Drybench Patent.

Patent and exclusivity dates in 2040 for NDAs on FDA's Paragraph IV list, as FDA lists them

Each patent and exclusivity date in 2040 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 (126)

7 Jan 2040 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 10,780,064, use patent
patent.txt line 16,935
Flags
use code U-3419
Product numbers
001
7 Jan 2040 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 10,925,842, use patent
patent.txt line 16,954
Flags
use code U-3419
Product numbers
001
7 Jan 2040 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 10,940,124, use patent
patent.txt line 16,956
Flags
use code U-3419
Product numbers
001
7 Jan 2040 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 10,966,942, use patent
patent.txt line 16,960
Flags
use code U-3419
Product numbers
001
10 Jan 2040 · NDA 208743 · ABALOPARATIDE
US 11,255,842, use patent
patent.txt line 9,292
Flags
use code U-3322
Product numbers
001
10 Jan 2040 · NDA 208743 · ABALOPARATIDE
US 11,680,942, use patent
patent.txt line 9,293
Flags
use code U-3322
Product numbers
001
22 Jan 2040 · NDA 213994 · EPHEDRINE SULFATE
US 10,869,845, product patent
patent.txt lines 15,422–15,423
Flags
product
Product numbers
001, 002
22 Jan 2040 · NDA 213994 · EPHEDRINE SULFATE
US 12,029,710, use patent
patent.txt line 15,424
Flags
use code U-3963
Product numbers
002
30 Jan 2040 · NDA 210951 · APALUTAMIDE
US 11,963,952, use patent
patent.txt lines 12,436, 12,454
Flags
use code U-3901
Product numbers
001, 002
30 Jan 2040 · NDA 210951 · APALUTAMIDE
US 12,303,497, use patent
patent.txt lines 12,438, 12,456
Flags
use code U-4448
Product numbers
001, 002
30 Jan 2040 · NDA 210951 · APALUTAMIDE
US 12,303,497, use patent
patent.txt lines 12,439, 12,457
Flags
use code U-4494
Product numbers
001, 002
11 Feb 2040 · NDA 210526 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 12,458,592, use patent
patent.txt lines 11,560, 11,566, 11,572, 11,578
Flags
use code U-3538
Product numbers
001, 002, 003, 004
12 Feb 2040 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,229,647, use patent
patent.txt line 15,922
Flags
use code U-3290
Product numbers
001
12 Feb 2040 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,229,647, use patent
patent.txt line 15,923
Flags
use code U-3974
Product numbers
001
12 Feb 2040 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,497,745, use patent
patent.txt line 15,929
Flags
use code U-3290
Product numbers
001
12 Feb 2040 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,497,745, use patent
patent.txt line 15,930
Flags
use code U-3974
Product numbers
001
12 Feb 2040 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,918,578, use patent
patent.txt line 15,931
Flags
use code U-3290
Product numbers
001
12 Feb 2040 · NDA 214662 · MARALIXIBAT CHLORIDE
US 11,918,578, use patent
patent.txt line 15,932
Flags
use code U-3974
Product numbers
001
12 Feb 2040 · NDA 214662 · MARALIXIBAT CHLORIDE
US 12,599,602, use patent
patent.txt line 15,933
Flags
use code U-3290
Product numbers
001
12 Feb 2040 · NDA 214662 · MARALIXIBAT CHLORIDE
US 12,599,602, use patent
patent.txt line 15,934
Flags
use code U-3974
Product numbers
001
12 Feb 2040 · NDA 219485 · MARALIXIBAT CHLORIDE
US 11,229,647, use patent
patent.txt lines 21,748, 21,757, 21,766, 21,775
Flags
use code U-4187
Product numbers
001, 002, 003, 004
12 Feb 2040 · NDA 219485 · MARALIXIBAT CHLORIDE
US 11,497,745, use patent
patent.txt lines 21,752, 21,761, 21,770, 21,779
Flags
use code U-4187
Product numbers
001, 002, 003, 004
18 Feb 2040 · NDA 211243 · ESKETAMINE HYDROCHLORIDE
US 11,883,526, use patent
patent.txt line 12,656
Flags
use code U-3812
Product numbers
001
18 Feb 2040 · NDA 211243 · ESKETAMINE HYDROCHLORIDE
US 11,883,526, use patent
patent.txt line 12,657
Flags
use code U-3813
Product numbers
001
18 Feb 2040 · NDA 211243 · ESKETAMINE HYDROCHLORIDE
US 11,883,526, use patent
patent.txt line 12,658
Flags
use code U-4120
Product numbers
001
2 Mar 2040 · NDA 214133 · LEVOKETOCONAZOLE
US 11,020,393, use patent
patent.txt line 15,559
Flags
use code U-3282
Product numbers
001
2 Mar 2040 · NDA 214133 · LEVOKETOCONAZOLE
US 11,278,547, use patent
patent.txt line 15,560
Flags
use code U-3282
Product numbers
001
2 Mar 2040 · NDA 214133 · LEVOKETOCONAZOLE
US 11,903,940, use patent
patent.txt line 15,562
Flags
use code U-3821
Product numbers
001
2 Mar 2040 · NDA 214133 · LEVOKETOCONAZOLE
US 12,377,096, use patent
patent.txt line 15,563
Flags
use code U-4236
Product numbers
001
9 Mar 2040 · NDA 202293 · DAPAGLIFLOZIN
US 10,973,836, use patent
patent.txt line 3,004
Flags
use code U-3127
Product numbers
002
9 Mar 2040 · NDA 202293 · DAPAGLIFLOZIN
US 11,903,955, use patent
patent.txt line 3,008
Flags
use code U-3825
Product numbers
002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 10,940,133, use patent
patent.txt line 12,561
Flags
use code U-3099
Product numbers
001
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,160,779, use patent
patent.txt lines 12,563, 12,604
Flags
use code U-3521
Product numbers
001, 002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,839,598, use patent
patent.txt lines 12,572, 12,613
Flags
use code U-3765
Product numbers
001, 002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,839,599, use patent
patent.txt lines 12,573, 12,614
Flags
use code U-3764
Product numbers
001, 002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,850,226, use patent
patent.txt lines 12,574, 12,615
Flags
use code U-3775
Product numbers
001, 002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,850,227, use patent
patent.txt lines 12,575, 12,616
Flags
use code U-3775
Product numbers
001, 002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,850,228, use patent
patent.txt lines 12,576, 12,617
Flags
use code U-3775
Product numbers
001, 002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,857,528, use patent
patent.txt lines 12,577, 12,618
Flags
use code U-3521
Product numbers
001, 002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,969,404, use patent
patent.txt lines 12,581, 12,622
Flags
use code U-3892
Product numbers
001, 002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,986,454, use patent
patent.txt lines 12,582, 12,623
Flags
use code U-3775
Product numbers
001, 002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,986,455, use patent
patent.txt lines 12,583, 12,624
Flags
use code U-3521
Product numbers
001, 002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 12,194,016, use patent
patent.txt lines 12,590, 12,631
Flags
use code U-4106
Product numbers
001, 002
19 Mar 2040 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 12,318,362, use patent
patent.txt line 12,593
Flags
use code U-3765
Product numbers
001
22 Mar 2040 · NDA 213006 · VIBEGRON
US 12,102,638, use patent
patent.txt line 14,564
Flags
use code U-3045
Product numbers
001
9 May 2040 · NDA 215431 · MELOXICAM; RIZATRIPTAN BENZOATE
US 12,685,736, use patent
patent.txt line 17,273
Flags
use code U-1719
Product numbers
001
13 May 2040 · NDA 215256 · SEMAGLUTIDE
US 11,478,533, use patent
patent.txt lines 16,605, 16,613, 16,621, 16,629, 16,637, 16,657, 16,669, 16,681, 16,693, 16,705, 16,713
Flags
use code U-3861
Product numbers
001, 002, 003, 004, 005, 007, 008, 009, 010, 011, 012
14 May 2040 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
US 11,407,735, substance patent
patent.txt lines 16,806, 16,810, 16,814
Flags
substance
Product numbers
001, 002, 003
14 May 2040 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
US 12,252,478, product patent
patent.txt lines 16,807, 16,811, 16,815
Flags
product
Product numbers
001, 002, 003
16 May 2040 · NDA 213407 · EPHEDRINE SULFATE
US 11,090,278, use patent
patent.txt line 14,975
Flags
use code U-3183
Product numbers
001
16 May 2040 · NDA 213407 · EPHEDRINE SULFATE
US 11,241,400, use patent
patent.txt line 14,976
Flags
use code U-3183
Product numbers
001
16 May 2040 · NDA 213407 · EPHEDRINE SULFATE
US 11,464,752, product patent
patent.txt lines 14,977, 14,980
Flags
product
Product numbers
001, 002
16 May 2040 · NDA 213407 · EPHEDRINE SULFATE
US 11,478,436, use patent
patent.txt line 14,978
Flags
use code U-3183
Product numbers
001
16 May 2040 · NDA 213407 · EPHEDRINE SULFATE
US 11,571,398, use patent
patent.txt lines 14,979, 14,981
Flags
use code U-3183
Product numbers
001, 002
17 May 2040 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
US 12,252,479, use patent
patent.txt lines 16,808, 16,812, 16,816
Flags
use code U-1374
Product numbers
001, 002, 003
28 May 2040 · NDA 215431 · MELOXICAM; RIZATRIPTAN BENZOATE
US 12,128,052, use patent
patent.txt line 17,262
Flags
use code U-1719
Product numbers
001
28 May 2040 · NDA 215431 · MELOXICAM; RIZATRIPTAN BENZOATE
US 12,551,488, use patent
patent.txt line 17,269
Flags
use code U-1719
Product numbers
001
28 May 2040 · NDA 215431 · MELOXICAM; RIZATRIPTAN BENZOATE
US 12,551,489, use patent
patent.txt line 17,270
Flags
use code U-1719
Product numbers
001
29 May 2040 · NDA 213702 · LURBINECTEDIN
US 12,324,806, use patent
patent.txt line 15,207
Flags
use code U-4212 delist requested
Product numbers
001
29 May 2040 · NDA 213702 · LURBINECTEDIN
US 12,433,890, use patent
patent.txt line 15,208
Flags
use code U-4305 delist requested
Product numbers
001
29 May 2040 · NDA 213702 · LURBINECTEDIN
US 12,440,490, use patent
patent.txt line 15,209
Flags
use code U-4252 delist requested
Product numbers
001
5 Jun 2040 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,433,884, use patent
patent.txt lines 17,069, 17,153
Flags
use code U-4514
Product numbers
001, 002
5 Jun 2040 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,472,156, use patent
patent.txt lines 17,071, 17,154
Flags
use code U-4516
Product numbers
001, 002
5 Jun 2040 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,576,078, use patent
patent.txt lines 17,075, 17,156
Flags
use code U-4516
Product numbers
001, 002
5 Jun 2040 · NDA 216185 · LACOSAMIDE
US 11,337,943, product and use patent
patent.txt lines 18,412, 18,418, 18,424
Flags
product use code U-3660
Product numbers
001, 002, 003
5 Jun 2040 · NDA 216185 · LACOSAMIDE
US 11,337,943, product and use patent
patent.txt lines 18,413, 18,419, 18,425
Flags
product use code U-3954
Product numbers
001, 002, 003
5 Jun 2040 · NDA 216185 · LACOSAMIDE
US 11,883,374, product and use patent
patent.txt lines 18,414, 18,420, 18,426
Flags
product use code U-3660
Product numbers
001, 002, 003
5 Jun 2040 · NDA 216185 · LACOSAMIDE
US 11,883,374, product and use patent
patent.txt lines 18,415, 18,421, 18,427
Flags
product use code U-3954
Product numbers
001, 002, 003
5 Jun 2040 · NDA 216185 · LACOSAMIDE
US 12,042,474, product and use patent
patent.txt lines 18,416, 18,422, 18,428
Flags
product use code U-3660
Product numbers
001, 002, 003
5 Jun 2040 · NDA 216185 · LACOSAMIDE
US 12,042,474, product and use patent
patent.txt lines 18,417, 18,423, 18,429
Flags
product use code U-3954
Product numbers
001, 002, 003
10 Jun 2040 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 11,590,138, use patent
patent.txt line 16,749
Flags
use code U-3551
Product numbers
001
10 Jun 2040 · NDA 218785 · ZANUBRUTINIB
US 12,233,069, product patent
patent.txt line 21,369
Flags
product
Product numbers
001
19 Jun 2040 · NDA 211616 · BEMPEDOIC ACID
US 11,613,511, substance patent
patent.txt line 12,891
Flags
substance
Product numbers
001
19 Jun 2040 · NDA 211616 · BEMPEDOIC ACID
US 11,760,714, product patent
patent.txt line 12,893
Flags
product
Product numbers
001
19 Jun 2040 · NDA 211616 · BEMPEDOIC ACID
US 11,926,584, use patent
patent.txt line 12,894
Flags
use code U-3873
Product numbers
001
19 Jun 2040 · NDA 211616 · BEMPEDOIC ACID
US 12,398,087, substance and product patent
patent.txt line 12,895
Flags
substance product
Product numbers
001
19 Jun 2040 · NDA 211616 · BEMPEDOIC ACID
US 12,404,227, substance and use patent
patent.txt line 12,896
Flags
substance use code U-4258
Product numbers
001
19 Jun 2040 · NDA 211617 · BEMPEDOIC ACID; EZETIMIBE
US 11,613,511, substance patent
patent.txt line 12,900
Flags
substance
Product numbers
001
19 Jun 2040 · NDA 211617 · BEMPEDOIC ACID; EZETIMIBE
US 11,760,714, product patent
patent.txt line 12,903
Flags
product
Product numbers
001
19 Jun 2040 · NDA 211617 · BEMPEDOIC ACID; EZETIMIBE
US 11,926,584, use patent
patent.txt line 12,904
Flags
use code U-3873
Product numbers
001
19 Jun 2040 · NDA 211617 · BEMPEDOIC ACID; EZETIMIBE
US 12,398,087, substance and product patent
patent.txt line 12,905
Flags
substance product
Product numbers
001
19 Jun 2040 · NDA 211617 · BEMPEDOIC ACID; EZETIMIBE
US 12,404,227, substance and use patent
patent.txt line 12,906
Flags
substance use code U-4258
Product numbers
001
2 Jul 2040 · NDA 212099 · DAROLUTAMIDE
US 12,611,397, product patent
patent.txt line 13,542
Flags
product
Product numbers
001
6 Jul 2040 · NDA 211280 · LASMIDITAN SUCCINATE
US 12,071,423, product patent
patent.txt lines 12,664, 12,668
Flags
product
Product numbers
001, 002
7 Jul 2040 · NDA 209500 · LUMATEPERONE TOSYLATE
US 12,090,155, product and use patent
patent.txt line 10,451
Flags
product use code U-4000
Product numbers
001
28 Jul 2040 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 12,233,067, use patent
patent.txt line 16,752
Flags
use code U-4151
Product numbers
001
31 Jul 2040 · NDA 216632 · ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 12,128,059, product and use patent
patent.txt line 18,878
Flags
product use code U-3713
Product numbers
001
31 Jul 2040 · NDA 216632 · ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 12,133,859, product patent
patent.txt line 18,879
Flags
product
Product numbers
001
31 Jul 2040 · NDA 216632 · ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 12,138,278, product patent
patent.txt line 18,880
Flags
product
Product numbers
001
31 Jul 2040 · NDA 216632 · ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 12,616,710, product patent
patent.txt line 18,881
Flags
product
Product numbers
001
10 Aug 2040 · NDA 209241 · VALBENAZINE TOSYLATE
US 10,940,141, use patent
patent.txt lines 9,941, 9,974, 10,007
Flags
use code U-1995
Product numbers
001, 002, 003
10 Aug 2040 · NDA 218390 · VALBENAZINE TOSYLATE
US 10,940,141, use patent
patent.txt lines 20,999, 21,032, 21,065
Flags
use code U-1995
Product numbers
001, 002, 003
21 Aug 2040 · NDA 214679 · TOPIRAMATE
US 11,433,046, use patent
patent.txt line 15,968
Flags
use code U-3413
Product numbers
001
21 Aug 2040 · NDA 214679 · TOPIRAMATE
US 11,433,046, use patent
patent.txt line 15,969
Flags
use code U-3414
Product numbers
001
21 Aug 2040 · NDA 214679 · TOPIRAMATE
US 11,433,046, use patent
patent.txt line 15,970
Flags
use code U-3415
Product numbers
001
21 Aug 2040 · NDA 214679 · TOPIRAMATE
US 11,633,374, product patent
patent.txt line 15,971
Flags
product
Product numbers
001
21 Aug 2040 · NDA 214679 · TOPIRAMATE
US 11,826,343, product patent
patent.txt line 15,972
Flags
product
Product numbers
001
21 Aug 2040 · NDA 214679 · TOPIRAMATE
US 11,911,362, product and use patent
patent.txt line 15,973
Flags
product use code U-3413
Product numbers
001
21 Aug 2040 · NDA 214679 · TOPIRAMATE
US 11,911,362, product and use patent
patent.txt line 15,974
Flags
product use code U-3414
Product numbers
001
21 Aug 2040 · NDA 214679 · TOPIRAMATE
US 11,911,362, product and use patent
patent.txt line 15,975
Flags
product use code U-3415
Product numbers
001
21 Aug 2040 · NDA 214679 · TOPIRAMATE
US 12,290,503, product and use patent
patent.txt line 15,976
Flags
product use code U-3413
Product numbers
001
21 Aug 2040 · NDA 214679 · TOPIRAMATE
US 12,290,503, product and use patent
patent.txt line 15,977
Flags
product use code U-3414
Product numbers
001
21 Aug 2040 · NDA 214679 · TOPIRAMATE
US 12,290,503, product and use patent
patent.txt line 15,978
Flags
product use code U-3415
Product numbers
001
27 Aug 2040 · NDA 210450 · ELAGOLIX SODIUM
US 11,690,845, use patent
patent.txt lines 11,390, 11,398
Flags
use code U-3654
Product numbers
001, 002
27 Aug 2040 · NDA 213388 · ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
US 11,690,845, use patent
patent.txt line 14,972
Flags
use code U-3655
Product numbers
001
30 Aug 2040 · NDA 213736 · PEMIGATINIB
US 11,628,162, use patent
patent.txt lines 15,228, 15,238, 15,248
Flags
use code U-3568
Product numbers
001, 002, 003
30 Aug 2040 · NDA 213736 · PEMIGATINIB
US 11,628,162, use patent
patent.txt lines 15,229, 15,239, 15,249
Flags
use code U-3569
Product numbers
001, 002, 003
30 Aug 2040 · NDA 213736 · PEMIGATINIB
US 11,628,162, use patent
patent.txt lines 15,230, 15,240, 15,250
Flags
use code U-3570
Product numbers
001, 002, 003
30 Aug 2040 · NDA 213736 · PEMIGATINIB
US 11,628,162, use patent
patent.txt lines 15,231, 15,241, 15,251
Flags
use code U-3571
Product numbers
001, 002, 003
1 Sep 2040 · NDA 214044 · TRAMADOL HYDROCHLORIDE
US 11,103,452, product and use patent
patent.txt line 15,459
Flags
product use code U-3197
Product numbers
001
1 Sep 2040 · NDA 214044 · TRAMADOL HYDROCHLORIDE
US 11,752,103, product and use patent
patent.txt line 15,460
Flags
product use code U-3197
Product numbers
001
4 Sep 2040 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 11,510,923, use patent
patent.txt line 16,744
Flags
use code U-3505
Product numbers
001
4 Sep 2040 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 11,590,137, use patent
patent.txt line 16,748
Flags
use code U-3505
Product numbers
001
4 Sep 2040 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 12,589,096, use patent
patent.txt line 16,755
Flags
use code U-3505
Product numbers
001
3 Oct 2040 · NDA 213736 · PEMIGATINIB
US 12,552,792, substance and product patent
patent.txt lines 15,232, 15,242, 15,252
Flags
substance product
Product numbers
001, 002, 003
13 Nov 2040 · NDA 214200 · TRILACICLIB DIHYDROCHLORIDE
US 12,168,666, substance and product patent
patent.txt line 15,642
Flags
substance product
Product numbers
001
10 Dec 2040 · NDA 209500 · LUMATEPERONE TOSYLATE
US 11,753,419, product patent
patent.txt lines 10,442, 10,480, 10,511
Flags
product delist requested
Product numbers
001, 002, 003
10 Dec 2040 · NDA 209500 · LUMATEPERONE TOSYLATE
US 12,122,792, product and use patent
patent.txt lines 10,452, 10,486, 10,517
Flags
product use code U-4019
Product numbers
001, 002, 003
10 Dec 2040 · NDA 209500 · LUMATEPERONE TOSYLATE
US 12,122,792, product and use patent
patent.txt lines 10,453, 10,487, 10,518
Flags
product use code U-4020
Product numbers
001, 002, 003
10 Dec 2040 · NDA 209500 · LUMATEPERONE TOSYLATE
US 12,122,792, product and use patent
patent.txt lines 10,454, 10,488, 10,519
Flags
product use code U-4340
Product numbers
001, 002, 003
10 Dec 2040 · NDA 209500 · LUMATEPERONE TOSYLATE
US 12,410,195, product patent
patent.txt lines 10,458, 10,490, 10,521
Flags
product
Product numbers
001, 002, 003
11 Dec 2040 · NDA 214517 · TASIMELTEON
US 11,202,770, product patent
patent.txt line 15,844
Flags
product
Product numbers
001
11 Dec 2040 · NDA 214517 · TASIMELTEON
US 12,447,141, use patent
patent.txt line 15,859
Flags
use code U-3003
Product numbers
001
28 Dec 2040 · NDA 208232 · OCTREOTIDE ACETATE
US 11,141,457, use patent
patent.txt line 8,360
Flags
use code U-3232
Product numbers
001
28 Dec 2040 · NDA 208232 · OCTREOTIDE ACETATE
US 11,890,316, use patent
patent.txt line 8,364
Flags
use code U-3232
Product numbers
001
28 Dec 2040 · NDA 216632 · ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
US 11,389,467, product and use patent
patent.txt line 18,877
Flags
product use code U-3713
Product numbers
001

Pediatric exclusivity, as listed (14)

18 Jan 2040 · NDA 202293 · DAPAGLIFLOZIN
US 11,826,376 with pediatric exclusivity, as listed
patent.txt line 3,005
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002
18 Jan 2040 · NDA 202293 · DAPAGLIFLOZIN
US 12,472,194 with pediatric exclusivity, as listed
patent.txt line 3,013
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002
1 May 2040 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
US 10,662,160 with pediatric exclusivity, as listed
patent.txt lines 15,467, 15,499
Flags
substance pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 May 2040 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
US 11,117,867 with pediatric exclusivity, as listed
patent.txt lines 15,471, 15,503
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 May 2040 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
US 11,618,733 with pediatric exclusivity, as listed
patent.txt lines 15,475, 15,507
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 May 2040 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
US 12,344,585 with pediatric exclusivity, as listed
patent.txt lines 15,481, 15,513
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 May 2040 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
US 12,545,645 with pediatric exclusivity, as listed
patent.txt lines 15,483, 15,515
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 May 2040 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
US 12,545,646 with pediatric exclusivity, as listed
patent.txt lines 15,485, 15,517
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 May 2040 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
US 12,545,647 with pediatric exclusivity, as listed
patent.txt lines 15,487, 15,519
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 May 2040 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
US 12,552,750 with pediatric exclusivity, as listed
patent.txt lines 15,489, 15,521
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 May 2040 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
US 12,590,068 with pediatric exclusivity, as listed
patent.txt lines 15,491, 15,523
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
1 May 2040 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
US 12,590,069 with pediatric exclusivity, as listed
patent.txt lines 15,493, 15,525
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
9 Sep 2040 · NDA 202293 · DAPAGLIFLOZIN
US 10,973,836 with pediatric exclusivity, as listed
patent.txt line 3,003
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002
9 Sep 2040 · NDA 202293 · DAPAGLIFLOZIN
US 11,903,955 with pediatric exclusivity, as listed
patent.txt line 3,007
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
002