Drybench Patent.

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

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

Listed patent expiry (28)

2 Jul 2044 · NDA 022496 · BUPIVACAINE
US 12,156,940, product patent
patent.txt lines 1,960, 1,986
Flags
product
Product numbers
001, 002
2 Jul 2044 · NDA 022496 · BUPIVACAINE
US 12,251,468, product and use patent
patent.txt lines 1,964, 1,990
Flags
product use code U-4152
Product numbers
001, 002
2 Jul 2044 · NDA 022496 · BUPIVACAINE
US 12,318,483, use patent
patent.txt lines 1,966, 1,992
Flags
use code U-4152
Product numbers
001, 002
2 Jul 2044 · NDA 022496 · BUPIVACAINE
US 12,370,142, product and use patent
patent.txt lines 1,967, 1,993
Flags
product use code U-4152
Product numbers
001, 002
2 Jul 2044 · NDA 022496 · BUPIVACAINE
US 12,728,094, product and use patent
patent.txt lines 1,968, 1,994
Flags
product use code U-4152
Product numbers
001, 002
2 Jul 2044 · NDA 022496 · BUPIVACAINE
US 12,728,095, product and use patent
patent.txt lines 1,969, 1,995
Flags
product use code U-4152
Product numbers
001, 002
16 Jul 2044 · NDA 220305 · ZIFTOMENIB
US 12,410,184, substance and product and use patent
patent.txt line 22,135
Flags
substance product use code U-4347
Product numbers
001
16 Jul 2044 · NDA 220305 · ZIFTOMENIB
US 12,410,184, substance and product and use patent
patent.txt line 22,136
Flags
substance product use code U-4348
Product numbers
001
16 Jul 2044 · NDA 220305 · ZIFTOMENIB
US 12,521,396, product patent
patent.txt line 22,137
Flags
product
Product numbers
001
18 Jul 2044 · NDA 217933 · ILOPROST
US 12,409,183, use patent
patent.txt line 20,778
Flags
use code U-4263
Product numbers
001
25 Jul 2044 · NDA 215793 · MITOMYCIN
US 12,740,940, use patent
patent.txt line 17,514
Flags
use code U-4605
Product numbers
001
2 Aug 2044 · NDA 215344 · MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE
US 12,290,529, product patent
patent.txt line 16,800
Flags
product
Product numbers
001
8 Aug 2044 · NDA 216830 · PHENYLEPHRINE HYDROCHLORIDE
US 12,564,561, product patent
patent.txt line 18,996
Flags
product
Product numbers
001
26 Sep 2044 · NDA 021924 · LEVOTHYROXINE SODIUM
US 12,564,565, product patent
patent.txt lines 785–799
Flags
product
Product numbers
002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016
26 Sep 2044 · NDA 206977 · LEVOTHYROXINE SODIUM
US 12,564,565, product patent
patent.txt lines 6,924, 6,929, 6,934, 6,939, 6,944, 6,949, 6,954, 6,959, 6,964, 6,969, 6,974, 6,979, 6,984, 6,989, 6,994
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015
27 Sep 2044 · NDA 217569 · VASOPRESSIN
US 12,447,190, product patent
patent.txt lines 20,008–20,009
Flags
product
Product numbers
001, 002
9 Oct 2044 · NDA 219843 · METHOCARBAMOL
US 12,390,439, product and use patent
patent.txt line 22,022
Flags
product use code U-4253
Product numbers
001
10 Oct 2044 · NDA 217900 · DEURUXOLITINIB PHOSPHATE
US 12,364,699, use patent
patent.txt line 20,763
Flags
use code U-3976
Product numbers
001
10 Oct 2044 · NDA 219379 · MIRDAMETINIB
US 12,390,430, use patent
patent.txt lines 21,652, 21,669, 21,684
Flags
use code U-4130
Product numbers
001, 002, 003
10 Oct 2044 · NDA 219389 · MIRDAMETINIB
US 12,390,430, use patent
patent.txt lines 21,704, 21,723
Flags
use code U-4130
Product numbers
001, 002
21 Nov 2044 · NDA 211746 · MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE
US 12,653,833, product and use patent
patent.txt line 13,149
Flags
product use code U-4564
Product numbers
001
6 Dec 2044 · NDA 219304 · VIMSELTINIB
US 12,447,149, product patent
patent.txt lines 21,597, 21,610, 21,623
Flags
product
Product numbers
001, 002, 003
6 Dec 2044 · NDA 219304 · VIMSELTINIB
US 12,528,787, substance and product patent
patent.txt lines 21,600, 21,613, 21,626
Flags
substance product
Product numbers
001, 002, 003
6 Dec 2044 · NDA 219304 · VIMSELTINIB
US 12,551,483, product patent
patent.txt lines 21,601, 21,614, 21,627
Flags
product
Product numbers
001, 002, 003
6 Dec 2044 · NDA 219304 · VIMSELTINIB
US 12,617,775, substance and product patent
patent.txt lines 21,603, 21,616, 21,629
Flags
substance product
Product numbers
001, 002, 003
6 Dec 2044 · NDA 219304 · VIMSELTINIB
US 12,643,883, substance and product patent
patent.txt lines 21,604, 21,617, 21,630
Flags
substance product
Product numbers
001, 002, 003
23 Dec 2044 · NDA 220406 · LEUCOVORIN CALCIUM
US 12,564,592, product patent
patent.txt lines 22,284–22,286
Flags
product
Product numbers
001, 002, 003
24 Dec 2044 · NDA 213498 · PONESIMOD
US 12,728,116, use patent
patent.txt lines 15,071, 15,077
Flags
use code U-4610
Product numbers
001, 010