Drybench Patent.
Patent and exclusivity dates from July to December 2027 for NDAs, as FDA's Orange Book lists them
Each patent and exclusivity date from July to December 2027 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, 2027January to June 2027
Listed patent expiry (365)
5 Jul 2027 · NDA 021992 · DESVENLAFAXINE SUCCINATE
US 8,269,040, substance patent
patent.txt lines 884–886- Flags
- substance
- Product numbers
- 001, 002, 003
6 Jul 2027 · NDA 202833 · INGENOL MEBUTATE
US 8,278,292, product patent
patent.txt lines 3,379, 3,391- Flags
- product
- Product numbers
- 001, 002
10 Jul 2027 · NDA 212295 · REMIMAZOLAM BESYLATE
US 10,472,365, use patent
patent.txt line 13,801- Flags
- use code U-2968
- Product numbers
- 001
10 Jul 2027 · NDA 212295 · REMIMAZOLAM BESYLATE
US 10,961,250, product and use patent
patent.txt line 13,803- Flags
- product use code U-2968
- Product numbers
- 001
10 Jul 2027 · NDA 212295 · REMIMAZOLAM BESYLATE
US 9,777,007, product patent
patent.txt line 13,806- Flags
- product
- Product numbers
- 001
10 Jul 2027 · NDA 212295 · REMIMAZOLAM BESYLATE
US 9,914,738, product patent
patent.txt line 13,808- Flags
- product
- Product numbers
- 001
11 Jul 2027 · NDA 209531 · NUSINERSEN SODIUM
US 7,838,657, substance patent
patent.txt line 10,617- Flags
- substance
- Product numbers
- 001
11 Jul 2027 · NDA 209531 · NUSINERSEN SODIUM
US 7,838,657, substance and product patent
patent.txt lines 10,625, 10,632- Flags
- substance product
- Product numbers
- 002, 003
14 Jul 2027 · NDA 204042 · CANAGLIFLOZIN
US 7,943,788, substance and product patent
patent.txt lines 4,237, 4,247- Flags
- substance product
- Product numbers
- 001, 002
14 Jul 2027 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,788, substance and product patent
patent.txt lines 4,512, 4,523, 4,534, 4,545- Flags
- substance product
- Product numbers
- 001, 002, 003, 004
14 Jul 2027 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,788, substance and product patent
patent.txt lines 6,004, 6,014, 6,024, 6,034- Flags
- substance product
- Product numbers
- 001, 002, 003, 004
18 Jul 2027 · NDA 022320 · ADAPALENE; BENZOYL PEROXIDE
US 8,071,644, product and use patent
patent.txt line 1,646- Flags
- product use code U-1078
- Product numbers
- 001
18 Jul 2027 · NDA 022320 · ADAPALENE; BENZOYL PEROXIDE
US 8,080,537, use patent
patent.txt line 1,647- Flags
- use code U-1078
- Product numbers
- 001
18 Jul 2027 · NDA 022320 · ADAPALENE; BENZOYL PEROXIDE
US 8,129,362, use patent
patent.txt line 1,648- Flags
- use code U-1078
- Product numbers
- 001
20 Jul 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 10,653,660, use patent
patent.txt lines 935, 951- Flags
- use code U-620
- Product numbers
- 001, 002
20 Jul 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 11,110,074, use patent
patent.txt lines 938, 954- Flags
- use code U-620
- Product numbers
- 001, 002
20 Jul 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 9,572,814, use patent
patent.txt lines 946, 962- Flags
- use code U-620
- Product numbers
- 001, 002
20 Jul 2027 · NDA 022581 · CALCIUM ACETATE
US 8,592,480, use patent
patent.txt line 2,134- Flags
- use code U-1469
- Product numbers
- 001
20 Jul 2027 · NDA 022581 · CALCIUM ACETATE
US 9,089,528, use patent
patent.txt line 2,135- Flags
- use code U-1469
- Product numbers
- 001
23 Jul 2027 · NDA 021400 · VARDENAFIL HYDROCHLORIDE
US 8,273,876, use patent
patent.txt lines 597–600- Flags
- use code U-1288
- Product numbers
- 001, 002, 003, 004
23 Jul 2027 · NDA 022266 · FENTANYL CITRATE
US 9,597,288, product and use patent
patent.txt lines 1,430–1,434- Flags
- product use code U-767
- Product numbers
- 001, 002, 003, 004, 005
23 Jul 2027 · NDA 205637 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 8,147,866, product and use patent
patent.txt lines 5,698, 5,702, 5,706- Flags
- product use code U-1521
- Product numbers
- 001, 002, 003
23 Jul 2027 · NDA 205637 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 9,655,843, product and use patent
patent.txt lines 5,701, 5,705, 5,709- Flags
- product use code U-2017
- Product numbers
- 001, 002, 003
23 Jul 2027 · NDA 207932 · BUPRENORPHINE HYDROCHLORIDE
US 8,147,866, product and use patent
patent.txt lines 7,655, 7,658, 7,661, 7,664, 7,667, 7,670, 7,673- Flags
- product use code U-1769
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
23 Jul 2027 · NDA 207932 · BUPRENORPHINE HYDROCHLORIDE
US 9,655,843, product and use patent
patent.txt lines 7,656, 7,659, 7,662, 7,665, 7,668, 7,671, 7,674- Flags
- product use code U-1556
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
23 Jul 2027 · NDA 208627 · TECOVIRIMAT
US 8,039,504, product patent
patent.txt line 9,015- Flags
- product
- Product numbers
- 001
23 Jul 2027 · NDA 214518 · TECOVIRIMAT
US 8,039,504, product patent
patent.txt line 15,864- Flags
- product
- Product numbers
- 001
24 Jul 2027 · NDA 019618 · MESALAMINE
US 7,645,801, substance and product patent
patent.txt line 157- Flags
- substance product
- Product numbers
- 002
27 Jul 2027 · NDA 206947 · LENVATINIB MESYLATE
US 9,006,256, use patent
patent.txt lines 6,894, 6,915- Flags
- use code U-1695
- Product numbers
- 001, 002
28 Jul 2027 · NDA 210238 · AVATROMBOPAG MALEATE
US 7,638,536, substance and product patent
patent.txt line 11,210- Flags
- substance product
- Product numbers
- 001
28 Jul 2027 · NDA 219696 · AVATROMBOPAG MALEATE
US 7,638,536, substance and product patent
patent.txt line 21,871- Flags
- substance product
- Product numbers
- 001
31 Jul 2027 · NDA 201699 · FIDAXOMICIN
US 7,378,508, substance and product patent
patent.txt line 2,551- Flags
- substance product
- Product numbers
- 001
31 Jul 2027 · NDA 201699 · FIDAXOMICIN
US 7,863,249, substance and product patent
patent.txt line 2,553- Flags
- substance product
- Product numbers
- 001
31 Jul 2027 · NDA 201699 · FIDAXOMICIN
US 8,859,510, use patent
patent.txt line 2,558- Flags
- use code U-2741
- Product numbers
- 001
31 Jul 2027 · NDA 201699 · FIDAXOMICIN
US 8,859,510, use patent
patent.txt line 2,559- Flags
- use code U-319
- Product numbers
- 001
31 Jul 2027 · NDA 213138 · FIDAXOMICIN
US 7,378,508, substance and product patent
patent.txt line 14,693- Flags
- substance product
- Product numbers
- 001
31 Jul 2027 · NDA 213138 · FIDAXOMICIN
US 7,863,249, product patent
patent.txt line 14,695- Flags
- product
- Product numbers
- 001
31 Jul 2027 · NDA 213138 · FIDAXOMICIN
US 8,859,510, use patent
patent.txt line 14,699- Flags
- use code U-2741
- Product numbers
- 001
1 Aug 2027 · NDA 022029 · MENTHOL; METHYL SALICYLATE
US 9,233,184, product patent
patent.txt lines 917, 919- Flags
- product
- Product numbers
- 001, 002
2 Aug 2027 · NDA 217899 · SELADELPAR LYSINE
US 7,301,050, substance and product patent
patent.txt line 20,755- Flags
- substance product
- Product numbers
- 001
3 Aug 2027 · NDA 021964 · METHYLNALTREXONE BROMIDE
US 12,303,592, product and use patent
patent.txt lines 831, 838, 845- Flags
- product use code U-4197
- Product numbers
- 001, 002, 003
3 Aug 2027 · NDA 021964 · METHYLNALTREXONE BROMIDE
US 12,303,592, product and use patent
patent.txt lines 832, 839, 846- Flags
- product use code U-4198
- Product numbers
- 001, 002, 003
3 Aug 2027 · NDA 202020 · PREDNISONE
US 9,504,699, use patent
patent.txt lines 2,616–2,617, 2,619- Flags
- use code U-1362
- Product numbers
- 001, 002, 003
5 Aug 2027 · NDA 203188 · IVACAFTOR
US 8,324,242, use patent
patent.txt line 3,660- Flags
- use code U-1311
- Product numbers
- 001
5 Aug 2027 · NDA 203188 · IVACAFTOR
US 8,324,242, use patent
patent.txt line 3,661- Flags
- use code U-1906
- Product numbers
- 001
5 Aug 2027 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,324,242, use patent
patent.txt line 6,098- Flags
- use code U-1311
- Product numbers
- 001
5 Aug 2027 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,324,242, use patent
patent.txt lines 6,099, 6,146- Flags
- use code U-1911
- Product numbers
- 001, 002
5 Aug 2027 · NDA 207925 · IVACAFTOR
US 8,324,242, use patent
patent.txt lines 7,510, 7,543- Flags
- use code U-2527
- Product numbers
- 001, 002
5 Aug 2027 · NDA 207925 · IVACAFTOR
US 8,324,242, use patent
patent.txt lines 7,508, 7,541, 7,574- Flags
- use code U-1311
- Product numbers
- 001, 002, 003
5 Aug 2027 · NDA 207925 · IVACAFTOR
US 8,324,242, use patent
patent.txt lines 7,509, 7,542, 7,575- Flags
- use code U-1906
- Product numbers
- 001, 002, 003
5 Aug 2027 · NDA 207925 · IVACAFTOR
US 8,324,242, use patent
patent.txt line 7,576- Flags
- use code U-2963
- Product numbers
- 003
5 Aug 2027 · NDA 207925 · IVACAFTOR
US 8,324,242, use patent
patent.txt lines 7,607, 7,635- Flags
- use code U-3609
- Product numbers
- 004, 005
5 Aug 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 8,324,242, use patent
patent.txt lines 11,433, 11,465- Flags
- use code U-2246
- Product numbers
- 001, 002
5 Aug 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,324,242, use patent
patent.txt lines 12,730, 12,772- Flags
- use code U-2374
- Product numbers
- 001, 002
5 Aug 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,324,242, use patent
patent.txt line 12,814- Flags
- use code U-3424
- Product numbers
- 003
5 Aug 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,324,242, use patent
patent.txt line 13,699- Flags
- use code U-3028
- Product numbers
- 001
5 Aug 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,324,242, use patent
patent.txt lines 13,700, 13,771- Flags
- use code U-3144
- Product numbers
- 001, 002
5 Aug 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,324,242, use patent
patent.txt lines 13,701, 13,772- Flags
- use code U-4073
- Product numbers
- 001, 002
5 Aug 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,324,242, use patent
patent.txt lines 13,702, 13,773- Flags
- use code U-4475
- Product numbers
- 001, 002
5 Aug 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,324,242, use patent
patent.txt lines 20,111, 20,186- Flags
- use code U-3589
- Product numbers
- 001, 002
5 Aug 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,324,242, use patent
patent.txt lines 20,112, 20,187- Flags
- use code U-4066
- Product numbers
- 001, 002
5 Aug 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,324,242, use patent
patent.txt lines 20,113, 20,188- Flags
- use code U-4476
- Product numbers
- 001, 002
5 Aug 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 8,324,242, use patent
patent.txt lines 21,205, 21,255- Flags
- use code U-4090
- Product numbers
- 001, 002
5 Aug 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 8,324,242, use patent
patent.txt lines 21,206, 21,256- Flags
- use code U-4464
- Product numbers
- 001, 002
6 Aug 2027 · NDA 208462 · IXAZOMIB CITRATE
US 7,687,662, substance and product patent
patent.txt lines 8,639, 8,646, 8,653- Flags
- substance product
- Product numbers
- 001, 002, 003
6 Aug 2027 · NDA 208462 · IXAZOMIB CITRATE
US 8,003,819, substance and product and use patent
patent.txt lines 8,640, 8,647, 8,654- Flags
- substance product use code U-2434
- Product numbers
- 001, 002, 003
6 Aug 2027 · NDA 208462 · IXAZOMIB CITRATE
US 8,530,694, substance and product and use patent
patent.txt lines 8,641, 8,648, 8,655- Flags
- substance product use code U-2434
- Product numbers
- 001, 002, 003
6 Aug 2027 · NDA 208462 · IXAZOMIB CITRATE
US 8,871,745, use patent
patent.txt lines 8,643, 8,650, 8,657- Flags
- use code U-2434
- Product numbers
- 001, 002, 003
8 Aug 2027 · NDA 206843 · DACLATASVIR DIHYDROCHLORIDE
US 8,900,566, use patent
patent.txt lines 6,828, 6,836- Flags
- use code U-1724
- Product numbers
- 001, 002
8 Aug 2027 · NDA 206843 · DACLATASVIR DIHYDROCHLORIDE
US 8,900,566, use patent
patent.txt lines 6,829, 6,837- Flags
- use code U-1725
- Product numbers
- 001, 002
8 Aug 2027 · NDA 206843 · DACLATASVIR DIHYDROCHLORIDE
US 9,421,192, substance and use patent
patent.txt lines 6,830, 6,838, 6,840- Flags
- substance use code U-1724
- Product numbers
- 001, 002, 003
8 Aug 2027 · NDA 206843 · DACLATASVIR DIHYDROCHLORIDE
US 9,421,192, substance and use patent
patent.txt lines 6,831, 6,839, 6,841- Flags
- substance use code U-1725
- Product numbers
- 001, 002, 003
11 Aug 2027 · NDA 206843 · DACLATASVIR DIHYDROCHLORIDE
US 8,642,025, substance and product and use patent
patent.txt lines 6,826, 6,834- Flags
- substance product use code U-1724
- Product numbers
- 001, 002
11 Aug 2027 · NDA 206843 · DACLATASVIR DIHYDROCHLORIDE
US 8,642,025, substance and product and use patent
patent.txt lines 6,827, 6,835- Flags
- substance product use code U-1725
- Product numbers
- 001, 002
12 Aug 2027 · NDA 201923 · FLUOCINOLONE ACETONIDE
US 8,871,241, product patent
patent.txt line 2,605- Flags
- product
- Product numbers
- 001
12 Aug 2027 · NDA 206162 · OLAPARIB
US 8,143,241, use patent
patent.txt line 6,426- Flags
- use code U-1634
- Product numbers
- 001
12 Aug 2027 · NDA 208447 · NIRAPARIB TOSYLATE
US 8,071,579, use patent
patent.txt line 8,633- Flags
- use code U-2655
- Product numbers
- 001
12 Aug 2027 · NDA 208447 · NIRAPARIB TOSYLATE
US 8,143,241, use patent
patent.txt line 8,635- Flags
- use code U-2655
- Product numbers
- 001
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,689, 8,746- Flags
- use code U-2480
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,690, 8,747- Flags
- use code U-2482
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,691, 8,748- Flags
- use code U-2483
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,692, 8,749- Flags
- use code U-2716
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,693, 8,750- Flags
- use code U-2819
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,694, 8,751- Flags
- use code U-2820
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,695, 8,752- Flags
- use code U-2821
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,696, 8,753- Flags
- use code U-2822
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,697, 8,754- Flags
- use code U-2823
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,698, 8,755- Flags
- use code U-2824
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,699, 8,756- Flags
- use code U-2832
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,700, 8,757- Flags
- use code U-2833
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,701, 8,758- Flags
- use code U-3333
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,702, 8,759- Flags
- use code U-3631
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,071,579, use patent
patent.txt lines 8,703, 8,760- Flags
- use code U-3695
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,704, 8,761- Flags
- use code U-2480
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,705, 8,762- Flags
- use code U-2482
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,706, 8,763- Flags
- use code U-2483
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,707, 8,764- Flags
- use code U-2716
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,708, 8,765- Flags
- use code U-2819
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,709, 8,766- Flags
- use code U-2820
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,710, 8,767- Flags
- use code U-2821
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,711, 8,768- Flags
- use code U-2822
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,712, 8,769- Flags
- use code U-2823
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,713, 8,770- Flags
- use code U-2824
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,714, 8,771- Flags
- use code U-2832
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,715, 8,772- Flags
- use code U-2833
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,716, 8,773- Flags
- use code U-3333
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,717, 8,774- Flags
- use code U-3631
- Product numbers
- 001, 002
12 Aug 2027 · NDA 208558 · OLAPARIB
US 8,143,241, use patent
patent.txt lines 8,718, 8,775- Flags
- use code U-3695
- Product numbers
- 001, 002
12 Aug 2027 · NDA 209115 · RUCAPARIB CAMSYLATE
US 8,071,579, use patent
patent.txt lines 9,733, 9,752, 9,771- Flags
- use code U-2012
- Product numbers
- 001, 002, 003
12 Aug 2027 · NDA 209115 · RUCAPARIB CAMSYLATE
US 8,071,579, use patent
patent.txt lines 9,734, 9,753, 9,772- Flags
- use code U-2273
- Product numbers
- 001, 002, 003
12 Aug 2027 · NDA 209115 · RUCAPARIB CAMSYLATE
US 8,071,579, use patent
patent.txt lines 9,735, 9,754, 9,773- Flags
- use code U-2830
- Product numbers
- 001, 002, 003
12 Aug 2027 · NDA 209115 · RUCAPARIB CAMSYLATE
US 8,143,241, use patent
patent.txt lines 9,736, 9,755, 9,774- Flags
- use code U-2012
- Product numbers
- 001, 002, 003
12 Aug 2027 · NDA 209115 · RUCAPARIB CAMSYLATE
US 8,143,241, use patent
patent.txt lines 9,737, 9,756, 9,775- Flags
- use code U-2273
- Product numbers
- 001, 002, 003
12 Aug 2027 · NDA 209115 · RUCAPARIB CAMSYLATE
US 8,143,241, use patent
patent.txt lines 9,738, 9,757, 9,776- Flags
- use code U-2830
- Product numbers
- 001, 002, 003
12 Aug 2027 · NDA 210331 · FLUOCINOLONE ACETONIDE
US 8,871,241, product patent
patent.txt line 11,310- Flags
- product
- Product numbers
- 001
12 Aug 2027 · NDA 214876 · NIRAPARIB TOSYLATE
US 8,071,579, use patent
patent.txt lines 16,277, 16,286, 16,295- Flags
- use code U-2655
- Product numbers
- 001, 002, 003
12 Aug 2027 · NDA 214876 · NIRAPARIB TOSYLATE
US 8,143,241, use patent
patent.txt lines 16,279, 16,288, 16,297- Flags
- use code U-2655
- Product numbers
- 001, 002, 003
12 Aug 2027 · NDA 216793 · ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
US 8,071,579, use patent
patent.txt lines 18,964, 18,988- Flags
- use code U-2830
- Product numbers
- 001, 002
12 Aug 2027 · NDA 216793 · ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
US 8,071,579, use patent
patent.txt lines 18,965, 18,989- Flags
- use code U-4368
- Product numbers
- 001, 002
12 Aug 2027 · NDA 216793 · ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
US 8,143,241, use patent
patent.txt lines 18,967, 18,991- Flags
- use code U-2830
- Product numbers
- 001, 002
12 Aug 2027 · NDA 216793 · ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
US 8,143,241, use patent
patent.txt lines 18,968, 18,992- Flags
- use code U-4368
- Product numbers
- 001, 002
13 Aug 2027 · NDA 021978 · DESONIDE
US 8,460,641, product and use patent
patent.txt line 864- Flags
- product use code U-1412
- Product numbers
- 001
13 Aug 2027 · NDA 203415 · ENZALUTAMIDE
US 7,709,517, substance and product patent
patent.txt line 3,861- Flags
- substance product
- Product numbers
- 001
13 Aug 2027 · NDA 213674 · ENZALUTAMIDE
US 7,709,517, substance and product patent
patent.txt lines 15,170, 15,188- Flags
- substance product
- Product numbers
- 001, 002
14 Aug 2027 · NDA 215192 · VADADUSTAT
US 8,343,952, substance and product patent
patent.txt lines 16,524, 16,538, 16,552- Flags
- substance product
- Product numbers
- 001, 002, 003
17 Aug 2027 · NDA 208159 · URIDINE TRIACETATE
US 7,776,838, use patent
patent.txt line 8,280- Flags
- use code U-1791
- Product numbers
- 001
19 Aug 2027 · NDA 203858 · LOMITAPIDE MESYLATE
US 7,932,268, use patent
patent.txt lines 4,167, 4,169, 4,171, 4,173–4,175, 4,177- Flags
- use code U-1316
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
20 Aug 2027 · NDA 022418 · FENOFIBRIC ACID
US 7,569,612, use patent
patent.txt lines 1,847, 1,854- Flags
- use code U-1000
- Product numbers
- 001, 002
20 Aug 2027 · NDA 022418 · FENOFIBRIC ACID
US 7,741,373, use patent
patent.txt lines 1,848, 1,855- Flags
- use code U-1059
- Product numbers
- 001, 002
20 Aug 2027 · NDA 022418 · FENOFIBRIC ACID
US 7,741,374, use patent
patent.txt lines 1,849, 1,856- Flags
- use code U-1060
- Product numbers
- 001, 002
20 Aug 2027 · NDA 022418 · FENOFIBRIC ACID
US 7,741,374, use patent
patent.txt lines 1,850, 1,857- Flags
- use code U-1061
- Product numbers
- 001, 002
20 Aug 2027 · NDA 022418 · FENOFIBRIC ACID
US 7,915,247, use patent
patent.txt lines 1,851, 1,858- Flags
- use code U-1000
- Product numbers
- 001, 002
20 Aug 2027 · NDA 022418 · FENOFIBRIC ACID
US 7,915,247, use patent
patent.txt lines 1,852, 1,859- Flags
- use code U-1059
- Product numbers
- 001, 002
20 Aug 2027 · NDA 022418 · FENOFIBRIC ACID
US 7,915,247, use patent
patent.txt lines 1,853, 1,860- Flags
- use code U-1061
- Product numbers
- 001, 002
24 Aug 2027 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 7,915,307, use patent
patent.txt lines 941, 957- Flags
- use code U-620
- Product numbers
- 001, 002
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 11,304,908, product patent
patent.txt lines 1,441, 1,456, 1,471, 1,486, 1,501, 1,515, 1,529- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 11,304,909, use patent
patent.txt lines 1,442, 1,457, 1,472, 1,487, 1,502, 1,516, 1,530- Flags
- use code U-1556
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 11,964,056, product patent
patent.txt lines 1,443, 1,458, 1,473, 1,488, 1,503, 1,517, 1,531- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 12,246,094, product patent
patent.txt lines 1,444, 1,459, 1,474, 1,489, 1,504, 1,518, 1,532- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 12,280,152, product patent
patent.txt lines 1,445, 1,460, 1,475, 1,490, 1,505, 1,519, 1,533- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 8,808,741, use patent
patent.txt lines 1,446, 1,461, 1,476, 1,491, 1,506, 1,520, 1,534- Flags
- use code U-1556
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 8,894,988, product patent
patent.txt lines 1,448, 1,463, 1,478, 1,493, 1,507, 1,521, 1,535- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,492,389, product patent
patent.txt lines 1,449, 1,464, 1,479, 1,494, 1,508, 1,522, 1,536- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,492,391, use patent
patent.txt lines 1,450, 1,465, 1,480, 1,495, 1,509, 1,523, 1,537- Flags
- use code U-1556
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,492,392, product patent
patent.txt lines 1,451, 1,466, 1,481, 1,496, 1,510, 1,524, 1,538- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,492,393, use patent
patent.txt lines 1,452, 1,467, 1,482, 1,497, 1,511, 1,525, 1,539- Flags
- use code U-1556
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,763,933, product patent
patent.txt lines 1,453, 1,468, 1,483, 1,498, 1,512, 1,526, 1,540- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,770,416, product patent
patent.txt lines 1,454, 1,469, 1,484, 1,499, 1,513, 1,527, 1,541- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 022272 · OXYCODONE HYDROCHLORIDE
US 9,775,808, product patent
patent.txt lines 1,455, 1,470, 1,485, 1,500, 1,514, 1,528, 1,542- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 11,304,908, product patent
patent.txt lines 6,615, 6,634, 6,653, 6,672, 6,691, 6,710, 6,729- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 11,304,909, use patent
patent.txt lines 6,616, 6,635, 6,654, 6,673, 6,692, 6,711, 6,730- Flags
- use code U-1556
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,084,816, product patent
patent.txt lines 6,618, 6,637, 6,656, 6,675, 6,694, 6,713, 6,732- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,095,614, use patent
patent.txt lines 6,619, 6,638, 6,657, 6,676, 6,695, 6,714, 6,733- Flags
- use code U-1556
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,095,615, product patent
patent.txt lines 6,620, 6,639, 6,658, 6,677, 6,696, 6,715, 6,734- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,486,412, product patent
patent.txt lines 6,621, 6,640, 6,659, 6,678, 6,697, 6,716, 6,735- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,486,413, product patent
patent.txt lines 6,622, 6,641, 6,660, 6,679, 6,698, 6,717, 6,736- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,492,389, product patent
patent.txt lines 6,623, 6,642, 6,661, 6,680, 6,699, 6,718, 6,737- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,492,390, use patent
patent.txt lines 6,624, 6,643, 6,662, 6,681, 6,700, 6,719, 6,738- Flags
- use code U-1556
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,492,391, use patent
patent.txt lines 6,625, 6,644, 6,663, 6,682, 6,701, 6,720, 6,739- Flags
- use code U-1556
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,545,380, use patent
patent.txt lines 6,626, 6,645, 6,664, 6,683, 6,702, 6,721, 6,740- Flags
- use code U-1556
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,763,933, product patent
patent.txt lines 6,629, 6,648, 6,667, 6,686, 6,705, 6,724, 6,743- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,770,416, product patent
patent.txt lines 6,630, 6,649, 6,668, 6,687, 6,706, 6,725, 6,744- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 Aug 2027 · NDA 206627 · HYDROCODONE BITARTRATE
US 9,775,809, product patent
patent.txt lines 6,631, 6,650, 6,669, 6,688, 6,707, 6,726, 6,745- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
26 Aug 2027 · NDA 022377 · SUMATRIPTAN SUCCINATE
US 7,811,254, product and use patent
patent.txt line 1,762- Flags
- product use code U-1083
- Product numbers
- 001
27 Aug 2027 · NDA 021641 · RASAGILINE MESYLATE
US 7,815,942, substance and product and use patent
patent.txt lines 654, 656- Flags
- substance product use code U-219
- Product numbers
- 001, 002
1 Sep 2027 · NDA 021829 · ROTIGOTINE
US 8,246,979, product and use patent
patent.txt lines 710, 715, 720, 725, 730, 735- Flags
- product use code U-1272
- Product numbers
- 001, 002, 003, 004, 005, 006
1 Sep 2027 · NDA 021829 · ROTIGOTINE
US 8,246,979, product and use patent
patent.txt lines 711, 716, 721, 726, 731, 736- Flags
- product use code U-1273
- Product numbers
- 001, 002, 003, 004, 005, 006
2 Sep 2027 · NDA 021361 · RIFAXIMIN
US 8,193,196, substance and product patent
patent.txt line 561- Flags
- substance product
- Product numbers
- 001
2 Sep 2027 · NDA 021361 · RIFAXIMIN
US 8,193,196, substance and product and use patent
patent.txt line 577- Flags
- substance product use code U-1707
- Product numbers
- 002
2 Sep 2027 · NDA 021361 · RIFAXIMIN
US 8,193,196, substance and product and use patent
patent.txt line 578- Flags
- substance product use code U-1708
- Product numbers
- 002
3 Sep 2027 · NDA 204417 · LEVETIRACETAM
US 8,163,306, product patent
patent.txt lines 4,676, 4,681- Flags
- product
- Product numbers
- 001, 002
5 Sep 2027 · NDA 022075 · ISTRADEFYLLINE
US 8,318,201, product patent
patent.txt lines 1,037, 1,039- Flags
- product
- Product numbers
- 001, 002
7 Sep 2027 · NDA 202278 · SUMATRIPTAN SUCCINATE
US 9,272,137, product patent
patent.txt line 2,972- Flags
- product
- Product numbers
- 001
8 Sep 2027 · NDA 208551 · FERRIC PYROPHOSPHATE CITRATE
US 7,857,977, use patent
patent.txt line 8,672- Flags
- use code U-1656
- Product numbers
- 001
8 Sep 2027 · NDA 208558 · OLAPARIB
US 7,449,464, substance and product patent
patent.txt lines 8,688, 8,745- Flags
- substance product
- Product numbers
- 001, 002
12 Sep 2027 · NDA 217785 · RESMETIROM
US 7,452,882, substance and product patent
patent.txt lines 20,377, 20,385, 20,392- Flags
- substance product
- Product numbers
- 001, 002, 003
13 Sep 2027 · NDA 207975 · HYDROCODONE BITARTRATE
US 9,216,176, product patent
patent.txt lines 7,875, 7,878, 7,881, 7,884, 7,887- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
13 Sep 2027 · NDA 207975 · HYDROCODONE BITARTRATE
US 9,572,803, product patent
patent.txt lines 7,876, 7,879, 7,882, 7,885, 7,888- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
13 Sep 2027 · NDA 217899 · SELADELPAR LYSINE
US 7,709,682, substance patent
patent.txt line 20,756- Flags
- substance
- Product numbers
- 001
14 Sep 2027 · NDA 207500 · ISAVUCONAZONIUM SULFATE
US 10,206,879, product patent
patent.txt lines 7,261, 7,267- Flags
- product
- Product numbers
- 001, 002
14 Sep 2027 · NDA 207500 · ISAVUCONAZONIUM SULFATE
US 10,603,280, product patent
patent.txt lines 7,263, 7,269- Flags
- product
- Product numbers
- 001, 002
14 Sep 2027 · NDA 209401 · CYTARABINE; DAUNORUBICIN
US 8,022,279, product and use patent
patent.txt line 10,336- Flags
- product use code U-3147
- Product numbers
- 001
15 Sep 2027 · NDA 219469 · ELINZANETANT
US 7,683,056, substance and product patent
patent.txt line 21,744- Flags
- substance product
- Product numbers
- 001
18 Sep 2027 · NDA 207071 · AZELAIC ACID
US 7,700,076, product patent
patent.txt line 7,006- Flags
- product
- Product numbers
- 001
20 Sep 2027 · NDA 021994 · TRAVOPROST
US 8,323,630, product patent
patent.txt line 888- Flags
- product
- Product numbers
- 001
20 Sep 2027 · NDA 021994 · TRAVOPROST
US 8,388,941, product patent
patent.txt line 889- Flags
- product
- Product numbers
- 001
22 Sep 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 8,026,284, use patent
patent.txt lines 3,814, 3,838- Flags
- use code U-1399
- Product numbers
- 001, 002
22 Sep 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 8,026,284, use patent
patent.txt lines 15,029, 15,053- Flags
- use code U-1399
- Product numbers
- 001, 002
25 Sep 2027 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,293,756, product patent
patent.txt lines 997, 1,011, 1,025- Flags
- product
- Product numbers
- 001, 002, 003
25 Sep 2027 · NDA 202057 · ICOSAPENT ETHYL
US 9,198,892, use patent
patent.txt lines 2,674, 2,736- Flags
- use code U-2706
- Product numbers
- 001, 002
26 Sep 2027 · NDA 021549 · APREPITANT
US 8,258,132, product and use patent
patent.txt lines 631, 633, 635- Flags
- product use code U-1743
- Product numbers
- 001, 002, 003
26 Sep 2027 · NDA 021549 · APREPITANT
US 8,258,132, product and use patent
patent.txt lines 632, 634, 636- Flags
- product use code U-901
- Product numbers
- 001, 002, 003
26 Sep 2027 · NDA 022434 · ARGATROBAN
US 7,589,106, product and use patent
patent.txt line 1,907- Flags
- product use code U-1163
- Product numbers
- 001
26 Sep 2027 · NDA 022434 · ARGATROBAN
US 7,687,516, product and use patent
patent.txt line 1,908- Flags
- product use code U-1164
- Product numbers
- 001
26 Sep 2027 · NDA 207865 · APREPITANT
US 8,258,132, product and use patent
patent.txt line 7,433- Flags
- product use code U-1916
- Product numbers
- 001
27 Sep 2027 · NDA 022504 · TESTOSTERONE
US 8,435,944, use patent
patent.txt line 2,008- Flags
- use code U-1390
- Product numbers
- 001
27 Sep 2027 · NDA 213422 · BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
US 10,265,265, product patent
patent.txt line 14,996- Flags
- product
- Product numbers
- 001
28 Sep 2027 · NDA 021529 · ETONOGESTREL
US 8,722,037, product patent
patent.txt line 625- Flags
- product
- Product numbers
- 002
29 Sep 2027 · NDA 209637 · SEMAGLUTIDE
US 9,457,154, product patent
patent.txt lines 10,696, 10,714, 10,731, 10,749- Flags
- product delist requested
- Product numbers
- 001, 002, 003, 004
2 Oct 2027 · NDA 021669 · CHLORHEXIDINE GLUCONATE
US 7,935,093, product and use patent
patent.txt line 674- Flags
- product use code U-1022
- Product numbers
- 001
3 Oct 2027 · NDA 208743 · ABALOPARATIDE
US 8,748,382, use patent
patent.txt line 9,299- Flags
- use code U-2009
- Product numbers
- 001
3 Oct 2027 · NDA 208743 · ABALOPARATIDE
US 8,748,382, use patent
patent.txt line 9,300- Flags
- use code U-3543
- Product numbers
- 001
3 Oct 2027 · NDA 210922 · PATISIRAN SODIUM
US 8,642,076, product patent
patent.txt line 12,401- Flags
- product
- Product numbers
- 001
4 Oct 2027 · NDA 206302 · NEBIVOLOL HYDROCHLORIDE; VALSARTAN
US 7,838,552, use patent
patent.txt line 6,458- Flags
- use code U-185
- Product numbers
- 001
5 Oct 2027 · NDA 204790 · DOLUTEGRAVIR SODIUM
US 8,129,385, substance and product patent
patent.txt lines 5,004, 5,008, 5,012- Flags
- substance product
- Product numbers
- 001, 002, 003
5 Oct 2027 · NDA 205551 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385, substance and product patent
patent.txt line 5,464- Flags
- substance product
- Product numbers
- 001
5 Oct 2027 · NDA 210192 · DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
US 8,129,385, substance and product patent
patent.txt line 11,207- Flags
- substance product
- Product numbers
- 001
5 Oct 2027 · NDA 211994 · DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385, substance and product patent
patent.txt line 13,377- Flags
- substance product
- Product numbers
- 001
5 Oct 2027 · NDA 213983 · DOLUTEGRAVIR SODIUM
US 8,129,385, substance and product patent
patent.txt line 15,419- Flags
- substance product
- Product numbers
- 001
5 Oct 2027 · NDA 215413 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385, substance and product patent
patent.txt line 16,886- Flags
- substance product
- Product numbers
- 001
10 Oct 2027 · NDA 212489 · OPICAPONE
US 9,745,290, product and use patent
patent.txt lines 14,095, 14,106- Flags
- product use code U-3869
- Product numbers
- 001, 002
12 Oct 2027 · NDA 205598 · MACIMORELIN ACETATE
US 8,192,719, use patent
patent.txt line 5,697- Flags
- use code U-2220
- Product numbers
- 001
13 Oct 2027 · NDA 213793 · SETMELANOTIDE ACETATE
US 9,458,195, substance and product patent
patent.txt line 15,272- Flags
- substance product
- Product numbers
- 001
16 Oct 2027 · NDA 209090 · LEVOCETIRIZINE DIHYDROCHLORIDE
US 8,633,194, product patent
patent.txt line 9,656- Flags
- product
- Product numbers
- 001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 8,563,613, product and use patent
patent.txt line 4,860- Flags
- product use code U-1488
- Product numbers
- 001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 8,871,809, use patent
patent.txt line 4,863- Flags
- use code U-1614
- Product numbers
- 001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,066,913, product and use patent
patent.txt line 4,864- Flags
- product use code U-1488
- Product numbers
- 001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,101,591, product and use patent
patent.txt line 4,865- Flags
- product use code U-1488
- Product numbers
- 001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,132,110, use patent
patent.txt line 4,866- Flags
- use code U-1488
- Product numbers
- 001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,168,304, product patent
patent.txt line 4,867- Flags
- product
- Product numbers
- 001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,168,305, use patent
patent.txt line 4,868- Flags
- use code U-1488
- Product numbers
- 001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,220,784, use patent
patent.txt line 4,869- Flags
- use code U-1488
- Product numbers
- 001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,339,551, use patent
patent.txt line 4,870- Flags
- use code U-1488
- Product numbers
- 001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,339,552, product and use patent
patent.txt line 4,871- Flags
- product use code U-1488
- Product numbers
- 001
17 Oct 2027 · NDA 204623 · DICLOFENAC SODIUM
US 9,539,335, use patent
patent.txt line 4,875- Flags
- use code U-1614
- Product numbers
- 001
17 Oct 2027 · NDA 213716 · VOCLOSPORIN
US 7,332,472, substance and product and use patent
patent.txt line 15,214- Flags
- substance product use code U-3056
- Product numbers
- 001
18 Oct 2027 · NDA 207071 · AZELAIC ACID
US 10,117,812, product and use patent
patent.txt line 7,005- Flags
- product use code U-1796
- Product numbers
- 001
25 Oct 2027 · NDA 021908 · LUBIPROSTONE
US 8,026,393, product patent
patent.txt lines 767, 770- Flags
- product
- Product numbers
- 001, 002
27 Oct 2027 · NDA 206256 · BELINOSTAT
US 8,835,501, product patent
patent.txt line 6,454- Flags
- product
- Product numbers
- 001
31 Oct 2027 · NDA 204417 · LEVETIRACETAM
US 8,431,156, product patent
patent.txt lines 4,678, 4,683- Flags
- product
- Product numbers
- 001, 002
31 Oct 2027 · NDA 204417 · LEVETIRACETAM
US 8,470,367, product patent
patent.txt lines 4,679, 4,684- Flags
- product
- Product numbers
- 001, 002
2 Nov 2027 · NDA 022192 · ILOPERIDONE
US 8,586,610, use patent
patent.txt lines 1,149, 1,163, 1,177, 1,191, 1,205, 1,219, 1,233- Flags
- use code U-1625
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
3 Nov 2027 · NDA 214965 · CYCLOSPORINE
US 8,298,568, product patent
patent.txt line 16,398- Flags
- product
- Product numbers
- 001
7 Nov 2027 · NDA 214793 · PIFLUFOLASTAT F-18
US 8,487,129, substance and product patent
patent.txt line 16,195- Flags
- substance product
- Product numbers
- 001
7 Nov 2027 · NDA 220089 · PIFLUFOLASTAT F-18
US 8,487,129, substance and product patent
patent.txt line 22,094- Flags
- substance product
- Product numbers
- 001
8 Nov 2027 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 10,307,376, use patent
patent.txt line 2,198- Flags
- use code U-1585
- Product numbers
- 001
8 Nov 2027 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 12,048,769, use patent
patent.txt line 2,206- Flags
- use code U-1585
- Product numbers
- 001
8 Nov 2027 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 8,318,788, use patent
patent.txt line 2,208- Flags
- use code U-1584
- Product numbers
- 001
8 Nov 2027 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 8,722,085, use patent
patent.txt line 2,209- Flags
- use code U-1585
- Product numbers
- 001
8 Nov 2027 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
US 9,125,868, use patent
patent.txt line 2,212- Flags
- use code U-1585
- Product numbers
- 001
8 Nov 2027 · NDA 208743 · ABALOPARATIDE
US 8,148,333, product patent
patent.txt line 9,298- Flags
- product
- Product numbers
- 001
8 Nov 2027 · NDA 209241 · VALBENAZINE TOSYLATE
US 8,357,697, use patent
patent.txt lines 9,953, 9,986, 10,019- Flags
- use code U-1995
- Product numbers
- 001, 002, 003
8 Nov 2027 · NDA 209241 · VALBENAZINE TOSYLATE
US 8,357,697, use patent
patent.txt lines 9,954, 9,987, 10,020- Flags
- use code U-3055
- Product numbers
- 001, 002, 003
8 Nov 2027 · NDA 218390 · VALBENAZINE TOSYLATE
US 8,357,697, use patent
patent.txt lines 21,011, 21,044, 21,077- Flags
- use code U-1995
- Product numbers
- 001, 002, 003
8 Nov 2027 · NDA 218390 · VALBENAZINE TOSYLATE
US 8,357,697, use patent
patent.txt lines 21,012, 21,045, 21,078- Flags
- use code U-3055
- Product numbers
- 001, 002, 003
11 Nov 2027 · NDA 202258 · BOCEPREVIR
US 7,772,178, product and use patent
patent.txt line 2,958- Flags
- product use code U-1128
- Product numbers
- 001
12 Nov 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
US 8,415,387, use patent
patent.txt lines 11,436, 11,468- Flags
- use code U-2246
- Product numbers
- 001, 002
12 Nov 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,415,387, use patent
patent.txt line 13,706- Flags
- use code U-3028
- Product numbers
- 001
12 Nov 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,415,387, use patent
patent.txt lines 13,707, 13,776- Flags
- use code U-3144
- Product numbers
- 001, 002
12 Nov 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,415,387, use patent
patent.txt lines 13,708, 13,777- Flags
- use code U-4073
- Product numbers
- 001, 002
12 Nov 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,415,387, use patent
patent.txt lines 13,709, 13,778- Flags
- use code U-4475
- Product numbers
- 001, 002
12 Nov 2027 · NDA 213586 · RISPERIDONE
US 8,221,778, product and use patent
patent.txt lines 15,093, 15,102, 15,111- Flags
- product use code U-601
- Product numbers
- 001, 002, 003
12 Nov 2027 · NDA 213586 · RISPERIDONE
US 8,221,778, product and use patent
patent.txt lines 15,092, 15,101, 15,110, 15,117, 15,123, 15,129, 15,135- Flags
- product use code U-543
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
12 Nov 2027 · NDA 213586 · RISPERIDONE
US 8,741,327, product and use patent
patent.txt lines 15,094, 15,103, 15,112, 15,118, 15,124, 15,130, 15,136- Flags
- product use code U-543
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 10,017,536, substance and use patent
patent.txt line 16,325- Flags
- substance use code U-3204
- Product numbers
- 001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 10,138,270, use patent
patent.txt line 16,326- Flags
- use code U-3204
- Product numbers
- 001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 10,793,596, substance and product and use patent
patent.txt line 16,327- Flags
- substance product use code U-3204
- Product numbers
- 001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 7,713,937, substance and product and use patent
patent.txt line 16,329- Flags
- substance product use code U-3204
- Product numbers
- 001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 7,727,963, substance and product and use patent
patent.txt line 16,330- Flags
- substance product use code U-3204
- Product numbers
- 001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 8,217,007, use patent
patent.txt line 16,331- Flags
- use code U-3204
- Product numbers
- 001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 8,236,766, use patent
patent.txt line 16,332- Flags
- use code U-3204
- Product numbers
- 001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 8,486,894, use patent
patent.txt line 16,333- Flags
- use code U-3204
- Product numbers
- 001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 8,536,131, substance and product and use patent
patent.txt line 16,334- Flags
- substance product use code U-3204
- Product numbers
- 001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 9,334,305, use patent
patent.txt line 16,335- Flags
- use code U-3204
- Product numbers
- 001
12 Nov 2027 · NDA 214916 · DIFELIKEFALIN ACETATE
US 9,359,399, use patent
patent.txt line 16,336- Flags
- use code U-3204
- Product numbers
- 001
12 Nov 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,415,387, use patent
patent.txt lines 20,116, 20,191- Flags
- use code U-3589
- Product numbers
- 001, 002
12 Nov 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,415,387, use patent
patent.txt lines 20,117, 20,192- Flags
- use code U-4066
- Product numbers
- 001, 002
12 Nov 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
US 8,415,387, use patent
patent.txt lines 20,118, 20,193- Flags
- use code U-4476
- Product numbers
- 001, 002
12 Nov 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 8,415,387, use patent
patent.txt lines 21,209, 21,259- Flags
- use code U-4082
- Product numbers
- 001, 002
12 Nov 2027 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
US 8,415,387, use patent
patent.txt lines 21,210, 21,260- Flags
- use code U-4463
- Product numbers
- 001, 002
13 Nov 2027 · NDA 205552 · IBRUTINIB
US 8,008,309, substance and product patent
patent.txt lines 5,510, 5,607- Flags
- substance product
- Product numbers
- 001, 002
13 Nov 2027 · NDA 210563 · IBRUTINIB
US 8,008,309, substance and product patent
patent.txt lines 11,633, 11,737, 11,841, 11,943- Flags
- substance product
- Product numbers
- 001, 002, 003, 004
13 Nov 2027 · NDA 217003 · IBRUTINIB
US 8,008,309, substance and product patent
patent.txt line 19,181- Flags
- substance product
- Product numbers
- 001
13 Nov 2027 · NDA 217347 · SOFPIRONIUM BROMIDE
US 8,628,759, use patent
patent.txt line 19,862- Flags
- use code U-2398
- Product numbers
- 001
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 10,314,790, product and use patent
patent.txt lines 2,441, 2,461, 2,481, 2,501- Flags
- product use code U-1675
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 10,314,790, product and use patent
patent.txt lines 2,442, 2,462, 2,482, 2,502- Flags
- product use code U-1992
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,298,580, product and use patent
patent.txt lines 2,445, 2,465, 2,485, 2,505- Flags
- product use code U-106
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,298,580, product and use patent
patent.txt lines 2,446, 2,466, 2,486, 2,506- Flags
- product use code U-1992
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,663,683, product and use patent
patent.txt lines 2,447, 2,467, 2,487, 2,507- Flags
- product use code U-106
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,663,683, product and use patent
patent.txt lines 2,448, 2,468, 2,488, 2,508- Flags
- product use code U-1992
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,877,248, product and use patent
patent.txt lines 2,449, 2,469, 2,489, 2,509- Flags
- product use code U-106
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,877,248, product and use patent
patent.txt lines 2,450, 2,470, 2,490, 2,510- Flags
- product use code U-1992
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,889,191, use patent
patent.txt lines 2,451, 2,471, 2,491, 2,511- Flags
- use code U-106
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,889,191, use patent
patent.txt lines 2,452, 2,472, 2,492, 2,512- Flags
- use code U-1992
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,992,989, product and use patent
patent.txt lines 2,453, 2,473, 2,493, 2,513- Flags
- product use code U-1675
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 8,992,989, product and use patent
patent.txt lines 2,454, 2,474, 2,494, 2,514- Flags
- product use code U-1992
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,549,940, product and use patent
patent.txt lines 2,455, 2,475, 2,495, 2,515- Flags
- product use code U-1675
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,549,940, product and use patent
patent.txt lines 2,456, 2,476, 2,496, 2,516- Flags
- product use code U-1992
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,555,004, product and use patent
patent.txt lines 2,457, 2,477, 2,497, 2,517- Flags
- product use code U-1675
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,555,004, product and use patent
patent.txt lines 2,458, 2,478, 2,498, 2,518- Flags
- product use code U-1992
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,622,983, product and use patent
patent.txt lines 2,459, 2,479, 2,499, 2,519- Flags
- product use code U-1675
- Product numbers
- 001, 002, 003, 004
16 Nov 2027 · NDA 201635 · TOPIRAMATE
US 9,622,983, product and use patent
patent.txt lines 2,460, 2,480, 2,500, 2,520- Flags
- product use code U-1992
- Product numbers
- 001, 002, 003, 004
18 Nov 2027 · NDA 215014 · PEGCETACOPLAN
US 9,169,307, substance and use patent
patent.txt line 16,442- Flags
- substance use code U-3123
- Product numbers
- 001
18 Nov 2027 · NDA 215014 · PEGCETACOPLAN
US 9,169,307, substance and use patent
patent.txt line 16,443- Flags
- substance use code U-4244
- Product numbers
- 001
18 Nov 2027 · NDA 217171 · PEGCETACOPLAN
US 9,169,307, substance and use patent
patent.txt line 19,288- Flags
- substance use code U-3541
- Product numbers
- 001
19 Nov 2027 · NDA 205098 · POLIDOCANOL
US 7,814,943, product and use patent
patent.txt line 5,201- Flags
- product use code U-1461
- Product numbers
- 001
19 Nov 2027 · NDA 207202 · ARIPIPRAZOLE
US 9,444,503, product and use patent
patent.txt lines 7,087, 7,114, 7,141, 7,168, 7,195, 7,222- Flags
- product use code U-2169
- Product numbers
- 001, 002, 003, 004, 005, 006
19 Nov 2027 · NDA 212950 · FOSTEMSAVIR TROMETHAMINE
US 7,745,625, substance patent
patent.txt line 14,513- Flags
- substance
- Product numbers
- 001
19 Nov 2027 · NDA 213591 · CAPMATINIB HYDROCHLORIDE
US 12,084,449, use patent
patent.txt lines 15,139, 15,146- Flags
- use code U-2813
- Product numbers
- 001, 002
19 Nov 2027 · NDA 213591 · CAPMATINIB HYDROCHLORIDE
US 8,461,330, substance and product patent
patent.txt lines 15,143, 15,150- Flags
- substance product
- Product numbers
- 001, 002
20 Nov 2027 · NDA 205755 · CERITINIB
US 8,377,921, use patent
patent.txt line 5,855- Flags
- use code U-1179
- Product numbers
- 001
20 Nov 2027 · NDA 205755 · CERITINIB
US 8,399,450, substance and product patent
patent.txt line 5,856- Flags
- substance product
- Product numbers
- 001
20 Nov 2027 · NDA 211225 · CERITINIB
US 8,377,921, use patent
patent.txt line 12,551- Flags
- use code U-1179
- Product numbers
- 001
20 Nov 2027 · NDA 211225 · CERITINIB
US 8,399,450, substance and product patent
patent.txt line 12,552- Flags
- substance product
- Product numbers
- 001
21 Nov 2027 · NDA 211810 · PEXIDARTINIB HYDROCHLORIDE
US 8,404,700, substance patent
patent.txt lines 13,195, 13,207- Flags
- substance
- Product numbers
- 001, 002
21 Nov 2027 · NDA 211810 · PEXIDARTINIB HYDROCHLORIDE
US 8,722,702, substance patent
patent.txt lines 13,197, 13,209- Flags
- substance
- Product numbers
- 001, 002
21 Nov 2027 · NDA 211810 · PEXIDARTINIB HYDROCHLORIDE
US 9,169,250, substance patent
patent.txt lines 13,198, 13,210- Flags
- substance
- Product numbers
- 001, 002
3 Dec 2027 · NDA 204042 · CANAGLIFLOZIN
US 8,513,202, substance and product and use patent
patent.txt lines 4,239, 4,249- Flags
- substance product use code U-2441
- Product numbers
- 001, 002
3 Dec 2027 · NDA 204042 · CANAGLIFLOZIN
US 8,513,202, substance and product and use patent
patent.txt lines 4,240, 4,250- Flags
- substance product use code U-2632
- Product numbers
- 001, 002
3 Dec 2027 · NDA 204042 · CANAGLIFLOZIN
US 8,513,202, substance and product and use patent
patent.txt lines 4,241, 4,251- Flags
- substance product use code U-493
- Product numbers
- 001, 002
3 Dec 2027 · NDA 204242 · BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
US 8,658,198, product and use patent
patent.txt lines 4,376, 4,386, 4,395, 4,404, 4,413, 4,420- Flags
- product use code U-1494
- Product numbers
- 001, 002, 003, 004, 005, 006
3 Dec 2027 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 4,514, 4,525, 4,536, 4,547- Flags
- substance product use code U-2441
- Product numbers
- 001, 002, 003, 004
3 Dec 2027 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 4,515, 4,526, 4,537, 4,548- Flags
- substance product use code U-2632
- Product numbers
- 001, 002, 003, 004
3 Dec 2027 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 4,516, 4,527, 4,538, 4,549- Flags
- substance product use code U-493
- Product numbers
- 001, 002, 003, 004
3 Dec 2027 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 6,006, 6,016, 6,026, 6,036- Flags
- substance product use code U-2441
- Product numbers
- 001, 002, 003, 004
3 Dec 2027 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 6,007, 6,017, 6,027, 6,037- Flags
- substance product use code U-2632
- Product numbers
- 001, 002, 003, 004
3 Dec 2027 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202, substance and product and use patent
patent.txt lines 6,008, 6,018, 6,028, 6,038- Flags
- substance product use code U-493
- Product numbers
- 001, 002, 003, 004
3 Dec 2027 · NDA 216165 · CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
US 7,687,488, substance and product and use patent
patent.txt line 18,411- Flags
- substance product use code U-3851
- Product numbers
- 001
4 Dec 2027 · NDA 215014 · PEGCETACOPLAN
US 7,888,323, substance patent
patent.txt line 16,440- Flags
- substance
- Product numbers
- 001
4 Dec 2027 · NDA 215014 · PEGCETACOPLAN
US 7,989,589, substance patent
patent.txt line 16,441- Flags
- substance
- Product numbers
- 001
4 Dec 2027 · NDA 217171 · PEGCETACOPLAN
US 7,888,323, substance patent
patent.txt line 19,283- Flags
- substance
- Product numbers
- 001
4 Dec 2027 · NDA 217171 · PEGCETACOPLAN
US 7,989,589, substance patent
patent.txt line 19,284- Flags
- substance
- Product numbers
- 001
7 Dec 2027 · NDA 202714 · CARFILZOMIB
US 7,737,112, product patent
patent.txt lines 3,141, 3,151, 3,161- Flags
- product
- Product numbers
- 001, 002, 003
8 Dec 2027 · NDA 207071 · AZELAIC ACID
US 9,265,725, product patent
patent.txt line 7,008- Flags
- product
- Product numbers
- 001
10 Dec 2027 · NDA 206333 · DEOXYCHOLIC ACID
US 7,622,130, use patent
patent.txt line 6,478- Flags
- use code U-1690
- Product numbers
- 001
10 Dec 2027 · NDA 206333 · DEOXYCHOLIC ACID
US 7,754,230, use patent
patent.txt line 6,479- Flags
- use code U-1690
- Product numbers
- 001
11 Dec 2027 · NDA 022081 · AMBRISENTAN
US 8,377,933, use patent
patent.txt lines 1,040, 1,043- Flags
- use code U-1754
- Product numbers
- 001, 002
11 Dec 2027 · NDA 022081 · AMBRISENTAN
US 9,474,752, use patent
patent.txt lines 1,041, 1,044- Flags
- use code U-1754
- Product numbers
- 001, 002
11 Dec 2027 · NDA 022257 · VALGANCICLOVIR HYDROCHLORIDE
US 8,889,109, product patent
patent.txt line 1,413- Flags
- product
- Product numbers
- 001
11 Dec 2027 · NDA 022257 · VALGANCICLOVIR HYDROCHLORIDE
US 9,642,911, product patent
patent.txt line 1,414- Flags
- product
- Product numbers
- 001
11 Dec 2027 · NDA 208794 · TELOTRISTAT ETIPRATE
US 7,553,840, substance patent
patent.txt line 9,458- Flags
- substance
- Product numbers
- 001
11 Dec 2027 · NDA 208794 · TELOTRISTAT ETIPRATE
US 7,968,559, use patent
patent.txt line 9,460- Flags
- use code U-1979
- Product numbers
- 001
12 Dec 2027 · NDA 022321 · MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
US 7,815,934, product patent
patent.txt lines 1,651, 1,658, 1,665, 1,672, 1,679, 1,686- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006
12 Dec 2027 · NDA 207621 · NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
US 7,815,934, product patent
patent.txt lines 7,399–7,404- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006
18 Dec 2027 · NDA 022535 · PIRFENIDONE
US 7,696,236, use patent
patent.txt line 2,059- Flags
- use code U-1601
- Product numbers
- 001
18 Dec 2027 · NDA 022535 · PIRFENIDONE
US 7,767,700, use patent
patent.txt line 2,061- Flags
- use code U-1601
- Product numbers
- 001
18 Dec 2027 · NDA 022535 · PIRFENIDONE
US 8,420,674, product and use patent
patent.txt line 2,069- Flags
- product use code U-1608
- Product numbers
- 001
18 Dec 2027 · NDA 203975 · UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 7,488,827, substance and product patent
patent.txt line 4,189- Flags
- substance product
- Product numbers
- 001
18 Dec 2027 · NDA 205382 · UMECLIDINIUM BROMIDE
US 7,488,827, substance and product patent
patent.txt line 5,287- Flags
- substance product
- Product numbers
- 001
18 Dec 2027 · NDA 208780 · PIRFENIDONE
US 7,767,700, use patent
patent.txt lines 9,336, 9,379, 9,422- Flags
- use code U-2080
- Product numbers
- 001, 002, 003
18 Dec 2027 · NDA 208780 · PIRFENIDONE
US 8,420,674, use patent
patent.txt lines 9,348, 9,391, 9,434- Flags
- use code U-2079
- Product numbers
- 001, 002, 003
18 Dec 2027 · NDA 209482 · FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 7,488,827, substance and product patent
patent.txt lines 10,407, 10,414- Flags
- substance product
- Product numbers
- 001, 002
19 Dec 2027 · NDA 050805 · DOXYCYCLINE
US 7,749,532, product and use patent
patent.txt line 2,159- Flags
- product use code U-1063
- Product numbers
- 001
19 Dec 2027 · NDA 050818 · DEXAMETHASONE; TOBRAMYCIN
US 8,101,582, product and use patent
patent.txt line 2,176- Flags
- product use code U-1082
- Product numbers
- 001
19 Dec 2027 · NDA 050818 · DEXAMETHASONE; TOBRAMYCIN
US 8,450,287, product patent
patent.txt line 2,177- Flags
- product
- Product numbers
- 001
19 Dec 2027 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 10,398,859, product patent
patent.txt line 6,277- Flags
- product
- Product numbers
- 001
23 Dec 2027 · NDA 022134 · ALCAFTADINE
US 8,664,215, use patent
patent.txt line 1,112- Flags
- use code U-3267
- Product numbers
- 001
23 Dec 2027 · NDA 204886 · VORAPAXAR SULFATE
US 7,304,078, substance and product and use patent
patent.txt line 5,181- Flags
- substance product use code U-1512
- Product numbers
- 001
24 Dec 2027 · NDA 021923 · SORAFENIB TOSYLATE
US 8,877,933, substance and product and use patent
patent.txt line 781- Flags
- substance product use code U-1624
- Product numbers
- 001
24 Dec 2027 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 7,598,257, substance and product and use patent
patent.txt lines 2,805, 2,834, 2,863, 2,892, 2,921- Flags
- substance product use code U-3227
- Product numbers
- 001, 002, 003, 004, 005
24 Dec 2027 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 7,598,257, substance and product and use patent
patent.txt lines 2,806, 2,835, 2,864, 2,893, 2,922- Flags
- substance product use code U-3228
- Product numbers
- 001, 002, 003, 004, 005
24 Dec 2027 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,415,362, substance and product patent
patent.txt lines 2,808, 2,837, 2,866, 2,895, 2,924- Flags
- substance product
- Product numbers
- 001, 002, 003, 004, 005
24 Dec 2027 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 7,598,257, substance and product patent
patent.txt line 16,757- Flags
- substance product
- Product numbers
- 001
24 Dec 2027 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,415,362, substance and product patent
patent.txt line 16,759- Flags
- substance product
- Product numbers
- 001
24 Dec 2027 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 7,598,257, substance and product and use patent
patent.txt lines 19,319, 19,372, 19,425, 19,478, 19,531- Flags
- substance product use code U-3227
- Product numbers
- 001, 002, 003, 004, 005
24 Dec 2027 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 7,598,257, substance and product and use patent
patent.txt lines 19,320, 19,373, 19,426, 19,479, 19,532- Flags
- substance product use code U-3228
- Product numbers
- 001, 002, 003, 004, 005
24 Dec 2027 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,415,362, substance and product patent
patent.txt lines 19,322, 19,375, 19,428, 19,481, 19,534- Flags
- substance product
- Product numbers
- 001, 002, 003, 004, 005
25 Dec 2027 · NDA 022527 · FINGOLIMOD HYDROCHLORIDE
US 10,543,179, use patent
patent.txt line 2,049- Flags
- use code U-2719
- Product numbers
- 001
26 Dec 2027 · NDA 019734 · NICARDIPINE HYDROCHLORIDE
US 7,612,102, product patent
patent.txt lines 160, 166, 172, 176- Flags
- product
- Product numbers
- 002, 003, 004, 005
26 Dec 2027 · NDA 019734 · NICARDIPINE HYDROCHLORIDE
US 9,364,564, product patent
patent.txt lines 163, 169, 175, 179- Flags
- product
- Product numbers
- 002, 003, 004, 005
28 Dec 2027 · NDA 209279 · BOSENTAN
US 7,959,945, product patent
patent.txt line 10,023- Flags
- product
- Product numbers
- 001
28 Dec 2027 · NDA 213189 · TIRBANIBULIN
US 10,323,001, product patent
patent.txt line 14,720- Flags
- product
- Product numbers
- 001
29 Dec 2027 · NDA 214012 · INCLISIRAN SODIUM
US 8,222,222, use patent
patent.txt line 15,439- Flags
- use code U-4249
- Product numbers
- 001
29 Dec 2027 · NDA 214012 · INCLISIRAN SODIUM
US 8,222,222, use patent
patent.txt line 15,440- Flags
- use code U-4413
- Product numbers
- 001
29 Dec 2027 · NDA 214012 · INCLISIRAN SODIUM
US 8,222,222, use patent
patent.txt line 15,441- Flags
- use code U-4414
- Product numbers
- 001
Pediatric exclusivity, as listed (61)
8 Jul 2027 · NDA 201532 · ERIBULIN MESYLATE
US RE46965 with pediatric exclusivity, as listed
patent.txt line 2,439- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
23 Jul 2027 · NDA 209401 · CYTARABINE; DAUNORUBICIN
US 7,850,990 with pediatric exclusivity, as listed
patent.txt line 10,333- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
23 Jul 2027 · NDA 209401 · CYTARABINE; DAUNORUBICIN
US 9,271,931 with pediatric exclusivity, as listed
patent.txt line 10,340- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
26 Jul 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,192,590 with pediatric exclusivity, as listed
patent.txt lines 3,817, 3,841- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 Jul 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,198,882 with pediatric exclusivity, as listed
patent.txt lines 3,819, 3,843- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 Jul 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,925,156 with pediatric exclusivity, as listed
patent.txt lines 3,823, 3,847- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 Jul 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,925,157 with pediatric exclusivity, as listed
patent.txt lines 3,825, 3,849- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 Jul 2027 · NDA 203389 · CYSTEAMINE BITARTRATE
US 9,925,158 with pediatric exclusivity, as listed
patent.txt lines 3,827, 3,851- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 Jul 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,192,590 with pediatric exclusivity, as listed
patent.txt lines 15,032, 15,056- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 Jul 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,198,882 with pediatric exclusivity, as listed
patent.txt lines 15,034, 15,058- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 Jul 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,925,156 with pediatric exclusivity, as listed
patent.txt lines 15,038, 15,062- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 Jul 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,925,157 with pediatric exclusivity, as listed
patent.txt lines 15,040, 15,064- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 Jul 2027 · NDA 213491 · CYSTEAMINE BITARTRATE
US 9,925,158 with pediatric exclusivity, as listed
patent.txt lines 15,042, 15,066- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
16 Aug 2027 · NDA 207695 · CRISABOROLE
US 8,501,712 with pediatric exclusivity, as listed
patent.txt line 7,409- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
16 Aug 2027 · NDA 207695 · CRISABOROLE
US 9,682,092 with pediatric exclusivity, as listed
patent.txt line 7,411- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
4 Sep 2027 · NDA 201699 · FIDAXOMICIN
US 7,906,489 with pediatric exclusivity, as listed
patent.txt line 2,554- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
4 Sep 2027 · NDA 213138 · FIDAXOMICIN
US 7,906,489 with pediatric exclusivity, as listed
patent.txt line 14,696- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
5 Sep 2027 · NDA 207103 · PALBOCICLIB
US RE47739 with pediatric exclusivity, as listed
patent.txt lines 7,038, 7,042, 7,046- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
5 Sep 2027 · NDA 212436 · PALBOCICLIB
US RE47739 with pediatric exclusivity, as listed
patent.txt lines 13,970, 13,976, 13,982- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
30 Sep 2027 · NDA 021936 · TIOTROPIUM BROMIDE
US 9,027,967 with pediatric exclusivity, as listed
patent.txt line 814- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
15 Oct 2027 · NDA 204629 · EMPAGLIFLOZIN
US 7,713,938 with pediatric exclusivity, as listed
patent.txt lines 4,901, 4,932- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
15 Oct 2027 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 7,713,938 with pediatric exclusivity, as listed
patent.txt lines 6,195, 6,227- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
15 Oct 2027 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,713,938 with pediatric exclusivity, as listed
patent.txt lines 6,316, 6,347, 6,376, 6,405- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
15 Oct 2027 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,713,938 with pediatric exclusivity, as listed
patent.txt lines 9,061, 9,093, 9,123, 9,153- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
15 Oct 2027 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 7,713,938 with pediatric exclusivity, as listed
patent.txt lines 14,245, 14,275, 14,305, 14,334- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
26 Oct 2027 · NDA 205552 · IBRUTINIB
US 8,563,563 with pediatric exclusivity, as listed
patent.txt lines 5,521, 5,618- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 Oct 2027 · NDA 210563 · IBRUTINIB
US 8,563,563 with pediatric exclusivity, as listed
patent.txt lines 11,645, 11,749, 11,853, 11,958- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
4 Nov 2027 · NDA 201280 · LINAGLIPTIN
US 11,033,552 with pediatric exclusivity, as listed
patent.txt line 2,328- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
4 Nov 2027 · NDA 201280 · LINAGLIPTIN
US 8,673,927 with pediatric exclusivity, as listed
patent.txt line 2,334- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
4 Nov 2027 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,673,927 with pediatric exclusivity, as listed
patent.txt lines 2,352, 2,370, 2,388- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
4 Nov 2027 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 11,033,552 with pediatric exclusivity, as listed
patent.txt lines 6,175, 6,207- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
4 Nov 2027 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 8,673,927 with pediatric exclusivity, as listed
patent.txt lines 6,199, 6,231- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
4 Nov 2027 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,673,927 with pediatric exclusivity, as listed
patent.txt lines 7,978, 7,997- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
4 Nov 2027 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 9,173,859 with pediatric exclusivity, as listed
patent.txt lines 7,984, 8,003- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
20 Nov 2027 · NDA 203188 · IVACAFTOR
US 7,495,103 with pediatric exclusivity, as listed
patent.txt line 3,657- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
20 Nov 2027 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 7,495,103 with pediatric exclusivity, as listed
patent.txt lines 6,093, 6,141- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
20 Nov 2027 · NDA 207925 · IVACAFTOR
US 7,495,103 with pediatric exclusivity, as listed
patent.txt lines 7,505, 7,538, 7,571, 7,604, 7,632- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
20 Nov 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 7,495,103 with pediatric exclusivity, as listed
patent.txt lines 12,725, 12,767, 12,809- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
24 Nov 2027 · NDA 021528 · KETOROLAC TROMETHAMINE
US 8,008,338 with pediatric exclusivity, as listed
patent.txt line 621- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
27 Nov 2027 · NDA 207620 · SACUBITRIL; VALSARTAN
US 8,877,938 with pediatric exclusivity, as listed
patent.txt lines 7,377, 7,385, 7,393- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
29 Nov 2027 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
US 7,378,423 with pediatric exclusivity, as listed
patent.txt lines 4,273, 4,293, 4,313- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
29 Nov 2027 · NDA 204410 · MACITENTAN
US 9,265,762 with pediatric exclusivity, as listed
patent.txt line 4,674- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
29 Nov 2027 · NDA 217513 · TRAMETINIB DIMETHYL SULFOXIDE
US 7,378,423 with pediatric exclusivity, as listed
patent.txt line 19,988- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
7 Dec 2027 · NDA 022030 · FESOTERODINE FUMARATE
US 7,807,715 with pediatric exclusivity, as listed
patent.txt lines 920, 926- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
7 Dec 2027 · NDA 022030 · FESOTERODINE FUMARATE
US 8,088,398 with pediatric exclusivity, as listed
patent.txt lines 922, 928- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
7 Dec 2027 · NDA 022030 · FESOTERODINE FUMARATE
US 8,501,723 with pediatric exclusivity, as listed
patent.txt lines 924, 930- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
14 Dec 2027 · NDA 203975 · UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
US 8,511,304 with pediatric exclusivity, as listed
patent.txt line 4,190- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
14 Dec 2027 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
US 8,511,304 with pediatric exclusivity, as listed
patent.txt lines 4,429, 4,440, 4,449- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 11,458,134 with pediatric exclusivity, as listed
patent.txt lines 4,696, 4,716, 4,736, 4,756- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 8,969,355 with pediatric exclusivity, as listed
patent.txt lines 4,702, 4,722, 4,742, 4,762- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,125,908 with pediatric exclusivity, as listed
patent.txt lines 4,704, 4,724, 4,744, 4,764- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,125,909 with pediatric exclusivity, as listed
patent.txt lines 4,706, 4,726, 4,746, 4,766- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,125,910 with pediatric exclusivity, as listed
patent.txt lines 4,708, 4,728, 4,748, 4,768- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,227,946 with pediatric exclusivity, as listed
patent.txt lines 4,710, 4,730, 4,750, 4,770- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
15 Dec 2027 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 9,861,630 with pediatric exclusivity, as listed
patent.txt lines 4,714, 4,734, 4,754, 4,774- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
20 Dec 2027 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,501,698 with pediatric exclusivity, as listed
patent.txt lines 1,257, 1,293- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
20 Dec 2027 · NDA 202293 · DAPAGLIFLOZIN
US 8,501,698 with pediatric exclusivity, as listed
patent.txt lines 2,993, 3,031- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
20 Dec 2027 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,501,698 with pediatric exclusivity, as listed
patent.txt lines 5,714, 5,724, 5,734, 5,744, 5,754- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
20 Dec 2027 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,501,698 with pediatric exclusivity, as listed
patent.txt lines 9,667, 9,681- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
20 Dec 2027 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,501,698 with pediatric exclusivity, as listed
patent.txt line 9,890- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
20 Dec 2027 · NDA 210874 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
US 8,501,698 with pediatric exclusivity, as listed
patent.txt lines 12,278, 12,288, 12,298, 12,308- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
Non-patent exclusivity (113)
1 Jul 2027 · NDA 205109 · FERRIC OXYHYDROXIDE
NPP exclusivity
exclusivity.txt line 448- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001
7 Jul 2027 · NDA 212576 · CEDAZURIDINE; DECITABINE
ODE-316 exclusivity
exclusivity.txt line 1,086- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
8 Jul 2027 · NDA 216264 · INDIGOTINDISULFONATE SODIUM
NCE exclusivity
exclusivity.txt line 1,747- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
9 Jul 2027 · NDA 215985 · ROFLUMILAST
NS exclusivity
exclusivity.txt line 1,684- Definition
- New strength (to be checked against FDA's list)
- Product numbers
- 002
17 Jul 2027 · NDA 215151 · VONOPRAZAN FUMARATE
I-948 exclusivity
exclusivity.txt line 1,477- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
21 Jul 2027 · NDA 212690 · CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
ODE-361 exclusivity
exclusivity.txt line 1,103- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
22 Jul 2027 · NDA 218718 · ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
NP exclusivity
exclusivity.txt line 2,178- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
31 Jul 2027 · NDA 210365 · CANNABIDIOL
ODE-326 exclusivity
exclusivity.txt line 874- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
31 Jul 2027 · NDA 210365 · CANNABIDIOL
ODE-332 exclusivity
exclusivity.txt line 875- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
5 Aug 2027 · NDA 022372 · MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
ODE-315 exclusivity
exclusivity.txt line 197- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
6 Aug 2027 · NDA 213464 · NIFURTIMOX
ODE-319 exclusivity
exclusivity.txt lines 1,224–1,225- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
7 Aug 2027 · NDA 213535 · RISDIPLAM
ODE-334 exclusivity
exclusivity.txt line 1,230- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
7 Aug 2027 · NDA 217186 · CARBIDOPA; LEVODOPA
NP exclusivity
exclusivity.txt lines 1,854–1,857- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
7 Aug 2027 · NDA 218276 · IPTACOPAN HYDROCHLORIDE
I-949 exclusivity
exclusivity.txt line 2,137- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
7 Aug 2027 · NDA 218590 · NALMEFENE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 2,170- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
12 Aug 2027 · NDA 020988 · PANTOPRAZOLE SODIUM
NPP exclusivity
exclusivity.txt line 112- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001
12 Aug 2027 · NDA 212154 · VILTOLARSEN
ODE-280 exclusivity
exclusivity.txt line 1,026- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
28 Aug 2027 · NDA 214787 · REMDESIVIR
PED exclusivity
exclusivity.txt lines 1,395, 1,401- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
29 Aug 2027 · NDA 209776 · MEROPENEM; VABORBACTAM
GAIN exclusivity
exclusivity.txt line 801- Definition
- Generating Antibiotic Incentives Now (to be checked against FDA's list)
- Product numbers
- 001
30 Aug 2027 · NDA 209899 · OZANIMOD HYDROCHLORIDE
M-309 exclusivity
exclusivity.txt lines 811–813- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
30 Aug 2027 · NDA 209939 · LETERMOVIR
NPP exclusivity
exclusivity.txt lines 820, 826- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
30 Aug 2027 · NDA 209940 · LETERMOVIR
NPP exclusivity
exclusivity.txt lines 832, 838- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
30 Aug 2027 · NDA 219104 · LETERMOVIR
NP exclusivity
exclusivity.txt lines 2,245, 2,249- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002
1 Sep 2027 · NDA 214120 · AZACITIDINE
ODE-320 exclusivity
exclusivity.txt lines 1,306–1,307- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
3 Sep 2027 · NDA 213227 · COPPER CU-64 DOTATATE
ODE-317 exclusivity
exclusivity.txt line 1,168- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
4 Sep 2027 · NDA 213721 · PRALSETINIB
ODE-318 exclusivity
exclusivity.txt line 1,247- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
6 Sep 2027 · NDA 207500 · ISAVUCONAZONIUM SULFATE
GAIN exclusivity
exclusivity.txt lines 590–591, 602- Definition
- Generating Antibiotic Incentives Now (to be checked against FDA's list)
- Product numbers
- 001, 002
6 Sep 2027 · NDA 207501 · ISAVUCONAZONIUM SULFATE
GAIN exclusivity
exclusivity.txt lines 611–612- Definition
- Generating Antibiotic Incentives Now (to be checked against FDA's list)
- Product numbers
- 001
9 Sep 2027 · NDA 214958 · DEUCRAVACITINIB
NCE exclusivity
exclusivity.txt line 1,437- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
13 Sep 2027 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
M-308 exclusivity
exclusivity.txt lines 203–206- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
14 Sep 2027 · NDA 022231 · TERLIPRESSIN ACETATE
NCE exclusivity
exclusivity.txt line 174- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
15 Sep 2027 · NDA 202022 · RILPIVIRINE HYDROCHLORIDE
PED exclusivity
exclusivity.txt line 229- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
15 Sep 2027 · NDA 209363 · SECNIDAZOLE
GAIN exclusivity
exclusivity.txt line 773- Definition
- Generating Antibiotic Incentives Now (to be checked against FDA's list)
- Product numbers
- 001
15 Sep 2027 · NDA 219016 · RILPIVIRINE HYDROCHLORIDE
PED exclusivity
exclusivity.txt line 2,229- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
17 Sep 2027 · NDA 209092 · RIBOCICLIB SUCCINATE
I-950 exclusivity
exclusivity.txt line 760- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
17 Sep 2027 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
I-951 exclusivity
exclusivity.txt line 814- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
19 Sep 2027 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
PED exclusivity
exclusivity.txt lines 704, 706- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
19 Sep 2027 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
PED exclusivity
exclusivity.txt line 1,314- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 002
21 Sep 2027 · NDA 216986 · GADOPICLENOL
NCE exclusivity
exclusivity.txt lines 1,813, 1,815, 1,817, 1,819, 1,821, 1,823, 1,825- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
22 Sep 2027 · NDA 215092 · OMIDENEPAG ISOPROPYL
NCE exclusivity
exclusivity.txt line 1,472- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
22 Sep 2027 · NDA 218490 · MACITENTAN; TADALAFIL
PED exclusivity
exclusivity.txt lines 2,158, 2,162- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
25 Sep 2027 · NDA 208065 · OSIMERTINIB MESYLATE
I-952 exclusivity
exclusivity.txt lines 689, 692- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
27 Sep 2027 · NDA 213246 · SELPERCATINIB
M-311 exclusivity
exclusivity.txt lines 1,169, 1,191- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
27 Sep 2027 · NDA 213246 · SELPERCATINIB
M-312 exclusivity
exclusivity.txt lines 1,170, 1,192- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
27 Sep 2027 · NDA 218160 · SELPERCATINIB
M-311 exclusivity
exclusivity.txt lines 2,039, 2,059, 2,079, 2,099- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
27 Sep 2027 · NDA 218160 · SELPERCATINIB
M-312 exclusivity
exclusivity.txt lines 2,040, 2,060, 2,080, 2,100- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
29 Sep 2027 · NDA 216660 · SODIUM PHENYLBUTYRATE; TAURURSODIOL
NCE exclusivity
exclusivity.txt line 1,775- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
30 Sep 2027 · NDA 214801 · FUTIBATINIB
NCE exclusivity
exclusivity.txt lines 1,404, 1,406- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002
30 Sep 2027 · NDA 214985 · DARIDOREXANT HYDROCHLORIDE
M-200 exclusivity
exclusivity.txt lines 1,439, 1,442- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
30 Sep 2027 · NDA 214985 · DARIDOREXANT HYDROCHLORIDE
M-310 exclusivity
exclusivity.txt lines 1,440, 1,443- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
3 Oct 2027 · NDA 206947 · LENVATINIB MESYLATE
PED exclusivity
exclusivity.txt lines 567, 571- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
4 Oct 2027 · NDA 208081 · AMINOLEVULINIC ACID HYDROCHLORIDE
D-194 exclusivity
exclusivity.txt line 695- Definition
- New dosing schedule (to be checked against FDA's list)
- Product numbers
- 001
11 Oct 2027 · NDA 022350 · SAXAGLIPTIN HYDROCHLORIDE
M-14 exclusivity
exclusivity.txt lines 195–196- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
11 Oct 2027 · NDA 200678 · METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
M-14 exclusivity
exclusivity.txt lines 212–214- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
13 Oct 2027 · NDA 211150 · PITOLISANT HYDROCHLORIDE
ODE-331 exclusivity
exclusivity.txt lines 934, 939- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
16 Oct 2027 · NDA 216962 · FOSCARBIDOPA; FOSLEVODOPA
NP exclusivity
exclusivity.txt line 1,809- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
18 Oct 2027 · NDA 217806 · TIRZEPATIDE
M-82 exclusivity
exclusivity.txt lines 1,943, 1,947, 1,951, 1,955, 1,959, 1,963, 1,967, 1,970, 1,973, 1,976, 1,979, 1,982, 1,985, 1,988, 1,991, 1,994, 1,997, 2,000, 2,003, 2,006, 2,009, 2,012, 2,015, 2,018- Definition
- Miscellaneous (to be checked against FDA's list)
- 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 Oct 2027 · NDA 208700 · LUTETIUM LU-177 DOTATATE
PED exclusivity
exclusivity.txt line 749- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
25 Oct 2027 · NDA 205437 · APREMILAST
PED exclusivity
exclusivity.txt lines 487, 493, 499- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
29 Oct 2027 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
I-953 exclusivity
exclusivity.txt lines 1,535, 1,543- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
29 Oct 2027 · NDA 215358 · ASCIMINIB HYDROCHLORIDE
I-954 exclusivity
exclusivity.txt lines 1,536, 1,544- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
30 Oct 2027 · NDA 202049 · MANNITOL
ODE-327 exclusivity
exclusivity.txt line 230- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
1 Nov 2027 · NDA 213004 · AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
GAIN exclusivity
exclusivity.txt line 1,137- Definition
- Generating Antibiotic Incentives Now (to be checked against FDA's list)
- Product numbers
- 001
1 Nov 2027 · NDA 219015 · MINOCYCLINE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 2,227- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
8 Nov 2027 · NDA 205422 · BREXPIPRAZOLE
PED exclusivity
exclusivity.txt lines 454, 459, 464, 469, 474, 479- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
8 Nov 2027 · NDA 213246 · SELPERCATINIB
PED exclusivity
exclusivity.txt lines 1,188–1,190, 1,210–1,212- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
8 Nov 2027 · NDA 218160 · SELPERCATINIB
PED exclusivity
exclusivity.txt lines 2,056–2,058, 2,076–2,078, 2,096–2,098, 2,116–2,118- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
14 Nov 2027 · NDA 204026 · POMALIDOMIDE
PED exclusivity
exclusivity.txt lines 350–351, 354–355, 358–359, 362–363- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
20 Nov 2027 · NDA 213969 · LONAFARNIB
ODE-324 exclusivity
exclusivity.txt lines 1,279–1,280- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
23 Nov 2027 · NDA 214103 · LUMASIRAN SODIUM
ODE-339 exclusivity
exclusivity.txt line 1,304- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
25 Nov 2027 · NDA 213793 · SETMELANOTIDE ACETATE
ODE-336 exclusivity
exclusivity.txt line 1,266- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
26 Nov 2027 · NDA 021539 · ACETYLCYSTEINE
D-196 exclusivity
exclusivity.txt line 124- Definition
- New dosing schedule (to be checked against FDA's list)
- Product numbers
- 001
29 Nov 2027 · NDA 213246 · SELPERCATINIB
PED exclusivity
exclusivity.txt lines 1,184, 1,206- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
1 Dec 2027 · NDA 205677 · TASIMELTEON
ODE-330 exclusivity
exclusivity.txt line 525- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
1 Dec 2027 · NDA 213721 · PRALSETINIB
ODE-340 exclusivity
exclusivity.txt line 1,248- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
1 Dec 2027 · NDA 213721 · PRALSETINIB
ODE-341 exclusivity
exclusivity.txt line 1,249- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
1 Dec 2027 · NDA 214517 · TASIMELTEON
ODE-329 exclusivity
exclusivity.txt line 1,338- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
1 Dec 2027 · NDA 215814 · OLUTASIDENIB
NCE exclusivity
exclusivity.txt line 1,607- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
3 Dec 2027 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
ODE-333 exclusivity
exclusivity.txt lines 1,298, 1,300- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
12 Dec 2027 · NDA 022225 · SUGAMMADEX SODIUM
NPP exclusivity
exclusivity.txt lines 170, 172- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
12 Dec 2027 · NDA 202293 · DAPAGLIFLOZIN
PED exclusivity
exclusivity.txt lines 269, 273- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
12 Dec 2027 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 516, 518, 520, 522, 524- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005
12 Dec 2027 · NDA 215272 · TAPINAROF
I-956 exclusivity
exclusivity.txt line 1,516- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
12 Dec 2027 · NDA 216340 · ADAGRASIB
NCE exclusivity
exclusivity.txt line 1,748- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
13 Dec 2027 · NDA 211358 · IVACAFTOR; LUMACAFTOR
M-14 exclusivity
exclusivity.txt lines 952, 956, 960- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
18 Dec 2027 · NDA 204042 · CANAGLIFLOZIN
NPP exclusivity
exclusivity.txt lines 364, 366- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
18 Dec 2027 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 388, 390, 392, 394- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
18 Dec 2027 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 536, 538, 540, 542- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
18 Dec 2027 · NDA 208065 · OSIMERTINIB MESYLATE
ODE-337 exclusivity
exclusivity.txt lines 690, 693- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
18 Dec 2027 · NDA 212306 · SELINEXOR
ODE-346 exclusivity
exclusivity.txt line 1,048- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
18 Dec 2027 · NDA 212306 · SELINEXOR
ODE* exclusivity
exclusivity.txt lines 1,049, 1,052, 1,055, 1,058, 1,061- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 002, 003, 004, 005, 006
18 Dec 2027 · NDA 213006 · VIBEGRON
I-955 exclusivity
exclusivity.txt line 1,143- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
19 Dec 2027 · NDA 210854 · BALOXAVIR MARBOXIL
M-187 exclusivity
exclusivity.txt lines 914–916- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
19 Dec 2027 · NDA 214410 · BALOXAVIR MARBOXIL
M-187 exclusivity
exclusivity.txt lines 1,328–1,330- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
20 Dec 2027 · NDA 210496 · ENCORAFENIB
I-957 exclusivity
exclusivity.txt lines 881, 885- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
20 Dec 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
M-313 exclusivity
exclusivity.txt lines 1,034, 1,040- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
20 Dec 2027 · NDA 213793 · SETMELANOTIDE ACETATE
NPP exclusivity
exclusivity.txt line 1,265- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001
20 Dec 2027 · NDA 216718 · OMAVELOXOLONE
M-270 exclusivity
exclusivity.txt line 1,784- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
20 Dec 2027 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
M-313 exclusivity
exclusivity.txt line 1,900- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
20 Dec 2027 · NDA 217806 · TIRZEPATIDE
I-958 exclusivity
exclusivity.txt lines 1,942, 1,946, 1,950, 1,954, 1,958, 1,962, 1,966, 1,969, 1,972, 1,975, 1,978, 1,981, 1,984, 1,987, 1,990, 1,993, 1,996, 1,999, 2,002, 2,005, 2,008, 2,011, 2,014, 2,017- Definition
- New indication (to be checked against FDA's list)
- 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
21 Dec 2027 · NDA 203188 · IVACAFTOR
ODE-338 exclusivity
exclusivity.txt line 303- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
21 Dec 2027 · NDA 207925 · IVACAFTOR
ODE-338 exclusivity
exclusivity.txt lines 628, 634, 640- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
21 Dec 2027 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
ODE-335 exclusivity
exclusivity.txt lines 877, 879- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
21 Dec 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
ODE-323 exclusivity
exclusivity.txt line 1,036- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
21 Dec 2027 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
ODE* exclusivity
exclusivity.txt line 1,041- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 002
22 Dec 2027 · NDA 215973 · LENACAPAVIR SODIUM
NCE exclusivity
exclusivity.txt line 1,679- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
22 Dec 2027 · NDA 215974 · LENACAPAVIR SODIUM
NCE exclusivity
exclusivity.txt line 1,681- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
22 Dec 2027 · NDA 220018 · LENACAPAVIR SODIUM
NCE exclusivity
exclusivity.txt line 2,368- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
22 Dec 2027 · NDA 220020 · LENACAPAVIR SODIUM
NCE exclusivity
exclusivity.txt line 2,370- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
22 Dec 2027 · NDA 221104 · BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM
NCE exclusivity
exclusivity.txt line 2,418- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
22 Dec 2027 · NDA 221443 · BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM
NCE exclusivity
exclusivity.txt line 2,420- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
23 Dec 2027 · NDA 214375 · XENON XE-129 HYPERPOLARIZED
NCE exclusivity
exclusivity.txt line 1,321- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
25 Dec 2027 · NDA 212102 · FENFLURAMINE HYDROCHLORIDE
PED exclusivity
exclusivity.txt line 1,023- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001