
use code U-2316
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,351,182, use patent
patent.txt lines 8,822, 8,854
Flags
use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,497,709, use patent
patent.txt line 8,855
Flags
use code U-2316
Product numbers
002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 11,497,709, use patent
patent.txt line 8,856
Flags
use code U-2317
Product numbers
002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 9,180,091, product and use patent
patent.txt lines 8,823, 8,857
Flags
product use code U-2316
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 9,180,091, product and use patent
patent.txt lines 8,824, 8,858
Flags
product use code U-2317
Product numbers
001, 002
21 Nov 2032 · NDA 208564 · ESTRADIOL
US 9,289,382, product patent
patent.txt lines 8,825, 8,859
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 10,052,386, product patent
patent.txt lines 11,106, 11,128
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 10,206,932, use patent
patent.txt lines 11,107, 11,129
Flags
use code U-2439
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 10,639,375, product patent
patent.txt line 11,108
Flags
product
Product numbers
001
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 10,675,288, use patent
patent.txt lines 11,109, 11,130
Flags
use code U-2439
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 10,806,740, product and use patent
patent.txt line 11,110
Flags
product use code U-2439
Product numbers
001
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 11,033,626, product and use patent
patent.txt lines 11,111, 11,131
Flags
product use code U-2439
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 11,103,513, use patent
patent.txt line 11,112
Flags
use code U-2439
Product numbers
001
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 11,103,516, product patent
patent.txt line 11,113
Flags
product
Product numbers
001
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 11,110,099, product patent
patent.txt line 11,114
Flags
product
Product numbers
001
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 11,166,963, product patent
patent.txt line 11,132
Flags
product
Product numbers
002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 11,529,360, product patent
patent.txt line 11,115
Flags
product
Product numbers
001
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 11,793,819, use patent
patent.txt lines 11,116, 11,133
Flags
use code U-2439
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 11,865,179, substance and product patent
patent.txt lines 11,117, 11,134
Flags
substance product
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 8,633,178, product patent
patent.txt lines 11,118, 11,135
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 8,846,648, use patent
patent.txt lines 11,119, 11,136
Flags
use code U-2439
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 8,846,649, product and use patent
patent.txt lines 11,120, 11,137
Flags
product use code U-2439
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 8,933,059, product and use patent
patent.txt line 11,138
Flags
product use code U-2439
Product numbers
002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 8,987,237, product patent
patent.txt lines 11,121, 11,139
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 8,993,548, product patent
patent.txt lines 11,122, 11,140
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 8,993,549, product patent
patent.txt lines 11,123, 11,141
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 9,006,222, product and use patent
patent.txt line 11,124
Flags
product use code U-2439
Product numbers
001
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 9,114,145, use patent
patent.txt lines 11,125, 11,142
Flags
use code U-2439
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 9,114,146, product and use patent
patent.txt lines 11,126, 11,143
Flags
product use code U-2439
Product numbers
001, 002
21 Nov 2032 · NDA 210132 · ESTRADIOL; PROGESTERONE
US 9,301,920, product and use patent
patent.txt lines 11,127, 11,144
Flags
product use code U-2439
Product numbers
001, 002
21 Nov 2032 · NDA 210496 · ENCORAFENIB
US 10,258,622, use patent
patent.txt line 11,519
Flags
use code U-2802
Product numbers
002
21 Nov 2032 · NDA 210496 · ENCORAFENIB
US 10,258,622, use patent
patent.txt line 11,520
Flags
use code U-4051
Product numbers
002
21 Nov 2032 · NDA 210496 · ENCORAFENIB
US 10,258,622, use patent
patent.txt line 11,521
Flags
use code U-4439
Product numbers
002
21 Nov 2032 · NDA 210496 · ENCORAFENIB
US 9,387,208, product patent
patent.txt lines 11,507, 11,535
Flags
product
Product numbers
001, 002
21 Nov 2032 · NDA 210496 · ENCORAFENIB
US 9,763,941, use patent
patent.txt lines 11,510, 11,541
Flags
use code U-2335
Product numbers
001, 002
26 Nov 2032 · NDA 214377 · VERICIGUAT
US 9,604,948, substance and product and use patent
patent.txt lines 15,740, 15,746, 15,752
Flags
substance product use code U-3062
Product numbers
001, 002, 003
28 Nov 2032 · NDA 211349 · GILTERITINIB FUMARATE
US 8,969,336, substance and product patent
patent.txt line 12,713
Flags
substance product
Product numbers
001
30 Nov 2032 · NDA 207924 · BARICITINIB
US 11,045,474, use patent
patent.txt lines 7,474, 7,480, 7,486
Flags
use code U-3372
Product numbers
001, 002, 003
30 Nov 2032 · NDA 207924 · BARICITINIB
US 9,089,574, use patent
patent.txt lines 7,478, 7,484, 7,489
Flags
use code U-3372
Product numbers
001, 002, 003
21 Dec 2032 · NDA 207932 · BUPRENORPHINE HYDROCHLORIDE
US 9,901,539, use patent
patent.txt lines 7,657, 7,660, 7,663, 7,666, 7,669, 7,672, 7,675
Flags
use code U-1556
Product numbers
001, 002, 003, 004, 005, 006, 007
28 Dec 2032 · NDA 213137 · VOXELOTOR
US 10,017,491, product patent
patent.txt lines 14,666, 14,679
Flags
product
Product numbers
001, 002
28 Dec 2032 · NDA 213137 · VOXELOTOR
US 10,034,879, substance and product patent
patent.txt lines 14,667, 14,680
Flags
substance product
Product numbers
001, 002
28 Dec 2032 · NDA 213137 · VOXELOTOR
US 10,806,733, substance patent
patent.txt lines 14,670, 14,683
Flags
substance
Product numbers
001, 002
28 Dec 2032 · NDA 216157 · VOXELOTOR
US 10,017,491, product patent
patent.txt line 18,365
Flags
product
Product numbers
001
28 Dec 2032 · NDA 216157 · VOXELOTOR
US 10,034,879, substance and product patent
patent.txt line 18,366
Flags
substance product
Product numbers
001
28 Dec 2032 · NDA 216157 · VOXELOTOR
US 10,806,733, substance patent
patent.txt line 18,368
Flags
substance
Product numbers
001

Pediatric exclusivity, as listed (27)

11 Feb 2032 · NDA 202811 · LINACLOTIDE
US 10,675,325 with pediatric exclusivity, as listed
patent.txt line 3,359
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
003
11 Feb 2032 · NDA 202811 · LINACLOTIDE
US 10,702,576 with pediatric exclusivity, as listed
patent.txt line 3,361
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
003
11 Mar 2032 · NDA 022450 · ACETAMINOPHEN
US 9,399,012 with pediatric exclusivity, as listed
patent.txt line 1,913
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
30 Apr 2032 · NDA 202811 · LINACLOTIDE
US 8,748,573 with pediatric exclusivity, as listed
patent.txt lines 3,335, 3,350
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
30 Apr 2032 · NDA 202811 · LINACLOTIDE
US 8,802,628 with pediatric exclusivity, as listed
patent.txt lines 3,339, 3,353
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
9 May 2032 · NDA 209092 · RIBOCICLIB SUCCINATE
US 9,193,732 with pediatric exclusivity, as listed
patent.txt line 9,710
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
9 May 2032 · NDA 209092 · RIBOCICLIB SUCCINATE
US 9,868,739 with pediatric exclusivity, as listed
patent.txt line 9,720
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
9 May 2032 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 9,193,732 with pediatric exclusivity, as listed
patent.txt line 11,051
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
9 May 2032 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 9,868,739 with pediatric exclusivity, as listed
patent.txt line 11,057
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
8 Jun 2032 · NDA 214787 · REMDESIVIR
US 11,492,353 with pediatric exclusivity, as listed
patent.txt lines 16,140, 16,174
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
4 Jul 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 8,242,158 with pediatric exclusivity, as listed
patent.txt lines 408, 421, 433
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004
4 Jul 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 8,338,470 with pediatric exclusivity, as listed
patent.txt lines 410, 423, 435
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004
4 Jul 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 8,455,527 with pediatric exclusivity, as listed
patent.txt lines 412, 425, 437
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004
4 Jul 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 8,648,106 with pediatric exclusivity, as listed
patent.txt lines 414, 427, 439
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004
4 Jul 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 9,320,712 with pediatric exclusivity, as listed
patent.txt lines 416, 429, 441
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004
4 Jul 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE
US 9,616,049 with pediatric exclusivity, as listed
patent.txt lines 418, 431, 443
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
002, 003, 004
28 Jul 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 8,580,304 with pediatric exclusivity, as listed
patent.txt lines 4,275, 4,295, 4,315
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
28 Jul 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 9,155,706 with pediatric exclusivity, as listed
patent.txt lines 4,285, 4,305, 4,325
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
28 Jul 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 9,271,941 with pediatric exclusivity, as listed
patent.txt lines 4,287, 4,307, 4,327
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
28 Jul 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 9,399,021 with pediatric exclusivity, as listed
patent.txt lines 4,289, 4,309, 4,329
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
4 Sep 2032 · NDA 021660 · PACLITAXEL
US 9,393,318 with pediatric exclusivity, as listed
patent.txt line 667
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
4 Sep 2032 · NDA 021660 · PACLITAXEL
US 9,597,409 with pediatric exclusivity, as listed
patent.txt line 671
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
7 Sep 2032 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 10,596,120 with pediatric exclusivity, as listed
patent.txt lines 9,038, 9,070, 9,102, 9,132
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
21 Sep 2032 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,278,096 with pediatric exclusivity, as listed
patent.txt lines 4,712, 4,732, 4,752, 4,772
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
30 Sep 2032 · NDA 022527 · FINGOLIMOD HYDROCHLORIDE
US 9,592,208 with pediatric exclusivity, as listed
patent.txt line 2,050
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
002
7 Oct 2032 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 9,061,029 with pediatric exclusivity, as listed
patent.txt lines 1,005, 1,019, 1,033
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
10 Nov 2032 · NDA 022088 · TEMSIROLIMUS
US 8,791,097 with pediatric exclusivity, as listed
patent.txt line 1,048
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001

Non-patent exclusivity (8)

20 Mar 2032 · NDA 215515 · VUTRISIRAN SODIUM
ODE-527 exclusivity
exclusivity.txt line 1,590
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
26 Mar 2032 · NDA 208692 · CABOZANTINIB S-MALATE
ODE-530 exclusivity
exclusivity.txt lines 740, 743, 746
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
26 Mar 2032 · NDA 216665 · DIAZOXIDE CHOLINE
ODE-532 exclusivity
exclusivity.txt lines 1,778, 1,780, 1,782
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
28 Apr 2032 · NDA 211675 · UPADACITINIB
ODE-538 exclusivity
exclusivity.txt line 988
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
20 Jun 2032 · NDA 208215 · EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
ODE-556 exclusivity
exclusivity.txt lines 697, 700
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
30 Jul 2032 · NDA 210251 · BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
ODE-540 exclusivity
exclusivity.txt lines 863, 867
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
19 Nov 2032 · NDA 213756 · SELUMETINIB SULFATE
ODE-545 exclusivity
exclusivity.txt lines 1,259, 1,263
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
23 Dec 2032 · NDA 216196 · MITAPIVAT SULFATE
ODE-522 exclusivity
exclusivity.txt line 1,744
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
004