Drybench Patent.
Patent and exclusivity dates from July to December 2026 for NDAs, as FDA's Orange Book lists them
Each patent and exclusivity date from July to December 2026 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, 2026January to June 2026
Listed patent expiry (477)
1 Jul 2026 · NDA 202834 · PERAMPANEL
US 8,772,497, substance patent
patent.txt lines 3,402–3,407- Flags
- substance
- Product numbers
- 001, 002, 003, 004, 005, 006
1 Jul 2026 · NDA 208277 · PERAMPANEL
US 8,772,497, substance patent
patent.txt line 8,441- Flags
- substance
- Product numbers
- 001
3 Jul 2026 · NDA 022217 · ALISKIREN HEMIFUMARATE; VALSARTAN
US 8,168,616, product patent
patent.txt lines 1,347–1,348- Flags
- product
- Product numbers
- 001, 002
6 Jul 2026 · NDA 203188 · IVACAFTOR
US 8,354,427, use patent
patent.txt line 3,663- Flags
- use code U-1311
- Product numbers
- 001
6 Jul 2026 · NDA 203188 · IVACAFTOR
US 8,354,427, use patent
patent.txt line 3,664- Flags
- use code U-1905
- Product numbers
- 001
6 Jul 2026 · NDA 207925 · IVACAFTOR
US 8,354,427, use patent
patent.txt lines 7,514, 7,547- Flags
- use code U-2528
- Product numbers
- 001, 002
6 Jul 2026 · NDA 207925 · IVACAFTOR
US 8,354,427, use patent
patent.txt lines 7,512, 7,545, 7,578- Flags
- use code U-1311
- Product numbers
- 001, 002, 003
6 Jul 2026 · NDA 207925 · IVACAFTOR
US 8,354,427, use patent
patent.txt lines 7,513, 7,546, 7,579- Flags
- use code U-1905
- Product numbers
- 001, 002, 003
6 Jul 2026 · NDA 207925 · IVACAFTOR
US 8,354,427, use patent
patent.txt line 7,580- Flags
- use code U-2964
- Product numbers
- 003
6 Jul 2026 · NDA 207925 · IVACAFTOR
US 8,354,427, use patent
patent.txt lines 7,609, 7,637- Flags
- use code U-3608
- Product numbers
- 004, 005
6 Jul 2026 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 8,354,427, use patent
patent.txt lines 11,434, 11,466- Flags
- use code U-3021
- Product numbers
- 001, 002
6 Jul 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,354,427, use patent
patent.txt line 13,703- Flags
- use code U-3029
- Product numbers
- 001
6 Jul 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,354,427, use patent
patent.txt lines 13,704, 13,774- Flags
- use code U-3145
- Product numbers
- 001, 002
6 Jul 2026 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,354,427, use patent
patent.txt lines 20,114, 20,189- Flags
- use code U-3593
- Product numbers
- 001, 002
6 Jul 2026 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 8,354,427, use patent
patent.txt lines 21,207, 21,257- Flags
- use code U-4091
- Product numbers
- 001, 002
11 Jul 2026 · NDA 208254 · NETARSUDIL MESYLATE
US 10,532,993, use patent
patent.txt line 8,393- Flags
- use code U-1524
- Product numbers
- 001
11 Jul 2026 · NDA 208254 · NETARSUDIL MESYLATE
US 10,882,840, use patent
patent.txt line 8,396- Flags
- use code U-1524
- Product numbers
- 001
11 Jul 2026 · NDA 208254 · NETARSUDIL MESYLATE
US 11,021,456, use patent
patent.txt line 8,398- Flags
- use code U-1524
- Product numbers
- 001
11 Jul 2026 · NDA 208254 · NETARSUDIL MESYLATE
US 8,450,344, substance and product and use patent
patent.txt line 8,403- Flags
- substance product use code U-1524
- Product numbers
- 001
11 Jul 2026 · NDA 208254 · NETARSUDIL MESYLATE
US 9,096,569, substance and product and use patent
patent.txt line 8,404- Flags
- substance product use code U-1524
- Product numbers
- 001
11 Jul 2026 · NDA 208259 · LATANOPROST; NETARSUDIL DIMESYLATE
US 10,532,993, use patent
patent.txt line 8,408- Flags
- use code U-1524
- Product numbers
- 001
11 Jul 2026 · NDA 208259 · LATANOPROST; NETARSUDIL DIMESYLATE
US 10,882,840, use patent
patent.txt line 8,411- Flags
- use code U-1524
- Product numbers
- 001
11 Jul 2026 · NDA 208259 · LATANOPROST; NETARSUDIL DIMESYLATE
US 11,021,456, use patent
patent.txt line 8,413- Flags
- use code U-1524
- Product numbers
- 001
11 Jul 2026 · NDA 208259 · LATANOPROST; NETARSUDIL DIMESYLATE
US 8,450,344, substance and product and use patent
patent.txt line 8,419- Flags
- substance product use code U-1524
- Product numbers
- 001
11 Jul 2026 · NDA 208259 · LATANOPROST; NETARSUDIL DIMESYLATE
US 9,096,569, substance and product and use patent
patent.txt line 8,420- Flags
- substance product use code U-1524
- Product numbers
- 001
17 Jul 2026 · NDA 209637 · SEMAGLUTIDE
US 10,220,155, product patent
patent.txt lines 10,686, 10,702, 10,720, 10,737- Flags
- product delist requested
- Product numbers
- 001, 002, 003, 004
17 Jul 2026 · NDA 209637 · SEMAGLUTIDE
US 11,097,063, product patent
patent.txt lines 10,690, 10,706, 10,723, 10,741- Flags
- product delist requested
- Product numbers
- 001, 002, 003, 004
17 Jul 2026 · NDA 209637 · SEMAGLUTIDE
US 8,920,383, product patent
patent.txt lines 10,693, 10,711, 10,728, 10,746- Flags
- product delist requested
- Product numbers
- 001, 002, 003, 004
17 Jul 2026 · NDA 209637 · SEMAGLUTIDE
US 9,775,953, product patent
patent.txt lines 10,699, 10,717, 10,734, 10,752- Flags
- product delist requested
- Product numbers
- 001, 002, 003, 004
18 Jul 2026 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,389,537, use patent
patent.txt lines 999, 1,013, 1,027- Flags
- use code U-1374
- Product numbers
- 001, 002, 003
18 Jul 2026 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,415,363, substance and product and use patent
patent.txt lines 1,001, 1,015, 1,029- Flags
- substance product use code U-1374
- Product numbers
- 001, 002, 003
18 Jul 2026 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,415,363, substance and product and use patent
patent.txt lines 1,002, 1,016, 1,030- Flags
- substance product use code U-1407
- Product numbers
- 001, 002, 003
18 Jul 2026 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,501,760, product patent
patent.txt lines 1,004, 1,018, 1,032- Flags
- product
- Product numbers
- 001, 002, 003
18 Jul 2026 · NDA 022519 · FAMOTIDINE; IBUPROFEN
US 8,067,451, product and use patent
patent.txt line 2,031- Flags
- product use code U-1196
- Product numbers
- 001
18 Jul 2026 · NDA 022519 · FAMOTIDINE; IBUPROFEN
US 8,309,127, product patent
patent.txt line 2,032- Flags
- product
- Product numbers
- 001
18 Jul 2026 · NDA 022519 · FAMOTIDINE; IBUPROFEN
US 8,318,202, product patent
patent.txt line 2,033- Flags
- product
- Product numbers
- 001
18 Jul 2026 · NDA 022519 · FAMOTIDINE; IBUPROFEN
US 8,449,910, product patent
patent.txt line 2,034- Flags
- product
- Product numbers
- 001
18 Jul 2026 · NDA 022519 · FAMOTIDINE; IBUPROFEN
US 8,501,228, use patent
patent.txt line 2,035- Flags
- use code U-1196
- Product numbers
- 001
19 Jul 2026 · NDA 022572 · MITOMYCIN
US 8,186,511, product patent
patent.txt line 2,102- Flags
- product
- Product numbers
- 001
19 Jul 2026 · NDA 022572 · MITOMYCIN
US 9,205,075, product patent
patent.txt line 2,103- Flags
- product
- Product numbers
- 001
20 Jul 2026 · NDA 202714 · CARFILZOMIB
US 7,417,042, substance and product patent
patent.txt lines 3,139, 3,149, 3,159- Flags
- substance product
- Product numbers
- 001, 002, 003
24 Jul 2026 · NDA 022221 · LIDOCAINE HYDROCHLORIDE
US 8,759,401, product and use patent
patent.txt line 1,351- Flags
- product use code U-1523
- Product numbers
- 001
26 Jul 2026 · NDA 212489 · OPICAPONE
US 9,550,759, use patent
patent.txt lines 14,091, 14,102- Flags
- use code U-3870
- Product numbers
- 001, 002
26 Jul 2026 · NDA 212489 · OPICAPONE
US 9,550,759, use patent
patent.txt lines 14,092, 14,103- Flags
- use code U-3871
- Product numbers
- 001, 002
26 Jul 2026 · NDA 212489 · OPICAPONE
US 9,550,759, use patent
patent.txt lines 14,093, 14,104- Flags
- use code U-3872
- Product numbers
- 001, 002
28 Jul 2026 · NDA 021436 · ARIPIPRAZOLE
US 9,125,939, use patent
patent.txt lines 602, 604, 606, 608, 610, 612- Flags
- use code U-1749
- Product numbers
- 001, 002, 003, 004, 005, 006
28 Jul 2026 · NDA 021729 · ARIPIPRAZOLE
US 9,125,939, use patent
patent.txt lines 689, 691- Flags
- use code U-1749
- Product numbers
- 002, 003
28 Jul 2026 · NDA 205123 · SIMEPREVIR SODIUM
US 8,349,869, substance and product and use patent
patent.txt line 5,263- Flags
- substance product use code U-1467
- Product numbers
- 001
28 Jul 2026 · NDA 205123 · SIMEPREVIR SODIUM
US 8,741,926, substance and use patent
patent.txt line 5,264- Flags
- substance use code U-1467
- Product numbers
- 001
28 Jul 2026 · NDA 205123 · SIMEPREVIR SODIUM
US 8,754,106, substance and use patent
patent.txt line 5,265- Flags
- substance use code U-1467
- Product numbers
- 001
28 Jul 2026 · NDA 205123 · SIMEPREVIR SODIUM
US 9,040,562, substance and product and use patent
patent.txt line 5,266- Flags
- substance product use code U-1467
- Product numbers
- 001
28 Jul 2026 · NDA 205123 · SIMEPREVIR SODIUM
US 9,353,103, use patent
patent.txt line 5,267- Flags
- use code U-1467
- Product numbers
- 001
28 Jul 2026 · NDA 205123 · SIMEPREVIR SODIUM
US 9,623,022, use patent
patent.txt line 5,268- Flags
- use code U-1467
- Product numbers
- 001
28 Jul 2026 · NDA 205123 · SIMEPREVIR SODIUM
US 9,856,265, substance and product and use patent
patent.txt line 5,269- Flags
- substance product use code U-1467
- Product numbers
- 001
28 Jul 2026 · NDA 207202 · ARIPIPRAZOLE
US 9,125,939, use patent
patent.txt lines 7,081, 7,108, 7,135, 7,162, 7,189, 7,216- Flags
- use code U-1749
- Product numbers
- 001, 002, 003, 004, 005, 006
30 Jul 2026 · NDA 203496 · TREPROSTINIL DIOLAMINE
US 7,417,070, substance patent
patent.txt lines 3,947, 3,956, 3,965, 3,974, 3,983- Flags
- substance
- Product numbers
- 001, 002, 003, 004, 005
30 Jul 2026 · NDA 210589 · FISH OIL TRIGLYCERIDES
US 9,566,260, product and use patent
patent.txt lines 12,033–12,034- Flags
- product use code U-2366
- Product numbers
- 001, 002
31 Jul 2026 · NDA 022024 · METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
US 7,785,627, product patent
patent.txt lines 912, 914- Flags
- product
- Product numbers
- 001, 002
31 Jul 2026 · NDA 022024 · METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
US 7,959,946, product patent
patent.txt lines 913, 915- Flags
- product
- Product numbers
- 001, 002
31 Jul 2026 · NDA 022239 · SUMATRIPTAN SUCCINATE
US 7,901,385, product patent
patent.txt line 1,358- Flags
- product
- Product numbers
- 001
31 Jul 2026 · NDA 210136 · BUPRENORPHINE
US 8,236,755, product and use patent
patent.txt lines 11,154, 11,162, 11,170, 11,178, 11,186, 11,194, 11,202- Flags
- product use code U-3620
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
2 Aug 2026 · NDA 022205 · BALSALAZIDE DISODIUM
US 9,192,616, use patent
patent.txt line 1,346- Flags
- use code U-1229
- Product numbers
- 001
2 Aug 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 7,790,755, product patent
patent.txt lines 1,552, 1,566- Flags
- product
- Product numbers
- 001, 002
2 Aug 2026 · NDA 202429 · VEMURAFENIB
US 8,470,818, use patent
patent.txt line 3,090- Flags
- use code U-1418
- Product numbers
- 001
2 Aug 2026 · NDA 202429 · VEMURAFENIB
US 8,470,818, use patent
patent.txt line 3,091- Flags
- use code U-2164
- Product numbers
- 001
3 Aug 2026 · NDA 209637 · SEMAGLUTIDE
US RE46363, product patent
patent.txt lines 10,701, 10,719, 10,736, 10,754- Flags
- product delist requested
- Product numbers
- 001, 002, 003, 004
4 Aug 2026 · NDA 204516 · PAROXETINE MESYLATE
US 8,946,251, substance and product and use patent
patent.txt line 4,824- Flags
- substance product use code U-904
- Product numbers
- 001
4 Aug 2026 · NDA 204516 · PAROXETINE MESYLATE
US 9,393,237, use patent
patent.txt line 4,825- Flags
- use code U-904
- Product numbers
- 001
6 Aug 2026 · NDA 208610 · DELAFLOXACIN MEGLUMINE
US 8,273,892, substance patent
patent.txt line 8,910- Flags
- substance
- Product numbers
- 001
6 Aug 2026 · NDA 208611 · DELAFLOXACIN MEGLUMINE
US 8,273,892, substance patent
patent.txt line 8,919- Flags
- substance
- Product numbers
- 001
10 Aug 2026 · NDA 206256 · BELINOSTAT
US 6,888,027, substance and product and use patent
patent.txt line 6,453- Flags
- substance product use code U-1544
- Product numbers
- 001
11 Aug 2026 · NDA 203505 · OSPEMIFENE
US 8,236,861, use patent
patent.txt line 3,991- Flags
- use code U-1369
- Product numbers
- 001
11 Aug 2026 · NDA 203505 · OSPEMIFENE
US 8,236,861, use patent
patent.txt line 3,992- Flags
- use code U-1370
- Product numbers
- 001
11 Aug 2026 · NDA 203505 · OSPEMIFENE
US 8,236,861, use patent
patent.txt line 3,993- Flags
- use code U-905
- Product numbers
- 001
13 Aug 2026 · NDA 021660 · PACLITAXEL
US 8,034,375, use patent
patent.txt line 662- Flags
- use code U-1290
- Product numbers
- 001
13 Aug 2026 · NDA 021879 · DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
US 7,659,282, use patent
patent.txt line 748- Flags
- use code U-1093
- Product numbers
- 001
14 Aug 2026 · NDA 018613 · MALATHION
US 7,977,324, product patent
patent.txt line 139- Flags
- product
- Product numbers
- 001
14 Aug 2026 · NDA 203756 · CABOZANTINIB S-MALATE
US 7,579,473, substance and product patent
patent.txt lines 4,146, 4,154- Flags
- substance product
- Product numbers
- 001, 002
14 Aug 2026 · NDA 208692 · CABOZANTINIB S-MALATE
US 7,579,473, substance and product patent
patent.txt lines 9,194, 9,214, 9,234- Flags
- substance product
- Product numbers
- 001, 002, 003
16 Aug 2026 · NDA 208437 · GLYCOPYRROLATE
US 11,278,683, product patent
patent.txt line 8,625- Flags
- product
- Product numbers
- 001
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt lines 1,245, 1,281- Flags
- use code U-2588
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt lines 1,246, 1,282- Flags
- use code U-2589
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt lines 1,247, 1,283- Flags
- use code U-2590
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt lines 1,248, 1,284- Flags
- use code U-2593
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt lines 1,249, 1,285- Flags
- use code U-2594
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt lines 1,250, 1,286- Flags
- use code U-2595
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt lines 1,251, 1,287- Flags
- use code U-2596
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt lines 1,252, 1,288- Flags
- use code U-3188
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt lines 1,253, 1,289- Flags
- use code U-3189
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt lines 1,254, 1,290- Flags
- use code U-3190
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt lines 1,260, 1,296- Flags
- use code U-2588
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt lines 1,261, 1,297- Flags
- use code U-2589
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt lines 1,262, 1,298- Flags
- use code U-2590
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt lines 1,263, 1,299- Flags
- use code U-2593
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt lines 1,264, 1,300- Flags
- use code U-3188
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt lines 1,265, 1,301- Flags
- use code U-3189
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt lines 1,266, 1,302- Flags
- use code U-3190
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt lines 1,268, 1,304- Flags
- use code U-2588
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt lines 1,269, 1,305- Flags
- use code U-2589
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt lines 1,270, 1,306- Flags
- use code U-2590
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt lines 1,271, 1,307- Flags
- use code U-2593
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt lines 1,272, 1,308- Flags
- use code U-2594
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt lines 1,273, 1,309- Flags
- use code U-2595
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt lines 1,274, 1,310- Flags
- use code U-2596
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt lines 1,275, 1,311- Flags
- use code U-3188
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt lines 1,276, 1,312- Flags
- use code U-3189
- Product numbers
- 001, 002
18 Aug 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt lines 1,277, 1,313- Flags
- use code U-3190
- Product numbers
- 001, 002
18 Aug 2026 · NDA 202293 · DAPAGLIFLOZIN
US 8,329,648, use patent
patent.txt lines 2,987, 3,025- Flags
- use code U-2139
- Product numbers
- 001, 002
18 Aug 2026 · NDA 202293 · DAPAGLIFLOZIN
US 8,329,648, use patent
patent.txt lines 2,988, 3,026- Flags
- use code U-2212
- Product numbers
- 001, 002
18 Aug 2026 · NDA 202293 · DAPAGLIFLOZIN
US 8,329,648, use patent
patent.txt lines 2,989, 3,027- Flags
- use code U-2213
- Product numbers
- 001, 002
18 Aug 2026 · NDA 202293 · DAPAGLIFLOZIN
US 8,906,851, use patent
patent.txt lines 3,002, 3,040- Flags
- use code U-2139
- Product numbers
- 001, 002
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt line 9,878- Flags
- use code U-2588
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt line 9,879- Flags
- use code U-2589
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt line 9,880- Flags
- use code U-2590
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt line 9,881- Flags
- use code U-2593
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt line 9,882- Flags
- use code U-2594
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt line 9,883- Flags
- use code U-2595
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt line 9,884- Flags
- use code U-2596
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt line 9,885- Flags
- use code U-3188
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt line 9,886- Flags
- use code U-3189
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,329,648, use patent
patent.txt line 9,887- Flags
- use code U-3190
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt line 9,902- Flags
- use code U-2588
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt line 9,903- Flags
- use code U-2589
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt line 9,904- Flags
- use code U-2590
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt line 9,905- Flags
- use code U-2593
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt line 9,906- Flags
- use code U-2597
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt line 9,907- Flags
- use code U-3188
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt line 9,908- Flags
- use code U-3189
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,906,851, use patent
patent.txt line 9,909- Flags
- use code U-3190
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt line 9,911- Flags
- use code U-2588
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt line 9,912- Flags
- use code U-2589
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt line 9,913- Flags
- use code U-2590
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt line 9,914- Flags
- use code U-2593
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt line 9,915- Flags
- use code U-2594
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt line 9,916- Flags
- use code U-2595
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt line 9,917- Flags
- use code U-2596
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt line 9,918- Flags
- use code U-2597
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt line 9,919- Flags
- use code U-3188
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt line 9,920- Flags
- use code U-3189
- Product numbers
- 001
18 Aug 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 9,884,092, use patent
patent.txt line 9,921- Flags
- use code U-3190
- Product numbers
- 001
18 Aug 2026 · NDA 217639 · ELACESTRANT HYDROCHLORIDE
US 7,612,114, substance and product and use patent
patent.txt lines 20,051, 20,058- Flags
- substance product use code U-3523
- Product numbers
- 001, 002
23 Aug 2026 · NDA 212801 · OSILODROSTAT PHOSPHATE
US 8,835,646, substance and product patent
patent.txt lines 14,416, 14,422, 14,428- Flags
- substance product
- Product numbers
- 001, 002, 003
24 Aug 2026 · NDA 020610 · BALSALAZIDE DISODIUM
US 7,452,872, use patent
patent.txt line 189- Flags
- use code U-141
- Product numbers
- 001
24 Aug 2026 · NDA 020610 · BALSALAZIDE DISODIUM
US 7,625,884, use patent
patent.txt line 191- Flags
- use code U-141
- Product numbers
- 001
24 Aug 2026 · NDA 022205 · BALSALAZIDE DISODIUM
US 7,452,872, use patent
patent.txt line 1,343- Flags
- use code U-1229
- Product numbers
- 001
24 Aug 2026 · NDA 022205 · BALSALAZIDE DISODIUM
US 7,625,884, use patent
patent.txt line 1,344- Flags
- use code U-1229
- Product numbers
- 001
24 Aug 2026 · NDA 203415 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt line 3,862- Flags
- use code U-1281
- Product numbers
- 001
24 Aug 2026 · NDA 203415 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt line 3,863- Flags
- use code U-1588
- Product numbers
- 001
24 Aug 2026 · NDA 203415 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt line 3,864- Flags
- use code U-2345
- Product numbers
- 001
24 Aug 2026 · NDA 203415 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt line 3,865- Flags
- use code U-2708
- Product numbers
- 001
24 Aug 2026 · NDA 203415 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt line 3,866- Flags
- use code U-3763
- Product numbers
- 001
24 Aug 2026 · NDA 207318 · PIMAVANSERIN TARTRATE
US 7,659,285, use patent
patent.txt lines 7,234, 7,243- Flags
- use code U-1844
- Product numbers
- 001, 002
24 Aug 2026 · NDA 210793 · PIMAVANSERIN TARTRATE
US 7,659,285, use patent
patent.txt line 12,148- Flags
- use code U-1844
- Product numbers
- 001
24 Aug 2026 · NDA 213674 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt lines 15,171, 15,189- Flags
- use code U-2345
- Product numbers
- 001, 002
24 Aug 2026 · NDA 213674 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt lines 15,172, 15,190- Flags
- use code U-2708
- Product numbers
- 001, 002
24 Aug 2026 · NDA 213674 · ENZALUTAMIDE
US 8,183,274, use patent
patent.txt lines 15,173, 15,191- Flags
- use code U-3763
- Product numbers
- 001, 002
27 Aug 2026 · NDA 203093 · ELVITEGRAVIR
US 7,176,220, substance and product and use patent
patent.txt lines 3,610, 3,616- Flags
- substance product use code U-257
- Product numbers
- 001, 002
27 Aug 2026 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 7,176,220, substance and product and use patent
patent.txt line 3,632- Flags
- substance product use code U-257
- Product numbers
- 001
27 Aug 2026 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 7,176,220, substance and product and use patent
patent.txt line 7,349- Flags
- substance product use code U-257
- Product numbers
- 001
28 Aug 2026 · NDA 021529 · ETONOGESTREL
US 8,888,745, product patent
patent.txt line 626- Flags
- product
- Product numbers
- 002
29 Aug 2026 · NDA 206302 · NEBIVOLOL HYDROCHLORIDE; VALSARTAN
US 7,803,838, product patent
patent.txt line 6,457- Flags
- product
- Product numbers
- 001
30 Aug 2026 · NDA 202811 · LINACLOTIDE
US 7,304,036, substance and product and use patent
patent.txt line 3,334- Flags
- substance product use code U-4345
- Product numbers
- 001
30 Aug 2026 · NDA 202811 · LINACLOTIDE
US 7,304,036, substance and product and use patent
patent.txt lines 3,332, 3,348- Flags
- substance product use code U-1278
- Product numbers
- 001, 002
30 Aug 2026 · NDA 202811 · LINACLOTIDE
US 7,304,036, substance and product and use patent
patent.txt lines 3,333, 3,349, 3,366- Flags
- substance product use code U-1516
- Product numbers
- 001, 002, 003
30 Aug 2026 · NDA 202811 · LINACLOTIDE
US 7,304,036, substance and product and use patent
patent.txt line 3,367- Flags
- substance product use code U-3644
- Product numbers
- 003
30 Aug 2026 · NDA 202811 · LINACLOTIDE
US 7,304,036, substance and product and use patent
patent.txt line 3,368- Flags
- substance product use code U-4566
- Product numbers
- 003
1 Sep 2026 · NDA 022275 · TOLVAPTAN
US 8,501,730, substance patent
patent.txt lines 1,544, 1,546, 1,548- Flags
- substance
- Product numbers
- 001, 002, 003
1 Sep 2026 · NDA 204441 · TOLVAPTAN
US 8,501,730, substance patent
patent.txt lines 4,687, 4,689, 4,691, 4,693, 4,695- Flags
- substance
- Product numbers
- 001, 002, 003, 004, 005
5 Sep 2026 · NDA 208791 · CHLOROPROCAINE HYDROCHLORIDE
US 8,969,412, product and use patent
patent.txt line 9,456- Flags
- product use code U-2609
- Product numbers
- 001
9 Sep 2026 · NDA 217779 · IMETELSTAT SODIUM
US 9,388,415, use patent
patent.txt lines 20,364, 20,370- Flags
- use code U-3956
- Product numbers
- 001, 002
9 Sep 2026 · NDA 217779 · IMETELSTAT SODIUM
US 9,388,416, use patent
patent.txt lines 20,365, 20,371- Flags
- use code U-3956
- Product numbers
- 001, 002
11 Sep 2026 · NDA 204410 · MACITENTAN
US 10,946,015, product and use patent
patent.txt line 4,667- Flags
- product use code U-1445
- Product numbers
- 001
11 Sep 2026 · NDA 218490 · MACITENTAN; TADALAFIL
US 10,946,015, product and use patent
patent.txt lines 21,093, 21,099- Flags
- product use code U-3881
- Product numbers
- 001, 002
12 Sep 2026 · NDA 202992 · TERIFLUNOMIDE
US 6,794,410, use patent
patent.txt lines 3,589, 3,595- Flags
- use code U-1285
- Product numbers
- 001, 002
14 Sep 2026 · NDA 207202 · ARIPIPRAZOLE
US 7,978,064, product patent
patent.txt lines 7,067, 7,094, 7,121, 7,148, 7,175, 7,202- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006
15 Sep 2026 · NDA 022502 · ADAPALENE
US 8,435,502, product and use patent
patent.txt line 2,003- Flags
- product use code U-1078
- Product numbers
- 001
15 Sep 2026 · NDA 022502 · ADAPALENE
US 8,709,392, product and use patent
patent.txt line 2,004- Flags
- product use code U-1078
- Product numbers
- 001
19 Sep 2026 · NDA 206947 · LENVATINIB MESYLATE
US 7,612,208, substance and product patent
patent.txt lines 6,892, 6,913- Flags
- substance product
- Product numbers
- 001, 002
22 Sep 2026 · NDA 021688 · CINACALCET HYDROCHLORIDE
US 7,829,595, product and use patent
patent.txt lines 675, 677, 679- Flags
- product use code U-1098
- Product numbers
- 001, 002, 003
22 Sep 2026 · NDA 021688 · CINACALCET HYDROCHLORIDE
US 9,375,405, product patent
patent.txt lines 676, 678, 680- Flags
- product
- Product numbers
- 001, 002, 003
22 Sep 2026 · NDA 022535 · PIRFENIDONE
US 7,767,225, product and use patent
patent.txt line 2,060- Flags
- product use code U-1602
- Product numbers
- 001
22 Sep 2026 · NDA 022535 · PIRFENIDONE
US 7,988,994, product and use patent
patent.txt line 2,064- Flags
- product use code U-1602
- Product numbers
- 001
22 Sep 2026 · NDA 022535 · PIRFENIDONE
US 8,753,679, product and use patent
patent.txt line 2,073- Flags
- product use code U-1602
- Product numbers
- 001
26 Sep 2026 · NDA 210655 · RISPERIDONE
US 10,058,554, use patent
patent.txt lines 12,064, 12,074- Flags
- use code U-2363
- Product numbers
- 001, 002
26 Sep 2026 · NDA 210655 · RISPERIDONE
US 9,597,402, product patent
patent.txt lines 12,072, 12,082- Flags
- product
- Product numbers
- 001, 002
27 Sep 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 8,105,626, product patent
patent.txt lines 1,554, 1,568- Flags
- product
- Product numbers
- 001, 002
2 Oct 2026 · NDA 021902 · SINECATECHINS
US 7,858,662, product and use patent
patent.txt line 765- Flags
- product use code U-172
- Product numbers
- 001
2 Oct 2026 · NDA 208610 · DELAFLOXACIN MEGLUMINE
US 8,252,813, product and use patent
patent.txt line 8,909- Flags
- product use code U-2028
- Product numbers
- 001
2 Oct 2026 · NDA 208611 · DELAFLOXACIN MEGLUMINE
US 8,252,813, product and use patent
patent.txt line 8,918- Flags
- product use code U-2028
- Product numbers
- 001
4 Oct 2026 · NDA 022568 · DONEPEZIL HYDROCHLORIDE
US 8,481,565, product patent
patent.txt line 2,097- Flags
- product
- Product numbers
- 001
4 Oct 2026 · NDA 204824 · METHOTREXATE
US 8,021,335, product patent
patent.txt lines 5,066, 5,081, 5,096, 5,111, 5,126, 5,141, 5,156, 5,171- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
4 Oct 2026 · NDA 209863 · TESTOSTERONE ENANTHATE
US 8,021,335, product patent
patent.txt lines 10,932, 10,955, 10,978- Flags
- product
- Product numbers
- 001, 002, 003
5 Oct 2026 · NDA 206192 · COBIMETINIB FUMARATE
US 11,597,699, use patent
patent.txt line 6,439- Flags
- use code U-3554
- Product numbers
- 001
5 Oct 2026 · NDA 206192 · COBIMETINIB FUMARATE
US 8,362,002, use patent
patent.txt line 6,443- Flags
- use code U-1776
- Product numbers
- 001
5 Oct 2026 · NDA 208854 · NALDEMEDINE TOSYLATE
US RE46375, substance and product and use patent
patent.txt line 9,583- Flags
- substance product use code U-1185
- Product numbers
- 001
10 Oct 2026 · NDA 021747 · ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
US 7,396,341, product patent
patent.txt line 695- Flags
- product delist requested
- Product numbers
- 001
10 Oct 2026 · NDA 021936 · TIOTROPIUM BROMIDE
US 7,396,341, product patent
patent.txt line 809- Flags
- product delist requested
- Product numbers
- 001
10 Oct 2026 · NDA 206756 · OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
US 7,396,341, product patent
patent.txt line 6,757- Flags
- product delist requested
- Product numbers
- 001
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,466,136, product patent
patent.txt lines 1,620, 1,628, 1,636- Flags
- product
- Product numbers
- 001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,466,137, use patent
patent.txt lines 1,621, 1,629, 1,637- Flags
- use code U-1103
- Product numbers
- 001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,466,138, use patent
patent.txt lines 1,622, 1,630, 1,638- Flags
- use code U-1103
- Product numbers
- 001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,486,925, product patent
patent.txt lines 1,623, 1,631, 1,639- Flags
- product
- Product numbers
- 001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,729,057, product patent
patent.txt lines 1,624, 1,632, 1,640- Flags
- product
- Product numbers
- 001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,741,881, use patent
patent.txt lines 1,625, 1,633, 1,641- Flags
- use code U-1103
- Product numbers
- 001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,754,070, product patent
patent.txt lines 1,626, 1,634, 1,642- Flags
- product
- Product numbers
- 001, 002, 003
12 Oct 2026 · NDA 022309 · TESTOSTERONE
US 8,759,329, product patent
patent.txt lines 1,627, 1,635, 1,643- Flags
- product
- Product numbers
- 001, 002, 003
12 Oct 2026 · NDA 214759 · TREOSULFAN
US 7,199,162, use patent
patent.txt lines 16,112–16,113- Flags
- use code U-4142
- Product numbers
- 001, 002
17 Oct 2026 · NDA 202860 · NITRIC OXIDE
US 7,618,594, product patent
patent.txt line 3,415- Flags
- product
- Product numbers
- 001
17 Oct 2026 · NDA 202860 · NITRIC OXIDE
US 7,947,227, use patent
patent.txt line 3,416- Flags
- use code U-3037
- Product numbers
- 001
22 Oct 2026 · NDA 202429 · VEMURAFENIB
US 7,504,509, substance and product patent
patent.txt line 3,087- Flags
- substance product
- Product numbers
- 001
23 Oct 2026 · NDA 022549 · LOXAPINE
US 8,387,612, product patent
patent.txt line 2,080- Flags
- product
- Product numbers
- 001
25 Oct 2026 · NDA 203255 · PASIREOTIDE PAMOATE
US 7,759,308, product patent
patent.txt lines 3,676, 3,679, 3,682, 3,685, 3,688- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
25 Oct 2026 · NDA 217171 · PEGCETACOPLAN
US 9,056,076, use patent
patent.txt line 19,287- Flags
- use code U-3540
- Product numbers
- 001
26 Oct 2026 · NDA 203093 · ELVITEGRAVIR
US 7,635,704, substance and product and use patent
patent.txt lines 3,612, 3,618- Flags
- substance product use code U-257
- Product numbers
- 001, 002
26 Oct 2026 · NDA 203093 · ELVITEGRAVIR
US 8,981,103, substance and product patent
patent.txt lines 3,614, 3,620- Flags
- substance product
- Product numbers
- 001, 002
26 Oct 2026 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 7,635,704, substance and product and use patent
patent.txt line 3,634- Flags
- substance product use code U-257
- Product numbers
- 001
26 Oct 2026 · NDA 203100 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 8,981,103, substance and product patent
patent.txt line 3,640- Flags
- substance product
- Product numbers
- 001
26 Oct 2026 · NDA 203585 · OMACETAXINE MEPESUCCINATE
US 6,987,103, use patent
patent.txt line 4,106- Flags
- use code U-1300
- Product numbers
- 001
26 Oct 2026 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 7,635,704, substance and product and use patent
patent.txt line 7,351- Flags
- substance product use code U-257
- Product numbers
- 001
26 Oct 2026 · NDA 207561 · COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 8,981,103, substance and product patent
patent.txt line 7,359- Flags
- substance product
- Product numbers
- 001
28 Oct 2026 · NDA 206966 · ABAMETAPIR
US 7,812,163, product and use patent
patent.txt line 6,917- Flags
- product use code U-2863
- Product numbers
- 001
31 Oct 2026 · NDA 207947 · SELEXIPAG
US 7,205,302, substance and product and use patent
patent.txt lines 7,699, 7,711, 7,723, 7,735, 7,747, 7,759, 7,771, 7,783, 7,795, 7,807- Flags
- substance product use code U-1797
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008, 010, 011
31 Oct 2026 · NDA 214275 · SELEXIPAG
US 7,205,302, substance and product and use patent
patent.txt line 15,659- Flags
- substance product use code U-1797
- Product numbers
- 001
2 Nov 2026 · NDA 209501 · PREGABALIN
US 10,022,447, use patent
patent.txt lines 10,532, 10,540, 10,548- Flags
- use code U-2136
- Product numbers
- 001, 002, 003
2 Nov 2026 · NDA 209501 · PREGABALIN
US 10,022,447, use patent
patent.txt lines 10,533, 10,541, 10,549- Flags
- use code U-2137
- Product numbers
- 001, 002, 003
2 Nov 2026 · NDA 209501 · PREGABALIN
US 8,945,620, product and use patent
patent.txt lines 10,535, 10,543, 10,551- Flags
- product use code U-2136
- Product numbers
- 001, 002, 003
2 Nov 2026 · NDA 209501 · PREGABALIN
US 8,945,620, product and use patent
patent.txt lines 10,536, 10,544, 10,552- Flags
- product use code U-2137
- Product numbers
- 001, 002, 003
2 Nov 2026 · NDA 209501 · PREGABALIN
US 9,144,559, product patent
patent.txt lines 10,538, 10,546, 10,554- Flags
- product
- Product numbers
- 001, 002, 003
5 Nov 2026 · NDA 210655 · RISPERIDONE
US 11,110,093, product and use patent
patent.txt lines 12,068, 12,078- Flags
- product use code U-3135
- Product numbers
- 001, 002
7 Nov 2026 · NDA 208383 · BETRIXABAN
US 9,555,023, use patent
patent.txt lines 8,559, 8,565- Flags
- use code U-1502
- Product numbers
- 001, 002
8 Nov 2026 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 7,973,038, use patent
patent.txt lines 6,096, 6,144- Flags
- use code U-1973
- Product numbers
- 001, 002
8 Nov 2026 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,741,933, use patent
patent.txt line 6,110- Flags
- use code U-1717
- Product numbers
- 001
8 Nov 2026 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,741,933, use patent
patent.txt lines 6,111, 6,156- Flags
- use code U-1909
- Product numbers
- 001, 002
8 Nov 2026 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 9,216,969, substance and product patent
patent.txt line 6,124- Flags
- substance product
- Product numbers
- 001
8 Nov 2026 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 9,216,969, product patent
patent.txt line 6,168- Flags
- product
- Product numbers
- 002
8 Nov 2026 · NDA 207620 · SACUBITRIL; VALSARTAN
US 9,388,134, use patent
patent.txt lines 7,380, 7,388, 7,396- Flags
- use code U-1723
- Product numbers
- 001, 002, 003
8 Nov 2026 · NDA 208383 · BETRIXABAN
US 7,598,276, substance patent
patent.txt lines 8,554, 8,560- Flags
- substance
- Product numbers
- 001, 002
8 Nov 2026 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 7,973,038, use patent
patent.txt lines 12,728, 12,770- Flags
- use code U-2374
- Product numbers
- 001, 002
8 Nov 2026 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 7,973,038, use patent
patent.txt line 12,812- Flags
- use code U-3424
- Product numbers
- 003
8 Nov 2026 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,741,933, use patent
patent.txt lines 12,740, 12,782- Flags
- use code U-2374
- Product numbers
- 001, 002
8 Nov 2026 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,741,933, use patent
patent.txt line 12,824- Flags
- use code U-3424
- Product numbers
- 003
8 Nov 2026 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,216,969, product patent
patent.txt lines 12,752, 12,794, 12,836- Flags
- product
- Product numbers
- 001, 002, 003
8 Nov 2026 · NDA 218591 · SACUBITRIL; VALSARTAN
US 9,388,134, use patent
patent.txt lines 21,133, 21,136- Flags
- use code U-1723
- Product numbers
- 001, 002
9 Nov 2026 · NDA 201292 · AFATINIB DIMALEATE
US 9,539,258, use patent
patent.txt lines 2,405, 2,415, 2,425- Flags
- use code U-1950
- Product numbers
- 001, 002, 003
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 11,197,822, product patent
patent.txt line 15,395- Flags
- product
- Product numbers
- 001
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 11,413,296, product patent
patent.txt line 15,398- Flags
- product
- Product numbers
- 001
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 8,497,258, use patent
patent.txt line 15,401- Flags
- use code U-3820
- Product numbers
- 001
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 8,679,545, product patent
patent.txt line 15,402- Flags
- product
- Product numbers
- 001
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 8,975,243, use patent
patent.txt line 15,403- Flags
- use code U-3820
- Product numbers
- 001
9 Nov 2026 · NDA 213976 · BUDESONIDE
US 9,119,863, use patent
patent.txt line 15,405- Flags
- use code U-3820
- Product numbers
- 001
10 Nov 2026 · NDA 022399 · GABAPENTIN ENACARBIL
US 8,026,279, substance and product patent
patent.txt lines 1,775, 1,779- Flags
- substance product
- Product numbers
- 001, 002
11 Nov 2026 · NDA 217225 · AVACINCAPTAD PEGOL SODIUM
US 8,236,773, use patent
patent.txt line 19,809- Flags
- use code U-3673
- Product numbers
- 001
12 Nov 2026 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 7,612,087, product patent
patent.txt line 6,577- Flags
- product
- Product numbers
- 001
12 Nov 2026 · NDA 217906 · AVIBACTAM SODIUM; AZTREONAM
US 7,612,087, product patent
patent.txt line 20,772- Flags
- product
- Product numbers
- 001
15 Nov 2026 · NDA 219042 · ZONGERTINIB
US 12,171,739, substance and product patent
patent.txt line 21,468- Flags
- substance product
- Product numbers
- 001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,777- Flags
- substance product use code U-1167
- Product numbers
- 001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,782- Flags
- substance product use code U-1501
- Product numbers
- 001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,783- Flags
- substance product use code U-1502
- Product numbers
- 001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,784- Flags
- substance product use code U-1729
- Product numbers
- 001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,785- Flags
- substance product use code U-1730
- Product numbers
- 001
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt lines 2,778, 2,790- Flags
- substance product use code U-1200
- Product numbers
- 001, 002
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt lines 2,779, 2,791- Flags
- substance product use code U-1301
- Product numbers
- 001, 002
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt lines 2,780, 2,792- Flags
- substance product use code U-1302
- Product numbers
- 001, 002
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt lines 2,781, 2,793- Flags
- substance product use code U-1323
- Product numbers
- 001, 002
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt lines 2,786, 2,794- Flags
- substance product use code U-4178
- Product numbers
- 001, 002
21 Nov 2026 · NDA 202155 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 2,798- Flags
- substance product use code U-4179
- Product numbers
- 003
21 Nov 2026 · NDA 220073 · APIXABAN
US 6,967,208, substance and product and use patent
patent.txt line 22,090- Flags
- substance product use code U-4180
- Product numbers
- 001
22 Nov 2026 · NDA 022239 · SUMATRIPTAN SUCCINATE
US 7,776,007, product patent
patent.txt line 1,357- Flags
- product
- Product numbers
- 001
23 Nov 2026 · NDA 203341 · BOSUTINIB MONOHYDRATE
US 7,767,678, substance and product patent
patent.txt lines 3,778, 3,789, 3,800- Flags
- substance product
- Product numbers
- 001, 002, 003
23 Nov 2026 · NDA 217729 · BOSUTINIB MONOHYDRATE
US 7,767,678, substance and product patent
patent.txt lines 20,346, 20,356- Flags
- substance product
- Product numbers
- 001, 002
24 Nov 2026 · NDA 021995 · SITAGLIPTIN PHOSPHATE
US 7,326,708, substance and product and use patent
patent.txt lines 891, 893, 895- Flags
- substance product use code U-802
- Product numbers
- 001, 002, 003
24 Nov 2026 · NDA 022044 · METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
US 7,326,708, substance and product and use patent
patent.txt lines 966, 970- Flags
- substance product use code U-802
- Product numbers
- 001, 002
24 Nov 2026 · NDA 202270 · METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
US 7,326,708, substance and product and use patent
patent.txt lines 2,961, 2,963, 2,965- Flags
- substance product use code U-1227
- Product numbers
- 001, 002, 003
24 Nov 2026 · NDA 209805 · ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
US 7,326,708, substance and product and use patent
patent.txt lines 10,803, 10,808- Flags
- substance product use code U-2214
- Product numbers
- 001, 002
24 Nov 2026 · NDA 210259 · ACALABRUTINIB
US 7,459,554, substance patent
patent.txt line 11,263- Flags
- substance
- Product numbers
- 001
24 Nov 2026 · NDA 216387 · ACALABRUTINIB MALEATE
US 7,459,554, substance patent
patent.txt line 18,790- Flags
- substance
- Product numbers
- 001
28 Nov 2026 · NDA 020533 · ROPIVACAINE HYDROCHLORIDE
US 7,857,802, product patent
patent.txt lines 186–187- Flags
- product
- Product numbers
- 006, 007
28 Nov 2026 · NDA 208054 · FLUCICLOVINE F-18
US 10,010,632, product patent
patent.txt line 8,034- Flags
- product
- Product numbers
- 001
28 Nov 2026 · NDA 208054 · FLUCICLOVINE F-18
US 10,953,112, use patent
patent.txt line 8,038- Flags
- use code U-1879
- Product numbers
- 001
28 Nov 2026 · NDA 208054 · FLUCICLOVINE F-18
US 9,387,266, use patent
patent.txt line 8,041- Flags
- use code U-1879
- Product numbers
- 001
28 Nov 2026 · NDA 215904 · GANAXOLONE
US 7,858,609, product patent
patent.txt line 18,083- Flags
- product
- Product numbers
- 001
28 Nov 2026 · NDA 215904 · GANAXOLONE
US 8,022,054, product patent
patent.txt line 18,084- Flags
- product
- Product numbers
- 001
28 Nov 2026 · NDA 215904 · GANAXOLONE
US 8,367,651, product patent
patent.txt line 18,086- Flags
- product
- Product numbers
- 001
28 Nov 2026 · NDA 215904 · GANAXOLONE
US 8,618,087, use patent
patent.txt line 18,087- Flags
- use code U-3374
- Product numbers
- 001
28 Nov 2026 · NDA 215904 · GANAXOLONE
US 9,029,355, product patent
patent.txt line 18,088- Flags
- product
- Product numbers
- 001
28 Nov 2026 · NDA 215904 · GANAXOLONE
US 9,056,116, use patent
patent.txt line 18,089- Flags
- use code U-3374
- Product numbers
- 001
29 Nov 2026 · NDA 209310 · MOMETASONE FUROATE
US 7,544,192, use patent
patent.txt line 10,074- Flags
- use code U-2272
- Product numbers
- 001
1 Dec 2026 · NDA 204384 · BEDAQUILINE FUMARATE
US 7,498,343, substance and product and use patent
patent.txt lines 4,656, 4,658- Flags
- substance product use code U-1321
- Product numbers
- 001, 002
1 Dec 2026 · NDA 218549 · BENZGALANTAMINE GLUCONATE
US 9,763,953, use patent
patent.txt lines 21,107, 21,111, 21,115- Flags
- use code U-713
- Product numbers
- 001, 002, 003
2 Dec 2026 · NDA 050793 · CLINDAMYCIN PHOSPHATE
US 9,789,057, product and use patent
patent.txt line 2,144- Flags
- product use code U-137
- Product numbers
- 001
4 Dec 2026 · NDA 204819 · RIOCIGUAT
US 7,173,037, substance and product patent
patent.txt lines 5,023, 5,030, 5,037, 5,044, 5,051- Flags
- substance product
- Product numbers
- 001, 002, 003, 004, 005
5 Dec 2026 · NDA 021641 · RASAGILINE MESYLATE
US 7,572,834, product patent
patent.txt lines 653, 655- Flags
- product
- Product numbers
- 001, 002
5 Dec 2026 · NDA 207356 · AMIKACIN SULFATE
US 8,632,804, use patent
patent.txt line 7,255- Flags
- use code U-2416
- Product numbers
- 001
5 Dec 2026 · NDA 207356 · AMIKACIN SULFATE
US 8,642,075, product patent
patent.txt line 7,256- Flags
- product
- Product numbers
- 001
5 Dec 2026 · NDA 207356 · AMIKACIN SULFATE
US 8,679,532, use patent
patent.txt line 7,257- Flags
- use code U-2415
- Product numbers
- 001
8 Dec 2026 · NDA 050813 · AMOXICILLIN
US 8,357,394, product patent
patent.txt line 2,173- Flags
- product
- Product numbers
- 001
8 Dec 2026 · NDA 050813 · AMOXICILLIN
US 8,778,924, substance and product and use patent
patent.txt line 2,174- Flags
- substance product use code U-897
- Product numbers
- 001
12 Dec 2026 · NDA 201739 · EPINEPHRINE
US 11,590,286, product patent
patent.txt lines 2,560, 2,568, 2,577- Flags
- product
- Product numbers
- 001, 002, 003
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 2,823, 2,852, 2,881, 2,910, 2,939- Flags
- use code U-3226
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 2,824, 2,853, 2,882, 2,911, 2,940- Flags
- use code U-3227
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 2,825, 2,854, 2,883, 2,912, 2,941- Flags
- use code U-3228
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 2,826, 2,855, 2,884, 2,913, 2,942- Flags
- use code U-3230
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,814,722, use patent
patent.txt lines 2,828, 2,857, 2,886, 2,915, 2,944- Flags
- use code U-3226
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 9,814,722, use patent
patent.txt lines 2,829, 2,858, 2,887, 2,916, 2,945- Flags
- use code U-3230
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 11,590,286, product patent
patent.txt line 5,875- Flags
- product
- Product numbers
- 001
12 Dec 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,867,996, substance and product and use patent
patent.txt lines 6,415, 6,423- Flags
- substance product use code U-1694
- Product numbers
- 001, 002
12 Dec 2026 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 11,590,286, product patent
patent.txt line 10,899- Flags
- product
- Product numbers
- 001
12 Dec 2026 · NDA 209964 · IVABRADINE
US 7,867,996, substance and product and use patent
patent.txt line 11,087- Flags
- substance product use code U-1694
- Product numbers
- 001
12 Dec 2026 · NDA 213756 · SELUMETINIB SULFATE
US 9,156,795, substance and product patent
patent.txt lines 15,260, 15,268- Flags
- substance product
- Product numbers
- 001, 002
12 Dec 2026 · NDA 213756 · SELUMETINIB SULFATE
US 9,562,017, substance and use patent
patent.txt lines 15,261, 15,269- Flags
- substance use code U-4357
- Product numbers
- 001, 002
12 Dec 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 10,639,310, use patent
patent.txt line 16,736- Flags
- use code U-3229
- Product numbers
- 001
12 Dec 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt line 16,766- Flags
- use code U-3229
- Product numbers
- 001
12 Dec 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt line 16,767- Flags
- use code U-3404
- Product numbers
- 001
12 Dec 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 9,974,790, use patent
patent.txt line 16,769- Flags
- use code U-3229
- Product numbers
- 001
12 Dec 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 9,974,790, use patent
patent.txt line 16,770- Flags
- use code U-3404
- Product numbers
- 001
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 11,744,832, use patent
patent.txt lines 19,311, 19,364, 19,417, 19,470, 19,523- Flags
- use code U-3226
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 11,744,832, use patent
patent.txt lines 19,312, 19,365, 19,418, 19,471, 19,524- Flags
- use code U-3230
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,530,485, product patent
patent.txt lines 19,323, 19,376, 19,429, 19,482, 19,535- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 19,334, 19,387, 19,440, 19,493, 19,546- Flags
- use code U-3226
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 19,335, 19,388, 19,441, 19,494, 19,547- Flags
- use code U-3227
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 19,336, 19,389, 19,442, 19,495, 19,548- Flags
- use code U-3228
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,079,912, use patent
patent.txt lines 19,337, 19,390, 19,443, 19,496, 19,549- Flags
- use code U-3230
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,206,187, use patent
patent.txt lines 19,338, 19,391, 19,444, 19,497, 19,550- Flags
- use code U-3227
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,206,187, use patent
patent.txt lines 19,339, 19,392, 19,445, 19,498, 19,551- Flags
- use code U-3228
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,814,722, use patent
patent.txt lines 19,340, 19,393, 19,446, 19,499, 19,552- Flags
- use code U-3226
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 9,814,722, use patent
patent.txt lines 19,341, 19,394, 19,447, 19,500, 19,553- Flags
- use code U-3230
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2026 · NDA 219943 · SELUMETINIB SULFATE
US 9,156,795, substance and product patent
patent.txt lines 22,066, 22,070- Flags
- substance product
- Product numbers
- 001, 002
12 Dec 2026 · NDA 219943 · SELUMETINIB SULFATE
US 9,562,017, substance and use patent
patent.txt lines 22,067, 22,071- Flags
- substance use code U-4357
- Product numbers
- 001, 002
14 Dec 2026 · NDA 200677 · PASIREOTIDE DIASPARTATE
US 7,473,761, substance and product patent
patent.txt lines 2,307–2,309- Flags
- substance product
- Product numbers
- 001, 002, 003
14 Dec 2026 · NDA 203255 · PASIREOTIDE PAMOATE
US 7,473,761, substance and product patent
patent.txt lines 3,675, 3,678, 3,681, 3,684, 3,687- Flags
- substance product
- Product numbers
- 001, 002, 003, 004, 005
16 Dec 2026 · NDA 212327 · FEDRATINIB HYDROCHLORIDE
US 7,825,246, substance patent
patent.txt line 13,952- Flags
- substance
- Product numbers
- 001
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,372,827, product patent
patent.txt lines 3,380, 3,392- Flags
- product
- Product numbers
- 001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,372,828, product patent
patent.txt lines 3,381, 3,393- Flags
- product
- Product numbers
- 001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,377,919, product patent
patent.txt lines 3,382, 3,394- Flags
- product
- Product numbers
- 001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,536,163, use patent
patent.txt lines 3,383, 3,395- Flags
- use code U-1440
- Product numbers
- 001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,716,271, use patent
patent.txt lines 3,384, 3,396- Flags
- use code U-1440
- Product numbers
- 001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 8,735,375, use patent
patent.txt lines 3,385, 3,397- Flags
- use code U-1440
- Product numbers
- 001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 9,820,959, product and use patent
patent.txt lines 3,387, 3,398- Flags
- product use code U-1440
- Product numbers
- 001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 9,833,428, product patent
patent.txt lines 3,388, 3,399- Flags
- product
- Product numbers
- 001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 9,833,429, product patent
patent.txt lines 3,389, 3,400- Flags
- product
- Product numbers
- 001, 002
18 Dec 2026 · NDA 202833 · INGENOL MEBUTATE
US 9,861,603, use patent
patent.txt lines 3,390, 3,401- Flags
- use code U-1440
- Product numbers
- 001, 002
19 Dec 2026 · NDA 211911 · BIMATOPROST
US 10,441,543, product patent
patent.txt line 13,223- Flags
- product
- Product numbers
- 001
19 Dec 2026 · NDA 211911 · BIMATOPROST
US 9,149,428, product patent
patent.txt line 13,227- Flags
- product
- Product numbers
- 001
19 Dec 2026 · NDA 211996 · TAFAMIDIS MEGLUMINE
US 7,214,695, substance and product patent
patent.txt line 13,380- Flags
- substance product
- Product numbers
- 001
19 Dec 2026 · NDA 211996 · TAFAMIDIS MEGLUMINE
US 7,214,696, use patent
patent.txt line 13,381- Flags
- use code U-2524
- Product numbers
- 001
19 Dec 2026 · NDA 212161 · TAFAMIDIS
US 7,214,695, substance and product patent
patent.txt line 13,611- Flags
- substance product
- Product numbers
- 001
19 Dec 2026 · NDA 212161 · TAFAMIDIS
US 7,214,696, use patent
patent.txt line 13,612- Flags
- use code U-2524
- Product numbers
- 001
20 Dec 2026 · NDA 205060 · OMEGA-3-CARBOXYLIC ACIDS
US 7,960,370, product patent
patent.txt line 5,194- Flags
- product
- Product numbers
- 001
20 Dec 2026 · NDA 216665 · DIAZOXIDE CHOLINE
US 7,572,789, substance and product patent
patent.txt lines 18,898, 18,904, 18,910- Flags
- substance product
- Product numbers
- 001, 002, 003
22 Dec 2026 · NDA 203469 · PONATINIB HYDROCHLORIDE
US 9,029,533, use patent
patent.txt lines 3,885, 3,902, 3,919, 3,936- Flags
- use code U-1283
- Product numbers
- 001, 002, 003, 004
22 Dec 2026 · NDA 203469 · PONATINIB HYDROCHLORIDE
US 9,029,533, use patent
patent.txt lines 3,886, 3,903, 3,920, 3,937- Flags
- use code U-1699
- Product numbers
- 001, 002, 003, 004
22 Dec 2026 · NDA 203469 · PONATINIB HYDROCHLORIDE
US 9,029,533, use patent
patent.txt lines 3,887, 3,904, 3,921, 3,938- Flags
- use code U-1700
- Product numbers
- 001, 002, 003, 004
22 Dec 2026 · NDA 203469 · PONATINIB HYDROCHLORIDE
US 9,029,533, use patent
patent.txt lines 3,888, 3,905, 3,922, 3,939- Flags
- use code U-1701
- Product numbers
- 001, 002, 003, 004
22 Dec 2026 · NDA 203469 · PONATINIB HYDROCHLORIDE
US 9,029,533, use patent
patent.txt lines 3,889, 3,906, 3,923, 3,940- Flags
- use code U-836
- Product numbers
- 001, 002, 003, 004
26 Dec 2026 · NDA 021976 · DARUNAVIR
US 7,700,645, substance and product patent
patent.txt lines 853, 855, 857, 859, 861, 863- Flags
- substance product
- Product numbers
- 001, 002, 003, 004, 005, 006
26 Dec 2026 · NDA 202895 · DARUNAVIR
US 7,700,645, substance and product patent
patent.txt line 3,519- Flags
- substance product
- Product numbers
- 001
26 Dec 2026 · NDA 205395 · COBICISTAT; DARUNAVIR ETHANOLATE
US 7,700,645, substance and product patent
patent.txt lines 5,297, 5,303- Flags
- substance product
- Product numbers
- 001, 002
26 Dec 2026 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 7,700,645, substance and product patent
patent.txt line 11,403- Flags
- substance product
- Product numbers
- 001
27 Dec 2026 · NDA 217779 · IMETELSTAT SODIUM
US 7,494,982, substance and product patent
patent.txt lines 20,362, 20,368- Flags
- substance product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 203188 · IVACAFTOR
US 8,410,274, product patent
patent.txt line 3,666- Flags
- product
- Product numbers
- 001
28 Dec 2026 · NDA 203188 · IVACAFTOR
US 8,754,224, substance and product patent
patent.txt line 3,668- Flags
- substance product
- Product numbers
- 001
28 Dec 2026 · NDA 203188 · IVACAFTOR
US 9,670,163, product and use patent
patent.txt line 3,670- Flags
- product use code U-1311
- Product numbers
- 001
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 7,514,444, substance and product patent
patent.txt lines 5,508, 5,605- Flags
- substance product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,476,284, use patent
patent.txt lines 5,512, 5,609- Flags
- use code U-1650
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,476,284, use patent
patent.txt lines 5,513, 5,610- Flags
- use code U-1946
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,515, 5,612- Flags
- use code U-1491
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,516, 5,613- Flags
- use code U-1650
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,517, 5,614- Flags
- use code U-1946
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,518, 5,615- Flags
- use code U-2241
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,519, 5,616- Flags
- use code U-2242
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 5,520, 5,617- Flags
- use code U-3422
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,697,711, substance and product patent
patent.txt lines 5,527, 5,624- Flags
- substance product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,703,780, use patent
patent.txt lines 5,529, 5,626- Flags
- use code U-1491
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,735,403, substance and product patent
patent.txt lines 5,531, 5,628- Flags
- substance product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,754,091, product patent
patent.txt lines 5,533, 5,630- Flags
- product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 5,535, 5,632- Flags
- use code U-1491
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 5,536, 5,633- Flags
- use code U-1650
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 5,537, 5,634- Flags
- use code U-1946
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 8,957,079, substance and product patent
patent.txt lines 5,539, 5,636- Flags
- substance product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 9,181,257, substance and product patent
patent.txt line 5,546- Flags
- substance product
- Product numbers
- 001
28 Dec 2026 · NDA 205552 · IBRUTINIB
US 9,181,257, substance patent
patent.txt line 5,644- Flags
- substance
- Product numbers
- 002
28 Dec 2026 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,410,274, product patent
patent.txt lines 6,101, 6,148- Flags
- product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,754,224, substance and product patent
patent.txt lines 6,113, 6,158- Flags
- substance product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 9,670,163, product and use patent
patent.txt lines 6,126, 6,170- Flags
- product use code U-1911
- Product numbers
- 001, 002
28 Dec 2026 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 9,931,334, product and use patent
patent.txt lines 6,128, 6,172- Flags
- product use code U-2276
- Product numbers
- 001, 002
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 8,410,274, product patent
patent.txt lines 7,516, 7,549, 7,582, 7,611, 7,639- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 8,754,224, substance and product patent
patent.txt lines 7,518, 7,551, 7,584, 7,613, 7,641- Flags
- substance product
- Product numbers
- 001, 002, 003, 004, 005
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 7,523, 7,556- Flags
- product use code U-2530
- Product numbers
- 001, 002
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 7,522, 7,555, 7,588- Flags
- product use code U-1311
- Product numbers
- 001, 002, 003
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 9,670,163, product and use patent
patent.txt line 7,589- Flags
- product use code U-2966
- Product numbers
- 003
28 Dec 2026 · NDA 207925 · IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 7,617, 7,645- Flags
- product use code U-3606
- Product numbers
- 004, 005
28 Dec 2026 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 8,410,274, product patent
patent.txt lines 11,435, 11,467- Flags
- product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 8,754,224, substance and product patent
patent.txt lines 11,439, 11,471- Flags
- substance product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 9,670,163, product and use patent
patent.txt lines 11,441, 11,473- Flags
- product use code U-2246
- Product numbers
- 001, 002
28 Dec 2026 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 9,931,334, product and use patent
patent.txt lines 11,442, 11,474- Flags
- product use code U-2275
- Product numbers
- 001, 002
28 Dec 2026 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 9,931,334, product and use patent
patent.txt lines 11,443, 11,475- Flags
- product use code U-2575
- Product numbers
- 001, 002
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 7,514,444, substance and product patent
patent.txt lines 11,631, 11,735, 11,839, 11,941- Flags
- substance product
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,476,284, use patent
patent.txt lines 11,635, 11,739, 11,843, 11,946- Flags
- use code U-1650
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,476,284, use patent
patent.txt lines 11,636, 11,740, 11,844, 11,947- Flags
- use code U-1946
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,476,284, use patent
patent.txt lines 11,637, 11,741, 11,845, 11,949- Flags
- use code U-2241
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,476,284, use patent
patent.txt line 11,945- Flags
- use code U-1456
- Product numbers
- 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,476,284, use patent
patent.txt line 11,948- Flags
- use code U-1947
- Product numbers
- 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,644, 11,748, 11,852- Flags
- use code U-3422
- Product numbers
- 001, 002, 003
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,639, 11,743, 11,847, 11,952- Flags
- use code U-1491
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,640, 11,744, 11,848, 11,953- Flags
- use code U-1650
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,641, 11,745, 11,849, 11,954- Flags
- use code U-1946
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,642, 11,746, 11,850, 11,956- Flags
- use code U-2241
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt lines 11,643, 11,747, 11,851, 11,957- Flags
- use code U-2242
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt line 11,951- Flags
- use code U-1456
- Product numbers
- 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,497,277, use patent
patent.txt line 11,955- Flags
- use code U-1947
- Product numbers
- 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,697,711, substance and product patent
patent.txt lines 11,652, 11,756, 11,860, 11,965- Flags
- substance product
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,703,780, use patent
patent.txt lines 11,654, 11,758, 11,862, 11,967- Flags
- use code U-1491
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,703,780, use patent
patent.txt lines 11,655, 11,759, 11,863, 11,968- Flags
- use code U-2242
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,735,403, substance and product patent
patent.txt lines 11,657, 11,761, 11,865, 11,970- Flags
- substance product
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,754,091, product patent
patent.txt lines 11,659, 11,763, 11,867, 11,974- Flags
- product
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 11,661, 11,765, 11,869, 11,977- Flags
- use code U-1491
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 11,662, 11,766, 11,870, 11,978- Flags
- use code U-1650
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 11,663, 11,767, 11,871, 11,979- Flags
- use code U-1946
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 11,664, 11,768, 11,872, 11,981- Flags
- use code U-2241
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt lines 11,665, 11,769, 11,873, 11,982- Flags
- use code U-2242
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt line 11,976- Flags
- use code U-1456
- Product numbers
- 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,952,015, use patent
patent.txt line 11,980- Flags
- use code U-1947
- Product numbers
- 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 8,957,079, substance and product patent
patent.txt lines 11,667, 11,771, 11,875, 11,984- Flags
- substance product
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 210563 · IBRUTINIB
US 9,181,257, substance patent
patent.txt lines 11,676, 11,780, 11,884, 11,993- Flags
- substance
- Product numbers
- 001, 002, 003, 004
28 Dec 2026 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,410,274, product patent
patent.txt lines 12,732, 12,774, 12,816- Flags
- product
- Product numbers
- 001, 002, 003
28 Dec 2026 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,754,224, substance and product patent
patent.txt lines 12,742, 12,784, 12,826- Flags
- substance product
- Product numbers
- 001, 002, 003
28 Dec 2026 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,670,163, product and use patent
patent.txt lines 12,754, 12,796- Flags
- product use code U-2376
- Product numbers
- 001, 002
28 Dec 2026 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,670,163, product and use patent
patent.txt line 12,838- Flags
- product use code U-3429
- Product numbers
- 003
28 Dec 2026 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,931,334, product and use patent
patent.txt lines 12,756, 12,798- Flags
- product use code U-2376
- Product numbers
- 001, 002
28 Dec 2026 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 9,931,334, product and use patent
patent.txt line 12,840- Flags
- product use code U-3429
- Product numbers
- 003
28 Dec 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,410,274, product patent
patent.txt lines 13,705, 13,775- Flags
- product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,754,224, substance and product patent
patent.txt lines 13,715, 13,783- Flags
- substance product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,670,163, product and use patent
patent.txt line 13,718- Flags
- product use code U-3031
- Product numbers
- 001
28 Dec 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 13,719, 13,785- Flags
- product use code U-3155
- Product numbers
- 001, 002
28 Dec 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 13,720, 13,786- Flags
- product use code U-4078
- Product numbers
- 001, 002
28 Dec 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 13,721, 13,787- Flags
- product use code U-4477
- Product numbers
- 001, 002
28 Dec 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,931,334, product and use patent
patent.txt line 13,722- Flags
- product use code U-3031
- Product numbers
- 001
28 Dec 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,931,334, product and use patent
patent.txt lines 13,723, 13,788- Flags
- product use code U-3155
- Product numbers
- 001, 002
28 Dec 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,931,334, product and use patent
patent.txt lines 13,724, 13,789- Flags
- product use code U-4078
- Product numbers
- 001, 002
28 Dec 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,931,334, product and use patent
patent.txt lines 13,725, 13,790- Flags
- product use code U-4479
- Product numbers
- 001, 002
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 7,514,444, substance and product patent
patent.txt line 19,179- Flags
- substance product
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,476,284, use patent
patent.txt line 19,182- Flags
- use code U-3843
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,476,284, use patent
patent.txt line 19,183- Flags
- use code U-3844
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,476,284, use patent
patent.txt line 19,184- Flags
- use code U-3845
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,497,277, use patent
patent.txt line 19,186- Flags
- use code U-2666
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,497,277, use patent
patent.txt line 19,187- Flags
- use code U-2970
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,497,277, use patent
patent.txt line 19,188- Flags
- use code U-3422
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,497,277, use patent
patent.txt line 19,189- Flags
- use code U-3842
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,497,277, use patent
patent.txt line 19,190- Flags
- use code U-3843
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,497,277, use patent
patent.txt line 19,191- Flags
- use code U-3844
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,497,277, use patent
patent.txt line 19,192- Flags
- use code U-3845
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,697,711, substance and product patent
patent.txt line 19,199- Flags
- substance product
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,703,780, use patent
patent.txt line 19,200- Flags
- use code U-2666
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,703,780, use patent
patent.txt line 19,201- Flags
- use code U-3842
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,735,403, substance and product patent
patent.txt line 19,203- Flags
- substance product
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,754,091, product patent
patent.txt line 19,205- Flags
- product
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,952,015, use patent
patent.txt line 19,206- Flags
- use code U-2666
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,952,015, use patent
patent.txt line 19,207- Flags
- use code U-3842
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,952,015, use patent
patent.txt line 19,208- Flags
- use code U-3843
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,952,015, use patent
patent.txt line 19,209- Flags
- use code U-3844
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,952,015, use patent
patent.txt line 19,210- Flags
- use code U-3845
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 8,957,079, substance and product patent
patent.txt line 19,212- Flags
- substance product
- Product numbers
- 001
28 Dec 2026 · NDA 217003 · IBRUTINIB
US 9,181,257, substance patent
patent.txt line 19,219- Flags
- substance
- Product numbers
- 001
28 Dec 2026 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,410,274, product patent
patent.txt lines 20,115, 20,190- Flags
- product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,754,224, substance and product patent
patent.txt lines 20,123, 20,198- Flags
- substance product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 20,125, 20,200- Flags
- product use code U-3591
- Product numbers
- 001, 002
28 Dec 2026 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 20,126, 20,201- Flags
- product use code U-4068
- Product numbers
- 001, 002
28 Dec 2026 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,670,163, product and use patent
patent.txt lines 20,127, 20,202- Flags
- product use code U-4478
- Product numbers
- 001, 002
28 Dec 2026 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,931,334, product and use patent
patent.txt lines 20,128, 20,203- Flags
- product use code U-3591
- Product numbers
- 001, 002
28 Dec 2026 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,931,334, product and use patent
patent.txt lines 20,129, 20,204- Flags
- product use code U-4068
- Product numbers
- 001, 002
28 Dec 2026 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 9,931,334, product and use patent
patent.txt lines 20,130, 20,205- Flags
- product use code U-4478
- Product numbers
- 001, 002
28 Dec 2026 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 8,410,274, product patent
patent.txt lines 21,208, 21,258- Flags
- product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 8,754,224, substance and product patent
patent.txt lines 21,214, 21,264- Flags
- substance product
- Product numbers
- 001, 002
28 Dec 2026 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 9,670,163, product and use patent
patent.txt lines 21,220, 21,271- Flags
- product use code U-4080
- Product numbers
- 001, 002
28 Dec 2026 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 9,670,163, product and use patent
patent.txt lines 21,221, 21,272- Flags
- product use code U-4470
- Product numbers
- 001, 002
28 Dec 2026 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 9,931,334, product and use patent
patent.txt lines 21,222, 21,273- Flags
- product use code U-4080
- Product numbers
- 001, 002
28 Dec 2026 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 9,931,334, product and use patent
patent.txt lines 21,223, 21,274- Flags
- product use code U-4469
- Product numbers
- 001, 002
Pediatric exclusivity, as listed (30)
8 Jul 2026 · NDA 205832 · NINTEDANIB ESYLATE
US 10,154,990 with pediatric exclusivity, as listed
patent.txt lines 5,894, 5,902- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
12 Jul 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,609,863 with pediatric exclusivity, as listed
patent.txt lines 1,365, 1,382- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
12 Jul 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,791,270 with pediatric exclusivity, as listed
patent.txt lines 1,369, 1,386, 1,399, 1,405- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
12 Jul 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,895,756 with pediatric exclusivity, as listed
patent.txt lines 1,373, 1,390- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
13 Jul 2026 · NDA 201292 · AFATINIB DIMALEATE
US RE43431 with pediatric exclusivity, as listed
patent.txt lines 2,406, 2,416, 2,426- Flags
- substance pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
17 Jul 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 8,461,187 with pediatric exclusivity, as listed
patent.txt lines 1,559, 1,573- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
17 Jul 2026 · NDA 208056 · DEXLANSOPRAZOLE
US 8,461,187 with pediatric exclusivity, as listed
patent.txt line 8,042- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
19 Jul 2026 · NDA 021395 · TIOTROPIUM BROMIDE
US 8,022,082 with pediatric exclusivity, as listed
patent.txt line 595- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
20 Jul 2026 · NDA 022088 · TEMSIROLIMUS
US 8,026,276 with pediatric exclusivity, as listed
patent.txt line 1,046- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
27 Jul 2026 · NDA 022225 · SUGAMMADEX SODIUM
US RE44733 with pediatric exclusivity, as listed
patent.txt lines 1,352, 1,354- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
19 Aug 2026 · NDA 021985 · ALISKIREN HEMIFUMARATE
US 8,617,595 with pediatric exclusivity, as listed
patent.txt lines 865, 867- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
21 Aug 2026 · NDA 021660 · PACLITAXEL
US 7,758,891 with pediatric exclusivity, as listed
patent.txt line 659- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
21 Aug 2026 · NDA 021660 · PACLITAXEL
US 8,268,348 with pediatric exclusivity, as listed
patent.txt line 663- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
21 Aug 2026 · NDA 021660 · PACLITAXEL
US 9,101,543 with pediatric exclusivity, as listed
patent.txt line 665- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
22 Aug 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,361,649 with pediatric exclusivity, as listed
patent.txt lines 6,410, 6,418- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
22 Aug 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,361,650 with pediatric exclusivity, as listed
patent.txt lines 6,412, 6,420- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
22 Aug 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,879,842 with pediatric exclusivity, as listed
patent.txt lines 6,416, 6,424- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
24 Aug 2026 · NDA 202236 · AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
US 8,168,620 with pediatric exclusivity, as listed
patent.txt line 2,956- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
28 Sep 2026 · NDA 021986 · DASATINIB
US 7,491,725 with pediatric exclusivity, as listed
patent.txt lines 869, 871, 873, 875, 877, 879- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
6 Oct 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358 with pediatric exclusivity, as listed
patent.txt lines 1,090, 1,098, 1,106- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
6 Oct 2026 · NDA 022117 · ASENAPINE MALEATE
US 8,022,228 with pediatric exclusivity, as listed
patent.txt lines 1,096, 1,104, 1,109- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
11 Oct 2026 · NDA 202343 · SIMVASTATIN; SITAGLIPTIN PHOSPHATE
US 7,326,708 with pediatric exclusivity, as listed
patent.txt lines 3,071, 3,073, 3,075, 3,077, 3,079, 3,081- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
12 Oct 2026 · NDA 205422 · BREXPIPRAZOLE
US 8,349,840 with pediatric exclusivity, as listed
patent.txt lines 5,309, 5,322, 5,335, 5,348, 5,361, 5,372- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
12 Oct 2026 · NDA 205422 · BREXPIPRAZOLE
US 8,618,109 with pediatric exclusivity, as listed
patent.txt lines 5,311, 5,324, 5,337, 5,350, 5,363, 5,374- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
12 Oct 2026 · NDA 205422 · BREXPIPRAZOLE
US 9,839,637 with pediatric exclusivity, as listed
patent.txt lines 5,314, 5,327, 5,340, 5,353, 5,366, 5,377- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
26 Nov 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 8,729,085 with pediatric exclusivity, as listed
patent.txt lines 2,245, 2,256, 2,267, 2,278, 2,289- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
26 Nov 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 8,883,794 with pediatric exclusivity, as listed
patent.txt lines 2,247, 2,258, 2,269, 2,280, 2,291- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
26 Nov 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 9,907,794 with pediatric exclusivity, as listed
patent.txt lines 2,254, 2,265, 2,276, 2,287, 2,298- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
7 Dec 2026 · NDA 022020 · PANTOPRAZOLE SODIUM
US 7,544,370 with pediatric exclusivity, as listed
patent.txt line 910- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
17 Dec 2026 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 7,144,884 with pediatric exclusivity, as listed
patent.txt lines 4,698, 4,718, 4,738, 4,758- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
Non-patent exclusivity (127)
3 Jul 2026 · NDA 022304 · TAPENTADOL HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 185, 187, 189- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
3 Jul 2026 · NDA 203794 · TAPENTADOL HYDROCHLORIDE
NPP exclusivity
exclusivity.txt line 340- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001
3 Jul 2026 · NDA 212306 · SELINEXOR
ODE-257 exclusivity
exclusivity.txt line 1,046- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
3 Jul 2026 · NDA 212306 · SELINEXOR
ODE* exclusivity
exclusivity.txt lines 1,050, 1,053, 1,056, 1,059, 1,062- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 002, 003, 004, 005, 006
9 Jul 2026 · NDA 215341 · FINERENONE
NCE exclusivity
exclusivity.txt lines 1,526, 1,529, 1,531- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
13 Jul 2026 · NDA 017031 · NORGESTREL
RTO exclusivity
exclusivity.txt line 100- Definition
- Reference listed drug, time to orphan (to be checked against FDA's list)
- Product numbers
- 001
13 Jul 2026 · NDA 214787 · REMDESIVIR
M-301 exclusivity
exclusivity.txt lines 1,391, 1,397- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
16 Jul 2026 · NDA 214429 · FEXINIDAZOLE
NCE exclusivity
exclusivity.txt line 1,331- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
16 Jul 2026 · NDA 214783 · BELUMOSUDIL MESYLATE
NCE exclusivity
exclusivity.txt line 1,389- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
19 Jul 2026 · NDA 205437 · APREMILAST
ODE-248 exclusivity
exclusivity.txt lines 484, 490, 496- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
19 Jul 2026 · NDA 210745 · APREMILAST
ODE* exclusivity
exclusivity.txt line 906- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
20 Jul 2026 · NDA 205437 · APREMILAST
M-299 exclusivity
exclusivity.txt lines 482, 488, 494- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
20 Jul 2026 · NDA 210745 · APREMILAST
M-299 exclusivity
exclusivity.txt line 905- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
20 Jul 2026 · NDA 215498 · ODEVIXIBAT
NCE exclusivity
exclusivity.txt lines 1,569, 1,573, 1,577, 1,581- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
21 Jul 2026 · NDA 215256 · SEMAGLUTIDE
D-190 exclusivity
exclusivity.txt line 1,508- Definition
- New dosing schedule (to be checked against FDA's list)
- Product numbers
- 004
27 Jul 2026 · NDA 022271 · ALOGLIPTIN BENZOATE
M-300 exclusivity
exclusivity.txt lines 182–184- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
27 Jul 2026 · NDA 203414 · ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
M-300 exclusivity
exclusivity.txt lines 319–320- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
2 Aug 2026 · NDA 209939 · LETERMOVIR
D-189 exclusivity
exclusivity.txt lines 818, 824- Definition
- New dosing schedule (to be checked against FDA's list)
- Product numbers
- 001, 002
2 Aug 2026 · NDA 209940 · LETERMOVIR
D-189 exclusivity
exclusivity.txt lines 830, 836- Definition
- New dosing schedule (to be checked against FDA's list)
- Product numbers
- 001, 002
2 Aug 2026 · NDA 211810 · PEXIDARTINIB HYDROCHLORIDE
ODE-250 exclusivity
exclusivity.txt line 1,001- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
2 Aug 2026 · NDA 211810 · PEXIDARTINIB HYDROCHLORIDE
ODE* exclusivity
exclusivity.txt line 1,002- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 002
9 Aug 2026 · NDA 204384 · BEDAQUILINE FUMARATE
ODE-251 exclusivity
exclusivity.txt line 420- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
9 Aug 2026 · NDA 204384 · BEDAQUILINE FUMARATE
ODE* exclusivity
exclusivity.txt line 424- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 002
11 Aug 2026 · NDA 216793 · ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
NP exclusivity
exclusivity.txt lines 1,788, 1,790- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002
13 Aug 2026 · NDA 215383 · BELZUTIFAN
NCE exclusivity
exclusivity.txt line 1,557- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
14 Aug 2026 · NDA 201848 · MELPHALAN HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 226- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
14 Aug 2026 · NDA 211150 · PITOLISANT HYDROCHLORIDE
ODE-255 exclusivity
exclusivity.txt lines 933, 938- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
14 Aug 2026 · NDA 212862 · PRETOMANID
ODE-253 exclusivity
exclusivity.txt line 1,126- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
15 Aug 2026 · NDA 212725 · ENTRECTINIB
ODE-265 exclusivity
exclusivity.txt lines 1,107, 1,111- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
15 Aug 2026 · NDA 212725 · ENTRECTINIB
ODE-313 exclusivity
exclusivity.txt lines 1,108, 1,112- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
15 Aug 2026 · NDA 218550 · ENTRECTINIB
ODE* exclusivity
exclusivity.txt lines 2,165–2,166- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
16 Aug 2026 · NDA 212327 · FEDRATINIB HYDROCHLORIDE
ODE-259 exclusivity
exclusivity.txt line 1,064- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
18 Aug 2026 · NDA 209241 · VALBENAZINE TOSYLATE
I-925 exclusivity
exclusivity.txt lines 767, 769, 771- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
18 Aug 2026 · NDA 218390 · VALBENAZINE TOSYLATE
I-925 exclusivity
exclusivity.txt lines 2,152–2,154- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
21 Aug 2026 · NDA 210828 · GALLIUM GA-68 EDOTREOTIDE
ODE-383 exclusivity
exclusivity.txt line 912- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
21 Aug 2026 · NDA 210828 · GALLIUM GA-68 EDOTREOTIDE
W exclusivity
exclusivity.txt line 913- Definition
- Code W, not in the supplied dictionary; FDA code-list date not recorded
- Product numbers
- 001
22 Aug 2026 · NDA 203094 · COBICISTAT
ODE-260 exclusivity
exclusivity.txt line 300- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
23 Aug 2026 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
M-232 exclusivity
exclusivity.txt lines 428, 430, 432, 434- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
23 Aug 2026 · NDA 214916 · DIFELIKEFALIN ACETATE
NCE exclusivity
exclusivity.txt line 1,415- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
28 Aug 2026 · NDA 204671 · SOFOSBUVIR
ODE* exclusivity
exclusivity.txt lines 444–445- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
28 Aug 2026 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
ODE* exclusivity
exclusivity.txt lines 534–535- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
28 Aug 2026 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
ODE-262 exclusivity
exclusivity.txt lines 1,074, 1,077- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
28 Aug 2026 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
ODE-263 exclusivity
exclusivity.txt lines 1,075, 1,078- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
28 Aug 2026 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
ODE-264 exclusivity
exclusivity.txt lines 1,076, 1,079- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
28 Aug 2026 · NDA 212480 · SOFOSBUVIR
ODE-258 exclusivity
exclusivity.txt lines 1,080–1,081- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
6 Sep 2026 · NDA 205832 · NINTEDANIB ESYLATE
ODE-261 exclusivity
exclusivity.txt lines 530, 532- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
15 Sep 2026 · NDA 215310 · MOBOCERTINIB SUCCINATE
NCE exclusivity
exclusivity.txt line 1,521- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
16 Sep 2026 · NDA 202806 · DABRAFENIB MESYLATE
PED exclusivity
exclusivity.txt lines 288, 292- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
16 Sep 2026 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
PED exclusivity
exclusivity.txt lines 370, 374, 378- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
16 Sep 2026 · NDA 217513 · TRAMETINIB DIMETHYL SULFOXIDE
PED exclusivity
exclusivity.txt line 1,885- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
16 Sep 2026 · NDA 217514 · DABRAFENIB MESYLATE
PED exclusivity
exclusivity.txt line 1,889- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
21 Sep 2026 · NDA 204629 · EMPAGLIFLOZIN
I-922 exclusivity
exclusivity.txt line 437- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
25 Sep 2026 · NDA 217064 · PHENTOLAMINE MESYLATE
NP exclusivity
exclusivity.txt line 1,839- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
26 Sep 2026 · NDA 203341 · BOSUTINIB MONOHYDRATE
I-923 exclusivity
exclusivity.txt lines 307, 311, 315- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
26 Sep 2026 · NDA 217729 · BOSUTINIB MONOHYDRATE
NP exclusivity
exclusivity.txt lines 1,920, 1,924- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002
28 Sep 2026 · NDA 215206 · ATOGEPANT
NCE exclusivity
exclusivity.txt lines 1,492, 1,494, 1,496- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
28 Sep 2026 · NDA 215211 · MIGLUSTAT
NP exclusivity
exclusivity.txt line 1,497- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
29 Sep 2026 · NDA 022335 · TECHNETIUM TC-99M LABELED CARBON
NP exclusivity
exclusivity.txt line 191- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
29 Sep 2026 · NDA 214662 · MARALIXIBAT CHLORIDE
NCE exclusivity
exclusivity.txt lines 1,348, 1,353- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002
29 Sep 2026 · NDA 219485 · MARALIXIBAT CHLORIDE
NCE exclusivity
exclusivity.txt lines 2,290, 2,292, 2,294, 2,296- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
2 Oct 2026 · NDA 205739 · PATIROMER SORBITEX CALCIUM
NPP exclusivity
exclusivity.txt lines 526–528- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
2 Oct 2026 · NDA 205739 · PATIROMER SORBITEX CALCIUM
NS exclusivity
exclusivity.txt line 529- Definition
- New strength (to be checked against FDA's list)
- Product numbers
- 004
3 Oct 2026 · NDA 211379 · DEXAMETHASONE
ODE-271 exclusivity
exclusivity.txt line 964- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
3 Oct 2026 · NDA 213535 · RISDIPLAM
M-270 exclusivity
exclusivity.txt line 1,229- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
3 Oct 2026 · NDA 219285 · RISDIPLAM
M-270 exclusivity
exclusivity.txt line 2,266- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
5 Oct 2026 · NDA 215985 · ROFLUMILAST
NPP exclusivity
exclusivity.txt line 1,683- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001
7 Oct 2026 · NDA 214487 · AVACOPAN
NCE exclusivity
exclusivity.txt line 1,335- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
8 Oct 2026 · NDA 210797 · AFAMELANOTIDE
ODE-270 exclusivity
exclusivity.txt line 911- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
11 Oct 2026 · NDA 210496 · ENCORAFENIB
I-928 exclusivity
exclusivity.txt lines 880, 884- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
11 Oct 2026 · NDA 210498 · BINIMETINIB
I-928 exclusivity
exclusivity.txt line 888- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
17 Oct 2026 · NDA 213931 · TENAPANOR HYDROCHLORIDE
NP exclusivity
exclusivity.txt lines 1,276–1,278- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
17 Oct 2026 · NDA 215320 · ACETAMINOPHEN; IBUPROFEN SODIUM
NP exclusivity
exclusivity.txt line 1,523- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
17 Oct 2026 · NDA 217836 · PILOCARPINE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 2,020- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
18 Oct 2026 · NDA 203496 · TREPROSTINIL DIOLAMINE
ODE-272 exclusivity
exclusivity.txt lines 331–335- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005
18 Oct 2026 · NDA 206316 · EDOXABAN TOSYLATE
M-14 exclusivity
exclusivity.txt lines 556–558- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
20 Oct 2026 · NDA 210365 · CANNABIDIOL
M-270 exclusivity
exclusivity.txt line 873- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
20 Oct 2026 · NDA 212725 · ENTRECTINIB
NPP exclusivity
exclusivity.txt lines 1,106, 1,110- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
20 Oct 2026 · NDA 214938 · VOSORITIDE
NPP exclusivity
exclusivity.txt lines 1,425, 1,429, 1,433- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
20 Oct 2026 · NDA 216632 · ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
NP exclusivity
exclusivity.txt line 1,774- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
20 Oct 2026 · NDA 218550 · ENTRECTINIB
NP exclusivity
exclusivity.txt line 2,164- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
21 Oct 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
ODE-275 exclusivity
exclusivity.txt line 1,035- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
21 Oct 2026 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
ODE* exclusivity
exclusivity.txt line 1,042- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 002
22 Oct 2026 · NDA 209964 · IVABRADINE
PED exclusivity
exclusivity.txt line 843- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
23 Oct 2026 · NDA 208447 · NIRAPARIB TOSYLATE
ODE-277 exclusivity
exclusivity.txt line 709- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
24 Oct 2026 · NDA 211192 · IVOSIDENIB
I-924 exclusivity
exclusivity.txt line 942- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
29 Oct 2026 · NDA 207925 · IVACAFTOR
PED exclusivity
exclusivity.txt lines 631, 637, 643- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
29 Oct 2026 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 1,538, 1,546, 1,552- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
30 Oct 2026 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
PED exclusivity
exclusivity.txt lines 780–781- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
1 Nov 2026 · NDA 215151 · VONOPRAZAN FUMARATE
NP exclusivity
exclusivity.txt lines 1,479, 1,482- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002
3 Nov 2026 · NDA 207925 · IVACAFTOR
PED exclusivity
exclusivity.txt lines 648, 654- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 004, 005
8 Nov 2026 · NDA 202293 · DAPAGLIFLOZIN
PED exclusivity
exclusivity.txt lines 270, 274- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
8 Nov 2026 · NDA 217806 · TIRZEPATIDE
NP exclusivity
exclusivity.txt lines 1,945, 1,949, 1,953, 1,957, 1,961, 1,965- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
9 Nov 2026 · NDA 022496 · BUPIVACAINE
I-929 exclusivity
exclusivity.txt lines 199–200- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
10 Nov 2026 · NDA 205422 · BREXPIPRAZOLE
PED exclusivity
exclusivity.txt lines 453, 458, 463, 468, 473, 478- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
13 Nov 2026 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
PED exclusivity
exclusivity.txt lines 385, 387- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 003
14 Nov 2026 · NDA 213217 · ZANUBRUTINIB
ODE-276 exclusivity
exclusivity.txt line 1,164- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
14 Nov 2026 · NDA 218785 · ZANUBRUTINIB
ODE* exclusivity
exclusivity.txt line 2,200- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
17 Nov 2026 · NDA 203415 · ENZALUTAMIDE
I-926 exclusivity
exclusivity.txt line 321- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
17 Nov 2026 · NDA 213674 · ENZALUTAMIDE
I-926 exclusivity
exclusivity.txt lines 1,241–1,242- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
19 Nov 2026 · NDA 214938 · VOSORITIDE
NCE exclusivity
exclusivity.txt lines 1,424, 1,428, 1,432- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
20 Nov 2026 · NDA 212194 · GIVOSIRAN SODIUM
ODE-273 exclusivity
exclusivity.txt line 1,028- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
21 Nov 2026 · NDA 210259 · ACALABRUTINIB
ODE-274 exclusivity
exclusivity.txt line 870- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
23 Nov 2026 · NDA 215596 · MARIBAVIR
NCE exclusivity
exclusivity.txt line 1,601- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
24 Nov 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
PED exclusivity
exclusivity.txt lines 242, 248, 254, 260, 266- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005
25 Nov 2026 · NDA 213137 · VOXELOTOR
ODE-281 exclusivity
exclusivity.txt line 1,155- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
25 Nov 2026 · NDA 216157 · VOXELOTOR
ODE* exclusivity
exclusivity.txt line 1,729- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
29 Nov 2026 · NDA 214907 · PAFOLACIANINE SODIUM
NCE exclusivity
exclusivity.txt line 1,413- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
5 Dec 2026 · NDA 216099 · DASATINIB
M-307 exclusivity
exclusivity.txt lines 1,723–1,728- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
8 Dec 2026 · NDA 207500 · ISAVUCONAZONIUM SULFATE
NPP exclusivity
exclusivity.txt lines 592, 603- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
8 Dec 2026 · NDA 207501 · ISAVUCONAZONIUM SULFATE
NPP exclusivity
exclusivity.txt line 613- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001
12 Dec 2026 · NDA 211970 · GOLODIRSEN
ODE-280 exclusivity
exclusivity.txt line 1,008- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
13 Dec 2026 · NDA 215500 · EFLORNITHINE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 1,585- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
13 Dec 2026 · NDA 218010 · TRAVOPROST
NP exclusivity
exclusivity.txt line 2,031- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
14 Dec 2026 · NDA 215383 · BELZUTIFAN
I-931 exclusivity
exclusivity.txt line 1,554- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
15 Dec 2026 · NDA 205551 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
PED exclusivity
exclusivity.txt line 501- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
15 Dec 2026 · NDA 215413 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
PED exclusivity
exclusivity.txt line 1,562- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
15 Dec 2026 · NDA 217242 · ROFLUMILAST
NP exclusivity
exclusivity.txt line 1,863- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
20 Dec 2026 · NDA 201280 · LINAGLIPTIN
PED exclusivity
exclusivity.txt line 216- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
20 Dec 2026 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 218, 220, 222- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
20 Dec 2026 · NDA 204629 · EMPAGLIFLOZIN
PED exclusivity
exclusivity.txt lines 439, 441- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
20 Dec 2026 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 545, 547, 549, 551- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
20 Dec 2026 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 679, 681- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
20 Dec 2026 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 726, 728, 730, 732- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
20 Dec 2026 · NDA 209569 · BRILLIANT BLUE G
ODE-282 exclusivity
exclusivity.txt line 796- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
22 Dec 2026 · NDA 214012 · INCLISIRAN SODIUM
NCE exclusivity
exclusivity.txt line 1,289- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
27 Dec 2026 · NDA 208558 · OLAPARIB
ODE-283 exclusivity
exclusivity.txt lines 713, 716- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
30 Dec 2026 · NDA 214133 · LEVOKETOCONAZOLE
NCE* exclusivity
exclusivity.txt line 1,308- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001