Drybench Patent.
Patent and exclusivity dates in 2025 for NDAs on FDA's Paragraph IV list, as FDA lists them
Each patent and exclusivity date in 2025 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 (44)
13 Jul 2025 · NDA 022291 · ELTROMBOPAG OLAMINE
US 7,547,719, substance and product and use patent
patent.txt lines 1,582, 1,587, 1,593, 1,599- Flags
- substance product use code U-2451
- Product numbers
- 001, 002, 003, 004
13 Jul 2025 · NDA 022291 · ELTROMBOPAG OLAMINE
US 7,547,719, substance and product and use patent
patent.txt lines 1,583, 1,588, 1,594, 1,600- Flags
- substance product use code U-2452
- Product numbers
- 001, 002, 003, 004
13 Jul 2025 · NDA 022291 · ELTROMBOPAG OLAMINE
US 7,547,719, substance and product and use patent
patent.txt lines 1,580, 1,585, 1,591, 1,597, 1,602- Flags
- substance product use code U-1306
- Product numbers
- 001, 002, 003, 004, 005
13 Jul 2025 · NDA 022291 · ELTROMBOPAG OLAMINE
US 7,547,719, substance and product and use patent
patent.txt lines 1,581, 1,586, 1,592, 1,598, 1,603- Flags
- substance product use code U-1575
- Product numbers
- 001, 002, 003, 004, 005
13 Jul 2025 · NDA 022291 · ELTROMBOPAG OLAMINE
US 7,547,719, substance and product and use patent
patent.txt lines 1,589, 1,595, 1,604- Flags
- substance product use code U-930
- Product numbers
- 002, 003, 005
13 Jul 2025 · NDA 207027 · ELTROMBOPAG OLAMINE
US 7,547,719, substance and product and use patent
patent.txt lines 6,996, 7,001- Flags
- substance product use code U-1306
- Product numbers
- 001, 002
13 Jul 2025 · NDA 207027 · ELTROMBOPAG OLAMINE
US 7,547,719, substance and product and use patent
patent.txt lines 6,997, 7,002- Flags
- substance product use code U-1575
- Product numbers
- 001, 002
13 Jul 2025 · NDA 207027 · ELTROMBOPAG OLAMINE
US 7,547,719, substance and product and use patent
patent.txt lines 6,998, 7,003- Flags
- substance product use code U-1736
- Product numbers
- 001, 002
13 Jul 2025 · NDA 207027 · ELTROMBOPAG OLAMINE
US 7,547,719, substance and product and use patent
patent.txt lines 6,999, 7,004- Flags
- substance product use code U-2452
- Product numbers
- 001, 002
13 Aug 2025 · NDA 022341 · LIRAGLUTIDE
US 8,114,833, substance and product patent
patent.txt line 1,722- Flags
- substance product
- Product numbers
- 001
13 Aug 2025 · NDA 206321 · LIRAGLUTIDE
US 8,114,833, product patent
patent.txt line 6,471- Flags
- product
- Product numbers
- 001
7 Sep 2025 · NDA 022512 · DABIGATRAN ETEXILATE MESYLATE
US 7,932,273, substance and product patent
patent.txt lines 2,014, 2,018, 2,022- Flags
- substance product
- Product numbers
- 001, 002, 003
11 Sep 2025 · NDA 022012 · CARVEDILOL PHOSPHATE
US 8,101,209, product patent
patent.txt lines 902, 904, 906, 908- Flags
- product
- Product numbers
- 001, 002, 003, 004
1 Oct 2025 · NDA 205832 · NINTEDANIB ESYLATE
US 6,762,180, substance and product patent
patent.txt lines 5,897, 5,905- Flags
- substance product
- Product numbers
- 001, 002
2 Oct 2025 · NDA 021926 · NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
US 7,332,183, product and use patent
patent.txt line 805- Flags
- product use code U-867
- Product numbers
- 001
2 Oct 2025 · NDA 021926 · NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
US 7,332,183, product and use patent
patent.txt line 807- Flags
- product use code U-1719
- Product numbers
- 002
4 Oct 2025 · NDA 202293 · DAPAGLIFLOZIN
US 6,515,117, substance and product and use patent
patent.txt lines 2,978, 3,016- Flags
- substance product use code U-2139
- Product numbers
- 001, 002
4 Oct 2025 · NDA 202293 · DAPAGLIFLOZIN
US 6,515,117, substance and product and use patent
patent.txt lines 2,979, 3,017- Flags
- substance product use code U-493
- Product numbers
- 001, 002
4 Oct 2025 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 6,515,117, substance and product and use patent
patent.txt lines 5,711, 5,721, 5,731, 5,741, 5,751- Flags
- substance product use code U-493
- Product numbers
- 001, 002, 003, 004, 005
4 Oct 2025 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 6,515,117, substance and product and use patent
patent.txt lines 9,658, 9,674- Flags
- substance product use code U-493
- Product numbers
- 001, 002
24 Oct 2025 · NDA 206947 · LENVATINIB MESYLATE
US 7,253,286, substance and product patent
patent.txt lines 6,890, 6,911- Flags
- substance product
- Product numbers
- 001, 002
30 Oct 2025 · NDA 021445 · EZETIMIBE
US 7,612,058, use patent
patent.txt line 615- Flags
- use code U-1027
- Product numbers
- 001
30 Oct 2025 · NDA 021445 · EZETIMIBE
US 7,612,058, use patent
patent.txt line 616- Flags
- use code U-1173
- Product numbers
- 001
31 Oct 2025 · NDA 207500 · ISAVUCONAZONIUM SULFATE
US 6,812,238, substance patent
patent.txt lines 7,265, 7,271- Flags
- substance
- Product numbers
- 001, 002
31 Oct 2025 · NDA 207501 · ISAVUCONAZONIUM SULFATE
US 6,812,238, substance patent
patent.txt line 7,273- Flags
- substance
- Product numbers
- 001
1 Nov 2025 · NDA 022334 · EVEROLIMUS
US 8,410,131, use patent
patent.txt lines 1,709, 1,712, 1,715, 1,718- Flags
- use code U-1368
- Product numbers
- 001, 002, 003, 004
1 Nov 2025 · NDA 203441 · TEDUGLUTIDE
US 7,847,061, use patent
patent.txt line 3,872- Flags
- use code U-1320 delist requested
- Product numbers
- 001
1 Nov 2025 · NDA 203441 · TEDUGLUTIDE
US 9,060,992, use patent
patent.txt line 3,874- Flags
- use code U-1320 delist requested
- Product numbers
- 001
16 Nov 2025 · NDA 022181 · SAPROPTERIN DIHYDROCHLORIDE
US 7,566,462, product patent
patent.txt line 1,139- Flags
- product
- Product numbers
- 001
16 Nov 2025 · NDA 022181 · SAPROPTERIN DIHYDROCHLORIDE
US 8,003,126, unflagged patent
patent.txt line 1,141- Flags
- not flagged
- Product numbers
- 001
26 Nov 2025 · NDA 201280 · LINAGLIPTIN
US 8,883,805, product patent
patent.txt line 2,341- Flags
- product
- Product numbers
- 001
26 Nov 2025 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,883,805, product patent
patent.txt lines 2,357, 2,375, 2,393- Flags
- product
- Product numbers
- 001, 002, 003
26 Nov 2025 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 8,883,805, product patent
patent.txt lines 6,202, 6,234- Flags
- product
- Product numbers
- 001, 002
26 Nov 2025 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,883,805, product patent
patent.txt lines 7,981, 8,000- Flags
- product
- Product numbers
- 001, 002
26 Nov 2025 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,883,805, product patent
patent.txt lines 14,250, 14,280, 14,310, 14,339- Flags
- product
- Product numbers
- 001, 002, 003, 004
5 Dec 2025 · NDA 204410 · MACITENTAN
US 7,094,781, substance and product patent
patent.txt line 4,669- Flags
- substance product
- Product numbers
- 001
8 Dec 2025 · NDA 203214 · TOFACITINIB CITRATE
US RE41783, substance patent
patent.txt lines 3,672, 3,674- Flags
- substance
- Product numbers
- 001, 002
8 Dec 2025 · NDA 208246 · TOFACITINIB CITRATE
US RE41783, substance patent
patent.txt lines 8,381, 8,390- Flags
- substance
- Product numbers
- 001, 002
8 Dec 2025 · NDA 213082 · TOFACITINIB CITRATE
US RE41783, substance patent
patent.txt line 14,661- Flags
- substance
- Product numbers
- 001
10 Dec 2025 · NDA 201023 · CABAZITAXEL
US 7,241,907, substance patent
patent.txt line 2,319- Flags
- substance
- Product numbers
- 001
11 Dec 2025 · NDA 203341 · BOSUTINIB MONOHYDRATE
US 7,417,148, use patent
patent.txt lines 3,774, 3,785, 3,796- Flags
- use code U-1283
- Product numbers
- 001, 002, 003
11 Dec 2025 · NDA 203341 · BOSUTINIB MONOHYDRATE
US 7,417,148, use patent
patent.txt lines 3,775, 3,786, 3,797- Flags
- use code U-3707
- Product numbers
- 001, 002, 003
11 Dec 2025 · NDA 203341 · BOSUTINIB MONOHYDRATE
US 7,417,148, use patent
patent.txt lines 3,776, 3,787, 3,798- Flags
- use code U-3708
- Product numbers
- 001, 002, 003
11 Dec 2025 · NDA 203341 · BOSUTINIB MONOHYDRATE
US 7,919,625, product patent
patent.txt lines 3,780, 3,791, 3,802- Flags
- product
- Product numbers
- 001, 002, 003
Non-patent exclusivity (9)
18 Jul 2025 · NDA 215309 · RUXOLITINIB PHOSPHATE
I-896 exclusivity
exclusivity.txt line 1,518- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
15 Aug 2025 · NDA 206947 · LENVATINIB MESYLATE
ODE-196 exclusivity
exclusivity.txt lines 565, 569- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
24 Aug 2025 · NDA 205552 · IBRUTINIB
NPP exclusivity
exclusivity.txt lines 502, 506- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
24 Aug 2025 · NDA 210563 · IBRUTINIB
NPP exclusivity
exclusivity.txt lines 889, 893, 897, 901- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
13 Sep 2025 · NDA 201532 · ERIBULIN MESYLATE
M-280 exclusivity
exclusivity.txt line 223- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
22 Oct 2025 · NDA 214787 · REMDESIVIR
NCE exclusivity
exclusivity.txt lines 1,392, 1,398- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002
26 Oct 2025 · NDA 021196 · SODIUM OXYBATE
ODE-231 exclusivity
exclusivity.txt line 117- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
19 Dec 2025 · NDA 202192 · RUXOLITINIB PHOSPHATE
M-285 exclusivity
exclusivity.txt lines 237, 243, 249, 255, 261- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005
21 Dec 2025 · NDA 021986 · DASATINIB
ODE-225 exclusivity
exclusivity.txt lines 145, 147, 149, 151, 153, 155- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006