Drybench Patent.

Patent and exclusivity dates from January to June 2044 for NDAs, as FDA's Orange Book lists them

Each patent and exclusivity date from January to June 2044 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, 2044 July to December 2044

Listed patent expiry (33)

23 Jan 2044 · NDA 219141 · HYDROCHLOROTHIAZIDE
US 11,878,022, product and use patent
patent.txt line 21,508
Flags
product use code U-4138
Product numbers
001
23 Jan 2044 · NDA 219141 · HYDROCHLOROTHIAZIDE
US 11,878,022, product and use patent
patent.txt line 21,509
Flags
product use code U-4139
Product numbers
001
30 Jan 2044 · NDA 220613 · CABOZANTINIB LAURYLSULFATE
US 12,415,784, unflagged patent
patent.txt lines 22,326, 22,339, 22,352
Flags
not flagged
Product numbers
001, 002, 003
30 Jan 2044 · NDA 220613 · CABOZANTINIB LAURYLSULFATE
US 12,516,025, use patent
patent.txt lines 22,327, 22,340, 22,353
Flags
use code U-1480
Product numbers
001, 002, 003
30 Jan 2044 · NDA 220613 · CABOZANTINIB LAURYLSULFATE
US 12,516,025, use patent
patent.txt lines 22,328, 22,341, 22,354
Flags
use code U-2488
Product numbers
001, 002, 003
30 Jan 2044 · NDA 220613 · CABOZANTINIB LAURYLSULFATE
US 12,516,025, use patent
patent.txt lines 22,329, 22,342, 22,355
Flags
use code U-4131
Product numbers
001, 002, 003
30 Jan 2044 · NDA 220613 · CABOZANTINIB LAURYLSULFATE
US 12,552,567, use patent
patent.txt lines 22,330, 22,343, 22,356
Flags
use code U-1480
Product numbers
001, 002, 003
30 Jan 2044 · NDA 220613 · CABOZANTINIB LAURYLSULFATE
US 12,552,567, use patent
patent.txt lines 22,331, 22,344, 22,357
Flags
use code U-2488
Product numbers
001, 002, 003
30 Jan 2044 · NDA 220613 · CABOZANTINIB LAURYLSULFATE
US 12,552,567, use patent
patent.txt lines 22,332, 22,345, 22,358
Flags
use code U-4131
Product numbers
001, 002, 003
30 Jan 2044 · NDA 220613 · CABOZANTINIB LAURYLSULFATE
US 12,552,749, use patent
patent.txt lines 22,333, 22,346, 22,359
Flags
use code U-1480
Product numbers
001, 002, 003
30 Jan 2044 · NDA 220613 · CABOZANTINIB LAURYLSULFATE
US 12,552,749, use patent
patent.txt lines 22,334, 22,347, 22,360
Flags
use code U-2488
Product numbers
001, 002, 003
30 Jan 2044 · NDA 220613 · CABOZANTINIB LAURYLSULFATE
US 12,552,749, use patent
patent.txt lines 22,335, 22,348, 22,361
Flags
use code U-4131
Product numbers
001, 002, 003
30 Jan 2044 · NDA 220613 · CABOZANTINIB LAURYLSULFATE
US 12,741,938, product patent
patent.txt lines 22,336, 22,349, 22,362
Flags
product
Product numbers
001, 002, 003
5 Feb 2044 · NDA 219379 · MIRDAMETINIB
US 12,661,330, use patent
patent.txt lines 21,653, 21,670, 21,685
Flags
use code U-4130
Product numbers
001, 002, 003
5 Feb 2044 · NDA 219389 · MIRDAMETINIB
US 12,661,330, use patent
patent.txt lines 21,705, 21,724
Flags
use code U-4130
Product numbers
001, 002
16 Feb 2044 · NDA 213036 · ARTESUNATE
US 12,121,506, product patent
patent.txt line 14,577
Flags
product
Product numbers
001
16 Feb 2044 · NDA 213036 · ARTESUNATE
US 12,390,442, use patent
patent.txt line 14,578
Flags
use code U-4433
Product numbers
001
26 Feb 2044 · NDA 218549 · BENZGALANTAMINE GLUCONATE
US 12,208,167, product and use patent
patent.txt lines 21,105, 21,109, 21,113
Flags
product use code U-713
Product numbers
001, 002, 003
5 Mar 2044 · NDA 218860 · ELAFIBRANOR
US 12,673,035, product and use patent
patent.txt line 21,406
Flags
product use code U-1854
Product numbers
001
15 Mar 2044 · NDA 218585 · ACECLIDINE HYDROCHLORIDE
US 12,414,942, use patent
patent.txt line 21,125
Flags
use code U-3741
Product numbers
001
15 Mar 2044 · NDA 219379 · MIRDAMETINIB
US 12,029,711, product and use patent
patent.txt lines 21,643, 21,661, 21,677
Flags
product use code U-4130
Product numbers
001, 002, 003
15 Mar 2044 · NDA 219389 · MIRDAMETINIB
US 12,029,711, product and use patent
patent.txt lines 21,695, 21,714
Flags
product use code U-4130
Product numbers
001, 002
15 Mar 2044 · NDA 219389 · MIRDAMETINIB
US 12,383,517, product and use patent
patent.txt lines 21,703, 21,722
Flags
product use code U-4130
Product numbers
001, 002
25 Mar 2044 · NDA 219070 · PALTUSOTINE HYDROCHLORIDE
US 12,208,092, use patent
patent.txt lines 21,476, 21,485
Flags
use code U-4282
Product numbers
001, 002
3 Apr 2044 · NDA 219873 · DESMOPRESSIN ACETATE
US 12,214,010, product patent
patent.txt line 22,026
Flags
product
Product numbers
001
3 Apr 2044 · NDA 219873 · DESMOPRESSIN ACETATE
US 12,343,372, product and use patent
patent.txt line 22,027
Flags
product use code U-4432
Product numbers
001
10 May 2044 · NDA 217900 · DEURUXOLITINIB PHOSPHATE
US 12,247,034, substance and product patent
patent.txt line 20,761
Flags
substance product
Product numbers
001
31 May 2044 · NDA 220358 · MILSAPERIDONE
US 12,478,619, use patent
patent.txt lines 22,142, 22,162, 22,182, 22,202, 22,222, 22,242, 22,262
Flags
use code U-4434
Product numbers
001, 002, 003, 004, 005, 006, 007
31 May 2044 · NDA 220358 · MILSAPERIDONE
US 12,478,619, use patent
patent.txt lines 22,143, 22,163, 22,183, 22,203, 22,223, 22,243, 22,263
Flags
use code U-4435
Product numbers
001, 002, 003, 004, 005, 006, 007
14 Jun 2044 · NDA 215344 · MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE
US 12,239,659, use patent
patent.txt line 16,799
Flags
use code U-4143
Product numbers
001
14 Jun 2044 · NDA 215344 · MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE
US 12,433,914, use patent
patent.txt line 16,801
Flags
use code U-4143
Product numbers
001
14 Jun 2044 · NDA 215344 · MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE
US 12,594,298, product patent
patent.txt line 16,802
Flags
product
Product numbers
001
25 Jun 2044 · NDA 217389 · ENSIFENTRINE
US 12,251,384, product patent
patent.txt line 19,906
Flags
product
Product numbers
001