Drybench Patent.

Patent and exclusivity dates from January to June 2028 for NDAs, as FDA's Orange Book lists them

Each patent and exclusivity date from January to June 2028 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, 2028 July to December 2028

Listed patent expiry (276)

2 Jan 2028 · NDA 022572 · MITOMYCIN
US 9,539,241, substance and product and use patent
patent.txt line 2,104
Flags
substance product use code U-2095
Product numbers
001
3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 10,512,640, use patent
patent.txt line 4,090
Flags
use code U-1969
Product numbers
001
3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 10,828,369, product patent
patent.txt line 4,092
Flags
product
Product numbers
001
3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 11,213,519, use patent
patent.txt line 4,094
Flags
use code U-2720
Product numbers
001
3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 11,872,218, use patent
patent.txt line 4,096
Flags
use code U-1969
Product numbers
001
3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 9,566,272, use patent
patent.txt line 4,101
Flags
use code U-1969
Product numbers
001
3 Jan 2028 · NDA 203567 · EFINACONAZOLE
US 9,877,955, use patent
patent.txt line 4,104
Flags
use code U-1969
Product numbers
001
7 Jan 2028 · NDA 202020 · PREDNISONE
US 8,168,218, product and use patent
patent.txt line 2,618
Flags
product use code U-1269
Product numbers
003
7 Jan 2028 · NDA 207953 · TRABECTEDIN
US 8,895,557, product patent
patent.txt line 7,815
Flags
product
Product numbers
001
9 Jan 2028 · NDA 022560 · RISEDRONATE SODIUM
US 7,645,459, product and use patent
patent.txt line 2,086
Flags
product use code U-662
Product numbers
001
9 Jan 2028 · NDA 022560 · RISEDRONATE SODIUM
US 7,645,460, product and use patent
patent.txt line 2,087
Flags
product use code U-662
Product numbers
001
11 Jan 2028 · NDA 022287 · DEXLANSOPRAZOLE
US 8,871,273, product patent
patent.txt lines 1,561, 1,575
Flags
product
Product numbers
001, 002
11 Jan 2028 · NDA 208056 · DEXLANSOPRAZOLE
US 8,871,273, product patent
patent.txt line 8,045
Flags
product
Product numbers
001
12 Jan 2028 · NDA 210331 · FLUOCINOLONE ACETONIDE
US 7,998,108, product and use patent
patent.txt line 11,309
Flags
product use code U-3410
Product numbers
001
15 Jan 2028 · NDA 214154 · DROSPIRENONE; ESTETROL
US 7,732,430, product and use patent
patent.txt line 15,571
Flags
product use code U-3152
Product numbers
001
17 Jan 2028 · NDA 205353 · PANOBINOSTAT LACTATE
US 7,989,494, substance and product patent
patent.txt lines 5,281, 5,283, 5,285
Flags
substance product
Product numbers
001, 002, 003
18 Jan 2028 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 11,234,954, use patent
patent.txt lines 939, 955
Flags
use code U-620
Product numbers
001, 002
18 Jan 2028 · NDA 211321 · MIDAZOLAM
US 8,217,033, product and use patent
patent.txt line 12,684
Flags
product use code U-2526
Product numbers
001
18 Jan 2028 · NDA 211321 · MIDAZOLAM
US 8,809,322, product patent
patent.txt line 12,685
Flags
product
Product numbers
001
18 Jan 2028 · NDA 211321 · MIDAZOLAM
US 9,289,432, product and use patent
patent.txt line 12,686
Flags
product use code U-2526
Product numbers
001
18 Jan 2028 · NDA 211321 · MIDAZOLAM
US 9,687,495, product and use patent
patent.txt line 12,687
Flags
product use code U-2526
Product numbers
001
22 Jan 2028 · NDA 208944 · AMANTADINE HYDROCHLORIDE
US 8,389,578, use patent
patent.txt lines 9,625, 9,642
Flags
use code U-2105
Product numbers
001, 002
22 Jan 2028 · NDA 209410 · AMANTADINE HYDROCHLORIDE
US 8,389,578, use patent
patent.txt lines 10,350, 10,360, 10,369, 10,378
Flags
use code U-219
Product numbers
001, 002, 003, 004
22 Jan 2028 · NDA 209410 · AMANTADINE HYDROCHLORIDE
US 8,389,578, use patent
patent.txt lines 10,351, 10,361, 10,370, 10,379
Flags
use code U-3054
Product numbers
001, 002, 003, 004
28 Jan 2028 · NDA 022075 · ISTRADEFYLLINE
US 7,727,993, product and use patent
patent.txt lines 1,036, 1,038
Flags
product use code U-2623
Product numbers
001, 002
28 Jan 2028 · NDA 022145 · RALTEGRAVIR POTASSIUM
US 8,852,632, substance and product and use patent
patent.txt line 1,116
Flags
substance product use code U-257
Product numbers
001
30 Jan 2028 · NDA 022252 · DIENOGEST; ESTRADIOL VALERATE
US 8,153,616, use patent
patent.txt line 1,408
Flags
use code U-1240
Product numbers
001
30 Jan 2028 · NDA 208745 · PLECANATIDE
US 7,041,786, substance patent
patent.txt line 9,308
Flags
substance
Product numbers
001
1 Feb 2028 · NDA 021658 · CICLESONIDE
US 8,371,292, use patent
patent.txt lines 657–658
Flags
use code U-1355
Product numbers
002, 003
1 Feb 2028 · NDA 022004 · CICLESONIDE
US 8,371,292, use patent
patent.txt line 900
Flags
use code U-1356
Product numbers
001
1 Feb 2028 · NDA 202129 · CICLESONIDE
US 8,371,292, use patent
patent.txt line 2,775
Flags
use code U-1357
Product numbers
001
2 Feb 2028 · NDA 205223 · METRONIDAZOLE
US 8,877,792, product patent
patent.txt line 5,275
Flags
product
Product numbers
001
3 Feb 2028 · NDA 050795 · DOXYCYCLINE HYCLATE
US 8,715,724, product patent
patent.txt lines 2,145–2,151, 2,155
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007, 008
3 Feb 2028 · NDA 214510 · BENZOYL PEROXIDE
US 12,156,946, product patent
patent.txt line 15,823
Flags
product
Product numbers
001
3 Feb 2028 · NDA 214510 · BENZOYL PEROXIDE
US 12,350,382, product patent
patent.txt line 15,826
Flags
product
Product numbers
001
3 Feb 2028 · NDA 214902 · BENZOYL PEROXIDE; TRETINOIN
US 12,156,946, product patent
patent.txt line 16,312
Flags
product
Product numbers
001
3 Feb 2028 · NDA 214902 · BENZOYL PEROXIDE; TRETINOIN
US 8,617,580, product patent
patent.txt line 16,317
Flags
product
Product numbers
001
5 Feb 2028 · NDA 021223 · ZOLEDRONIC ACID
US 7,932,241, product patent
patent.txt line 503
Flags
product
Product numbers
003
5 Feb 2028 · NDA 021817 · ZOLEDRONIC ACID
US 7,932,241, product patent
patent.txt line 701
Flags
product
Product numbers
001
7 Feb 2028 · NDA 204063 · DIMETHYL FUMARATE
US 8,399,514, use patent
patent.txt lines 4,261, 4,270
Flags
use code U-1384
Product numbers
001, 002
7 Feb 2028 · NDA 208081 · AMINOLEVULINIC ACID HYDROCHLORIDE
US 11,540,981, product patent
patent.txt line 8,109
Flags
product
Product numbers
001
13 Feb 2028 · NDA 210655 · RISPERIDONE
US 10,010,612, product patent
patent.txt lines 12,063, 12,073
Flags
product
Product numbers
001, 002
13 Feb 2028 · NDA 210655 · RISPERIDONE
US 10,376,590, use patent
patent.txt lines 12,065, 12,075
Flags
use code U-2608
Product numbers
001, 002
13 Feb 2028 · NDA 210655 · RISPERIDONE
US 11,013,809, product and use patent
patent.txt lines 12,067, 12,077
Flags
product use code U-3135
Product numbers
001, 002
13 Feb 2028 · NDA 210655 · RISPERIDONE
US 11,712,475, use patent
patent.txt lines 12,069, 12,079
Flags
use code U-3135
Product numbers
001, 002
13 Feb 2028 · NDA 210655 · RISPERIDONE
US 9,180,197, product patent
patent.txt lines 12,070, 12,080
Flags
product
Product numbers
001, 002
13 Feb 2028 · NDA 210655 · RISPERIDONE
US 9,186,413, use patent
patent.txt lines 12,071, 12,081
Flags
use code U-543
Product numbers
001, 002
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt line 4,007
Flags
use code U-1432
Product numbers
001
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,008, 4,031, 4,056, 4,078
Flags
use code U-3312
Product numbers
001, 002, 003, 004
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,009, 4,032, 4,057, 4,079
Flags
use code U-3313
Product numbers
001, 002, 003, 004
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,010, 4,033, 4,058, 4,080
Flags
use code U-3314
Product numbers
001, 002, 003, 004
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,011, 4,034, 4,059, 4,081
Flags
use code U-3636
Product numbers
001, 002, 003, 004
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,028, 4,053
Flags
use code U-2555
Product numbers
002, 003
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,029, 4,054
Flags
use code U-2556
Product numbers
002, 003
15 Feb 2028 · NDA 203565 · FERRIC CARBOXYMALTOSE
US 7,754,702, use patent
patent.txt lines 4,030, 4,055
Flags
use code U-2557
Product numbers
002, 003
16 Feb 2028 · NDA 205437 · APREMILAST
US 7,427,638, substance and product patent
patent.txt lines 5,405, 5,417, 5,429
Flags
substance product
Product numbers
001, 002, 003
16 Feb 2028 · NDA 210745 · APREMILAST
US 7,427,638, substance and product patent
patent.txt line 12,137
Flags
substance product
Product numbers
001
17 Feb 2028 · NDA 211280 · LASMIDITAN SUCCINATE
US 7,423,050, substance and product and use patent
patent.txt lines 12,666, 12,670, 12,673
Flags
substance product use code U-1719
Product numbers
001, 002, 003
19 Feb 2028 · NDA 205223 · METRONIDAZOLE
US 7,893,097, product patent
patent.txt line 5,273
Flags
product
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 8,461,140, product patent
patent.txt line 6,483
Flags
product
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 8,546,367, product and use patent
patent.txt line 6,484
Flags
product use code U-1690
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 8,883,770, product patent
patent.txt line 6,486
Flags
product
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 9,522,155, product and use patent
patent.txt line 6,487
Flags
product use code U-1940
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 9,636,349, use patent
patent.txt line 6,488
Flags
use code U-1940
Product numbers
001
21 Feb 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 9,949,986, use patent
patent.txt line 6,489
Flags
use code U-1940
Product numbers
001
23 Feb 2028 · NDA 205435 · TEDIZOLID PHOSPHATE
US 8,420,676, substance and product and use patent
patent.txt line 5,386
Flags
substance product use code U-282
Product numbers
001
23 Feb 2028 · NDA 205436 · TEDIZOLID PHOSPHATE
US 8,420,676, substance and product and use patent
patent.txt line 5,393
Flags
substance product use code U-282
Product numbers
001
1 Mar 2028 · NDA 219474 · DIFAMILAST
US RE46792, substance and product and use patent
patent.txt line 21,746
Flags
substance product use code U-4445
Product numbers
001
7 Mar 2028 · NDA 022427 · KETOROLAC TROMETHAMINE
US 8,512,717, product patent
patent.txt line 1,893
Flags
product
Product numbers
001
7 Mar 2028 · NDA 022427 · KETOROLAC TROMETHAMINE
US 9,192,571, product patent
patent.txt line 1,894
Flags
product
Product numbers
001
8 Mar 2028 · NDA 021880 · LENALIDOMIDE
US 8,741,929, use patent
patent.txt lines 750, 752, 754, 756, 758, 760
Flags
use code U-1983
Product numbers
001, 002, 003, 004, 005, 006
10 Mar 2028 · NDA 022387 · TREPROSTINIL
US 9,339,507, product patent
patent.txt line 1,767
Flags
product
Product numbers
001
12 Mar 2028 · NDA 201739 · EPINEPHRINE
US 7,947,017, product patent
patent.txt lines 2,561, 2,570, 2,579
Flags
product
Product numbers
001, 002, 003
12 Mar 2028 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 7,947,017, product patent
patent.txt line 5,878
Flags
product
Product numbers
001
12 Mar 2028 · NDA 209500 · LUMATEPERONE TOSYLATE
US 10,464,938, product patent
patent.txt lines 10,435, 10,471, 10,502
Flags
product
Product numbers
001, 002, 003
12 Mar 2028 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 7,947,017, product patent
patent.txt line 10,902
Flags
product
Product numbers
001
13 Mar 2028 · NDA 021747 · ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
US 7,837,235, product patent
patent.txt line 696
Flags
product delist requested
Product numbers
001
13 Mar 2028 · NDA 021936 · TIOTROPIUM BROMIDE
US 7,837,235, product patent
patent.txt line 811
Flags
product delist requested
Product numbers
001
13 Mar 2028 · NDA 206756 · OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
US 7,837,235, product patent
patent.txt line 6,760
Flags
product delist requested
Product numbers
001
13 Mar 2028 · NDA 213756 · SELUMETINIB SULFATE
US 7,425,637, substance patent
patent.txt lines 15,258, 15,266
Flags
substance
Product numbers
001, 002
13 Mar 2028 · NDA 215192 · VADADUSTAT
US 7,811,595, substance and product patent
patent.txt lines 16,522, 16,536, 16,550
Flags
substance product
Product numbers
001, 002, 003
13 Mar 2028 · NDA 219943 · SELUMETINIB SULFATE
US 7,425,637, substance patent
patent.txt lines 22,064, 22,068
Flags
substance
Product numbers
001, 002
18 Mar 2028 · NDA 021991 · VORINOSTAT
US 8,450,372, use patent
patent.txt line 883
Flags
use code U-892
Product numbers
001
19 Mar 2028 · NDA 211672 · LEFAMULIN ACETATE
US 8,153,689, substance and product patent
patent.txt line 12,967
Flags
substance product
Product numbers
001
19 Mar 2028 · NDA 211673 · LEFAMULIN ACETATE
US 8,153,689, substance and product patent
patent.txt line 12,971
Flags
substance product
Product numbers
001
21 Mar 2028 · NDA 022200 · EXENATIDE SYNTHETIC
US 8,361,972, use patent
patent.txt lines 1,256, 1,292
Flags
use code U-2588
Product numbers
001, 002
21 Mar 2028 · NDA 202293 · DAPAGLIFLOZIN
US 8,221,786, product patent
patent.txt lines 2,985, 3,023
Flags
product
Product numbers
001, 002
21 Mar 2028 · NDA 202293 · DAPAGLIFLOZIN
US 8,361,972, use patent
patent.txt lines 2,991, 3,029
Flags
use code U-2139
Product numbers
001, 002
21 Mar 2028 · NDA 202293 · DAPAGLIFLOZIN
US 8,361,972, use patent
patent.txt lines 2,992, 3,030
Flags
use code U-493
Product numbers
001, 002
21 Mar 2028 · NDA 202293 · DAPAGLIFLOZIN
US 8,716,251, product patent
patent.txt lines 2,998, 3,036
Flags
product
Product numbers
001, 002
21 Mar 2028 · NDA 204671 · SOFOSBUVIR
US 8,334,270, substance and product and use patent
patent.txt lines 4,948, 4,966
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 204671 · SOFOSBUVIR
US 8,580,765, substance and product and use patent
patent.txt lines 4,950, 4,968
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 204671 · SOFOSBUVIR
US 9,085,573, substance and product and use patent
patent.txt lines 4,958, 4,976
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,334,270, substance and product and use patent
patent.txt lines 5,919, 5,952
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,580,765, substance and product and use patent
patent.txt lines 5,921, 5,954
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 8,735,372, use patent
patent.txt lines 5,927, 5,960
Flags
use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 205834 · LEDIPASVIR; SOFOSBUVIR
US 9,085,573, substance and product and use patent
patent.txt lines 5,935, 5,968
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,334,270, substance and product and use patent
patent.txt lines 8,490, 8,520
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,580,765, substance and product and use patent
patent.txt lines 8,494, 8,524
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 8,735,372, use patent
patent.txt lines 8,500, 8,530
Flags
use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 208341 · SOFOSBUVIR; VELPATASVIR
US 9,085,573, substance and product and use patent
patent.txt lines 8,508, 8,538
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,221,786, product patent
patent.txt lines 9,662, 9,678
Flags
product
Product numbers
001, 002
21 Mar 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,361,972, use patent
patent.txt line 9,664
Flags
use code U-1976
Product numbers
001
21 Mar 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,361,972, use patent
patent.txt line 9,665
Flags
use code U-1977
Product numbers
001
21 Mar 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,361,972, use patent
patent.txt lines 9,666, 9,680
Flags
use code U-493
Product numbers
001, 002
21 Mar 2028 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 8,716,251, product patent
patent.txt lines 9,672, 9,684
Flags
product
Product numbers
001, 002
21 Mar 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,334,270, substance and product and use patent
patent.txt line 9,823
Flags
substance product use code U-2039
Product numbers
001
21 Mar 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,334,270, substance and product and use patent
patent.txt line 9,824
Flags
substance product use code U-2040
Product numbers
001
21 Mar 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,580,765, substance and product and use patent
patent.txt line 9,829
Flags
substance product use code U-2039
Product numbers
001
21 Mar 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,580,765, substance and product and use patent
patent.txt line 9,830
Flags
substance product use code U-2040
Product numbers
001
21 Mar 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,735,372, substance and product and use patent
patent.txt line 9,838
Flags
substance product use code U-2039
Product numbers
001
21 Mar 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,735,372, substance and product and use patent
patent.txt line 9,839
Flags
substance product use code U-2040
Product numbers
001
21 Mar 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,957,046, use patent
patent.txt line 9,849
Flags
use code U-2039
Product numbers
001
21 Mar 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 8,957,046, use patent
patent.txt line 9,850
Flags
use code U-2040
Product numbers
001
21 Mar 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 9,085,573, substance and product and use patent
patent.txt line 9,852
Flags
substance product use code U-2039
Product numbers
001
21 Mar 2028 · NDA 209195 · SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
US 9,085,573, substance and product and use patent
patent.txt line 9,853
Flags
substance product use code U-2040
Product numbers
001
21 Mar 2028 · NDA 209210 · EXENATIDE SYNTHETIC
US 8,361,972, use patent
patent.txt line 9,889
Flags
use code U-2588
Product numbers
001
21 Mar 2028 · NDA 210874 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
US 8,716,251, product patent
patent.txt lines 12,281, 12,291, 12,301, 12,311
Flags
product
Product numbers
001, 002, 003, 004
21 Mar 2028 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,334,270, substance and product and use patent
patent.txt lines 13,992, 14,023
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,580,765, substance and product and use patent
patent.txt lines 13,994, 14,025
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 8,735,372, use patent
patent.txt lines 14,000, 14,031
Flags
use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 212477 · LEDIPASVIR; SOFOSBUVIR
US 9,085,573, substance and product and use patent
patent.txt lines 14,008, 14,039
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 212480 · SOFOSBUVIR
US 8,334,270, substance and product and use patent
patent.txt lines 14,056, 14,072
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 212480 · SOFOSBUVIR
US 8,580,765, substance and product and use patent
patent.txt lines 14,058, 14,074
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 212480 · SOFOSBUVIR
US 9,085,573, substance and product and use patent
patent.txt lines 14,066, 14,082
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,334,270, substance and product and use patent
patent.txt lines 15,583, 15,611
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,580,765, substance and product and use patent
patent.txt lines 15,587, 15,615
Flags
substance product use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 8,735,372, use patent
patent.txt lines 15,593, 15,621
Flags
use code U-1470
Product numbers
001, 002
21 Mar 2028 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
US 9,085,573, substance and product and use patent
patent.txt lines 15,601, 15,629
Flags
substance product use code U-1470
Product numbers
001, 002
22 Mar 2028 · NDA 020263 · LEUPROLIDE ACETATE
US 9,617,303, use patent
patent.txt line 182
Flags
use code U-3611
Product numbers
009
22 Mar 2028 · NDA 020517 · LEUPROLIDE ACETATE
US 9,617,303, use patent
patent.txt line 185
Flags
use code U-4001
Product numbers
003
26 Mar 2028 · NDA 200796 · AZILSARTAN KAMEDOXOMIL
US 9,066,936, product patent
patent.txt lines 2,310–2,311
Flags
product
Product numbers
001, 002
26 Mar 2028 · NDA 202331 · AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
US 9,066,936, product patent
patent.txt lines 3,065, 3,068
Flags
product
Product numbers
001, 002
27 Mar 2028 · NDA 022388 · KETOTIFEN FUMARATE
US 9,474,746, product patent
patent.txt line 1,770
Flags
product
Product numbers
001
28 Mar 2028 · NDA 022192 · ILOPERIDONE
US 10,570,453, use patent
patent.txt lines 1,145, 1,159, 1,173, 1,187, 1,201, 1,215, 1,229
Flags
use code U-4562
Product numbers
001, 002, 003, 004, 005, 006, 007
28 Mar 2028 · NDA 022192 · ILOPERIDONE
US 10,570,453, use patent
patent.txt lines 1,146, 1,160, 1,174, 1,188, 1,202, 1,216, 1,230
Flags
use code U-4563
Product numbers
001, 002, 003, 004, 005, 006, 007
28 Mar 2028 · NDA 206316 · EDOXABAN TOSYLATE
US 9,149,532, product patent
patent.txt lines 6,464, 6,466, 6,468
Flags
product
Product numbers
001, 002, 003
28 Mar 2028 · NDA 220358 · MILSAPERIDONE
US 10,570,453, use patent
patent.txt lines 22,140, 22,160, 22,180, 22,200, 22,220, 22,240, 22,260
Flags
use code U-4436
Product numbers
001, 002, 003, 004, 005, 006, 007
28 Mar 2028 · NDA 220358 · MILSAPERIDONE
US 10,570,453, use patent
patent.txt lines 22,141, 22,161, 22,181, 22,201, 22,221, 22,241, 22,261
Flags
use code U-4437
Product numbers
001, 002, 003, 004, 005, 006, 007
30 Mar 2028 · NDA 021026 · MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE
US 8,147,852, use patent
patent.txt line 398
Flags
use code U-1426
Product numbers
001
3 Apr 2028 · NDA 215192 · VADADUSTAT
US 8,323,671, use patent
patent.txt lines 16,523, 16,537, 16,551
Flags
use code U-3876
Product numbers
001, 002, 003
4 Apr 2028 · NDA 201635 · TOPIRAMATE
US 8,298,576, product and use patent
patent.txt lines 2,443, 2,463, 2,483, 2,503
Flags
product use code U-106
Product numbers
001, 002, 003, 004
4 Apr 2028 · NDA 201635 · TOPIRAMATE
US 8,298,576, product and use patent
patent.txt lines 2,444, 2,464, 2,484, 2,504
Flags
product use code U-1992
Product numbers
001, 002, 003, 004
7 Apr 2028 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 8,875,704, product and use patent
patent.txt line 6,282
Flags
product use code U-1809
Product numbers
001
11 Apr 2028 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 10,548,871, use patent
patent.txt lines 934, 950
Flags
use code U-620
Product numbers
001, 002
11 Apr 2028 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 11,096,920, use patent
patent.txt lines 937, 953
Flags
use code U-620
Product numbers
001, 002
11 Apr 2028 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 9,907,780, product patent
patent.txt lines 948, 964
Flags
product
Product numbers
001, 002
17 Apr 2028 · NDA 219616 · AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
US 8,247,411, substance and product patent
patent.txt line 21,801
Flags
substance product
Product numbers
001
19 Apr 2028 · NDA 211810 · PEXIDARTINIB HYDROCHLORIDE
US 8,461,169, use patent
patent.txt lines 13,196, 13,208
Flags
use code U-2606
Product numbers
001, 002
21 Apr 2028 · NDA 200533 · TAPENTADOL HYDROCHLORIDE
US 11,344,512, use patent
patent.txt lines 2,221, 2,226, 2,231, 2,236, 2,241
Flags
use code U-3391
Product numbers
001, 002, 003, 004, 005
21 Apr 2028 · NDA 200533 · TAPENTADOL HYDROCHLORIDE
US 11,344,512, use patent
patent.txt lines 2,222, 2,227, 2,232, 2,237, 2,242
Flags
use code U-3392
Product numbers
001, 002, 003, 004, 005
21 Apr 2028 · NDA 204623 · DICLOFENAC SODIUM
US 8,252,838, product and use patent
patent.txt line 4,857
Flags
product use code U-1489
Product numbers
001
25 Apr 2028 · NDA 208010 · CALCIFEDIOL
US 11,154,509, use patent
patent.txt line 7,951
Flags
use code U-3815
Product numbers
001
25 Apr 2028 · NDA 208010 · CALCIFEDIOL
US 8,207,149, use patent
patent.txt line 7,956
Flags
use code U-1871
Product numbers
001
25 Apr 2028 · NDA 208010 · CALCIFEDIOL
US 8,778,373, use patent
patent.txt line 7,959
Flags
use code U-1873
Product numbers
001
25 Apr 2028 · NDA 208010 · CALCIFEDIOL
US 9,408,858, use patent
patent.txt line 7,961
Flags
use code U-1888
Product numbers
001
25 Apr 2028 · NDA 208010 · CALCIFEDIOL
US 9,498,486, use patent
patent.txt line 7,962
Flags
use code U-3814
Product numbers
001
25 Apr 2028 · NDA 208010 · CALCIFEDIOL
US 9,925,147, product and use patent
patent.txt line 7,964
Flags
product use code U-2255
Product numbers
001
25 Apr 2028 · NDA 208010 · CALCIFEDIOL
US 9,925,147, product and use patent
patent.txt line 7,965
Flags
product use code U-2256
Product numbers
001
25 Apr 2028 · NDA 208010 · CALCIFEDIOL
US 9,925,147, product and use patent
patent.txt line 7,966
Flags
product use code U-2257
Product numbers
001
25 Apr 2028 · NDA 208010 · CALCIFEDIOL
US 9,925,147, product and use patent
patent.txt line 7,967
Flags
product use code U-2258
Product numbers
001
25 Apr 2028 · NDA 208010 · CALCIFEDIOL
US 9,925,147, product and use patent
patent.txt line 7,968
Flags
product use code U-2259
Product numbers
001
26 Apr 2028 · NDA 022421 · PRAMIPEXOLE DIHYDROCHLORIDE
US 7,695,734, product patent
patent.txt lines 1,861, 1,863, 1,865, 1,867, 1,869, 1,871, 1,873
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,525,045, use patent
patent.txt line 8,932
Flags
use code U-2371
Product numbers
001
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 10,925,866, use patent
patent.txt line 8,945
Flags
use code U-2371
Product numbers
001
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 11,033,538, use patent
patent.txt line 8,946
Flags
use code U-2371
Product numbers
001
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 12,599,595, use patent
patent.txt line 8,985
Flags
use code U-2371
Product numbers
001
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 9,999,618, use patent
patent.txt line 8,991
Flags
use code U-2372
Product numbers
001
28 Apr 2028 · NDA 208623 · MIGALASTAT HYDROCHLORIDE
US 9,999,618, use patent
patent.txt line 8,992
Flags
use code U-2373
Product numbers
001
29 Apr 2028 · NDA 205755 · CERITINIB
US 7,964,592, substance and product patent
patent.txt line 5,853
Flags
substance product
Product numbers
001
29 Apr 2028 · NDA 211225 · CERITINIB
US 7,964,592, substance and product patent
patent.txt line 12,549
Flags
substance product
Product numbers
001
29 Apr 2028 · NDA 214096 · TEPOTINIB HYDROCHLORIDE
US 9,284,300, product patent
patent.txt line 15,533
Flags
product
Product numbers
001
30 Apr 2028 · NDA 018612 · NICOTINE POLACRILEX
US 8,323,683, unflagged patent
patent.txt line 137
Flags
not flagged
Product numbers
002
30 Apr 2028 · NDA 020066 · NICOTINE POLACRILEX
US 8,323,683, product patent
patent.txt line 180
Flags
product
Product numbers
002
1 May 2028 · NDA 022036 · DOXEPIN HYDROCHLORIDE
US 9,107,898, use patent
patent.txt lines 943, 959
Flags
use code U-620
Product numbers
001, 002
1 May 2028 · NDA 203479 · CLOZAPINE
US 8,057,811, product patent
patent.txt line 3,943
Flags
product
Product numbers
001
2 May 2028 · NDA 208552 · OXYMETAZOLINE HYDROCHLORIDE
US 7,812,049, use patent
patent.txt line 8,677
Flags
use code U-1959
Product numbers
001
3 May 2028 · NDA 214133 · LEVOKETOCONAZOLE
US 9,918,984, use patent
patent.txt line 15,564
Flags
use code U-3283
Product numbers
001
4 May 2028 · NDA 216203 · SOTAGLIFLOZIN
US 7,781,577, substance and product and use patent
patent.txt lines 18,465, 18,468
Flags
substance product use code U-3628
Product numbers
001, 002
5 May 2028 · NDA 022387 · TREPROSTINIL
US 9,358,240, use patent
patent.txt line 1,768
Flags
use code U-1849
Product numbers
001
5 May 2028 · NDA 208712 · PACRITINIB CITRATE
US 9,573,964, use patent
patent.txt line 9,265
Flags
use code U-3331
Product numbers
001
5 May 2028 · NDA 208712 · PACRITINIB CITRATE
US 9,573,964, use patent
patent.txt line 9,266
Flags
use code U-3332
Product numbers
001
7 May 2028 · NDA 022563 · CALCIPOTRIENE
US 8,263,580, product and use patent
patent.txt line 2,092
Flags
product use code U-1280
Product numbers
001
7 May 2028 · NDA 022563 · CALCIPOTRIENE
US 8,263,580, product and use patent
patent.txt line 2,093
Flags
product use code U-2662
Product numbers
001
9 May 2028 · NDA 022526 · FLIBANSERIN
US 7,151,103, use patent
patent.txt line 2,048
Flags
use code U-1734
Product numbers
001
9 May 2028 · NDA 217564 · FRUQUINTINIB
US 8,212,033, use patent
patent.txt lines 20,003, 20,007
Flags
use code U-3753
Product numbers
001, 002
10 May 2028 · NDA 022535 · PIRFENIDONE
US 8,383,150, product and use patent
patent.txt line 2,068
Flags
product use code U-2361
Product numbers
001
10 May 2028 · NDA 208780 · PIRFENIDONE
US 8,383,150, product and use patent
patent.txt lines 9,347, 9,390, 9,433
Flags
product use code U-2361
Product numbers
001, 002, 003
15 May 2028 · NDA 206829 · CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US 7,129,232, substance and product and use patent
patent.txt line 6,798
Flags
substance product use code U-1676
Product numbers
001
15 May 2028 · NDA 206829 · CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US 7,129,232, substance and product and use patent
patent.txt line 6,799
Flags
substance product use code U-3360
Product numbers
001
15 May 2028 · NDA 206829 · CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US 7,129,232, substance and product and use patent
patent.txt line 6,800
Flags
substance product use code U-3361
Product numbers
001
15 May 2028 · NDA 206829 · CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US 7,129,232, substance and product and use patent
patent.txt line 6,801
Flags
substance product use code U-36
Product numbers
001
15 May 2028 · NDA 206829 · CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US 7,129,232, substance and product and use patent
patent.txt line 6,802
Flags
substance product use code U-4542
Product numbers
001
15 May 2028 · NDA 206829 · CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US 7,129,232, substance and product and use patent
patent.txt line 6,803
Flags
substance product use code U-4543
Product numbers
001
15 May 2028 · NDA 206829 · CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US 7,129,232, substance and product and use patent
patent.txt line 6,804
Flags
substance product use code U-4547
Product numbers
001
15 May 2028 · NDA 206829 · CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US 7,129,232, substance and product and use patent
patent.txt line 6,805
Flags
substance product use code U-4550
Product numbers
001
16 May 2028 · NDA 206333 · DEOXYCHOLIC ACID
US 8,242,294, substance patent
patent.txt line 6,481
Flags
substance
Product numbers
001
16 May 2028 · NDA 215429 · VENLAFAXINE BESYLATE
US 7,776,358, product patent
patent.txt line 16,911
Flags
product
Product numbers
001
23 May 2028 · NDA 021883 · DALBAVANCIN HYDROCHLORIDE
US 6,900,175, use patent
patent.txt line 761
Flags
use code U-3499
Product numbers
001
23 May 2028 · NDA 203255 · PASIREOTIDE PAMOATE
US 9,351,923, product patent
patent.txt lines 3,677, 3,680, 3,683, 3,686, 3,689
Flags
product
Product numbers
001, 002, 003, 004, 005
23 May 2028 · NDA 210872 · ISOPROPYL ALCOHOL
US 8,703,828, product patent
patent.txt line 12,271
Flags
product
Product numbers
001
23 May 2028 · NDA 210872 · ISOPROPYL ALCOHOL
US 9,629,368, use patent
patent.txt line 12,272
Flags
use code U-1397
Product numbers
001
29 May 2028 · NDA 216203 · SOTAGLIFLOZIN
US 8,476,413, substance and product and use patent
patent.txt lines 18,467, 18,470
Flags
substance product use code U-3628
Product numbers
001, 002
30 May 2028 · NDA 201917 · TELAPREVIR
US 8,431,615, use patent
patent.txt line 2,595
Flags
use code U-1398
Product numbers
001
30 May 2028 · NDA 206406 · TACROLIMUS
US 10,166,190, product patent
patent.txt lines 6,497, 6,512, 6,527
Flags
product
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 10,864,199, use patent
patent.txt lines 6,498, 6,513, 6,528
Flags
use code U-2677
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 10,864,199, use patent
patent.txt lines 6,499, 6,514, 6,529
Flags
use code U-2678
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 11,110,081, use patent
patent.txt lines 6,500, 6,515, 6,530
Flags
use code U-2678
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 11,123,331, use patent
patent.txt lines 6,501, 6,516, 6,531
Flags
use code U-2677
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 11,419,823, product patent
patent.txt lines 6,502, 6,517, 6,532
Flags
product
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 12,083,103, use patent
patent.txt lines 6,503, 6,518, 6,533
Flags
use code U-2678
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 12,403,095, product patent
patent.txt lines 6,504, 6,519, 6,534
Flags
product
Product numbers
001, 002, 003
30 May 2028 · NDA 206406 · TACROLIMUS
US 9,549,918, product patent
patent.txt lines 6,511, 6,526, 6,541
Flags
product
Product numbers
001, 002, 003
30 May 2028 · NDA 214096 · TEPOTINIB HYDROCHLORIDE
US 8,921,357, substance and product patent
patent.txt line 15,530
Flags
substance product
Product numbers
001
31 May 2028 · NDA 022502 · ADAPALENE
US 7,998,467, product and use patent
patent.txt line 2,002
Flags
product use code U-1078
Product numbers
001
3 Jun 2028 · NDA 018708 · QUAZEPAM
US 7,608,616, use patent
patent.txt lines 141–142
Flags
use code U-1012
Product numbers
001, 003
3 Jun 2028 · NDA 207318 · PIMAVANSERIN TARTRATE
US 7,732,615, substance and product patent
patent.txt lines 7,236, 7,245
Flags
substance product
Product numbers
001, 002
3 Jun 2028 · NDA 210793 · PIMAVANSERIN TARTRATE
US 7,732,615, substance and product patent
patent.txt line 12,150
Flags
substance product
Product numbers
001
4 Jun 2028 · NDA 022203 · AZELASTINE HYDROCHLORIDE
US 8,071,073, product patent
patent.txt lines 1,338–1,339
Flags
product
Product numbers
001, 002
4 Jun 2028 · NDA 211580 · INDOCYANINE GREEN
US 8,185,176, use patent
patent.txt line 12,887
Flags
use code U-2462
Product numbers
001
4 Jun 2028 · NDA 213872 · AZELASTINE HYDROCHLORIDE
US 8,071,073, product patent
patent.txt lines 15,284–15,285
Flags
product
Product numbers
001, 002
6 Jun 2028 · NDA 021252 · MESALAMINE
US 8,217,083, product patent
patent.txt line 506
Flags
product
Product numbers
002
6 Jun 2028 · NDA 021252 · MESALAMINE
US 8,436,051, product patent
patent.txt line 507
Flags
product
Product numbers
002
8 Jun 2028 · NDA 021925 · GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
US 8,071,130, product patent
patent.txt lines 801, 803
Flags
product
Product numbers
001, 002
9 Jun 2028 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
US 8,895,057, use patent
patent.txt lines 2,111, 2,117, 2,123, 2,129
Flags
use code U-3398
Product numbers
001, 002, 003, 004
9 Jun 2028 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
US 8,895,058, product patent
patent.txt lines 2,112, 2,118, 2,124, 2,130
Flags
product
Product numbers
001, 002, 003, 004
9 Jun 2028 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
US 9,011,905, product patent
patent.txt lines 2,113, 2,119, 2,125, 2,131
Flags
product
Product numbers
001, 002, 003, 004
9 Jun 2028 · NDA 022580 · PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
US 9,011,906, use patent
patent.txt lines 2,114, 2,120, 2,126, 2,132
Flags
use code U-3398
Product numbers
001, 002, 003, 004
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 10,016,429, use patent
patent.txt lines 2,802, 2,831, 2,860, 2,889, 2,918
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 10,016,429, use patent
patent.txt lines 2,803, 2,832, 2,861, 2,890, 2,919
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,722,693, substance and product patent
patent.txt lines 2,810, 2,839, 2,868, 2,897, 2,926
Flags
substance product
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 2,812, 2,841, 2,870, 2,899, 2,928
Flags
use code U-1573
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 2,813, 2,842, 2,871, 2,900, 2,929
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 2,814, 2,843, 2,872, 2,901, 2,930
Flags
use code U-3227
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 2,815, 2,844, 2,873, 2,902, 2,931
Flags
use code U-3228
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 2,816, 2,845, 2,874, 2,903, 2,932
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 2,818, 2,847, 2,876, 2,905, 2,934
Flags
use code U-1201
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 2,819, 2,848, 2,877, 2,906, 2,935
Flags
use code U-1622
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 2,820, 2,849, 2,878, 2,907, 2,936
Flags
use code U-3227
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 2,821, 2,850, 2,879, 2,908, 2,937
Flags
use code U-3228
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 10,610,530, use patent
patent.txt line 16,733
Flags
use code U-3229
Product numbers
001
12 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 10,610,530, use patent
patent.txt line 16,734
Flags
use code U-3404
Product numbers
001
12 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,722,693, substance and product patent
patent.txt line 16,761
Flags
substance product
Product numbers
001
12 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt line 16,763
Flags
use code U-3229
Product numbers
001
12 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt line 16,764
Flags
use code U-3404
Product numbers
001
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 10,016,429, use patent
patent.txt lines 19,290, 19,343, 19,396, 19,449, 19,502
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 10,016,429, use patent
patent.txt lines 19,291, 19,344, 19,397, 19,450, 19,503
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 11,213,528, product patent
patent.txt lines 19,295, 19,348, 19,401, 19,454, 19,507
Flags
product
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,722,693, substance and product patent
patent.txt lines 19,325, 19,378, 19,431, 19,484, 19,537
Flags
substance product
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 19,327, 19,380, 19,433, 19,486, 19,539
Flags
use code U-3226
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 19,328, 19,381, 19,434, 19,487, 19,540
Flags
use code U-3227
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 19,329, 19,382, 19,435, 19,488, 19,541
Flags
use code U-3228
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,822,481, use patent
patent.txt lines 19,330, 19,383, 19,436, 19,489, 19,542
Flags
use code U-3230
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 19,332, 19,385, 19,438, 19,491, 19,544
Flags
use code U-3227
Product numbers
001, 002, 003, 004, 005
12 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,829,013, use patent
patent.txt lines 19,333, 19,386, 19,439, 19,492, 19,545
Flags
use code U-3228
Product numbers
001, 002, 003, 004, 005
13 Jun 2028 · NDA 205353 · PANOBINOSTAT LACTATE
US 8,883,842, use patent
patent.txt lines 5,282, 5,284, 5,286
Flags
use code U-1669
Product numbers
001, 002, 003
15 Jun 2028 · NDA 021947 · FENTANYL CITRATE
US 7,862,832, product patent
patent.txt lines 821, 823, 825, 827, 829
Flags
product
Product numbers
001, 002, 003, 004, 005
15 Jun 2028 · NDA 021947 · FENTANYL CITRATE
US 7,862,833, product patent
patent.txt lines 822, 824, 826, 828, 830
Flags
product
Product numbers
001, 002, 003, 004, 005
17 Jun 2028 · NDA 209092 · RIBOCICLIB SUCCINATE
US 8,324,225, substance and product patent
patent.txt line 9,697
Flags
substance product
Product numbers
001
17 Jun 2028 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
US 8,324,225, substance and product patent
patent.txt line 11,042
Flags
substance product
Product numbers
001
19 Jun 2028 · NDA 218571 · ETRIPAMIL
US 10,010,522, use patent
patent.txt line 21,116
Flags
use code U-38
Product numbers
001
19 Jun 2028 · NDA 218571 · ETRIPAMIL
US 10,010,523, substance patent
patent.txt line 21,117
Flags
substance
Product numbers
001
19 Jun 2028 · NDA 218571 · ETRIPAMIL
US 9,227,918, product patent
patent.txt line 21,120
Flags
product
Product numbers
001
19 Jun 2028 · NDA 218571 · ETRIPAMIL
US 9,463,179, use patent
patent.txt line 21,121
Flags
use code U-4370
Product numbers
001
20 Jun 2028 · NDA 205435 · TEDIZOLID PHOSPHATE
US 7,816,379, substance and product and use patent
patent.txt line 5,385
Flags
substance product use code U-2507
Product numbers
001
20 Jun 2028 · NDA 205436 · TEDIZOLID PHOSPHATE
US 7,816,379, substance and product and use patent
patent.txt line 5,392
Flags
substance product use code U-2507
Product numbers
001
20 Jun 2028 · NDA 205739 · PATIROMER SORBITEX CALCIUM
US 8,147,873, product patent
patent.txt lines 5,825, 5,832, 5,839, 5,846
Flags
product
Product numbers
001, 002, 003, 004
21 Jun 2028 · NDA 215168 · FLURPIRIDAZ F-18
US 8,226,929, use patent
patent.txt line 16,508
Flags
use code U-4011
Product numbers
001
22 Jun 2028 · NDA 021892 · SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
US 7,687,075, substance and product patent
patent.txt line 762
Flags
substance product
Product numbers
001
27 Jun 2028 · NDA 022271 · ALOGLIPTIN BENZOATE
US 7,807,689, substance and product and use patent
patent.txt lines 1,435, 1,437, 1,439
Flags
substance product use code U-1337
Product numbers
001, 002, 003
27 Jun 2028 · NDA 022426 · ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
US 7,807,689, substance and product and use patent
patent.txt lines 1,880, 1,882, 1,884, 1,886, 1,888, 1,890
Flags
substance product use code U-1337
Product numbers
001, 002, 003, 004, 005, 006
27 Jun 2028 · NDA 203414 · ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
US 7,807,689, substance and product and use patent
patent.txt lines 3,853, 3,855
Flags
substance product use code U-1337
Product numbers
001, 002
27 Jun 2028 · NDA 205223 · METRONIDAZOLE
US 8,658,678, use patent
patent.txt line 5,274
Flags
use code U-1682
Product numbers
001
28 Jun 2028 · NDA 211970 · GOLODIRSEN
US RE47691, product patent
patent.txt line 13,310
Flags
product
Product numbers
001
29 Jun 2028 · NDA 210656 · GLASDEGIB MALEATE
US 8,431,597, product patent
patent.txt lines 12,087, 12,092
Flags
product
Product numbers
001, 002
30 Jun 2028 · NDA 212327 · FEDRATINIB HYDROCHLORIDE
US 8,138,199, use patent
patent.txt line 13,953
Flags
use code U-2607
Product numbers
001

Pediatric exclusivity, as listed (40)

14 Jan 2028 · NDA 204042 · CANAGLIFLOZIN
US 7,943,788 with pediatric exclusivity, as listed
patent.txt lines 4,236, 4,246
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
14 Jan 2028 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,788 with pediatric exclusivity, as listed
patent.txt lines 4,511, 4,522, 4,533, 4,544
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
14 Jan 2028 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 7,943,788 with pediatric exclusivity, as listed
patent.txt lines 6,003, 6,013, 6,023, 6,033
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
27 Jan 2028 · NDA 206947 · LENVATINIB MESYLATE
US 9,006,256 with pediatric exclusivity, as listed
patent.txt lines 6,893, 6,914
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
31 Jan 2028 · NDA 201699 · FIDAXOMICIN
US 7,378,508 with pediatric exclusivity, as listed
patent.txt line 2,550
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
31 Jan 2028 · NDA 201699 · FIDAXOMICIN
US 7,863,249 with pediatric exclusivity, as listed
patent.txt line 2,552
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
31 Jan 2028 · NDA 201699 · FIDAXOMICIN
US 8,859,510 with pediatric exclusivity, as listed
patent.txt line 2,557
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
31 Jan 2028 · NDA 213138 · FIDAXOMICIN
US 7,378,508 with pediatric exclusivity, as listed
patent.txt line 14,692
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
31 Jan 2028 · NDA 213138 · FIDAXOMICIN
US 7,863,249 with pediatric exclusivity, as listed
patent.txt line 14,694
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
31 Jan 2028 · NDA 213138 · FIDAXOMICIN
US 8,859,510 with pediatric exclusivity, as listed
patent.txt line 14,698
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Feb 2028 · NDA 203188 · IVACAFTOR
US 8,324,242 with pediatric exclusivity, as listed
patent.txt line 3,659
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Feb 2028 · NDA 206038 · IVACAFTOR; LUMACAFTOR
US 8,324,242 with pediatric exclusivity, as listed
patent.txt lines 6,097, 6,145
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
5 Feb 2028 · NDA 207925 · IVACAFTOR
US 8,324,242 with pediatric exclusivity, as listed
patent.txt lines 7,507, 7,540, 7,573, 7,606, 7,634
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
5 Feb 2028 · NDA 211358 · IVACAFTOR; LUMACAFTOR
US 8,324,242 with pediatric exclusivity, as listed
patent.txt lines 12,729, 12,771, 12,813
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
14 Mar 2028 · NDA 207500 · ISAVUCONAZONIUM SULFATE
US 10,206,879 with pediatric exclusivity, as listed
patent.txt lines 7,260, 7,266
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
14 Mar 2028 · NDA 207500 · ISAVUCONAZONIUM SULFATE
US 10,603,280 with pediatric exclusivity, as listed
patent.txt lines 7,262, 7,268
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
14 Mar 2028 · NDA 209401 · CYTARABINE; DAUNORUBICIN
US 8,022,279 with pediatric exclusivity, as listed
patent.txt line 10,335
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001
22 Mar 2028 · NDA 203389 · CYSTEAMINE BITARTRATE
US 8,026,284 with pediatric exclusivity, as listed
patent.txt lines 3,813, 3,837
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
22 Mar 2028 · NDA 213491 · CYSTEAMINE BITARTRATE
US 8,026,284 with pediatric exclusivity, as listed
patent.txt lines 15,028, 15,052
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
25 Mar 2028 · NDA 022068 · NILOTINIB HYDROCHLORIDE
US 8,293,756 with pediatric exclusivity, as listed
patent.txt lines 996, 1,010, 1,024
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
5 Apr 2028 · NDA 204790 · DOLUTEGRAVIR SODIUM
US 8,129,385 with pediatric exclusivity, as listed
patent.txt lines 5,003, 5,007, 5,011
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
5 Apr 2028 · NDA 205551 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385 with pediatric exclusivity, as listed
patent.txt line 5,463
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Apr 2028 · NDA 210192 · DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
US 8,129,385 with pediatric exclusivity, as listed
patent.txt line 11,206
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Apr 2028 · NDA 211994 · DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385 with pediatric exclusivity, as listed
patent.txt line 13,376
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Apr 2028 · NDA 213983 · DOLUTEGRAVIR SODIUM
US 8,129,385 with pediatric exclusivity, as listed
patent.txt line 15,418
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
5 Apr 2028 · NDA 215413 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
US 8,129,385 with pediatric exclusivity, as listed
patent.txt line 16,885
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
12 Apr 2028 · NDA 205598 · MACIMORELIN ACETATE
US 8,192,719 with pediatric exclusivity, as listed
patent.txt line 5,696
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
13 May 2028 · NDA 205552 · IBRUTINIB
US 8,008,309 with pediatric exclusivity, as listed
patent.txt lines 5,509, 5,606
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
13 May 2028 · NDA 210563 · IBRUTINIB
US 8,008,309 with pediatric exclusivity, as listed
patent.txt lines 11,632, 11,736, 11,840, 11,942
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
13 May 2028 · NDA 217003 · IBRUTINIB
US 8,008,309 with pediatric exclusivity, as listed
patent.txt line 19,180
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
3 Jun 2028 · NDA 204042 · CANAGLIFLOZIN
US 8,513,202 with pediatric exclusivity, as listed
patent.txt lines 4,238, 4,248
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
3 Jun 2028 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202 with pediatric exclusivity, as listed
patent.txt lines 4,513, 4,524, 4,535, 4,546
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
3 Jun 2028 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 8,513,202 with pediatric exclusivity, as listed
patent.txt lines 6,005, 6,015, 6,025, 6,035
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
7 Jun 2028 · NDA 202714 · CARFILZOMIB
US 7,737,112 with pediatric exclusivity, as listed
patent.txt lines 3,140, 3,150, 3,160
Flags
product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
24 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 7,598,257 with pediatric exclusivity, as listed
patent.txt lines 2,804, 2,833, 2,862, 2,891, 2,920
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
24 Jun 2028 · NDA 202192 · RUXOLITINIB PHOSPHATE
US 8,415,362 with pediatric exclusivity, as listed
patent.txt lines 2,807, 2,836, 2,865, 2,894, 2,923
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
24 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 7,598,257 with pediatric exclusivity, as listed
patent.txt line 16,756
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
24 Jun 2028 · NDA 215309 · RUXOLITINIB PHOSPHATE
US 8,415,362 with pediatric exclusivity, as listed
patent.txt line 16,758
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001
24 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 7,598,257 with pediatric exclusivity, as listed
patent.txt lines 19,318, 19,371, 19,424, 19,477, 19,530
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005
24 Jun 2028 · NDA 217180 · RUXOLITINIB PHOSPHATE
US 8,415,362 with pediatric exclusivity, as listed
patent.txt lines 19,321, 19,374, 19,427, 19,480, 19,533
Flags
substance product pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004, 005

Non-patent exclusivity (113)

1 Jan 2028 · NDA 205109 · FERRIC OXYHYDROXIDE
PED exclusivity
exclusivity.txt line 449
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
14 Jan 2028 · NDA 202570 · CRIZOTINIB
ODE-328 exclusivity
exclusivity.txt lines 276, 278
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
16 Jan 2028 · NDA 210259 · ACALABRUTINIB
I-960 exclusivity
exclusivity.txt line 869
Definition
New indication (to be checked against FDA's list)
Product numbers
001
16 Jan 2028 · NDA 214665 · SOTORASIB
I-962 exclusivity
exclusivity.txt lines 1,358, 1,362, 1,366
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003
16 Jan 2028 · NDA 216387 · ACALABRUTINIB MALEATE
I-960 exclusivity
exclusivity.txt line 1,752
Definition
New indication (to be checked against FDA's list)
Product numbers
001
17 Jan 2028 · NDA 211243 · ESKETAMINE HYDROCHLORIDE
I-959 exclusivity
exclusivity.txt line 950
Definition
New indication (to be checked against FDA's list)
Product numbers
001
20 Jan 2028 · NDA 214373 · BEXAGLIFLOZIN
NCE exclusivity
exclusivity.txt line 1,320
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
21 Jan 2028 · NDA 212690 · CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
PED exclusivity
exclusivity.txt line 1,105
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
22 Jan 2028 · NDA 022562 · CARGLUMIC ACID
ODE-345 exclusivity
exclusivity.txt line 202
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
27 Jan 2028 · NDA 216059 · PIRTOBRUTINIB
NCE exclusivity
exclusivity.txt lines 1,714, 1,719
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
27 Jan 2028 · NDA 217639 · ELACESTRANT HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 1,898–1,899
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
28 Jan 2028 · NDA 209637 · SEMAGLUTIDE
I-961 exclusivity
exclusivity.txt lines 797–800
Definition
New indication (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
30 Jan 2028 · NDA 215431 · MELOXICAM; RIZATRIPTAN BENZOATE
NP exclusivity
exclusivity.txt line 1,565
Definition
New product (to be checked against FDA's list)
Product numbers
001
31 Jan 2028 · NDA 217188 · NIRMATRELVIR; RITONAVIR
D-195 exclusivity
exclusivity.txt line 1,858
Definition
New dosing schedule (to be checked against FDA's list)
Product numbers
001
1 Feb 2028 · NDA 216951 · DAPRODUSTAT
NCE exclusivity
exclusivity.txt lines 1,803–1,807
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
3 Feb 2028 · NDA 214056 · APOMORPHINE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 1,295
Definition
New product (to be checked against FDA's list)
Product numbers
001
3 Feb 2028 · NDA 214096 · TEPOTINIB HYDROCHLORIDE
ODE-325 exclusivity
exclusivity.txt line 1,303
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
7 Feb 2028 · NDA 210867 · MOXIDECTIN
NPP exclusivity
exclusivity.txt line 921
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
7 Feb 2028 · NDA 217906 · AVIBACTAM SODIUM; AZTREONAM
NP exclusivity
exclusivity.txt line 2,028
Definition
New product (to be checked against FDA's list)
Product numbers
001
17 Feb 2028 · NDA 216403 · SPARSENTAN
NCE exclusivity
exclusivity.txt lines 1,754, 1,758
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
21 Feb 2028 · NDA 203214 · TOFACITINIB CITRATE
M-14 exclusivity
exclusivity.txt line 305
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
21 Feb 2028 · NDA 209819 · BUPRENORPHINE
M-314 exclusivity
exclusivity.txt lines 809–810
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
21 Feb 2028 · NDA 213082 · TOFACITINIB CITRATE
M-14 exclusivity
exclusivity.txt line 1,153
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
21 Feb 2028 · NDA 219488 · CHENODIOL
NP exclusivity
exclusivity.txt line 2,297
Definition
New product (to be checked against FDA's list)
Product numbers
001
24 Feb 2028 · NDA 218201 · COPPER
NP exclusivity
exclusivity.txt line 2,125
Definition
New product (to be checked against FDA's list)
Product numbers
001
25 Feb 2028 · NDA 213026 · CASIMERSEN
ODE-347 exclusivity
exclusivity.txt line 1,145
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
26 Feb 2028 · NDA 214018 · FOSDENOPTERIN HYDROBROMIDE
ODE-342 exclusivity
exclusivity.txt line 1,293
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
28 Feb 2028 · NDA 204410 · MACITENTAN
M-187 exclusivity
exclusivity.txt line 426
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001
28 Feb 2028 · NDA 216718 · OMAVELOXOLONE
NCE exclusivity
exclusivity.txt line 1,785
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
3 Mar 2028 · NDA 210868 · LORLATINIB
ODE-349 exclusivity
exclusivity.txt lines 923–924
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
9 Mar 2028 · NDA 216386 · ZAVEGEPANT HYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 1,750
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
10 Mar 2028 · NDA 217026 · TROFINETIDE
NCE exclusivity
exclusivity.txt line 1,835
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
10 Mar 2028 · NDA 219884 · TROFINETIDE
NCE exclusivity
exclusivity.txt lines 2,342, 2,346, 2,350
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
17 Mar 2028 · NDA 209092 · RIBOCICLIB SUCCINATE
PED exclusivity
exclusivity.txt line 763
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
17 Mar 2028 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE
PED exclusivity
exclusivity.txt line 817
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
17 Mar 2028 · NDA 210134 · GLUCAGON
NPP exclusivity
exclusivity.txt line 846
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
20 Mar 2028 · NDA 215515 · VUTRISIRAN SODIUM
I-964 exclusivity
exclusivity.txt line 1,587
Definition
New indication (to be checked against FDA's list)
Product numbers
001
20 Mar 2028 · NDA 218276 · IPTACOPAN HYDROCHLORIDE
I-963 exclusivity
exclusivity.txt line 2,138
Definition
New indication (to be checked against FDA's list)
Product numbers
001
22 Mar 2028 · NDA 217417 · REZAFUNGIN ACETATE
NCE exclusivity
exclusivity.txt line 1,875
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
24 Mar 2028 · NDA 217759 · LENIOLISIB PHOSPHATE
NCE exclusivity
exclusivity.txt lines 1,928, 1,931, 1,934
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002, 003
26 Mar 2028 · NDA 216665 · DIAZOXIDE CHOLINE
NP exclusivity
exclusivity.txt lines 1,777, 1,779, 1,781
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002, 003
27 Mar 2028 · NDA 213246 · SELPERCATINIB
PED exclusivity
exclusivity.txt lines 1,182–1,183, 1,204–1,205
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
27 Mar 2028 · NDA 215842 · NEDOSIRAN SODIUM
NPP exclusivity
exclusivity.txt lines 1,614, 1,618, 1,622
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003
27 Mar 2028 · NDA 218160 · SELPERCATINIB
PED exclusivity
exclusivity.txt lines 2,051–2,052, 2,071–2,072, 2,091–2,092, 2,111–2,112
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
28 Mar 2028 · NDA 215833 · LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
I-965 exclusivity
exclusivity.txt line 1,610
Definition
New indication (to be checked against FDA's list)
Product numbers
001
30 Mar 2028 · NDA 209401 · CYTARABINE; DAUNORUBICIN
ODE-350 exclusivity
exclusivity.txt line 782
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
4 Apr 2028 · NDA 205435 · TEDIZOLID PHOSPHATE
NPP exclusivity
exclusivity.txt line 480
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
4 Apr 2028 · NDA 205436 · TEDIZOLID PHOSPHATE
NPP exclusivity
exclusivity.txt line 481
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
7 Apr 2028 · NDA 208742 · DEXAMETHASONE
NPP exclusivity
exclusivity.txt line 754
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
15 Apr 2028 · NDA 211635 · DIAZEPAM
NPP exclusivity
exclusivity.txt lines 970, 972, 974
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003
17 Apr 2028 · NDA 202155 · APIXABAN
NPP exclusivity
exclusivity.txt lines 231, 233
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002
17 Apr 2028 · NDA 202155 · APIXABAN
NS exclusivity
exclusivity.txt line 235
Definition
New strength (to be checked against FDA's list)
Product numbers
003
17 Apr 2028 · NDA 220073 · APIXABAN
NP exclusivity
exclusivity.txt line 2,372
Definition
New product (to be checked against FDA's list)
Product numbers
001
25 Apr 2028 · NDA 215887 · TOFERSEN
NCE exclusivity
exclusivity.txt line 1,667
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
28 Apr 2028 · NDA 211675 · UPADACITINIB
I-966 exclusivity
exclusivity.txt line 985
Definition
New indication (to be checked against FDA's list)
Product numbers
001
30 Apr 2028 · NDA 021825 · DEFERIPRONE
ODE-417 exclusivity
exclusivity.txt lines 125, 128
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
30 Apr 2028 · NDA 021825 · DEFERIPRONE
ODE-420 exclusivity
exclusivity.txt lines 126, 129
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
30 Apr 2028 · NDA 021825 · DEFERIPRONE
ODE-421 exclusivity
exclusivity.txt lines 127, 130
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
30 Apr 2028 · NDA 208030 · DEFERIPRONE
ODE-417 exclusivity
exclusivity.txt lines 682, 685
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
30 Apr 2028 · NDA 208030 · DEFERIPRONE
ODE-418 exclusivity
exclusivity.txt lines 683, 686
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
30 Apr 2028 · NDA 208030 · DEFERIPRONE
ODE-419 exclusivity
exclusivity.txt lines 684, 687
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
30 Apr 2028 · NDA 212269 · DEFERIPRONE
ODE-417 exclusivity
exclusivity.txt line 1,029
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
30 Apr 2028 · NDA 212269 · DEFERIPRONE
ODE-420 exclusivity
exclusivity.txt line 1,030
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
30 Apr 2028 · NDA 212269 · DEFERIPRONE
ODE-421 exclusivity
exclusivity.txt line 1,031
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
30 Apr 2028 · NDA 217901 · DIHYDROERGOTAMINE MESYLATE
NP exclusivity
exclusivity.txt line 2,026
Definition
New product (to be checked against FDA's list)
Product numbers
001
9 May 2028 · NDA 020899 · ALBUMIN HUMAN
NPP exclusivity
exclusivity.txt line 111
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
9 May 2028 · NDA 205422 · BREXPIPRAZOLE
M-315 exclusivity
exclusivity.txt lines 452, 457, 462, 467, 472, 477
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005, 006
12 May 2028 · NDA 216578 · FEZOLINETANT
NCE exclusivity
exclusivity.txt line 1,769
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
14 May 2028 · NDA 215014 · PEGCETACOPLAN
ODE-351 exclusivity
exclusivity.txt line 1,461
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
14 May 2028 · NDA 215383 · BELZUTIFAN
I-968 exclusivity
exclusivity.txt line 1,555
Definition
New indication (to be checked against FDA's list)
Product numbers
001
18 May 2028 · NDA 216675 · PERFLUOROHEXYLOCTANE
NCE exclusivity
exclusivity.txt line 1,783
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
22 May 2028 · NDA 202714 · CARFILZOMIB
M-14 exclusivity
exclusivity.txt lines 280, 282, 284
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
22 May 2028 · NDA 207925 · IVACAFTOR
M-14 exclusivity
exclusivity.txt lines 626, 632, 638, 644, 650
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
22 May 2028 · NDA 217242 · ROFLUMILAST
I-969 exclusivity
exclusivity.txt line 1,862
Definition
New indication (to be checked against FDA's list)
Product numbers
001
23 May 2028 · NDA 213005 · TREPROSTINIL SODIUM
NP exclusivity
exclusivity.txt lines 1,139–1,142
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
23 May 2028 · NDA 216974 · DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM
NCE exclusivity
exclusivity.txt line 1,812
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
25 May 2028 · NDA 216023 · FLOTUFOLASTAT F-18 GALLIUM
NCE exclusivity
exclusivity.txt line 1,712
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
25 May 2028 · NDA 217188 · NIRMATRELVIR; RITONAVIR
NCE exclusivity
exclusivity.txt line 1,859
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
26 May 2028 · NDA 216203 · SOTAGLIFLOZIN
NCE exclusivity
exclusivity.txt lines 1,745–1,746
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001, 002
28 May 2028 · NDA 214622 · INFIGRATINIB PHOSPHATE
ODE-353 exclusivity
exclusivity.txt lines 1,344, 1,346
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
28 May 2028 · NDA 214665 · SOTORASIB
ODE-352 exclusivity
exclusivity.txt lines 1,360, 1,364
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
28 May 2028 · NDA 214665 · SOTORASIB
ODE* exclusivity
exclusivity.txt line 1,368
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
003
3 Jun 2028 · NDA 212099 · DAROLUTAMIDE
I-971 exclusivity
exclusivity.txt line 1,020
Definition
New indication (to be checked against FDA's list)
Product numbers
001
3 Jun 2028 · NDA 214094 · BEROTRALSTAT DIHYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 1,299, 1,301
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
4 Jun 2028 · NDA 214460 · BRINCIDOFOVIR
ODE-354 exclusivity
exclusivity.txt line 1,333
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
4 Jun 2028 · NDA 214461 · BRINCIDOFOVIR
ODE-354 exclusivity
exclusivity.txt line 1,334
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
5 Jun 2028 · NDA 219423 · AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
NP exclusivity
exclusivity.txt lines 2,283–2,285
Definition
New product (to be checked against FDA's list)
Product numbers
001, 002, 003
8 Jun 2028 · NDA 212273 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
ODE-357 exclusivity
exclusivity.txt lines 1,037, 1,043
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002
10 Jun 2028 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
I-967 exclusivity
exclusivity.txt line 775
Definition
New indication (to be checked against FDA's list)
Product numbers
001
10 Jun 2028 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
ODE-372 exclusivity
exclusivity.txt line 778
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
10 Jun 2028 · NDA 214187 · SOFOSBUVIR; VELPATASVIR
ODE-376 exclusivity
exclusivity.txt line 1,311
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
10 Jun 2028 · NDA 215110 · GLECAPREVIR; PIBRENTASVIR
I-967 exclusivity
exclusivity.txt line 1,473
Definition
New indication (to be checked against FDA's list)
Product numbers
001
10 Jun 2028 · NDA 215110 · GLECAPREVIR; PIBRENTASVIR
ODE-372 exclusivity
exclusivity.txt line 1,474
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
11 Jun 2028 · NDA 020862 · DOXERCALCIFEROL
M-14 exclusivity
exclusivity.txt lines 108–110
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
12 Jun 2028 · NDA 022225 · SUGAMMADEX SODIUM
PED exclusivity
exclusivity.txt lines 171, 173
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
12 Jun 2028 · NDA 215793 · MITOMYCIN
NP exclusivity
exclusivity.txt line 1,606
Definition
New product (to be checked against FDA's list)
Product numbers
001
13 Jun 2028 · NDA 211358 · IVACAFTOR; LUMACAFTOR
PED exclusivity
exclusivity.txt lines 954, 958, 962
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
16 Jun 2028 · NDA 212608 · AVAPRITINIB
ODE-356 exclusivity
exclusivity.txt lines 1,087, 1,090, 1,093, 1,097, 1,100
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005
17 Jun 2028 · NDA 205053 · POSACONAZOLE
ODE-355 exclusivity
exclusivity.txt line 447
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
17 Jun 2028 · NDA 205596 · POSACONAZOLE
ODE-355 exclusivity
exclusivity.txt line 511
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
18 Jun 2028 · NDA 204042 · CANAGLIFLOZIN
PED exclusivity
exclusivity.txt lines 365, 367
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002
18 Jun 2028 · NDA 204353 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 389, 391, 393, 395
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
18 Jun 2028 · NDA 205879 · CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
PED exclusivity
exclusivity.txt lines 537, 539, 541, 543
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
18 Jun 2028 · NDA 220018 · LENACAPAVIR SODIUM
NP exclusivity
exclusivity.txt line 2,369
Definition
New product (to be checked against FDA's list)
Product numbers
001
18 Jun 2028 · NDA 220020 · LENACAPAVIR SODIUM
NP exclusivity
exclusivity.txt line 2,371
Definition
New product (to be checked against FDA's list)
Product numbers
001
20 Jun 2028 · NDA 203094 · COBICISTAT
NPP exclusivity
exclusivity.txt line 299
Definition
New patient population (to be checked against FDA's list)
Product numbers
001
20 Jun 2028 · NDA 203094 · COBICISTAT
NS exclusivity
exclusivity.txt line 301
Definition
New strength (to be checked against FDA's list)
Product numbers
002
20 Jun 2028 · NDA 208215 · EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
M-316 exclusivity
exclusivity.txt lines 696, 698
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002
21 Jun 2028 · NDA 203188 · IVACAFTOR
PED exclusivity
exclusivity.txt line 304
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
21 Jun 2028 · NDA 207925 · IVACAFTOR
PED exclusivity
exclusivity.txt lines 629, 635, 641
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003
23 Jun 2028 · NDA 214965 · CYCLOSPORINE
ODE-358 exclusivity
exclusivity.txt line 1,438
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
23 Jun 2028 · NDA 215830 · RITLECITINIB TOSYLATE
NCE exclusivity
exclusivity.txt line 1,609
Definition
New chemical entity (to be checked against FDA's list)
Product numbers
001
25 Jun 2028 · NDA 210303 · PLAZOMICIN SULFATE
GAIN exclusivity
exclusivity.txt line 871
Definition
Generating Antibiotic Incentives Now (to be checked against FDA's list)
Product numbers
001