Drybench Patent.
Patent and exclusivity dates in 2038 for NDAs on FDA's Paragraph IV list, as FDA lists them
Each patent and exclusivity date in 2038 that FDA's Orange Book lists, as captured on 14 October 2026, for the 607 NDAs that FDA's Paragraph IV list names, as captured on 17 October 2026, and whose Orange Book capture lists a patent or exclusivity. Each entry is named by its rule and linked to its NDA page. A date here belongs to one patent or one exclusivity on the products named; the same NDA may have other listed dates, earlier or later, so no date here stands for a product.
FDA capture · review pending. Each date is shown as captured from FDA's Orange Book files. Dates are as FDA lists them, and Drybench computes none; patent dates are submitted by the applicant, and FDA does not verify them. Spreadsheet day numbers are shown as dates; a cell that cannot be read as one date is left off this page and shown as written on its NDA page. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- Paragraph IV list captured
- 17 October 2026
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
This page covers only NDAs that FDA's Paragraph IV list names and that have Orange Book listings. It does not cover other NDAs or any BLA. NCE exclusivity dates are here as FDA lists them; NCE-1 dates, computed from them, are on the NCE-1 calendar.
Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
NCE-1, one year before a listed NCE exclusivity date and the one date Drybench computes, is on its own page: NCE-1 dates from the Orange Book
Listed patent expiry (197)
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
10 Jul 2038 · NDA 214787 · REMDESIVIR
US 10,675,296, product patent
patent.txt line 16,124- Flags
- product
- Product numbers
- 001
10 Jul 2038 · NDA 214787 · REMDESIVIR
US 11,266,681, use patent
patent.txt line 16,132- Flags
- use code U-3831
- Product numbers
- 001
10 Jul 2038 · NDA 214787 · REMDESIVIR
US 11,266,681, use patent
patent.txt line 16,133- Flags
- use code U-3832
- Product numbers
- 001
10 Jul 2038 · NDA 214787 · REMDESIVIR
US 11,975,017, product patent
patent.txt line 16,149- Flags
- product
- Product numbers
- 001
10 Jul 2038 · NDA 217470 · NALMEFENE HYDROCHLORIDE
US 11,458,091, product and use patent
patent.txt line 19,986- Flags
- product use code U-3630
- Product numbers
- 001
19 Jul 2038 · NDA 210455 · COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
US 10,786,518, use patent
patent.txt line 11,402- Flags
- use code U-2978
- Product numbers
- 001
25 Jul 2038 · NDA 208700 · LUTETIUM LU-177 DOTATATE
US 10,596,276, product patent
patent.txt line 9,244- Flags
- product
- Product numbers
- 001
25 Jul 2038 · NDA 208700 · LUTETIUM LU-177 DOTATATE
US 10,596,278, product patent
patent.txt line 9,246- Flags
- product
- Product numbers
- 001
25 Jul 2038 · NDA 208700 · LUTETIUM LU-177 DOTATATE
US 11,904,027, product patent
patent.txt line 9,248- Flags
- product
- Product numbers
- 001
25 Jul 2038 · NDA 208700 · LUTETIUM LU-177 DOTATATE
US 12,144,873, use patent
patent.txt line 9,250- Flags
- use code U-4036
- Product numbers
- 001
25 Jul 2038 · NDA 208700 · LUTETIUM LU-177 DOTATATE
US 12,151,003, product and use patent
patent.txt line 9,252- Flags
- product use code U-4036
- Product numbers
- 001
25 Jul 2038 · NDA 208700 · LUTETIUM LU-177 DOTATATE
US 12,161,732, product and use patent
patent.txt line 9,254- Flags
- product use code U-4036
- Product numbers
- 001
25 Jul 2038 · NDA 208700 · LUTETIUM LU-177 DOTATATE
US 12,168,063, product and use patent
patent.txt line 9,256- Flags
- product use code U-4036
- Product numbers
- 001
25 Jul 2038 · NDA 208700 · LUTETIUM LU-177 DOTATATE
US 12,415,003, use patent
patent.txt line 9,258- Flags
- use code U-4036
- Product numbers
- 001
25 Jul 2038 · NDA 208700 · LUTETIUM LU-177 DOTATATE
US 12,491,272, use patent
patent.txt line 9,260- Flags
- use code U-4036
- Product numbers
- 001
17 Aug 2038 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,903,938, substance and use patent
patent.txt line 8,977- Flags
- substance use code U-2371
- Product numbers
- 001
18 Aug 2038 · NDA 214273 · ZONISAMIDE
US 11,478,456, use patent
patent.txt line 15,654- Flags
- use code U-3458
- Product numbers
- 001
18 Aug 2038 · NDA 214273 · ZONISAMIDE
US 11,529,333, product patent
patent.txt line 15,655- Flags
- product
- Product numbers
- 001
18 Aug 2038 · NDA 214273 · ZONISAMIDE
US 12,491,179, product patent
patent.txt line 15,656- Flags
- product
- Product numbers
- 001
18 Aug 2038 · NDA 214273 · ZONISAMIDE
US 12,685,723, product patent
patent.txt line 15,657- Flags
- product
- Product numbers
- 001
20 Aug 2038 · NDA 210450 · ELAGOLIX SODIUM
US 12,102,637, product patent
patent.txt lines 11,393, 11,399- Flags
- product
- Product numbers
- 001, 002
20 Aug 2038 · NDA 213388 · ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
US 12,083,227, product and use patent
patent.txt line 14,973- Flags
- product use code U-2842
- Product numbers
- 001
22 Aug 2038 · NDA 202107 · MIFEPRISTONE
US 10,231,983, use patent
patent.txt line 2,761- Flags
- use code U-1643
- Product numbers
- 001
22 Aug 2038 · NDA 202107 · MIFEPRISTONE
US 10,314,850, use patent
patent.txt line 2,762- Flags
- use code U-1643
- Product numbers
- 001
22 Aug 2038 · NDA 202107 · MIFEPRISTONE
US 10,780,097, use patent
patent.txt line 2,766- Flags
- use code U-1643
- Product numbers
- 001
23 Aug 2038 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 11,065,213, product patent
patent.txt lines 9,616, 9,633- Flags
- product
- Product numbers
- 001, 002
23 Aug 2038 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 11,077,073, use patent
patent.txt lines 9,617, 9,634- Flags
- use code U-2106
- Product numbers
- 001, 002
23 Aug 2038 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 11,077,073, use patent
patent.txt lines 9,618, 9,635- Flags
- use code U-2224
- Product numbers
- 001, 002
23 Aug 2038 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 11,077,073, use patent
patent.txt lines 9,619, 9,636- Flags
- use code U-3180
- Product numbers
- 001, 002
23 Aug 2038 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 12,233,033, use patent
patent.txt lines 9,622, 9,639- Flags
- use code U-2106
- Product numbers
- 001, 002
23 Aug 2038 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 12,233,033, use patent
patent.txt lines 9,623, 9,640- Flags
- use code U-2224
- Product numbers
- 001, 002
23 Aug 2038 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 12,233,033, use patent
patent.txt lines 9,624, 9,641- Flags
- use code U-3180
- Product numbers
- 001, 002
24 Aug 2038 · NDA 209637 · SEMAGLUTIDE
US 10,888,605, product and use patent
patent.txt lines 10,755, 10,762, 10,770- Flags
- product use code U-1852
- Product numbers
- 005, 006, 007
24 Aug 2038 · NDA 209637 · SEMAGLUTIDE
US 11,752,198, product and use patent
patent.txt lines 10,758, 10,765, 10,773- Flags
- product use code U-1852
- Product numbers
- 005, 006, 007
24 Aug 2038 · NDA 209637 · SEMAGLUTIDE
US 12,214,017, product and use patent
patent.txt lines 10,759, 10,766, 10,774- Flags
- product use code U-1852
- Product numbers
- 005, 006, 007
24 Aug 2038 · NDA 215256 · SEMAGLUTIDE
US 10,888,605, product and use patent
patent.txt lines 16,603, 16,611, 16,619, 16,627, 16,635, 16,653, 16,665, 16,677, 16,689, 16,701- Flags
- product use code U-3162
- Product numbers
- 001, 002, 003, 004, 005, 007, 008, 009, 010, 011
24 Aug 2038 · NDA 215256 · SEMAGLUTIDE
US 10,888,605, product and use patent
patent.txt line 16,645- Flags
- product use code U-4418
- Product numbers
- 006
24 Aug 2038 · NDA 215256 · SEMAGLUTIDE
US 11,752,198, product and use patent
patent.txt lines 16,606, 16,614, 16,622, 16,630, 16,638, 16,658, 16,670, 16,682, 16,694, 16,706- Flags
- product use code U-3162
- Product numbers
- 001, 002, 003, 004, 005, 007, 008, 009, 010, 011
24 Aug 2038 · NDA 215256 · SEMAGLUTIDE
US 11,752,198, product and use patent
patent.txt line 16,647- Flags
- product use code U-4418
- Product numbers
- 006
24 Aug 2038 · NDA 215256 · SEMAGLUTIDE
US 12,214,017, product and use patent
patent.txt lines 16,607, 16,615, 16,623, 16,631, 16,640, 16,660, 16,672, 16,684, 16,696, 16,708- Flags
- product use code U-3162
- Product numbers
- 001, 002, 003, 004, 005, 007, 008, 009, 010, 011
24 Aug 2038 · NDA 215256 · SEMAGLUTIDE
US 12,214,017, product and use patent
patent.txt line 16,649- Flags
- product use code U-4418
- Product numbers
- 006
27 Aug 2038 · NDA 210793 · PIMAVANSERIN TARTRATE
US 10,449,185, product patent
patent.txt line 12,139- Flags
- product
- Product numbers
- 001
27 Aug 2038 · NDA 210793 · PIMAVANSERIN TARTRATE
US 10,646,480, product patent
patent.txt line 12,141- Flags
- product
- Product numbers
- 001
27 Aug 2038 · NDA 210793 · PIMAVANSERIN TARTRATE
US 10,849,891, product and use patent
patent.txt line 12,143- Flags
- product use code U-1974
- Product numbers
- 001
27 Aug 2038 · NDA 210793 · PIMAVANSERIN TARTRATE
US 11,452,721, product patent
patent.txt line 12,145- Flags
- product
- Product numbers
- 001
5 Sep 2038 · NDA 210192 · DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
US 12,011,506, product patent
patent.txt line 11,205- Flags
- product
- Product numbers
- 001
7 Sep 2038 · NDA 213189 · TIRBANIBULIN
US 10,669,236, substance and product patent
patent.txt line 14,722- Flags
- substance product
- Product numbers
- 001
18 Sep 2038 · NDA 209241 · VALBENAZINE TOSYLATE
US 11,026,939, product and use patent
patent.txt lines 9,945, 9,978, 10,011- Flags
- product use code U-1995
- Product numbers
- 001, 002, 003
18 Sep 2038 · NDA 209241 · VALBENAZINE TOSYLATE
US 11,026,939, product and use patent
patent.txt lines 9,946, 9,979, 10,012- Flags
- product use code U-3055
- Product numbers
- 001, 002, 003
18 Sep 2038 · NDA 209241 · VALBENAZINE TOSYLATE
US 11,311,532, product and use patent
patent.txt lines 9,948, 9,981, 10,014- Flags
- product use code U-1995
- Product numbers
- 001, 002, 003
18 Sep 2038 · NDA 209241 · VALBENAZINE TOSYLATE
US 11,311,532, product and use patent
patent.txt lines 9,949, 9,982, 10,015- Flags
- product use code U-3055
- Product numbers
- 001, 002, 003
18 Sep 2038 · NDA 218390 · VALBENAZINE TOSYLATE
US 11,026,939, product and use patent
patent.txt lines 21,003, 21,036, 21,069- Flags
- product use code U-1995
- Product numbers
- 001, 002, 003
18 Sep 2038 · NDA 218390 · VALBENAZINE TOSYLATE
US 11,026,939, product and use patent
patent.txt lines 21,004, 21,037, 21,070- Flags
- product use code U-3055
- Product numbers
- 001, 002, 003
18 Sep 2038 · NDA 218390 · VALBENAZINE TOSYLATE
US 11,311,532, product and use patent
patent.txt lines 21,006, 21,039, 21,072- Flags
- product use code U-1995
- Product numbers
- 001, 002, 003
18 Sep 2038 · NDA 218390 · VALBENAZINE TOSYLATE
US 11,311,532, product and use patent
patent.txt lines 21,007, 21,040, 21,073- Flags
- product use code U-3055
- Product numbers
- 001, 002, 003
24 Sep 2038 · NDA 210526 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 11,590,081, product and use patent
patent.txt lines 11,559, 11,565, 11,571, 11,577- Flags
- product use code U-3538
- Product numbers
- 001, 002, 003, 004
24 Sep 2038 · NDA 210526 · AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
US 12,734,132, use patent
patent.txt lines 11,561, 11,567, 11,573, 11,579- Flags
- use code U-3538
- Product numbers
- 001, 002, 003, 004
25 Sep 2038 · NDA 210854 · BALOXAVIR MARBOXIL
US 11,261,198, product patent
patent.txt lines 12,186, 12,197, 12,208- Flags
- product
- Product numbers
- 001, 002, 003
1 Oct 2038 · NDA 213535 · RISDIPLAM
US 12,350,273, use patent
patent.txt line 15,084- Flags
- use code U-1943
- Product numbers
- 001
1 Oct 2038 · NDA 219285 · RISDIPLAM
US 12,350,273, use patent
patent.txt line 21,575- Flags
- use code U-1943
- Product numbers
- 001
4 Oct 2038 · NDA 210868 · LORLATINIB
US 11,299,500, substance patent
patent.txt lines 12,262, 12,267- Flags
- substance
- Product numbers
- 001, 002
4 Oct 2038 · NDA 213535 · RISDIPLAM
US 11,534,444, use patent
patent.txt line 15,080- Flags
- use code U-1943
- Product numbers
- 001
4 Oct 2038 · NDA 219285 · RISDIPLAM
US 11,534,444, use patent
patent.txt line 21,572- Flags
- use code U-1943
- Product numbers
- 001
10 Oct 2038 · NDA 209637 · SEMAGLUTIDE
US 12,295,988, use patent
patent.txt lines 10,707, 10,742, 10,775- Flags
- use code U-1852
- Product numbers
- 002, 004, 007
10 Oct 2038 · NDA 209637 · SEMAGLUTIDE
US 12,295,988, use patent
patent.txt line 10,724- Flags
- use code U-2628
- Product numbers
- 003
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 10,584,124, substance and use patent
patent.txt lines 14,827, 14,854- Flags
- substance use code U-3450
- Product numbers
- 001, 002
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 10,584,124, substance and use patent
patent.txt lines 14,828, 14,855- Flags
- substance use code U-3949
- Product numbers
- 001, 002
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 10,584,124, substance and use patent
patent.txt lines 14,829, 14,856- Flags
- substance use code U-3950
- Product numbers
- 001, 002
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 10,584,124, substance and use patent
patent.txt lines 14,830, 14,857- Flags
- substance use code U-3951
- Product numbers
- 001, 002
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 10,786,489, product and use patent
patent.txt lines 14,832, 14,859- Flags
- product use code U-3450
- Product numbers
- 001, 002
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 10,786,489, product and use patent
patent.txt lines 14,833, 14,860- Flags
- product use code U-3949
- Product numbers
- 001, 002
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 10,786,489, product and use patent
patent.txt lines 14,834, 14,861- Flags
- product use code U-3950
- Product numbers
- 001, 002
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 10,786,489, product and use patent
patent.txt lines 14,835, 14,862- Flags
- product use code U-3951
- Product numbers
- 001, 002
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 12,138,250, use patent
patent.txt lines 14,837, 14,864- Flags
- use code U-3450
- Product numbers
- 001, 002
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 12,138,250, use patent
patent.txt lines 14,838, 14,865- Flags
- use code U-3949
- Product numbers
- 001, 002
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 12,138,250, use patent
patent.txt lines 14,839, 14,866- Flags
- use code U-3950
- Product numbers
- 001, 002
10 Oct 2038 · NDA 213246 · SELPERCATINIB
US 12,138,250, use patent
patent.txt lines 14,840, 14,867- Flags
- use code U-3951
- Product numbers
- 001, 002
10 Oct 2038 · NDA 215256 · SEMAGLUTIDE
US 12,029,779, use patent
patent.txt lines 16,639, 16,659, 16,671, 16,683, 16,695, 16,707, 16,714- Flags
- use code U-3162
- Product numbers
- 005, 007, 008, 009, 010, 011, 012
10 Oct 2038 · NDA 215256 · SEMAGLUTIDE
US 12,029,779, use patent
patent.txt line 16,648- Flags
- use code U-4418
- Product numbers
- 006
10 Oct 2038 · NDA 215256 · SEMAGLUTIDE
US 12,551,536, use patent
patent.txt lines 16,641, 16,650, 16,661, 16,673, 16,685, 16,697, 16,709, 16,715- Flags
- use code U-4418
- Product numbers
- 005, 006, 007, 008, 009, 010, 011, 012
11 Oct 2038 · NDA 216196 · MITAPIVAT SULFATE
US 11,234,976, use patent
patent.txt lines 18,433, 18,442, 18,451- Flags
- use code U-3321
- Product numbers
- 001, 002, 003
1 Nov 2038 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 12,384,743, substance and product and use patent
patent.txt lines 12,594, 12,633- Flags
- substance product use code U-2548
- Product numbers
- 001, 002
13 Nov 2038 · NDA 215272 · TAPINAROF
US 10,647,649, substance patent
patent.txt line 16,721- Flags
- substance
- Product numbers
- 001
13 Nov 2038 · NDA 215272 · TAPINAROF
US 11,597,692, substance and product patent
patent.txt line 16,725- Flags
- substance product
- Product numbers
- 001
14 Nov 2038 · NDA 209241 · VALBENAZINE TOSYLATE
US 11,654,142, use patent
patent.txt lines 9,951, 9,984, 10,017- Flags
- use code U-3055
- Product numbers
- 001, 002, 003
14 Nov 2038 · NDA 211843 · TIOPRONIN
US 11,458,104, use patent
patent.txt lines 13,213–13,214- Flags
- use code U-3441
- Product numbers
- 001, 002
14 Nov 2038 · NDA 218390 · VALBENAZINE TOSYLATE
US 11,654,142, use patent
patent.txt lines 21,009, 21,042, 21,075- Flags
- use code U-3055
- Product numbers
- 001, 002, 003
17 Nov 2038 · NDA 209388 · METOCLOPRAMIDE HYDROCHLORIDE
US 12,377,064, use patent
patent.txt line 10,292- Flags
- use code U-2843
- Product numbers
- 001
21 Nov 2038 · NDA 216196 · MITAPIVAT SULFATE
US 11,254,652, substance and product patent
patent.txt lines 18,434, 18,443, 18,452, 18,460- Flags
- substance product
- Product numbers
- 001, 002, 003, 004
23 Nov 2038 · NDA 022561 · CLADRIBINE
US 10,849,919, use patent
patent.txt line 2,089- Flags
- use code U-3411
- Product numbers
- 001
13 Dec 2038 · NDA 205494 · ELIGLUSTAT TARTRATE
US 10,888,544, use patent
patent.txt line 5,451- Flags
- use code U-3040
- Product numbers
- 001
13 Dec 2038 · NDA 205494 · ELIGLUSTAT TARTRATE
US 10,888,544, use patent
patent.txt line 5,452- Flags
- use code U-3041
- Product numbers
- 001
24 Dec 2038 · NDA 214522 · TADALAFIL
US 11,382,917, product and use patent
patent.txt line 15,871- Flags
- product use code U-3397
- Product numbers
- 001
24 Dec 2038 · NDA 214522 · TADALAFIL
US 11,666,576, product and use patent
patent.txt line 15,872- Flags
- product use code U-3397
- Product numbers
- 001
24 Dec 2038 · NDA 214522 · TADALAFIL
US 11,975,006, product and use patent
patent.txt line 15,873- Flags
- product use code U-3397
- Product numbers
- 001
24 Dec 2038 · NDA 214522 · TADALAFIL
US 12,186,322, product and use patent
patent.txt line 15,874- Flags
- product use code U-3397
- Product numbers
- 001
24 Dec 2038 · NDA 214522 · TADALAFIL
US 12,691,120, product and use patent
patent.txt line 15,875- Flags
- product use code U-3397
- Product numbers
- 001
24 Dec 2038 · NDA 214522 · TADALAFIL
US 12,697,338, product and use patent
patent.txt line 15,876- Flags
- product use code U-3397
- Product numbers
- 001
24 Dec 2038 · NDA 214522 · TADALAFIL
US 12,708,626, product and use patent
patent.txt line 15,877- Flags
- product use code U-3397
- Product numbers
- 001
24 Dec 2038 · NDA 214522 · TADALAFIL
US 12,721,849, product and use patent
patent.txt line 15,878- Flags
- product use code U-3397
- Product numbers
- 001
24 Dec 2038 · NDA 214522 · TADALAFIL
US 12,734,175, product patent
patent.txt line 15,879- Flags
- product
- Product numbers
- 001
Pediatric exclusivity, as listed (14)
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
15 Sep 2038 · NDA 208082 · DEUTETRABENAZINE
US 11,179,386 with pediatric exclusivity, as listed
patent.txt lines 8,113, 8,145, 8,177- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
15 Sep 2038 · NDA 208082 · DEUTETRABENAZINE
US 11,813,232 with pediatric exclusivity, as listed
patent.txt lines 8,127, 8,159, 8,191- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
15 Sep 2038 · NDA 216354 · DEUTETRABENAZINE
US 11,179,386 with pediatric exclusivity, as listed
patent.txt lines 18,526, 18,556, 18,586, 18,616, 18,646, 18,676, 18,706, 18,736- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
15 Sep 2038 · NDA 216354 · DEUTETRABENAZINE
US 11,813,232 with pediatric exclusivity, as listed
patent.txt lines 18,540, 18,570, 18,600, 18,630, 18,660, 18,690, 18,720, 18,750- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
15 Nov 2038 · NDA 206947 · LENVATINIB MESYLATE
US 12,226,409 with pediatric exclusivity, as listed
patent.txt lines 6,885, 6,906- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
29 Dec 2038 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
US 10,452,815 with pediatric exclusivity, as listed
patent.txt line 13,549- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001