Drybench Patent.

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

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

Listed patent expiry (37)

6 Jan 2042 · NDA 215401 · DEXTROAMPHETAMINE
US 11,559,501, product patent
patent.txt lines 16,869, 16,873, 16,877, 16,881
Flags
product
Product numbers
001, 002, 003, 004
10 Jan 2042 · NDA 217294 · FUROSEMIDE
US 12,403,120, product and use patent
patent.txt line 19,840
Flags
product use code U-4576
Product numbers
001
11 Jan 2042 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,833,164, use patent
patent.txt line 8,976
Flags
use code U-2371
Product numbers
001
13 Jan 2042 · NDA 218549 · BENZGALANTAMINE GLUCONATE
US 11,795,176, substance and use patent
patent.txt lines 21,104, 21,108, 21,112
Flags
substance use code U-713
Product numbers
001, 002, 003
24 Jan 2042 · NDA 220910 · DARAXONRASIB
US 12,280,113, substance and product patent
patent.txt lines 22,396, 22,398
Flags
substance product
Product numbers
001, 002
28 Jan 2042 · NDA 217785 · RESMETIROM
US 12,661,359, use patent
patent.txt lines 20,375, 20,383, 20,391
Flags
use code U-4568
Product numbers
001, 002, 003
3 Feb 2042 · NDA 022387 · TREPROSTINIL
US 11,826,327, use patent
patent.txt line 1,766
Flags
use code U-3749
Product numbers
001
3 Feb 2042 · NDA 214324 · TREPROSTINIL
US 11,826,327, use patent
patent.txt lines 15,679, 15,687, 15,695, 15,703, 15,711
Flags
use code U-3749
Product numbers
001, 002, 003, 004, 005
7 Feb 2042 · NDA 214755 · SODIUM OXYBATE
US 11,583,510, use patent
patent.txt lines 16,004, 16,033, 16,063, 16,092
Flags
use code U-3578
Product numbers
001, 002, 003, 004
6 Mar 2042 · NDA 219666 · SEPIAPTERIN
US 12,257,252, use patent
patent.txt lines 21,853, 21,857
Flags
use code U-4250
Product numbers
001, 002
8 Mar 2042 · NDA 212608 · AVAPRITINIB
US 12,060,354, use patent
patent.txt lines 14,188, 14,197, 14,205
Flags
use code U-2726
Product numbers
001, 002, 003
16 Mar 2042 · NDA 214755 · SODIUM OXYBATE
US 11,779,557, use patent
patent.txt lines 16,008, 16,037, 16,067, 16,096
Flags
use code U-3705
Product numbers
001, 002, 003, 004
17 Mar 2042 · NDA 022496 · BUPIVACAINE
US 11,931,459, use patent
patent.txt lines 1,956, 1,982
Flags
use code U-3839
Product numbers
001, 002
17 Mar 2042 · NDA 022496 · BUPIVACAINE
US 11,931,459, use patent
patent.txt lines 1,957, 1,983
Flags
use code U-3840
Product numbers
001, 002
17 Mar 2042 · NDA 213586 · RISPERIDONE
US 12,329,851, use patent
patent.txt lines 15,089, 15,098, 15,107, 15,115, 15,121, 15,127, 15,133
Flags
use code U-4214
Product numbers
001, 002, 003, 004, 005, 006, 007
1 Apr 2042 · NDA 217469 · CYCLOSPORINE
US 12,059,449, product and use patent
patent.txt line 19,983
Flags
product use code U-1483
Product numbers
001
7 Apr 2042 · NDA 215910 · PHENOBARBITAL SODIUM
US 11,857,683, product and use patent
patent.txt line 18,090
Flags
product use code U-3779
Product numbers
001
7 Apr 2042 · NDA 215910 · PHENOBARBITAL SODIUM
US 12,636,254, product and use patent
patent.txt line 18,091
Flags
product use code U-3779
Product numbers
001
15 Apr 2042 · NDA 214520 · HEPARIN SODIUM; TAUROLIDINE
US 11,738,120, substance and product patent
patent.txt lines 15,867, 15,869
Flags
substance product
Product numbers
001, 002
23 Apr 2042 · NDA 208054 · FLUCICLOVINE F-18
US 11,980,674, use patent
patent.txt line 8,040
Flags
use code U-2450
Product numbers
001
1 May 2042 · NDA 220442 · ENSITRELVIR
US 11,814,368, substance and product and use patent
patent.txt line 22,287
Flags
substance product use code U-4553
Product numbers
001
1 May 2042 · NDA 220442 · ENSITRELVIR
US 12,559,474, substance and product and use patent
patent.txt line 22,288
Flags
substance product use code U-4553
Product numbers
001
7 May 2042 · NDA 216190 · TIZANIDINE HYDROCHLORIDE
US 12,042,484, product and use patent
patent.txt line 18,430
Flags
product use code U-2779
Product numbers
001
7 May 2042 · NDA 216190 · TIZANIDINE HYDROCHLORIDE
US 12,263,158, product and use patent
patent.txt line 18,431
Flags
product use code U-2779
Product numbers
001
13 May 2042 · NDA 215168 · FLURPIRIDAZ F-18
US 12,527,884, product and use patent
patent.txt line 16,506
Flags
product use code U-4406
Product numbers
001
26 May 2042 · NDA 217628 · CLOTRIMAZOLE
US 12,246,006, product and use patent
patent.txt line 20,044
Flags
product use code U-4276
Product numbers
001
27 May 2042 · NDA 210745 · APREMILAST
US 11,752,129, product and use patent
patent.txt line 12,130
Flags
product use code U-4264
Product numbers
001
27 May 2042 · NDA 210745 · APREMILAST
US 11,752,129, product and use patent
patent.txt line 12,131
Flags
product use code U-4265
Product numbers
001
27 May 2042 · NDA 210745 · APREMILAST
US 11,752,129, product and use patent
patent.txt line 12,132
Flags
product use code U-4266
Product numbers
001
27 May 2042 · NDA 210745 · APREMILAST
US 11,969,409, product patent
patent.txt line 12,133
Flags
product
Product numbers
001
27 May 2042 · NDA 210745 · APREMILAST
US 12,427,136, use patent
patent.txt line 12,134
Flags
use code U-1858
Product numbers
001
27 May 2042 · NDA 210745 · APREMILAST
US 12,427,136, use patent
patent.txt line 12,135
Flags
use code U-4290
Product numbers
001
27 May 2042 · NDA 210745 · APREMILAST
US 12,427,136, use patent
patent.txt line 12,136
Flags
use code U-4291
Product numbers
001
27 May 2042 · NDA 213004 · AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
US 11,878,011, use patent
patent.txt line 14,535
Flags
use code U-3816
Product numbers
001
10 Jun 2042 · NDA 211635 · DIAZEPAM
US 12,599,611, use patent
patent.txt lines 12,914, 12,922, 12,930
Flags
use code U-4455
Product numbers
001, 002, 003
17 Jun 2042 · NDA 212099 · DAROLUTAMIDE
US 12,329,742, product patent
patent.txt line 13,541
Flags
product
Product numbers
001
30 Jun 2042 · NDA 215383 · BELZUTIFAN
US 12,358,870, product patent
patent.txt line 16,819
Flags
product
Product numbers
001