Drybench Patent.

Patent and exclusivity dates in 2044 for NDAs on FDA's Paragraph IV list, as FDA lists them

Each patent and exclusivity date in 2044 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 (12)

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
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
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
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