Drybench Patent.

Patent and exclusivity dates in 2042 for NDAs on FDA's Paragraph IV list, as FDA lists them

Each patent and exclusivity date in 2042 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 (35)

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
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
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
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
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
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
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
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
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
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
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
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
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