Drybench Patent.
Patent and exclusivity dates in 2043 for NDAs on FDA's Paragraph IV list, as FDA lists them
Each patent and exclusivity date in 2043 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 (87)
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 14,752- Flags
- use code U-3715
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 14,753- Flags
- use code U-3716
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 14,754- Flags
- use code U-3717
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 14,755- Flags
- use code U-3718
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 14,756- Flags
- use code U-3719
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 14,757- Flags
- use code U-3720
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 14,758- Flags
- use code U-3875
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 14,767- Flags
- use code U-3715
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 14,768- Flags
- use code U-3716
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 14,769- Flags
- use code U-3717
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 14,770- Flags
- use code U-3718
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 14,771- Flags
- use code U-3719
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 14,772- Flags
- use code U-3720
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 14,773- Flags
- use code U-3875
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 14,774- Flags
- use code U-3715
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 14,775- Flags
- use code U-3716
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 14,776- Flags
- use code U-3717
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 14,777- Flags
- use code U-3718
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 14,778- Flags
- use code U-3719
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 14,779- Flags
- use code U-3720
- Product numbers
- 001
19 Jan 2043 · NDA 213217 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 14,780- Flags
- use code U-3875
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 21,333- Flags
- use code U-3715
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 21,334- Flags
- use code U-3716
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 21,335- Flags
- use code U-3717
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 21,336- Flags
- use code U-3718
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 21,337- Flags
- use code U-3719
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 21,338- Flags
- use code U-3720
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,786,531, use patent
patent.txt line 21,339- Flags
- use code U-3875
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 21,348- Flags
- use code U-3715
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 21,349- Flags
- use code U-3716
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 21,350- Flags
- use code U-3717
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 21,351- Flags
- use code U-3718
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 21,352- Flags
- use code U-3719
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 21,353- Flags
- use code U-3720
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,896,596, use patent
patent.txt line 21,354- Flags
- use code U-3875
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 21,355- Flags
- use code U-3715
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 21,356- Flags
- use code U-3716
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 21,357- Flags
- use code U-3717
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 21,358- Flags
- use code U-3718
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 21,359- Flags
- use code U-3719
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 21,360- Flags
- use code U-3720
- Product numbers
- 001
19 Jan 2043 · NDA 218785 · ZANUBRUTINIB
US 11,911,386, use patent
patent.txt line 21,361- Flags
- use code U-3875
- Product numbers
- 001
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 11,717,518, use patent
patent.txt line 17,044- Flags
- use code U-3419
- Product numbers
- 001
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 11,925,636, use patent
patent.txt line 17,052- Flags
- use code U-3419
- Product numbers
- 001
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,156,914, product patent
patent.txt line 17,059- Flags
- product
- Product numbers
- 001
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,239,642, use patent
patent.txt line 17,062- Flags
- use code U-4515
- Product numbers
- 001
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,263,161, use patent
patent.txt line 17,063- Flags
- use code U-4515
- Product numbers
- 001
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,310,961, use patent
patent.txt line 17,064- Flags
- use code U-3419
- Product numbers
- 001
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,357,697, use patent
patent.txt line 17,065- Flags
- use code U-3419
- Product numbers
- 001
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,472,174, use patent
patent.txt lines 17,072, 17,155- Flags
- use code U-4515
- Product numbers
- 001, 002
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,478,622, use patent
patent.txt line 17,073- Flags
- use code U-4515
- Product numbers
- 001
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,564,587, use patent
patent.txt line 17,074- Flags
- use code U-4515
- Product numbers
- 001
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,661,408, use patent
patent.txt line 17,078- Flags
- use code U-3419
- Product numbers
- 001
20 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,678,506, product patent
patent.txt lines 17,079, 17,157- Flags
- product
- Product numbers
- 001, 002
23 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 11,730,706, use patent
patent.txt line 17,045- Flags
- use code U-3419
- Product numbers
- 001
23 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 11,883,373, use patent
patent.txt line 17,050- Flags
- use code U-3419
- Product numbers
- 001
23 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,194,005, use patent
patent.txt line 17,060- Flags
- use code U-4523
- Product numbers
- 001
23 Jan 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,364,674, use patent
patent.txt line 17,066- Flags
- use code U-4516
- Product numbers
- 001
23 Jan 2043 · NDA 215935 · BUDESONIDE
US 11,896,719, use patent
patent.txt line 18,092- Flags
- use code U-3810
- Product numbers
- 001
23 Jan 2043 · NDA 215935 · BUDESONIDE
US 12,171,882, use patent
patent.txt line 18,093- Flags
- use code U-4085
- Product numbers
- 001
23 Jan 2043 · NDA 215935 · BUDESONIDE
US 12,171,882, use patent
patent.txt line 18,094- Flags
- use code U-4086
- Product numbers
- 001
23 Jan 2043 · NDA 215935 · BUDESONIDE
US 12,171,883, product patent
patent.txt line 18,095- Flags
- product
- Product numbers
- 001
23 Jan 2043 · NDA 215935 · BUDESONIDE
US 12,311,057, product and use patent
patent.txt line 18,096- Flags
- product use code U-4085
- Product numbers
- 001
23 Jan 2043 · NDA 215935 · BUDESONIDE
US 12,311,057, product and use patent
patent.txt line 18,097- Flags
- product use code U-4086
- Product numbers
- 001
23 Jan 2043 · NDA 215935 · BUDESONIDE
US 12,311,057, product and use patent
patent.txt line 18,098- Flags
- product use code U-4204
- Product numbers
- 001
25 Jan 2043 · NDA 215431 · MELOXICAM; RIZATRIPTAN BENZOATE
US 12,005,118, use patent
patent.txt line 17,261- Flags
- use code U-1719
- Product numbers
- 001
2 Feb 2043 · NDA 022496 · BUPIVACAINE
US 11,918,565, use patent
patent.txt lines 1,954, 1,980- Flags
- use code U-3841
- Product numbers
- 001, 002
2 Feb 2043 · NDA 022496 · BUPIVACAINE
US 12,226,610, use patent
patent.txt lines 1,961, 1,987- Flags
- use code U-4148
- Product numbers
- 001, 002
2 Feb 2043 · NDA 022496 · BUPIVACAINE
US 12,226,610, use patent
patent.txt lines 1,962, 1,988- Flags
- use code U-4149
- Product numbers
- 001, 002
2 Feb 2043 · NDA 022496 · BUPIVACAINE
US 12,226,610, use patent
patent.txt lines 1,963, 1,989- Flags
- use code U-4150
- Product numbers
- 001, 002
15 Feb 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 11,986,444, use patent
patent.txt line 17,054- Flags
- use code U-3419
- Product numbers
- 001
15 Feb 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,036,191, use patent
patent.txt line 17,055- Flags
- use code U-3419
- Product numbers
- 001
15 Feb 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,370,154, use patent
patent.txt line 17,067- Flags
- use code U-4518
- Product numbers
- 001
15 Feb 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,599,576, use patent
patent.txt line 17,076- Flags
- use code U-4518
- Product numbers
- 001
23 Feb 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 11,752,144, use patent
patent.txt line 17,046- Flags
- use code U-3419
- Product numbers
- 001
23 Feb 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,042,473, use patent
patent.txt line 17,056- Flags
- use code U-3419
- Product numbers
- 001
23 Feb 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,146,889, use patent
patent.txt line 17,058- Flags
- use code U-3419
- Product numbers
- 001
23 Feb 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,472,155, use patent
patent.txt line 17,070- Flags
- use code U-4519
- Product numbers
- 001
27 Feb 2043 · NDA 215206 · ATOGEPANT
US 12,350,259, use patent
patent.txt line 16,560- Flags
- use code U-4234
- Product numbers
- 001
2 Mar 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 11,839,612, use patent
patent.txt line 17,048- Flags
- use code U-3419
- Product numbers
- 001
20 Apr 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 11,844,797, use patent
patent.txt line 17,049- Flags
- use code U-3778
- Product numbers
- 001
20 Apr 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,194,036, use patent
patent.txt line 17,061- Flags
- use code U-4521
- Product numbers
- 001
5 Oct 2043 · NDA 219485 · MARALIXIBAT CHLORIDE
US 12,296,050, product and use patent
patent.txt lines 21,753, 21,762, 21,771, 21,780- Flags
- product use code U-4186
- Product numbers
- 001, 002, 003, 004
5 Oct 2043 · NDA 219485 · MARALIXIBAT CHLORIDE
US 12,296,050, product and use patent
patent.txt lines 21,754, 21,763, 21,772, 21,781- Flags
- product use code U-4187
- Product numbers
- 001, 002, 003, 004
11 Oct 2043 · NDA 215596 · MARIBAVIR
US 12,295,940, substance and product patent
patent.txt line 17,473- Flags
- substance product
- Product numbers
- 001
11 Oct 2043 · NDA 215596 · MARIBAVIR
US 12,527,771, substance and product patent
patent.txt line 17,477- Flags
- substance product
- Product numbers
- 001
28 Nov 2043 · NDA 215430 · BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
US 12,653,795, use patent
patent.txt line 17,077- Flags
- use code U-4516
- Product numbers
- 001