Drybench Patent.
Patent and exclusivity dates from January to June 2038 for NDAs, as FDA's Orange Book lists them
Each patent and exclusivity date from January to June 2038 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, 2038July to December 2038
Listed patent expiry (192)
4 Jan 2038 · NDA 022555 · HEXAMINOLEVULINATE HYDROCHLORIDE
US 11,235,168, use patent
patent.txt line 2,082- Flags
- use code U-2250
- Product numbers
- 001
5 Jan 2038 · NDA 212937 · SODIUM THIOSULFATE
US 10,596,190, use patent
patent.txt line 14,506- Flags
- use code U-3443 delist requested
- Product numbers
- 001
5 Jan 2038 · NDA 217639 · ELACESTRANT HYDROCHLORIDE
US 10,385,008, substance and product patent
patent.txt lines 20,046, 20,053- Flags
- substance product
- Product numbers
- 001, 002
5 Jan 2038 · NDA 217639 · ELACESTRANT HYDROCHLORIDE
US 10,745,343, use patent
patent.txt lines 20,048, 20,055- Flags
- use code U-3523
- Product numbers
- 001, 002
8 Jan 2038 · NDA 209776 · MEROPENEM; VABORBACTAM
US 12,478,606, use patent
patent.txt line 10,788- Flags
- use code U-3421
- Product numbers
- 001
12 Jan 2038 · NDA 020965 · AMINOLEVULINIC ACID HYDROCHLORIDE
US 10,357,567, use patent
patent.txt line 388- Flags
- use code U-3163
- Product numbers
- 001
12 Jan 2038 · NDA 020965 · AMINOLEVULINIC ACID HYDROCHLORIDE
US 11,077,192, use patent
patent.txt line 389- Flags
- use code U-3163
- Product numbers
- 001
12 Jan 2038 · NDA 020965 · AMINOLEVULINIC ACID HYDROCHLORIDE
US 11,135,293, use patent
patent.txt line 390- Flags
- use code U-3163
- Product numbers
- 001
12 Jan 2038 · NDA 020965 · AMINOLEVULINIC ACID HYDROCHLORIDE
US 11,571,478, use patent
patent.txt line 393- Flags
- use code U-3163
- Product numbers
- 001
12 Jan 2038 · NDA 020965 · AMINOLEVULINIC ACID HYDROCHLORIDE
US 11,690,914, use patent
patent.txt line 394- Flags
- use code U-3163
- Product numbers
- 001
12 Jan 2038 · NDA 020965 · AMINOLEVULINIC ACID HYDROCHLORIDE
US 12,296,011, use patent
patent.txt line 397- Flags
- use code U-3163
- Product numbers
- 001
23 Jan 2038 · NDA 219423 · AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
US 10,322,117, product patent
patent.txt line 21,730- Flags
- product
- Product numbers
- 001
23 Jan 2038 · NDA 219423 · AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
US 10,799,487, product and use patent
patent.txt line 21,732- Flags
- product use code U-3448
- Product numbers
- 002
23 Jan 2038 · NDA 219423 · AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
US 12,465,599, product patent
patent.txt lines 21,731, 21,733- Flags
- product
- Product numbers
- 001, 002
23 Jan 2038 · NDA 219423 · AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
US 12,673,047, product patent
patent.txt line 21,734- Flags
- product
- Product numbers
- 003
24 Jan 2038 · NDA 216018 · RANOLAZINE
US 10,898,444, product patent
patent.txt line 18,174- Flags
- product
- Product numbers
- 002
24 Jan 2038 · NDA 216018 · RANOLAZINE
US 11,510,878, product patent
patent.txt lines 18,173, 18,175- Flags
- product
- Product numbers
- 001, 002
24 Jan 2038 · NDA 216018 · RANOLAZINE
US 12,161,761, product patent
patent.txt line 18,176- Flags
- product
- Product numbers
- 002
25 Jan 2038 · NDA 205489 · METHYLPHENIDATE
US 11,166,947, use patent
patent.txt lines 5,439, 5,443, 5,447- Flags
- use code U-3299
- Product numbers
- 001, 002, 003
26 Jan 2038 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 11,395,888, product patent
patent.txt lines 7,446, 7,461- Flags
- product
- Product numbers
- 001, 002
26 Jan 2038 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 11,793,953, product patent
patent.txt lines 7,450, 7,465- Flags
- product
- Product numbers
- 001, 002
26 Jan 2038 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 11,865,247, product patent
patent.txt line 7,466- Flags
- product delist requested
- Product numbers
- 002
26 Jan 2038 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 11,896,759, product patent
patent.txt line 7,467- Flags
- product delist requested
- Product numbers
- 002
26 Jan 2038 · NDA 207921 · BECLOMETHASONE DIPROPIONATE
US 12,296,089, product patent
patent.txt lines 7,452, 7,469- Flags
- product
- Product numbers
- 001, 002
27 Jan 2038 · NDA 209589 · CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
US 12,458,634, product patent
patent.txt line 10,659- Flags
- product
- Product numbers
- 001
30 Jan 2038 · NDA 214628 · NOREPINEPHRINE BITARTRATE
US 10,159,657, product patent
patent.txt lines 15,900, 15,907, 15,914- Flags
- product
- Product numbers
- 001, 002, 003
30 Jan 2038 · NDA 214628 · NOREPINEPHRINE BITARTRATE
US 10,226,436, product and use patent
patent.txt lines 15,901, 15,908, 15,915- Flags
- product use code U-3461
- Product numbers
- 001, 002, 003
30 Jan 2038 · NDA 214628 · NOREPINEPHRINE BITARTRATE
US 10,420,735, product and use patent
patent.txt lines 15,902, 15,909, 15,916- Flags
- product use code U-3461
- Product numbers
- 001, 002, 003
30 Jan 2038 · NDA 214628 · NOREPINEPHRINE BITARTRATE
US 10,568,850, product patent
patent.txt lines 15,903, 15,910, 15,917- Flags
- product
- Product numbers
- 001, 002, 003
30 Jan 2038 · NDA 214628 · NOREPINEPHRINE BITARTRATE
US 11,413,259, product and use patent
patent.txt lines 15,904, 15,911, 15,918- Flags
- product use code U-3461
- Product numbers
- 001, 002, 003
30 Jan 2038 · NDA 214628 · NOREPINEPHRINE BITARTRATE
US 11,602,508, product patent
patent.txt lines 15,905, 15,912, 15,919- Flags
- product
- Product numbers
- 001, 002, 003
30 Jan 2038 · NDA 214628 · NOREPINEPHRINE BITARTRATE
US 12,245,996, product patent
patent.txt lines 15,906, 15,913, 15,920- Flags
- product
- Product numbers
- 001, 002, 003
30 Jan 2038 · NDA 219835 · VEPDEGESTRANT
US 10,647,698, substance and product patent
patent.txt lines 22,010, 22,013- Flags
- substance product
- Product numbers
- 001, 002
2 Feb 2038 · NDA 209128 · SUFENTANIL CITRATE
US 11,672,738, product patent
patent.txt line 9,789- Flags
- product
- Product numbers
- 001
2 Feb 2038 · NDA 212018 · ERDAFITINIB
US 11,077,106, use patent
patent.txt lines 13,390, 13,408, 13,426- Flags
- use code U-3196
- Product numbers
- 001, 002, 003
2 Feb 2038 · NDA 212018 · ERDAFITINIB
US 11,077,106, use patent
patent.txt lines 13,391, 13,409, 13,427- Flags
- use code U-3808
- Product numbers
- 001, 002, 003
6 Feb 2038 · NDA 214697 · EPINEPHRINE
US 10,576,156, product patent
patent.txt lines 15,979, 15,987- Flags
- product
- Product numbers
- 001, 002
6 Feb 2038 · NDA 214697 · EPINEPHRINE
US 11,173,209, use patent
patent.txt lines 15,981, 15,989- Flags
- use code U-3979
- Product numbers
- 001, 002
6 Feb 2038 · NDA 215960 · TEBIPENEM PIVOXIL HYDROBROMIDE
US 10,889,587, substance and product and use patent
patent.txt line 18,101- Flags
- substance product use code U-4570
- Product numbers
- 001
9 Feb 2038 · NDA 209510 · AMISULPRIDE
US 11,357,753, use patent
patent.txt lines 10,556, 10,572- Flags
- use code U-2754
- Product numbers
- 001, 002
9 Feb 2038 · NDA 209510 · AMISULPRIDE
US 12,005,042, use patent
patent.txt lines 10,557, 10,573- Flags
- use code U-1744
- Product numbers
- 001, 002
9 Feb 2038 · NDA 209510 · AMISULPRIDE
US 12,005,042, use patent
patent.txt lines 10,558, 10,574- Flags
- use code U-2754
- Product numbers
- 001, 002
9 Feb 2038 · NDA 209510 · AMISULPRIDE
US 12,005,042, use patent
patent.txt lines 10,559, 10,575- Flags
- use code U-3467
- Product numbers
- 001, 002
9 Feb 2038 · NDA 209510 · AMISULPRIDE
US 12,329,740, use patent
patent.txt lines 10,562, 10,578- Flags
- use code U-2754
- Product numbers
- 001, 002
9 Feb 2038 · NDA 209510 · AMISULPRIDE
US 12,329,740, use patent
patent.txt lines 10,563, 10,579- Flags
- use code U-3467
- Product numbers
- 001, 002
15 Feb 2038 · NDA 209410 · AMANTADINE HYDROCHLORIDE
US 10,213,393, use patent
patent.txt lines 10,342, 10,352, 10,362, 10,371- Flags
- use code U-20
- Product numbers
- 001, 002, 003, 004
15 Feb 2038 · NDA 209410 · AMANTADINE HYDROCHLORIDE
US 10,213,394, use patent
patent.txt lines 10,343, 10,353, 10,363, 10,372- Flags
- use code U-2497
- Product numbers
- 001, 002, 003, 004
15 Feb 2038 · NDA 209410 · AMANTADINE HYDROCHLORIDE
US 10,500,170, use patent
patent.txt lines 10,344, 10,354, 10,364, 10,373- Flags
- use code U-20
- Product numbers
- 001, 002, 003, 004
15 Feb 2038 · NDA 209410 · AMANTADINE HYDROCHLORIDE
US 10,500,171, use patent
patent.txt lines 10,345, 10,355, 10,365, 10,374- Flags
- use code U-2497
- Product numbers
- 001, 002, 003, 004
15 Feb 2038 · NDA 209410 · AMANTADINE HYDROCHLORIDE
US 10,500,172, use patent
patent.txt lines 10,346, 10,356, 10,366, 10,375- Flags
- use code U-2497
- Product numbers
- 001, 002, 003, 004
15 Feb 2038 · NDA 209410 · AMANTADINE HYDROCHLORIDE
US 10,512,617, use patent
patent.txt lines 10,347, 10,357, 10,367, 10,376- Flags
- use code U-2497
- Product numbers
- 001, 002, 003, 004
15 Feb 2038 · NDA 209410 · AMANTADINE HYDROCHLORIDE
US 11,890,261, use patent
patent.txt lines 10,348, 10,358- Flags
- use code U-2497
- Product numbers
- 001, 002
16 Feb 2038 · NDA 216540 · ACORAMIDIS HYDROCHLORIDE
US 10,513,497, substance patent
patent.txt line 18,852- Flags
- substance
- Product numbers
- 001
16 Feb 2038 · NDA 216540 · ACORAMIDIS HYDROCHLORIDE
US 11,919,865, use patent
patent.txt line 18,856- Flags
- use code U-4046
- Product numbers
- 001
26 Feb 2038 · NDA 217686 · APROCITENTAN
US 10,919,881, substance and product patent
patent.txt line 20,328- Flags
- substance product
- Product numbers
- 001
26 Feb 2038 · NDA 217686 · APROCITENTAN
US 12,297,189, product patent
patent.txt line 20,332- Flags
- product
- Product numbers
- 001
27 Feb 2038 · NDA 212099 · DAROLUTAMIDE
US 11,168,058, substance and product patent
patent.txt line 13,540- Flags
- substance product
- Product numbers
- 001
2 Mar 2038 · NDA 217686 · APROCITENTAN
US 11,787,782, use patent
patent.txt line 20,331- Flags
- use code U-3877
- Product numbers
- 001
9 Mar 2038 · NDA 211675 · UPADACITINIB
US 11,564,922, use patent
patent.txt lines 12,988, 13,033, 13,054- Flags
- use code U-3624
- Product numbers
- 001, 002, 003
9 Mar 2038 · NDA 211675 · UPADACITINIB
US 11,564,922, use patent
patent.txt lines 12,989, 13,034, 13,055- Flags
- use code U-4303
- Product numbers
- 001, 002, 003
9 Mar 2038 · NDA 211675 · UPADACITINIB
US 11,607,411, use patent
patent.txt lines 12,990, 13,035, 13,056- Flags
- use code U-3341
- Product numbers
- 001, 002, 003
9 Mar 2038 · NDA 211675 · UPADACITINIB
US 11,607,411, use patent
patent.txt lines 12,991, 13,036, 13,057- Flags
- use code U-4302
- Product numbers
- 001, 002, 003
12 Mar 2038 · NDA 213189 · TIRBANIBULIN
US 10,617,693, use patent
patent.txt line 14,721- Flags
- use code U-3015
- Product numbers
- 001
12 Mar 2038 · NDA 213189 · TIRBANIBULIN
US 11,497,750, use patent
patent.txt line 14,723- Flags
- use code U-3015
- Product numbers
- 001
12 Mar 2038 · NDA 213189 · TIRBANIBULIN
US 12,667,576, use patent
patent.txt line 14,724- Flags
- use code U-4577
- Product numbers
- 001
13 Mar 2038 · NDA 216951 · DAPRODUSTAT
US 11,117,871, substance and product and use patent
patent.txt lines 19,044, 19,050, 19,056, 19,062, 19,068- Flags
- substance product use code U-3535
- Product numbers
- 001, 002, 003, 004, 005
13 Mar 2038 · NDA 216951 · DAPRODUSTAT
US 11,649,217, product and use patent
patent.txt lines 19,046, 19,052, 19,058, 19,064, 19,070- Flags
- product use code U-3535
- Product numbers
- 001, 002, 003, 004, 005
13 Mar 2038 · NDA 217899 · SELADELPAR LYSINE
US 10,272,058, use patent
patent.txt line 20,752- Flags
- use code U-1854
- Product numbers
- 001
15 Mar 2038 · NDA 208082 · DEUTETRABENAZINE
US 11,179,386, product and use patent
patent.txt lines 8,114, 8,146, 8,178- Flags
- product use code U-1995
- Product numbers
- 001, 002, 003
15 Mar 2038 · NDA 208082 · DEUTETRABENAZINE
US 11,179,386, product and use patent
patent.txt lines 8,115, 8,147, 8,179- Flags
- product use code U-3055
- Product numbers
- 001, 002, 003
15 Mar 2038 · NDA 208082 · DEUTETRABENAZINE
US 11,813,232, product patent
patent.txt lines 8,128, 8,160, 8,192- Flags
- product
- Product numbers
- 001, 002, 003
15 Mar 2038 · NDA 216354 · DEUTETRABENAZINE
US 11,179,386, product and use patent
patent.txt lines 18,527, 18,557, 18,587, 18,617, 18,647, 18,677, 18,707, 18,737- Flags
- product use code U-1995
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
15 Mar 2038 · NDA 216354 · DEUTETRABENAZINE
US 11,179,386, product and use patent
patent.txt lines 18,528, 18,558, 18,588, 18,618, 18,648, 18,678, 18,708, 18,738- Flags
- product use code U-3055
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
15 Mar 2038 · NDA 216354 · DEUTETRABENAZINE
US 11,813,232, product patent
patent.txt lines 18,541, 18,571, 18,601, 18,631, 18,661, 18,691, 18,721, 18,751- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
23 Mar 2038 · NDA 021137 · LEVOTHYROXINE SODIUM
US 10,231,931, product patent
patent.txt lines 465, 467, 469, 471, 473, 475, 477, 479, 481, 483- Flags
- product
- Product numbers
- 003, 004, 005, 006, 007, 008, 009, 010, 011, 012
23 Mar 2038 · NDA 021137 · LEVOTHYROXINE SODIUM
US 10,406,108, product patent
patent.txt lines 466, 468, 470, 472, 474, 476, 478, 480, 482, 484- Flags
- product
- Product numbers
- 003, 004, 005, 006, 007, 008, 009, 010, 011, 012
27 Mar 2038 · NDA 208447 · NIRAPARIB TOSYLATE
US 11,091,459, product patent
patent.txt line 8,630- Flags
- product
- Product numbers
- 001
27 Mar 2038 · NDA 208447 · NIRAPARIB TOSYLATE
US 11,673,877, product and use patent
patent.txt line 8,631- Flags
- product use code U-3646
- Product numbers
- 001
27 Mar 2038 · NDA 208447 · NIRAPARIB TOSYLATE
US 11,673,877, product and use patent
patent.txt line 8,632- Flags
- product use code U-3647
- Product numbers
- 001
27 Mar 2038 · NDA 214876 · NIRAPARIB TOSYLATE
US 11,091,459, product patent
patent.txt lines 16,273, 16,282, 16,291- Flags
- product
- Product numbers
- 001, 002, 003
27 Mar 2038 · NDA 214876 · NIRAPARIB TOSYLATE
US 11,673,877, product and use patent
patent.txt lines 16,274, 16,283, 16,292- Flags
- product use code U-3646
- Product numbers
- 001, 002, 003
27 Mar 2038 · NDA 214876 · NIRAPARIB TOSYLATE
US 11,673,877, product and use patent
patent.txt lines 16,275, 16,284, 16,293- Flags
- product use code U-3647
- Product numbers
- 001, 002, 003
27 Mar 2038 · NDA 216793 · ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
US 11,091,459, substance and product patent
patent.txt lines 18,948, 18,972- Flags
- substance product
- Product numbers
- 001, 002
27 Mar 2038 · NDA 216793 · ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
US 11,673,877, substance and product and use patent
patent.txt lines 18,951, 18,975- Flags
- substance product use code U-2830
- Product numbers
- 001, 002
27 Mar 2038 · NDA 216793 · ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
US 11,673,877, substance and product and use patent
patent.txt lines 18,952, 18,976- Flags
- substance product use code U-4368
- Product numbers
- 001, 002
29 Mar 2038 · NDA 218037 · DANICOPAN
US 9,796,741, substance and use patent
patent.txt lines 20,787, 20,789- Flags
- substance use code U-3933
- Product numbers
- 001, 002
9 Apr 2038 · NDA 215014 · PEGCETACOPLAN
US 11,040,107, product and use patent
patent.txt line 16,421- Flags
- product use code U-3172
- Product numbers
- 001
9 Apr 2038 · NDA 215014 · PEGCETACOPLAN
US 11,040,107, product and use patent
patent.txt line 16,422- Flags
- product use code U-3173
- Product numbers
- 001
9 Apr 2038 · NDA 215014 · PEGCETACOPLAN
US 11,040,107, product and use patent
patent.txt line 16,423- Flags
- product use code U-3174
- Product numbers
- 001
9 Apr 2038 · NDA 215014 · PEGCETACOPLAN
US 11,040,107, product and use patent
patent.txt line 16,424- Flags
- product use code U-4241
- Product numbers
- 001
16 Apr 2038 · NDA 203340 · NIMODIPINE
US 10,342,787, product and use patent
patent.txt line 3,764- Flags
- product use code U-2804
- Product numbers
- 002
16 Apr 2038 · NDA 203340 · NIMODIPINE
US 10,576,070, product and use patent
patent.txt line 3,765- Flags
- product use code U-2804
- Product numbers
- 002
16 Apr 2038 · NDA 203340 · NIMODIPINE
US 11,207,306, use patent
patent.txt line 3,766- Flags
- use code U-2804
- Product numbers
- 002
16 Apr 2038 · NDA 203340 · NIMODIPINE
US 11,413,277, product and use patent
patent.txt line 3,767- Flags
- product use code U-2804
- Product numbers
- 002
16 Apr 2038 · NDA 203340 · NIMODIPINE
US 11,806,338, product patent
patent.txt line 3,768- Flags
- product
- Product numbers
- 002
16 Apr 2038 · NDA 203340 · NIMODIPINE
US 12,186,308, product and use patent
patent.txt line 3,769- Flags
- product use code U-2804
- Product numbers
- 002
16 Apr 2038 · NDA 219666 · SEPIAPTERIN
US 11,072,614, substance and use patent
patent.txt lines 21,850, 21,854- Flags
- substance use code U-4251
- Product numbers
- 001, 002
18 Apr 2038 · NDA 219008 · LAZERTINIB MESYLATE
US 11,453,656, substance and product patent
patent.txt lines 21,436, 21,445- Flags
- substance product
- Product numbers
- 001, 002
18 Apr 2038 · NDA 219008 · LAZERTINIB MESYLATE
US 11,981,659, use patent
patent.txt lines 21,439, 21,448- Flags
- use code U-3985
- Product numbers
- 001, 002
18 Apr 2038 · NDA 219008 · LAZERTINIB MESYLATE
US 12,318,390, product patent
patent.txt lines 21,441, 21,450- Flags
- product
- Product numbers
- 001, 002
19 Apr 2038 · NDA 210450 · ELAGOLIX SODIUM
US 11,690,854, use patent
patent.txt line 11,391- Flags
- use code U-3653
- Product numbers
- 001
20 Apr 2038 · NDA 210850 · SINCALIDE
US 11,110,063, product and use patent
patent.txt line 12,167- Flags
- product use code U-3481
- Product numbers
- 001
20 Apr 2038 · NDA 210850 · SINCALIDE
US 11,110,063, product and use patent
patent.txt line 12,168- Flags
- product use code U-3482
- Product numbers
- 001
20 Apr 2038 · NDA 210850 · SINCALIDE
US 11,110,063, product and use patent
patent.txt line 12,169- Flags
- product use code U-3483
- Product numbers
- 001
20 Apr 2038 · NDA 210850 · SINCALIDE
US 11,318,100, product and use patent
patent.txt line 12,170- Flags
- product use code U-3477
- Product numbers
- 001
20 Apr 2038 · NDA 210850 · SINCALIDE
US 11,318,100, product and use patent
patent.txt line 12,171- Flags
- product use code U-3478
- Product numbers
- 001
20 Apr 2038 · NDA 210850 · SINCALIDE
US 11,318,100, product and use patent
patent.txt line 12,172- Flags
- product use code U-3479
- Product numbers
- 001
20 Apr 2038 · NDA 210850 · SINCALIDE
US 11,318,100, product and use patent
patent.txt line 12,173- Flags
- product use code U-3480
- Product numbers
- 001
20 Apr 2038 · NDA 210850 · SINCALIDE
US 11,737,983, product and use patent
patent.txt line 12,174- Flags
- product use code U-3482
- Product numbers
- 001
20 Apr 2038 · NDA 210850 · SINCALIDE
US 11,737,983, product and use patent
patent.txt line 12,175- Flags
- product use code U-3689
- Product numbers
- 001
26 Apr 2038 · NDA 219249 · INAVOLISIB
US 11,028,100, substance and product patent
patent.txt lines 21,559, 21,566- Flags
- substance product
- Product numbers
- 001, 002
27 Apr 2038 · NDA 213411 · TUCATINIB
US 11,207,324, use patent
patent.txt lines 14,982, 14,989- Flags
- use code U-3783
- Product numbers
- 001, 002
27 Apr 2038 · NDA 213411 · TUCATINIB
US 11,666,572, use patent
patent.txt lines 14,984, 14,991- Flags
- use code U-3783
- Product numbers
- 001, 002
27 Apr 2038 · NDA 213411 · TUCATINIB
US 12,048,698, use patent
patent.txt lines 14,985, 14,992- Flags
- use code U-3783
- Product numbers
- 001, 002
30 Apr 2038 · NDA 208743 · ABALOPARATIDE
US 10,996,208, product patent
patent.txt line 9,291- Flags
- product
- Product numbers
- 001
30 Apr 2038 · NDA 208743 · ABALOPARATIDE
US 11,782,041, product and use patent
patent.txt line 9,294- Flags
- product use code U-2009
- Product numbers
- 001
30 Apr 2038 · NDA 208743 · ABALOPARATIDE
US 11,782,041, product and use patent
patent.txt line 9,295- Flags
- product use code U-3543
- Product numbers
- 001
30 Apr 2038 · NDA 208743 · ABALOPARATIDE
US 11,977,067, product patent
patent.txt line 9,296- Flags
- product
- Product numbers
- 001
30 Apr 2038 · NDA 210951 · APALUTAMIDE
US 10,702,508, use patent
patent.txt lines 12,433, 12,451- Flags
- use code U-3012
- Product numbers
- 001, 002
3 May 2038 · NDA 211723 · TAZEMETOSTAT HYDROBROMIDE
US 12,168,014, use patent
patent.txt line 13,107- Flags
- use code U-2736
- Product numbers
- 001
3 May 2038 · NDA 211723 · TAZEMETOSTAT HYDROBROMIDE
US 12,168,014, use patent
patent.txt line 13,108- Flags
- use code U-2852
- Product numbers
- 001
3 May 2038 · NDA 211723 · TAZEMETOSTAT HYDROBROMIDE
US 12,168,014, use patent
patent.txt line 13,109- Flags
- use code U-2853
- Product numbers
- 001
3 May 2038 · NDA 214846 · ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
US 11,793,812, use patent
patent.txt line 16,237- Flags
- use code U-2360
- Product numbers
- 001
11 May 2038 · NDA 211882 · TAZAROTENE
US 11,311,482, use patent
patent.txt line 13,220- Flags
- use code U-2368
- Product numbers
- 001
11 May 2038 · NDA 211882 · TAZAROTENE
US 12,128,137, product and use patent
patent.txt line 13,222- Flags
- product use code U-2368
- Product numbers
- 001
15 May 2038 · NDA 206947 · LENVATINIB MESYLATE
US 12,226,409, use patent
patent.txt lines 6,886, 6,907- Flags
- use code U-4146
- Product numbers
- 001, 002
15 May 2038 · NDA 213224 · OCTREOTIDE ACETATE
US 10,342,850, product patent
patent.txt line 14,797- Flags
- product
- Product numbers
- 001
18 May 2038 · NDA 215431 · MELOXICAM; RIZATRIPTAN BENZOATE
US 12,472,256, use patent
patent.txt line 17,264- Flags
- use code U-4356
- Product numbers
- 001
18 May 2038 · NDA 215431 · MELOXICAM; RIZATRIPTAN BENZOATE
US 12,472,257, use patent
patent.txt line 17,265- Flags
- use code U-4134
- Product numbers
- 001
18 May 2038 · NDA 215431 · MELOXICAM; RIZATRIPTAN BENZOATE
US 12,472,258, product patent
patent.txt line 17,266- Flags
- product
- Product numbers
- 001
18 May 2038 · NDA 215431 · MELOXICAM; RIZATRIPTAN BENZOATE
US 12,616,752, use patent
patent.txt line 17,272- Flags
- use code U-4510
- Product numbers
- 001
20 May 2038 · NDA 212304 · DONEPEZIL HYDROCHLORIDE
US 10,835,499, product and use patent
patent.txt lines 13,812, 13,823- Flags
- product use code U-3334
- Product numbers
- 001, 002
21 May 2038 · NDA 214665 · SOTORASIB
US 10,519,146, substance and product patent
patent.txt lines 15,938, 15,948, 15,958- Flags
- substance product
- Product numbers
- 001, 002, 003
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,251,873, use patent
patent.txt line 8,928- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,471,053, use patent
patent.txt line 8,931- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,792,278, use patent
patent.txt line 8,933- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,792,279, use patent
patent.txt line 8,934- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,799,491, use patent
patent.txt line 8,935- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,806,727, use patent
patent.txt line 8,936- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,849,889, use patent
patent.txt line 8,938- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,849,890, use patent
patent.txt line 8,939- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,857,141, use patent
patent.txt line 8,940- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,857,142, use patent
patent.txt line 8,941- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,874,655, use patent
patent.txt line 8,942- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,874,656, use patent
patent.txt line 8,943- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,874,657, use patent
patent.txt line 8,944- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,278,536, use patent
patent.txt line 8,949- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,278,537, use patent
patent.txt line 8,950- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,278,538, use patent
patent.txt line 8,951- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,278,539, use patent
patent.txt line 8,952- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,278,540, use patent
patent.txt line 8,953- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,304,940, substance patent
patent.txt line 8,954- Flags
- substance
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,357,761, use patent
patent.txt line 8,955- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,357,762, use patent
patent.txt line 8,956- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,357,763, use patent
patent.txt line 8,957- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,357,764, substance patent
patent.txt line 8,958- Flags
- substance
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,357,765, substance patent
patent.txt line 8,959- Flags
- substance
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,376,244, substance patent
patent.txt line 8,961- Flags
- substance
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,389,436, use patent
patent.txt line 8,962- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,389,437, use patent
patent.txt line 8,963- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,426,396, substance patent
patent.txt line 8,964- Flags
- substance
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,458,128, use patent
patent.txt line 8,965- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,612,593, substance patent
patent.txt line 8,966- Flags
- substance
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,612,594, substance patent
patent.txt line 8,967- Flags
- substance
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,633,387, substance patent
patent.txt line 8,969- Flags
- substance
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,666,564, use patent
patent.txt line 8,972- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,786,516, substance patent
patent.txt line 8,973- Flags
- substance
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,813,255, use patent
patent.txt line 8,974- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 12,042,488, substance patent
patent.txt line 8,978- Flags
- substance
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 12,042,489, substance and use patent
patent.txt line 8,979- Flags
- substance use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 12,042,490, use patent
patent.txt line 8,980- Flags
- use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 12,109,205, substance and use patent
patent.txt line 8,981- Flags
- substance use code U-2371
- Product numbers
- 001
30 May 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 12,280,042, substance and use patent
patent.txt line 8,982- Flags
- substance use code U-2371
- Product numbers
- 001
1 Jun 2038 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 10,912,754, use patent
patent.txt lines 12,560, 12,602- Flags
- use code U-3082
- Product numbers
- 001, 002
1 Jun 2038 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 10,959,976, use patent
patent.txt lines 12,562, 12,603- Flags
- use code U-3151
- Product numbers
- 001, 002
1 Jun 2038 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,648,232, use patent
patent.txt lines 12,566, 12,607- Flags
- use code U-3602
- Product numbers
- 001, 002
1 Jun 2038 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,865,098, use patent
patent.txt lines 12,578, 12,619- Flags
- use code U-2548
- Product numbers
- 001, 002
14 Jun 2038 · NDA 210045 · AMLODIPINE BESYLATE; CELECOXIB
US 10,350,171, product patent
patent.txt lines 11,103–11,105- Flags
- product
- Product numbers
- 001, 002, 003
14 Jun 2038 · NDA 219249 · INAVOLISIB
US 12,410,189, use patent
patent.txt lines 21,561, 21,568- Flags
- use code U-4024
- Product numbers
- 001, 002
18 Jun 2038 · NDA 217604 · PYRIDOSTIGMINE BROMIDE
US 10,881,617, product patent
patent.txt line 20,035- Flags
- product
- Product numbers
- 001
18 Jun 2038 · NDA 217604 · PYRIDOSTIGMINE BROMIDE
US 10,925,833, product patent
patent.txt line 20,036- Flags
- product
- Product numbers
- 001
18 Jun 2038 · NDA 217604 · PYRIDOSTIGMINE BROMIDE
US 10,987,311, product patent
patent.txt line 20,037- Flags
- product
- Product numbers
- 001
18 Jun 2038 · NDA 217604 · PYRIDOSTIGMINE BROMIDE
US 11,229,606, product patent
patent.txt line 20,038- Flags
- product
- Product numbers
- 001
18 Jun 2038 · NDA 217604 · PYRIDOSTIGMINE BROMIDE
US 11,478,425, product and use patent
patent.txt line 20,039- Flags
- product use code U-4012
- Product numbers
- 001
18 Jun 2038 · NDA 217604 · PYRIDOSTIGMINE BROMIDE
US 11,666,536, product patent
patent.txt line 20,040- Flags
- product
- Product numbers
- 001
18 Jun 2038 · NDA 217604 · PYRIDOSTIGMINE BROMIDE
US 11,911,515, product patent
patent.txt line 20,041- Flags
- product
- Product numbers
- 001
18 Jun 2038 · NDA 217604 · PYRIDOSTIGMINE BROMIDE
US 12,042,559, product patent
patent.txt line 20,042- Flags
- product
- Product numbers
- 001
18 Jun 2038 · NDA 217604 · PYRIDOSTIGMINE BROMIDE
US 12,233,166, product patent
patent.txt line 20,043- Flags
- product
- Product numbers
- 001
20 Jun 2038 · NDA 211844 · MIDAZOLAM
US 10,966,990, product patent
patent.txt lines 13,215–13,216- Flags
- product
- Product numbers
- 001, 002
22 Jun 2038 · NDA 209819 · BUPRENORPHINE
US 10,646,484, use patent
patent.txt line 10,864- Flags
- use code U-2489
- Product numbers
- 002
29 Jun 2038 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
US 10,452,815, use patent
patent.txt line 13,550- Flags
- use code U-2859 delist requested
- Product numbers
- 001
29 Jun 2038 · NDA 217514 · DABRAFENIB MESYLATE
US 11,504,333, product patent
patent.txt line 19,993- Flags
- product
- Product numbers
- 001
Pediatric exclusivity, as listed (11)
2 Feb 2038 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
US 10,603,290 with pediatric exclusivity, as listed
patent.txt line 13,555- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
2 Feb 2038 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
US 11,040,018 with pediatric exclusivity, as listed
patent.txt line 13,560- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
2 Feb 2038 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
US 11,406,606 with pediatric exclusivity, as listed
patent.txt line 13,563- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
2 Feb 2038 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
US 11,759,440 with pediatric exclusivity, as listed
patent.txt line 13,566- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
2 Feb 2038 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
US 11,786,487 with pediatric exclusivity, as listed
patent.txt line 13,568- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
10 Apr 2038 · NDA 213246 · SELPERCATINIB
US 10,112,942 with pediatric exclusivity, as listed
patent.txt lines 14,814, 14,841- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
10 Apr 2038 · NDA 213246 · SELPERCATINIB
US 10,137,124 with pediatric exclusivity, as listed
patent.txt lines 14,816, 14,843- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
10 Apr 2038 · NDA 213246 · SELPERCATINIB
US 10,172,851 with pediatric exclusivity, as listed
patent.txt lines 14,821, 14,848- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
10 Apr 2038 · NDA 218160 · SELPERCATINIB
US 10,112,942 with pediatric exclusivity, as listed
patent.txt lines 20,796, 20,813, 20,830, 20,847- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
10 Apr 2038 · NDA 218160 · SELPERCATINIB
US 10,137,124 with pediatric exclusivity, as listed
patent.txt lines 20,798, 20,815, 20,832, 20,849- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
10 Apr 2038 · NDA 218160 · SELPERCATINIB
US 10,172,851 with pediatric exclusivity, as listed
patent.txt lines 20,803, 20,820, 20,837, 20,854- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004