Drybench Patent.
NCE-1 dates from the Orange Book
Each date here is a new chemical entity (NCE) exclusivity date as FDA lists it in the Orange Book, minus one calendar year: the one date Drybench computes. Under 21 USC 355(j)(5)(F)(ii) and 21 CFR 314.108(b)(2), an ANDA referencing a drug with NCE exclusivity may not be submitted until five years after the first approval, except that one with a Paragraph IV certification may be submitted after four. This page does not say that any ANDA has been or will be submitted, when a generic may be approved or marketed, or whether a date has passed.
FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- NCE-1 entries
- 221
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
Dates computed from 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.
- Where pediatric exclusivity applies, 21 USC 355a(b)(1)(A)(i)(I) reads those four years as four and a half. Rows marked "PED listed on this product: not adjusted" have a PED exclusivity on the same product; their date is not moved. A pediatric exclusivity granted after this capture is not shown on any row.
- A Paragraph IV certification is made against a listed patent. Rows marked "no patent listed on this product" have none in the patent file as captured.
- The NCE date is FDA's listed date; Drybench does not check it against the approval date.
2021
19 Jun 2021 · DELAFLOXACIN MEGLUMINE · NDA 208610
exclusivity.txt line 722- NCE date as listed
- 19 Jun 2022
- Product numbers
- 001
19 Jun 2021 · DELAFLOXACIN MEGLUMINE · NDA 208611
exclusivity.txt line 724- NCE date as listed
- 19 Jun 2022
- Product numbers
- 001
29 Aug 2021 · MEROPENEM; VABORBACTAM · NDA 209776
exclusivity.txt line 802- NCE date as listed
- 29 Aug 2022
- Product numbers
- 001
15 Sep 2021 · SECNIDAZOLE · NDA 209363
exclusivity.txt line 774- NCE date as listed
- 15 Sep 2022
- Product numbers
- 001
2022
25 Jun 2022 · PLAZOMICIN SULFATE · NDA 210303
exclusivity.txt line 872- NCE date as listed
- 25 Jun 2023
- Product numbers
- 001
27 Aug 2022 · ERAVACYCLINE DIHYDROCHLORIDE · NDA 211109
exclusivity.txt lines 929, 931- NCE date as listed
- 27 Aug 2023
- Product numbers
- 001, 002
2 Oct 2022 · OMADACYCLINE TOSYLATE · NDA 209816
exclusivity.txt line 805- NCE date as listed
- 2 Oct 2023
- Product numbers
- 001
2 Oct 2022 · OMADACYCLINE TOSYLATE · NDA 209817
exclusivity.txt line 808- NCE date as listed
- 2 Oct 2023
- Product numbers
- 001
16 Nov 2022 · RIFAMYCIN SODIUM · NDA 210910
exclusivity.txt line 926- NCE date as listed
- 16 Nov 2023
- Product numbers
- 001
- Flags
- no patent listed on this product
2023
16 Jul 2023 · CILASTATIN SODIUM; IMIPENEM; RELEBACTAM · NDA 212819
exclusivity.txt line 1,121- NCE date as listed
- 16 Jul 2024
- Product numbers
- 001
14 Aug 2023 · PRETOMANID · NDA 212862
exclusivity.txt line 1,125- NCE date as listed
- 14 Aug 2024
- Product numbers
- 001
- Flags
- no patent listed on this product
19 Aug 2023 · LEFAMULIN ACETATE · NDA 211672
exclusivity.txt line 980- NCE date as listed
- 19 Aug 2024
- Product numbers
- 001
19 Aug 2023 · LEFAMULIN ACETATE · NDA 211673
exclusivity.txt line 982- NCE date as listed
- 19 Aug 2024
- Product numbers
- 001
14 Nov 2023 · CEFIDEROCOL SULFATE TOSYLATE · NDA 209445
exclusivity.txt line 785- NCE date as listed
- 14 Nov 2024
- Product numbers
- 001
2024
22 Oct 2024 · REMDESIVIR · NDA 214787
exclusivity.txt lines 1,392, 1,398- NCE date as listed
- 22 Oct 2025
- Product numbers
- 001, 002
- Flags
- PED listed on this product: not adjusted
2025
19 Jan 2025 · VERICIGUAT · NDA 214377
exclusivity.txt lines 1,323, 1,325, 1,327- NCE date as listed
- 19 Jan 2026
- Product numbers
- 001, 002, 003
21 Jan 2025 · CABOTEGRAVIR SODIUM · NDA 212887
exclusivity.txt line 1,127- NCE date as listed
- 21 Jan 2026
- Product numbers
- 001
21 Jan 2025 · CABOTEGRAVIR; RILPIVIRINE · NDA 212888
exclusivity.txt lines 1,128–1,129- NCE date as listed
- 21 Jan 2026
- Product numbers
- 001, 002
21 Jan 2025 · CABOTEGRAVIR · NDA 215499
exclusivity.txt line 1,584- NCE date as listed
- 21 Jan 2026
- Product numbers
- 001
22 Jan 2025 · VOCLOSPORIN · NDA 213716
exclusivity.txt line 1,246- NCE date as listed
- 22 Jan 2026
- Product numbers
- 001
3 Feb 2025 · TEPOTINIB HYDROCHLORIDE · NDA 214096
exclusivity.txt line 1,302- NCE date as listed
- 3 Feb 2026
- Product numbers
- 001
5 Feb 2025 · UMBRALISIB TOSYLATE · NDA 213176
exclusivity.txt line 1,159- NCE date as listed
- 5 Feb 2026
- Product numbers
- 001
12 Feb 2025 · TRILACICLIB DIHYDROCHLORIDE · NDA 214200
exclusivity.txt line 1,315- NCE date as listed
- 12 Feb 2026
- Product numbers
- 001
25 Feb 2025 · CASIMERSEN · NDA 213026
exclusivity.txt line 1,144- NCE date as listed
- 25 Feb 2026
- Product numbers
- 001
26 Feb 2025 · FOSDENOPTERIN HYDROBROMIDE · NDA 214018
exclusivity.txt line 1,292- NCE date as listed
- 26 Feb 2026
- Product numbers
- 001
10 Mar 2025 · TIVOZANIB HYDROCHLORIDE · NDA 212904
exclusivity.txt lines 1,130–1,131- NCE date as listed
- 10 Mar 2026
- Product numbers
- 001, 002
18 Mar 2025 · PONESIMOD · NDA 213498
exclusivity.txt lines 1,227–1,228- NCE date as listed
- 18 Mar 2026
- Product numbers
- 001, 010
22 Mar 2025 · DASIGLUCAGON HYDROCHLORIDE · NDA 214231
exclusivity.txt lines 1,316, 1,318- NCE date as listed
- 22 Mar 2026
- Product numbers
- 001, 002
2 Apr 2025 · VILOXAZINE HYDROCHLORIDE · NDA 211964
exclusivity.txt lines 1,005–1,007- NCE date as listed
- 2 Apr 2026
- Product numbers
- 001, 002, 003
15 Apr 2025 · DROSPIRENONE; ESTETROL · NDA 214154
exclusivity.txt line 1,310- NCE date as listed
- 15 Apr 2026
- Product numbers
- 001
7 May 2025 · DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE · NDA 212994
exclusivity.txt lines 1,134–1,136- NCE date as listed
- 7 May 2026
- Product numbers
- 001, 002, 003
14 May 2025 · PEGCETACOPLAN · NDA 215014
exclusivity.txt line 1,460- NCE date as listed
- 14 May 2026
- Product numbers
- 001
14 May 2025 · PEGCETACOPLAN · NDA 217171
exclusivity.txt line 1,842- NCE date as listed
- 14 May 2026
- Product numbers
- 001
26 May 2025 · PIFLUFOLASTAT F-18 · NDA 214793
exclusivity.txt line 1,403- NCE date as listed
- 26 May 2026
- Product numbers
- 001
26 May 2025 · PIFLUFOLASTAT F-18 · NDA 220089
exclusivity.txt line 2,374- NCE date as listed
- 26 May 2026
- Product numbers
- 001
28 May 2025 · OLANZAPINE; SAMIDORPHAN L-MALATE · NDA 213378
exclusivity.txt lines 1,214–1,217- NCE date as listed
- 28 May 2026
- Product numbers
- 001, 002, 003, 004
28 May 2025 · INFIGRATINIB PHOSPHATE · NDA 214622
exclusivity.txt lines 1,343, 1,345- NCE date as listed
- 28 May 2026
- Product numbers
- 001, 002
28 May 2025 · SOTORASIB · NDA 214665
exclusivity.txt lines 1,359, 1,363, 1,367- NCE date as listed
- 28 May 2026
- Product numbers
- 001, 002, 003
1 Jun 2025 · IBREXAFUNGERP CITRATE · NDA 214900
exclusivity.txt line 1,412- NCE date as listed
- 1 Jun 2026
- Product numbers
- 001
9 Jul 2025 · FINERENONE · NDA 215341
exclusivity.txt lines 1,526, 1,529, 1,531- NCE date as listed
- 9 Jul 2026
- Product numbers
- 001, 002, 003
16 Jul 2025 · FEXINIDAZOLE · NDA 214429
exclusivity.txt line 1,331- NCE date as listed
- 16 Jul 2026
- Product numbers
- 001
- Flags
- no patent listed on this product
16 Jul 2025 · BELUMOSUDIL MESYLATE · NDA 214783
exclusivity.txt line 1,389- NCE date as listed
- 16 Jul 2026
- Product numbers
- 001
20 Jul 2025 · ODEVIXIBAT · NDA 215498
exclusivity.txt lines 1,569, 1,573, 1,577, 1,581- NCE date as listed
- 20 Jul 2026
- Product numbers
- 001, 002, 003, 004
13 Aug 2025 · BELZUTIFAN · NDA 215383
exclusivity.txt line 1,557- NCE date as listed
- 13 Aug 2026
- Product numbers
- 001
23 Aug 2025 · DIFELIKEFALIN ACETATE · NDA 214916
exclusivity.txt line 1,415- NCE date as listed
- 23 Aug 2026
- Product numbers
- 001
15 Sep 2025 · MOBOCERTINIB SUCCINATE · NDA 215310
exclusivity.txt line 1,521- NCE date as listed
- 15 Sep 2026
- Product numbers
- 001
28 Sep 2025 · ATOGEPANT · NDA 215206
exclusivity.txt lines 1,492, 1,494, 1,496- NCE date as listed
- 28 Sep 2026
- Product numbers
- 001, 002, 003
29 Sep 2025 · MARALIXIBAT CHLORIDE · NDA 214662
exclusivity.txt lines 1,348, 1,353- NCE date as listed
- 29 Sep 2026
- Product numbers
- 001, 002
29 Sep 2025 · MARALIXIBAT CHLORIDE · NDA 219485
exclusivity.txt lines 2,290, 2,292, 2,294, 2,296- NCE date as listed
- 29 Sep 2026
- Product numbers
- 001, 002, 003, 004
7 Oct 2025 · AVACOPAN · NDA 214487
exclusivity.txt line 1,335- NCE date as listed
- 7 Oct 2026
- Product numbers
- 001
29 Oct 2025 · ASCIMINIB HYDROCHLORIDE · NDA 215358
exclusivity.txt lines 1,538, 1,546, 1,552- NCE date as listed
- 29 Oct 2026
- Product numbers
- 001, 002, 003
19 Nov 2025 · VOSORITIDE · NDA 214938
exclusivity.txt lines 1,424, 1,428, 1,432- NCE date as listed
- 19 Nov 2026
- Product numbers
- 001, 002, 003
23 Nov 2025 · MARIBAVIR · NDA 215596
exclusivity.txt line 1,601- NCE date as listed
- 23 Nov 2026
- Product numbers
- 001
29 Nov 2025 · PAFOLACIANINE SODIUM · NDA 214907
exclusivity.txt line 1,413- NCE date as listed
- 29 Nov 2026
- Product numbers
- 001
22 Dec 2025 · INCLISIRAN SODIUM · NDA 214012
exclusivity.txt line 1,289- NCE date as listed
- 22 Dec 2026
- Product numbers
- 001
2026
14 Jan 2026 · ABROCITINIB · NDA 213871
exclusivity.txt lines 1,270, 1,272, 1,274- NCE date as listed
- 14 Jan 2027
- Product numbers
- 001, 002, 003
17 Feb 2026 · MITAPIVAT SULFATE · NDA 216196
exclusivity.txt lines 1,736, 1,738, 1,740, 1,742- NCE date as listed
- 17 Feb 2027
- Product numbers
- 001, 002, 003, 004
28 Feb 2026 · PACRITINIB CITRATE · NDA 208712
exclusivity.txt line 752- NCE date as listed
- 28 Feb 2027
- Product numbers
- 001
23 Mar 2026 · LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN · NDA 215833
exclusivity.txt line 1,612- NCE date as listed
- 23 Mar 2027
- Product numbers
- 001
7 Apr 2026 · DARIDOREXANT HYDROCHLORIDE · NDA 214985
exclusivity.txt lines 1,441, 1,444- NCE date as listed
- 7 Apr 2027
- Product numbers
- 001, 002
26 Apr 2026 · OTESECONAZOLE · NDA 215888
exclusivity.txt line 1,670- NCE date as listed
- 26 Apr 2027
- Product numbers
- 001
28 Apr 2026 · MAVACAMTEN · NDA 214998
exclusivity.txt lines 1,447, 1,450, 1,453, 1,456- NCE date as listed
- 28 Apr 2027
- Product numbers
- 001, 002, 003, 004
3 May 2026 · VONOPRAZAN FUMARATE · NDA 215151
exclusivity.txt lines 1,478, 1,481- NCE date as listed
- 3 May 2027
- Product numbers
- 001, 002
3 May 2026 · AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE · NDA 215152
exclusivity.txt line 1,484- NCE date as listed
- 3 May 2027
- Product numbers
- 001
3 May 2026 · AMOXICILLIN; VONOPRAZAN FUMARATE · NDA 215153
exclusivity.txt line 1,486- NCE date as listed
- 3 May 2027
- Product numbers
- 001
13 May 2026 · TIRZEPATIDE · NDA 215866
exclusivity.txt lines 1,625, 1,627, 1,629, 1,631, 1,633–1,635, 1,637, 1,639, 1,641, 1,643–1,645, 1,647, 1,649, 1,651, 1,653, 1,655, 1,657, 1,659, 1,661, 1,663, 1,665–1,666- NCE date as listed
- 13 May 2027
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024
13 May 2026 · TIRZEPATIDE · NDA 217806
exclusivity.txt lines 1,944, 1,948, 1,952, 1,956, 1,960, 1,964, 1,968, 1,971, 1,974, 1,977, 1,980, 1,983, 1,986, 1,989, 1,992, 1,995, 1,998, 2,001, 2,004, 2,007, 2,010, 2,013, 2,016, 2,019- NCE date as listed
- 13 May 2027
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024
23 May 2026 · TAPINAROF · NDA 215272
exclusivity.txt line 1,517- NCE date as listed
- 23 May 2027
- Product numbers
- 001
1 Jun 2026 · GANAXOLONE · NDA 215904
exclusivity.txt line 1,672- NCE date as listed
- 1 Jun 2027
- Product numbers
- 001
13 Jun 2026 · VUTRISIRAN SODIUM · NDA 215515
exclusivity.txt line 1,588- NCE date as listed
- 13 Jun 2027
- Product numbers
- 001
8 Jul 2026 · INDIGOTINDISULFONATE SODIUM · NDA 216264
exclusivity.txt line 1,747- NCE date as listed
- 8 Jul 2027
- Product numbers
- 001
9 Sep 2026 · DEUCRAVACITINIB · NDA 214958
exclusivity.txt line 1,437- NCE date as listed
- 9 Sep 2027
- Product numbers
- 001
14 Sep 2026 · TERLIPRESSIN ACETATE · NDA 022231
exclusivity.txt line 174- NCE date as listed
- 14 Sep 2027
- Product numbers
- 001
21 Sep 2026 · GADOPICLENOL · NDA 216986
exclusivity.txt lines 1,813, 1,815, 1,817, 1,819, 1,821, 1,823, 1,825- NCE date as listed
- 21 Sep 2027
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
22 Sep 2026 · OMIDENEPAG ISOPROPYL · NDA 215092
exclusivity.txt line 1,472- NCE date as listed
- 22 Sep 2027
- Product numbers
- 001
29 Sep 2026 · SODIUM PHENYLBUTYRATE; TAURURSODIOL · NDA 216660
exclusivity.txt line 1,775- NCE date as listed
- 29 Sep 2027
- Product numbers
- 001
30 Sep 2026 · FUTIBATINIB · NDA 214801
exclusivity.txt lines 1,404, 1,406- NCE date as listed
- 30 Sep 2027
- Product numbers
- 001, 002
1 Dec 2026 · OLUTASIDENIB · NDA 215814
exclusivity.txt line 1,607- NCE date as listed
- 1 Dec 2027
- Product numbers
- 001
12 Dec 2026 · ADAGRASIB · NDA 216340
exclusivity.txt line 1,748- NCE date as listed
- 12 Dec 2027
- Product numbers
- 001
22 Dec 2026 · LENACAPAVIR SODIUM · NDA 215973
exclusivity.txt line 1,679- NCE date as listed
- 22 Dec 2027
- Product numbers
- 001
22 Dec 2026 · LENACAPAVIR SODIUM · NDA 215974
exclusivity.txt line 1,681- NCE date as listed
- 22 Dec 2027
- Product numbers
- 001
22 Dec 2026 · LENACAPAVIR SODIUM · NDA 220018
exclusivity.txt line 2,368- NCE date as listed
- 22 Dec 2027
- Product numbers
- 001
22 Dec 2026 · LENACAPAVIR SODIUM · NDA 220020
exclusivity.txt line 2,370- NCE date as listed
- 22 Dec 2027
- Product numbers
- 001
22 Dec 2026 · BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM · NDA 221104
exclusivity.txt line 2,418- NCE date as listed
- 22 Dec 2027
- Product numbers
- 001
22 Dec 2026 · BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM · NDA 221443
exclusivity.txt line 2,420- NCE date as listed
- 22 Dec 2027
- Product numbers
- 001
23 Dec 2026 · XENON XE-129 HYPERPOLARIZED · NDA 214375
exclusivity.txt line 1,321- NCE date as listed
- 23 Dec 2027
- Product numbers
- 001
2027
20 Jan 2027 · BEXAGLIFLOZIN · NDA 214373
exclusivity.txt line 1,320- NCE date as listed
- 20 Jan 2028
- Product numbers
- 001
27 Jan 2027 · PIRTOBRUTINIB · NDA 216059
exclusivity.txt lines 1,714, 1,719- NCE date as listed
- 27 Jan 2028
- Product numbers
- 001, 002
27 Jan 2027 · ELACESTRANT HYDROCHLORIDE · NDA 217639
exclusivity.txt lines 1,898–1,899- NCE date as listed
- 27 Jan 2028
- Product numbers
- 001, 002
1 Feb 2027 · DAPRODUSTAT · NDA 216951
exclusivity.txt lines 1,803–1,807- NCE date as listed
- 1 Feb 2028
- Product numbers
- 001, 002, 003, 004, 005
17 Feb 2027 · SPARSENTAN · NDA 216403
exclusivity.txt lines 1,754, 1,758- NCE date as listed
- 17 Feb 2028
- Product numbers
- 001, 002
28 Feb 2027 · OMAVELOXOLONE · NDA 216718
exclusivity.txt line 1,785- NCE date as listed
- 28 Feb 2028
- Product numbers
- 001
9 Mar 2027 · ZAVEGEPANT HYDROCHLORIDE · NDA 216386
exclusivity.txt line 1,750- NCE date as listed
- 9 Mar 2028
- Product numbers
- 001
10 Mar 2027 · TROFINETIDE · NDA 217026
exclusivity.txt line 1,835- NCE date as listed
- 10 Mar 2028
- Product numbers
- 001
- Flags
- PED listed on this product: not adjusted
10 Mar 2027 · TROFINETIDE · NDA 219884
exclusivity.txt lines 2,342, 2,346, 2,350- NCE date as listed
- 10 Mar 2028
- Product numbers
- 001, 002, 003
- Flags
- PED listed on this product: not adjusted
22 Mar 2027 · REZAFUNGIN ACETATE · NDA 217417
exclusivity.txt line 1,875- NCE date as listed
- 22 Mar 2028
- Product numbers
- 001
24 Mar 2027 · LENIOLISIB PHOSPHATE · NDA 217759
exclusivity.txt line 1,928- NCE date as listed
- 24 Mar 2028
- Product numbers
- 001
24 Mar 2027 · LENIOLISIB PHOSPHATE · NDA 217759
exclusivity.txt lines 1,931, 1,934- NCE date as listed
- 24 Mar 2028
- Product numbers
- 002, 003
- Flags
- no patent listed on this product
25 Apr 2027 · TOFERSEN · NDA 215887
exclusivity.txt line 1,667- NCE date as listed
- 25 Apr 2028
- Product numbers
- 001
12 May 2027 · FEZOLINETANT · NDA 216578
exclusivity.txt line 1,769- NCE date as listed
- 12 May 2028
- Product numbers
- 001
18 May 2027 · PERFLUOROHEXYLOCTANE · NDA 216675
exclusivity.txt line 1,783- NCE date as listed
- 18 May 2028
- Product numbers
- 001
23 May 2027 · DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM · NDA 216974
exclusivity.txt line 1,812- NCE date as listed
- 23 May 2028
- Product numbers
- 001
25 May 2027 · FLOTUFOLASTAT F-18 GALLIUM · NDA 216023
exclusivity.txt line 1,712- NCE date as listed
- 25 May 2028
- Product numbers
- 001
25 May 2027 · NIRMATRELVIR; RITONAVIR · NDA 217188
exclusivity.txt line 1,859- NCE date as listed
- 25 May 2028
- Product numbers
- 001
26 May 2027 · SOTAGLIFLOZIN · NDA 216203
exclusivity.txt lines 1,745–1,746- NCE date as listed
- 26 May 2028
- Product numbers
- 001, 002
23 Jun 2027 · RITLECITINIB TOSYLATE · NDA 215830
exclusivity.txt line 1,609- NCE date as listed
- 23 Jun 2028
- Product numbers
- 001
20 Jul 2027 · QUIZARTINIB DIHYDROCHLORIDE · NDA 216993
exclusivity.txt lines 1,827, 1,829- NCE date as listed
- 20 Jul 2028
- Product numbers
- 001, 002
21 Jul 2027 · CANTHARIDIN · NDA 212905
exclusivity.txt line 1,132- NCE date as listed
- 21 Jul 2028
- Product numbers
- 001
24 Jul 2027 · LOTILANER · NDA 217603
exclusivity.txt line 1,893- NCE date as listed
- 24 Jul 2028
- Product numbers
- 001
16 Aug 2027 · PALOVAROTENE · NDA 215559
exclusivity.txt lines 1,591, 1,593, 1,595, 1,597, 1,599- NCE date as listed
- 16 Aug 2028
- Product numbers
- 001, 002, 003, 004, 005
8 Sep 2027 · MOTIXAFORTIDE ACETATE · NDA 217159
exclusivity.txt line 1,840- NCE date as listed
- 8 Sep 2028
- Product numbers
- 001
15 Sep 2027 · MOMELOTINIB DIHYDROCHLORIDE · NDA 216873
exclusivity.txt lines 1,797, 1,799, 1,801- NCE date as listed
- 15 Sep 2028
- Product numbers
- 001, 002, 003
22 Sep 2027 · GEPIRONE HYDROCHLORIDE · NDA 021164
exclusivity.txt lines 113–116- NCE date as listed
- 22 Sep 2028
- Product numbers
- 001, 002, 003, 004
29 Sep 2027 · NEDOSIRAN SODIUM · NDA 215842
exclusivity.txt lines 1,613, 1,617, 1,621- NCE date as listed
- 29 Sep 2028
- Product numbers
- 001, 002, 003
12 Oct 2027 · ETRASIMOD ARGININE · NDA 216956
exclusivity.txt line 1,808- NCE date as listed
- 12 Oct 2028
- Product numbers
- 001
17 Oct 2027 · ZILUCOPLAN SODIUM · NDA 216834
exclusivity.txt lines 1,791, 1,793, 1,795- NCE date as listed
- 17 Oct 2028
- Product numbers
- 001, 002, 003
26 Oct 2027 · VAMOROLONE · NDA 215239
exclusivity.txt line 1,498- NCE date as listed
- 26 Oct 2028
- Product numbers
- 001
31 Oct 2027 · ZURANOLONE · NDA 217369
exclusivity.txt lines 1,866–1,868- NCE date as listed
- 31 Oct 2028
- Product numbers
- 001, 002, 003
8 Nov 2027 · FRUQUINTINIB · NDA 217564
exclusivity.txt lines 1,891–1,892- NCE date as listed
- 8 Nov 2028
- Product numbers
- 001, 002
15 Nov 2027 · HEPARIN SODIUM; TAUROLIDINE · NDA 214520
exclusivity.txt lines 1,340, 1,342- NCE date as listed
- 15 Nov 2028
- Product numbers
- 001, 002
15 Nov 2027 · REPOTRECTINIB · NDA 218213
exclusivity.txt lines 2,126, 2,129- NCE date as listed
- 15 Nov 2028
- Product numbers
- 001, 002
16 Nov 2027 · CAPIVASERTIB · NDA 218197
exclusivity.txt lines 2,122, 2,124- NCE date as listed
- 16 Nov 2028
- Product numbers
- 001, 002
27 Nov 2027 · NIROGACESTAT HYDROBROMIDE · NDA 217677
exclusivity.txt lines 1,911, 1,913, 1,915- NCE date as listed
- 27 Nov 2028
- Product numbers
- 001, 002, 003
5 Dec 2027 · IPTACOPAN HYDROCHLORIDE · NDA 218276
exclusivity.txt line 2,139- NCE date as listed
- 5 Dec 2028
- Product numbers
- 001
18 Dec 2027 · BIRCH TRITERPENES · NDA 215064
exclusivity.txt line 1,470- NCE date as listed
- 18 Dec 2028
- Product numbers
- 001
21 Dec 2027 · EPLONTERSEN SODIUM · NDA 217388
exclusivity.txt line 1,870- NCE date as listed
- 21 Dec 2028
- Product numbers
- 001
2028
5 Jan 2028 · BERDAZIMER SODIUM · NDA 217424
exclusivity.txt line 1,877- NCE date as listed
- 5 Jan 2029
- Product numbers
- 001
22 Feb 2028 · CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM · NDA 216165
exclusivity.txt line 1,735- NCE date as listed
- 22 Feb 2029
- Product numbers
- 001
14 Mar 2028 · RESMETIROM · NDA 217785
exclusivity.txt lines 1,939–1,941- NCE date as listed
- 14 Mar 2029
- Product numbers
- 001, 002, 003
21 Mar 2028 · GIVINOSTAT HYDROCHLORIDE · NDA 217865
exclusivity.txt line 2,021- NCE date as listed
- 21 Mar 2029
- Product numbers
- 001
22 Mar 2028 · APROCITENTAN · NDA 217686
exclusivity.txt line 1,917- NCE date as listed
- 22 Mar 2029
- Product numbers
- 001
27 Mar 2028 · VADADUSTAT · NDA 215192
exclusivity.txt lines 1,488–1,490- NCE date as listed
- 27 Mar 2029
- Product numbers
- 001, 002, 003
29 Mar 2028 · DANICOPAN · NDA 218037
exclusivity.txt lines 2,034, 2,036- NCE date as listed
- 29 Mar 2029
- Product numbers
- 001, 002
3 Apr 2028 · CEFTOBIPROLE MEDOCARIL SODIUM · NDA 218275
exclusivity.txt line 2,136- NCE date as listed
- 3 Apr 2029
- Product numbers
- 001
- Flags
- no patent listed on this product
17 Apr 2028 · PEGULICIANINE ACETATE · NDA 214511
exclusivity.txt line 1,337- NCE date as listed
- 17 Apr 2029
- Product numbers
- 001
23 Apr 2028 · TOVORAFENIB · NDA 217700
exclusivity.txt line 1,918- NCE date as listed
- 23 Apr 2029
- Product numbers
- 001
23 Apr 2028 · TOVORAFENIB · NDA 218033
exclusivity.txt line 2,032- NCE date as listed
- 23 Apr 2029
- Product numbers
- 001
26 Apr 2028 · MAVORIXAFOR · NDA 218709
exclusivity.txt line 2,176- NCE date as listed
- 26 Apr 2029
- Product numbers
- 001
10 Jun 2028 · ELAFIBRANOR · NDA 218860
exclusivity.txt line 2,210- NCE date as listed
- 10 Jun 2029
- Product numbers
- 001
20 Jun 2028 · SOFPIRONIUM BROMIDE · NDA 217347
exclusivity.txt line 1,865- NCE date as listed
- 20 Jun 2029
- Product numbers
- 001
26 Jun 2028 · ENSIFENTRINE · NDA 217389
exclusivity.txt line 1,872- NCE date as listed
- 26 Jun 2029
- Product numbers
- 001
25 Jul 2028 · DEURUXOLITINIB PHOSPHATE · NDA 217900
exclusivity.txt line 2,025- NCE date as listed
- 25 Jul 2029
- Product numbers
- 001
6 Aug 2028 · VORASIDENIB · NDA 218784
exclusivity.txt lines 2,191, 2,193- NCE date as listed
- 6 Aug 2029
- Product numbers
- 001, 002
9 Aug 2028 · PALOPEGTERIPARATIDE · NDA 216490
exclusivity.txt lines 1,761, 1,763, 1,765- NCE date as listed
- 9 Aug 2029
- Product numbers
- 001, 002, 003
14 Aug 2028 · SELADELPAR LYSINE · NDA 217899
exclusivity.txt line 2,023- NCE date as listed
- 14 Aug 2029
- Product numbers
- 001
19 Aug 2028 · LAZERTINIB MESYLATE · NDA 219008
exclusivity.txt lines 2,225–2,226- NCE date as listed
- 19 Aug 2029
- Product numbers
- 001, 002
20 Sep 2028 · ARIMOCLOMOL CITRATE · NDA 214927
exclusivity.txt lines 1,416, 1,418, 1,420, 1,422- NCE date as listed
- 20 Sep 2029
- Product numbers
- 001, 002, 003, 004
24 Sep 2028 · LEVACETYLLEUCINE · NDA 219132
exclusivity.txt line 2,253- NCE date as listed
- 24 Sep 2029
- Product numbers
- 001
26 Sep 2028 · TROSPIUM CHLORIDE; XANOMELINE TARTRATE · NDA 216158
exclusivity.txt lines 1,731–1,733- NCE date as listed
- 26 Sep 2029
- Product numbers
- 001, 002, 003
27 Sep 2028 · FLURPIRIDAZ F-18 · NDA 215168
exclusivity.txt line 1,487- NCE date as listed
- 27 Sep 2029
- Product numbers
- 001
10 Oct 2028 · INAVOLISIB · NDA 219249
exclusivity.txt lines 2,264–2,265- NCE date as listed
- 10 Oct 2029
- Product numbers
- 001, 002
25 Oct 2028 · PROBENECID; SULOPENEM ETZADROXIL · NDA 213972
exclusivity.txt line 1,282- NCE date as listed
- 25 Oct 2029
- Product numbers
- 001
15 Nov 2028 · REVUMENIB CITRATE · NDA 218944
exclusivity.txt lines 2,213, 2,217, 2,221- NCE date as listed
- 15 Nov 2029
- Product numbers
- 001, 002, 003
22 Nov 2028 · ACORAMIDIS HYDROCHLORIDE · NDA 216540
exclusivity.txt line 1,767- NCE date as listed
- 22 Nov 2029
- Product numbers
- 001
22 Nov 2028 · LANDIOLOL HYDROCHLORIDE · NDA 217202
exclusivity.txt line 1,860- NCE date as listed
- 22 Nov 2029
- Product numbers
- 001
27 Nov 2028 · IOMEPROL · NDA 216016
exclusivity.txt lines 1,686–1,698- NCE date as listed
- 27 Nov 2029
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013
- Flags
- no patent listed on this product
27 Nov 2028 · IOMEPROL · NDA 216017
exclusivity.txt lines 1,699–1,711- NCE date as listed
- 27 Nov 2029
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013
- Flags
- no patent listed on this product
13 Dec 2028 · CRINECERFONT · NDA 218808
exclusivity.txt lines 2,202, 2,204, 2,206- NCE date as listed
- 13 Dec 2029
- Product numbers
- 001, 002, 003
13 Dec 2028 · CRINECERFONT · NDA 218820
exclusivity.txt line 2,208- NCE date as listed
- 13 Dec 2029
- Product numbers
- 001
18 Dec 2028 · ENSARTINIB HYDROCHLORIDE · NDA 218171
exclusivity.txt lines 2,119–2,120- NCE date as listed
- 18 Dec 2029
- Product numbers
- 001, 002
20 Dec 2028 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM · NDA 218730
exclusivity.txt lines 2,179, 2,182- NCE date as listed
- 20 Dec 2029
- Product numbers
- 001, 002
2029
21 Jan 2029 · TREOSULFAN · NDA 214759
exclusivity.txt lines 1,382, 1,385- NCE date as listed
- 21 Jan 2030
- Product numbers
- 001, 002
30 Jan 2029 · SUZETRIGINE · NDA 219209
exclusivity.txt line 2,263- NCE date as listed
- 30 Jan 2030
- Product numbers
- 001
11 Feb 2029 · MIRDAMETINIB · NDA 219379
exclusivity.txt lines 2,272, 2,274, 2,276- NCE date as listed
- 11 Feb 2030
- Product numbers
- 001, 002, 003
11 Feb 2029 · MIRDAMETINIB · NDA 219389
exclusivity.txt lines 2,278, 2,280- NCE date as listed
- 11 Feb 2030
- Product numbers
- 001, 002
14 Feb 2029 · VIMSELTINIB · NDA 219304
exclusivity.txt lines 2,269–2,271- NCE date as listed
- 14 Feb 2030
- Product numbers
- 001, 002, 003
25 Mar 2029 · GEPOTIDACIN MESYLATE · NDA 218230
exclusivity.txt line 2,134- NCE date as listed
- 25 Mar 2030
- Product numbers
- 001
28 Mar 2029 · FITUSIRAN SODIUM · NDA 219019
exclusivity.txt lines 2,230, 2,233- NCE date as listed
- 28 Mar 2030
- Product numbers
- 001, 002
2 Apr 2029 · ATRASENTAN HYDROCHLORIDE · NDA 219208
exclusivity.txt line 2,262- NCE date as listed
- 2 Apr 2030
- Product numbers
- 001
8 May 2029 · AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE · NDA 219616
exclusivity.txt line 2,301- NCE date as listed
- 8 May 2030
- Product numbers
- 001
28 May 2029 · ACOLTREMON · NDA 217370
exclusivity.txt line 1,869- NCE date as listed
- 28 May 2030
- Product numbers
- 001
11 Jun 2029 · TALETRECTINIB ADIPATE · NDA 219713
exclusivity.txt line 2,320- NCE date as listed
- 11 Jun 2030
- Product numbers
- 001
2 Jul 2029 · SUNVOZERTINIB · NDA 219839
exclusivity.txt lines 2,334–2,335- NCE date as listed
- 2 Jul 2030
- Product numbers
- 001, 002
3 Jul 2029 · SEBETRALSTAT · NDA 219301
exclusivity.txt line 2,267- NCE date as listed
- 3 Jul 2030
- Product numbers
- 001
23 Jul 2029 · DELGOCITINIB · NDA 219155
exclusivity.txt line 2,255- NCE date as listed
- 23 Jul 2030
- Product numbers
- 001
28 Jul 2029 · SEPIAPTERIN · NDA 219666
exclusivity.txt lines 2,311, 2,313- NCE date as listed
- 28 Jul 2030
- Product numbers
- 001, 002
31 Jul 2029 · ACECLIDINE HYDROCHLORIDE · NDA 218585
exclusivity.txt line 2,169- NCE date as listed
- 31 Jul 2030
- Product numbers
- 001
6 Aug 2029 · DORDAVIPRONE HYDROCHLORIDE · NDA 219876
exclusivity.txt line 2,338- NCE date as listed
- 6 Aug 2030
- Product numbers
- 001
8 Aug 2029 · ZONGERTINIB · NDA 219042
exclusivity.txt line 2,236- NCE date as listed
- 8 Aug 2030
- Product numbers
- 001
12 Aug 2029 · BRENSOCATIB · NDA 217673
exclusivity.txt lines 1,909–1,910- NCE date as listed
- 12 Aug 2030
- Product numbers
- 001, 002
29 Aug 2029 · RILZABRUTINIB · NDA 219685
exclusivity.txt line 2,316- NCE date as listed
- 29 Aug 2030
- Product numbers
- 001
19 Sep 2029 · ELAMIPRETIDE HYDROCHLORIDE · NDA 215244
exclusivity.txt line 1,500- NCE date as listed
- 19 Sep 2030
- Product numbers
- 001
25 Sep 2029 · IMLUNESTRANT TOSYLATE · NDA 218881
exclusivity.txt line 2,212- NCE date as listed
- 25 Sep 2030
- Product numbers
- 001
25 Sep 2029 · PALTUSOTINE HYDROCHLORIDE · NDA 219070
exclusivity.txt lines 2,237, 2,239- NCE date as listed
- 25 Sep 2030
- Product numbers
- 001, 002
30 Sep 2029 · REMIBRUTINIB · NDA 218436
exclusivity.txt line 2,155- NCE date as listed
- 30 Sep 2030
- Product numbers
- 001
7 Oct 2029 · NERANDOMILAST · NDA 218764
exclusivity.txt lines 2,186, 2,189- NCE date as listed
- 7 Oct 2030
- Product numbers
- 001, 002
24 Oct 2029 · ELINZANETANT · NDA 219469
exclusivity.txt line 2,287- NCE date as listed
- 24 Oct 2030
- Product numbers
- 001
3 Nov 2029 · DOXECITINE; DOXRIBTIMINE · NDA 219792
exclusivity.txt line 2,331- NCE date as listed
- 3 Nov 2030
- Product numbers
- 001
13 Nov 2029 · ZIFTOMENIB · NDA 220305
exclusivity.txt line 2,383- NCE date as listed
- 13 Nov 2030
- Product numbers
- 001
19 Nov 2029 · SEVABERTINIB · NDA 219972
exclusivity.txt line 2,366- NCE date as listed
- 19 Nov 2030
- Product numbers
- 001
12 Dec 2029 · ETRIPAMIL · NDA 218571
exclusivity.txt line 2,168- NCE date as listed
- 12 Dec 2030
- Product numbers
- 001
12 Dec 2029 · ZOLIFLODACIN · NDA 219491
exclusivity.txt line 2,300- NCE date as listed
- 12 Dec 2030
- Product numbers
- 001
19 Dec 2029 · AFICAMTEN · NDA 219083
exclusivity.txt lines 2,241–2,244- NCE date as listed
- 19 Dec 2030
- Product numbers
- 001, 002, 003, 004
30 Dec 2029 · TRADIPITANT · NDA 220152
exclusivity.txt line 2,378- NCE date as listed
- 30 Dec 2030
- Product numbers
- 001
2030
12 Jan 2030 · COPPER HISTIDINATE · NDA 211241
exclusivity.txt line 948- NCE date as listed
- 12 Jan 2031
- Product numbers
- 001
- Flags
- no patent listed on this product
12 Feb 2030 · DIFAMILAST · NDA 219474
exclusivity.txt line 2,288- NCE date as listed
- 12 Feb 2031
- Product numbers
- 001
20 Feb 2030 · MILSAPERIDONE · NDA 220358
exclusivity.txt lines 2,384–2,390- NCE date as listed
- 20 Feb 2031
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
27 Feb 2030 · NAVEPEGRITIDE · NDA 219164
exclusivity.txt lines 2,256, 2,258, 2,260- NCE date as listed
- 27 Feb 2031
- Product numbers
- 001, 002, 003
17 Mar 2030 · ICOTROKINRA HYDROCHLORIDE · NDA 220149
exclusivity.txt line 2,377- NCE date as listed
- 17 Mar 2031
- Product numbers
- 001
17 Mar 2030 · LINERIXIBAT · NDA 220295
exclusivity.txt line 2,381- NCE date as listed
- 17 Mar 2031
- Product numbers
- 001
25 Mar 2030 · RELACORILANT · NDA 220641
exclusivity.txt line 2,400- NCE date as listed
- 25 Mar 2031
- Product numbers
- 001
1 Apr 2030 · ORFORGLIPRON CALCIUM · NDA 220934
exclusivity.txt lines 2,410–2,415- NCE date as listed
- 1 Apr 2031
- Product numbers
- 001, 002, 003, 004, 005, 006
20 Apr 2030 · DORAVIRINE; ISLATRAVIR · NDA 216964
exclusivity.txt line 1,810- NCE date as listed
- 20 Apr 2031
- Product numbers
- 001
1 May 2030 · VEPDEGESTRANT · NDA 219835
exclusivity.txt lines 2,332–2,333- NCE date as listed
- 1 May 2031
- Product numbers
- 001, 002
13 May 2030 · SONROTOCLAX · NDA 220711
exclusivity.txt lines 2,401–2,404- NCE date as listed
- 13 May 2031
- Product numbers
- 001, 002, 003, 004
15 May 2030 · BAXDROSTAT · NDA 219878
exclusivity.txt lines 2,340–2,341- NCE date as listed
- 15 May 2031
- Product numbers
- 001, 002
29 May 2030 · ENSITRELVIR · NDA 220442
exclusivity.txt line 2,392- NCE date as listed
- 29 May 2031
- Product numbers
- 001
29 May 2030 · CEFEPIME HYDROCHLORIDE; ZIDEBACTAM · NDA 220787
exclusivity.txt line 2,406- NCE date as listed
- 29 May 2031
- Product numbers
- 001
12 Jun 2030 · GADOQUATRANE · NDA 219627
exclusivity.txt lines 2,305–2,310- NCE date as listed
- 12 Jun 2031
- Product numbers
- 001, 002, 003, 004, 005, 006
17 Jun 2030 · TEBIPENEM PIVOXIL HYDROBROMIDE · NDA 215960
exclusivity.txt line 1,678- NCE date as listed
- 17 Jun 2031
- Product numbers
- 001
14 Jul 2030 · GEDATOLISIB · NDA 219908
exclusivity.txt line 2,354- NCE date as listed
- 14 Jul 2031
- Product numbers
- 001
- Flags
- no patent listed on this product
15 Jul 2030 · ENLICITIDE DECANOATE · NDA 220848
exclusivity.txt line 2,407- NCE date as listed
- 15 Jul 2031
- Product numbers
- 001
22 Jul 2030 · ZIDESAMTINIB · NDA 220185
exclusivity.txt lines 2,379–2,380- NCE date as listed
- 22 Jul 2031
- Product numbers
- 001, 002
13 Aug 2030 · FLORQUINITAU F-18 · NDA 220496
exclusivity.txt line 2,394- NCE date as listed
- 13 Aug 2031
- Product numbers
- 001
13 Aug 2030 · IBERDOMIDE HYDROCHLORIDE · NDA 221075
exclusivity.txt lines 2,416–2,417- NCE date as listed
- 13 Aug 2031
- Product numbers
- 001, 002
26 Aug 2030 · DARAXONRASIB · NDA 220910
exclusivity.txt lines 2,408–2,409- NCE date as listed
- 26 Aug 2031
- Product numbers
- 001, 002
27 Aug 2030 · BREPOCITINIB TOSYLATE · NDA 220106
exclusivity.txt line 2,375- NCE date as listed
- 27 Aug 2031
- Product numbers
- 001
27 Aug 2030 · CIPEPOFOL · NDA 220482
exclusivity.txt line 2,393- NCE date as listed
- 27 Aug 2031
- Product numbers
- 001
28 Aug 2030 · RUSFERTIDE ACETATE · NDA 220605
exclusivity.txt lines 2,395–2,399- NCE date as listed
- 28 Aug 2031
- Product numbers
- 001, 002, 003, 004, 005
4 Sep 2030 · CAMIZESTRANT · NDA 220359
exclusivity.txt line 2,391- NCE date as listed
- 4 Sep 2031
- Product numbers
- 001
11 Sep 2030 · FLORETYROSINE F-18 · NDA 218592
exclusivity.txt line 2,171- NCE date as listed
- 11 Sep 2031
- Product numbers
- 001
- Flags
- no patent listed on this product