Drybench Patent.

Patent and exclusivity dates from July to December 2042 for NDAs, as FDA's Orange Book lists them

Each patent and exclusivity date from July to December 2042 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, 2042 January to June 2042

Listed patent expiry (78)

6 Jul 2042 · NDA 213006 · VIBEGRON
US 12,357,636, use patent
patent.txt line 14,566
Flags
use code U-4219
Product numbers
001
7 Jul 2042 · NDA 213721 · PRALSETINIB
US 12,448,366, substance patent
patent.txt line 15,220
Flags
substance
Product numbers
001
8 Jul 2042 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
US 11,504,354, product patent
patent.txt lines 20,241, 20,270, 20,299
Flags
product
Product numbers
001, 002, 003
8 Jul 2042 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
US 11,612,588, product and use patent
patent.txt lines 20,242, 20,271, 20,300
Flags
product use code U-3754
Product numbers
001, 002, 003
8 Jul 2042 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
US 12,110,277, product patent
patent.txt lines 20,259, 20,288, 20,317
Flags
product
Product numbers
001, 002, 003
8 Jul 2042 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
US 12,234,210, product patent
patent.txt lines 20,262, 20,291, 20,320
Flags
product
Product numbers
001, 002, 003
8 Jul 2042 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
US 12,247,012, product patent
patent.txt lines 20,263, 20,292, 20,321
Flags
product
Product numbers
001, 002, 003
8 Jul 2042 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
US 12,599,587, product patent
patent.txt lines 20,265, 20,294, 20,323
Flags
product
Product numbers
001, 002, 003
11 Jul 2042 · NDA 214938 · VOSORITIDE
US 12,233,106, use patent
patent.txt lines 16,356, 16,364, 16,372
Flags
use code U-3927
Product numbers
001, 002, 003
12 Jul 2042 · NDA 217026 · TROFINETIDE
US 11,827,600, substance and product and use patent
patent.txt line 19,252
Flags
substance product use code U-3556
Product numbers
001
12 Jul 2042 · NDA 217026 · TROFINETIDE
US 12,492,167, substance and product and use patent
patent.txt line 19,254
Flags
substance product use code U-3556
Product numbers
001
12 Jul 2042 · NDA 219884 · TROFINETIDE
US 11,827,600, substance and product and use patent
patent.txt lines 22,040, 22,048, 22,056
Flags
substance product use code U-3556
Product numbers
001, 002, 003
12 Jul 2042 · NDA 219884 · TROFINETIDE
US 12,492,167, substance and product and use patent
patent.txt lines 22,042, 22,050, 22,058
Flags
substance product use code U-3556
Product numbers
001, 002, 003
14 Jul 2042 · NDA 214783 · BELUMOSUDIL MESYLATE
US 12,097,202, use patent
patent.txt line 16,119
Flags
use code U-4014
Product numbers
001
15 Jul 2042 · NDA 218571 · ETRIPAMIL
US 12,257,224, use patent
patent.txt line 21,119
Flags
use code U-4370
Product numbers
001
15 Jul 2042 · NDA 219083 · AFICAMTEN
US 12,370,179, use patent
patent.txt lines 21,488, 21,490, 21,492, 21,494
Flags
use code U-4371
Product numbers
001, 002, 003, 004
15 Jul 2042 · NDA 220256 · CLONIDINE HYDROCHLORIDE
US 12,233,049, product patent
patent.txt line 22,121
Flags
product
Product numbers
001
15 Jul 2042 · NDA 220256 · CLONIDINE HYDROCHLORIDE
US 12,440,474, product patent
patent.txt line 22,122
Flags
product
Product numbers
001
15 Jul 2042 · NDA 220256 · CLONIDINE HYDROCHLORIDE
US 12,721,837, product patent
patent.txt line 22,123
Flags
product
Product numbers
001
29 Jul 2042 · NDA 212209 · BENDAMUSTINE HYDROCHLORIDE
US 11,707,450, product patent
patent.txt line 13,622
Flags
product
Product numbers
001
29 Jul 2042 · NDA 212209 · BENDAMUSTINE HYDROCHLORIDE
US 11,844,784, product patent
patent.txt line 13,623
Flags
product
Product numbers
001
29 Jul 2042 · NDA 212209 · BENDAMUSTINE HYDROCHLORIDE
US 12,208,086, product patent
patent.txt line 13,624
Flags
product
Product numbers
001
29 Jul 2042 · NDA 212209 · BENDAMUSTINE HYDROCHLORIDE
US 12,419,867, product patent
patent.txt line 13,625
Flags
product
Product numbers
001
4 Aug 2042 · NDA 217470 · NALMEFENE HYDROCHLORIDE
US 12,290,596, use patent
patent.txt line 19,987
Flags
use code U-4182
Product numbers
001
11 Aug 2042 · NDA 217900 · DEURUXOLITINIB PHOSPHATE
US 12,285,432, use patent
patent.txt line 20,762
Flags
use code U-3976
Product numbers
001
19 Aug 2042 · NDA 217242 · ROFLUMILAST
US 12,453,721, product patent
patent.txt line 19,833
Flags
product
Product numbers
001
8 Sep 2042 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
US 11,807,611, product and use patent
patent.txt lines 20,243, 20,272, 20,301
Flags
product use code U-3754
Product numbers
001, 002, 003
8 Sep 2042 · NDA 217677 · NIROGACESTAT HYDROBROMIDE
US 11,844,780, product and use patent
patent.txt lines 20,245, 20,274, 20,303
Flags
product use code U-3754
Product numbers
001, 002, 003
23 Sep 2042 · NDA 215331 · BORTEZOMIB
US 11,679,119, use patent
patent.txt lines 16,783, 16,788
Flags
use code U-3632
Product numbers
001, 002
23 Sep 2042 · NDA 215331 · BORTEZOMIB
US 11,679,119, use patent
patent.txt lines 16,784, 16,789
Flags
use code U-3633
Product numbers
001, 002
23 Sep 2042 · NDA 215331 · BORTEZOMIB
US 11,752,164, use patent
patent.txt lines 16,785, 16,790
Flags
use code U-3632
Product numbers
001, 002
23 Sep 2042 · NDA 215331 · BORTEZOMIB
US 11,752,164, use patent
patent.txt lines 16,786, 16,791
Flags
use code U-3633
Product numbers
001, 002
23 Sep 2042 · NDA 215331 · BORTEZOMIB
US 12,005,069, product patent
patent.txt lines 16,787, 16,792
Flags
product
Product numbers
001, 002
24 Sep 2042 · NDA 210365 · CANNABIDIOL
US 12,661,365, use patent
patent.txt line 11,370
Flags
use code U-4573
Product numbers
001
24 Sep 2042 · NDA 210365 · CANNABIDIOL
US 12,661,365, use patent
patent.txt line 11,371
Flags
use code U-4574
Product numbers
001
24 Sep 2042 · NDA 210365 · CANNABIDIOL
US 12,661,365, use patent
patent.txt line 11,372
Flags
use code U-4575
Product numbers
001
27 Sep 2042 · NDA 215206 · ATOGEPANT
US 12,465,598, use patent
patent.txt line 16,562
Flags
use code U-4355
Product numbers
001
27 Sep 2042 · NDA 215206 · ATOGEPANT
US 12,622,897, use patent
patent.txt lines 16,563, 16,570
Flags
use code U-4536
Product numbers
001, 002
30 Sep 2042 · NDA 215904 · GANAXOLONE
US 12,115,169, use patent
patent.txt line 18,080
Flags
use code U-3374
Product numbers
001
30 Sep 2042 · NDA 215904 · GANAXOLONE
US 12,268,696, use patent
patent.txt line 18,082
Flags
use code U-3374
Product numbers
001
30 Sep 2042 · NDA 220185 · ZIDESAMTINIB
US 12,043,626, substance and product patent
patent.txt lines 22,113, 22,117
Flags
substance product
Product numbers
001, 002
30 Sep 2042 · NDA 220185 · ZIDESAMTINIB
US 12,630,560, use patent
patent.txt lines 22,115, 22,119
Flags
use code U-4579
Product numbers
001, 002
6 Oct 2042 · NDA 213973 · RIPRETINIB
US 11,779,572, use patent
patent.txt line 15,364
Flags
use code U-3714
Product numbers
001
10 Oct 2042 · NDA 213498 · PONESIMOD
US 11,951,097, use patent
patent.txt lines 15,069, 15,075
Flags
use code U-3891
Product numbers
001, 010
17 Oct 2042 · NDA 217684 · VIGABATRIN
US 12,290,499, product patent
patent.txt line 20,326
Flags
product
Product numbers
001
5 Nov 2042 · NDA 214846 · ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
US 12,551,447, product patent
patent.txt line 16,241
Flags
product
Product numbers
001
10 Nov 2042 · NDA 220142 · BRIMONIDINE TARTRATE; CARBACHOL
US 12,268,662, product and use patent
patent.txt line 22,099
Flags
product use code U-3741
Product numbers
001
10 Nov 2042 · NDA 220142 · BRIMONIDINE TARTRATE; CARBACHOL
US 12,268,662, product and use patent
patent.txt line 22,100
Flags
product use code U-4419
Product numbers
001
10 Nov 2042 · NDA 220142 · BRIMONIDINE TARTRATE; CARBACHOL
US 12,268,662, product and use patent
patent.txt line 22,101
Flags
product use code U-4420
Product numbers
001
12 Nov 2042 · NDA 216490 · PALOPEGTERIPARATIDE
US 12,403,182, product and use patent
patent.txt lines 18,830, 18,839, 18,848
Flags
product use code U-3982
Product numbers
001, 002, 003
12 Nov 2042 · NDA 219164 · NAVEPEGRITIDE
US 12,377,133, product and use patent
patent.txt lines 21,521, 21,533, 21,545
Flags
product use code U-4425
Product numbers
001, 002, 003
18 Nov 2042 · NDA 215596 · MARIBAVIR
US 12,213,989, use patent
patent.txt line 17,472
Flags
use code U-4137
Product numbers
001
18 Nov 2042 · NDA 215596 · MARIBAVIR
US 12,433,907, use patent
patent.txt line 17,474
Flags
use code U-4289
Product numbers
001
18 Nov 2042 · NDA 215596 · MARIBAVIR
US 12,447,170, use patent
patent.txt line 17,476
Flags
use code U-4328
Product numbers
001
26 Nov 2042 · NDA 208065 · OSIMERTINIB MESYLATE
US 12,465,608, use patent
patent.txt lines 8,055, 8,072
Flags
use code U-3823
Product numbers
001, 002
26 Nov 2042 · NDA 211801 · TENAPANOR HYDROCHLORIDE
US 12,539,299, product patent
patent.txt line 13,184
Flags
product
Product numbers
001
26 Nov 2042 · NDA 213931 · TENAPANOR HYDROCHLORIDE
US 12,539,299, product patent
patent.txt lines 15,308, 15,316, 15,324
Flags
product
Product numbers
001, 002, 003
10 Dec 2042 · NDA 212576 · CEDAZURIDINE; DECITABINE
US 12,697,347, use patent
patent.txt line 14,177
Flags
use code U-4587
Product numbers
001
13 Dec 2042 · NDA 218230 · GEPOTIDACIN MESYLATE
US 12,528,809, substance and product and use patent
patent.txt line 20,920
Flags
substance product use code U-4361
Product numbers
001
13 Dec 2042 · NDA 218230 · GEPOTIDACIN MESYLATE
US 12,528,809, substance and product and use patent
patent.txt line 20,921
Flags
substance product use code U-4408
Product numbers
001
16 Dec 2042 · NDA 217370 · ACOLTREMON
US 11,850,221, product and use patent
patent.txt line 19,882
Flags
product use code U-1900
Product numbers
001
16 Dec 2042 · NDA 217370 · ACOLTREMON
US 12,336,971, use patent
patent.txt line 19,883
Flags
use code U-1900
Product numbers
001
18 Dec 2042 · NDA 218944 · REVUMENIB CITRATE
US 12,564,590, product and use patent
patent.txt lines 21,422, 21,427, 21,432
Flags
product use code U-4045
Product numbers
001, 002, 003
18 Dec 2042 · NDA 218944 · REVUMENIB CITRATE
US 12,564,590, product and use patent
patent.txt lines 21,423, 21,428, 21,433
Flags
product use code U-4327
Product numbers
001, 002, 003
29 Dec 2042 · NDA 219616 · AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
US 11,873,296, product and use patent
patent.txt line 21,797
Flags
product use code U-4196
Product numbers
001
29 Dec 2042 · NDA 219616 · AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
US 12,509,450, product patent
patent.txt line 21,798
Flags
product
Product numbers
001
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,771,666, use patent
patent.txt lines 12,568, 12,609
Flags
use code U-3693
Product numbers
001, 002
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,771,667, use patent
patent.txt lines 12,569, 12,610
Flags
use code U-3693
Product numbers
001, 002
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,779,554, use patent
patent.txt lines 12,570, 12,611
Flags
use code U-3693
Product numbers
001, 002
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,793,776, use patent
patent.txt lines 12,571, 12,612
Flags
use code U-3693
Product numbers
001, 002
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,872,203, use patent
patent.txt lines 12,579, 12,620
Flags
use code U-3693
Product numbers
001, 002
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,872,204, use patent
patent.txt lines 12,580, 12,621
Flags
use code U-3693
Product numbers
001, 002
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 12,005,036, use patent
patent.txt lines 12,585, 12,626
Flags
use code U-3693
Product numbers
001, 002
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 12,036,194, use patent
patent.txt lines 12,586, 12,627
Flags
use code U-3693
Product numbers
001, 002
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 12,064,411, use patent
patent.txt lines 12,587, 12,628
Flags
use code U-3693
Product numbers
001, 002
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 12,090,126, use patent
patent.txt lines 12,588, 12,629
Flags
use code U-3693
Product numbers
001, 002
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 12,102,609, use patent
patent.txt lines 12,589, 12,630
Flags
use code U-3693
Product numbers
001, 002
30 Dec 2042 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 12,263,145, use patent
patent.txt line 12,592
Flags
use code U-3693
Product numbers
001