Drybench Patent.
Patent and exclusivity dates from January to June 2026 for NDAs, as FDA's Orange Book lists them
Each patent and exclusivity date from January to June 2026 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, 2026July to December 2026
Listed patent expiry (222)
7 Jan 2026 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 7,112,592, substance and product and use patent
patent.txt line 6,573- Flags
- substance product use code U-2244
- Product numbers
- 001
7 Jan 2026 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 7,112,592, substance and product and use patent
patent.txt line 6,574- Flags
- substance product use code U-2508
- Product numbers
- 001
7 Jan 2026 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 7,112,592, substance and product and use patent
patent.txt line 6,575- Flags
- substance product use code U-282
- Product numbers
- 001
7 Jan 2026 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME
US 7,112,592, substance and product and use patent
patent.txt line 6,576- Flags
- substance product use code U-3818
- Product numbers
- 001
7 Jan 2026 · NDA 217906 · AVIBACTAM SODIUM; AZTREONAM
US 7,112,592, substance and product and use patent
patent.txt line 20,771- Flags
- substance product use code U-4147
- Product numbers
- 001
8 Jan 2026 · NDA 205832 · NINTEDANIB ESYLATE
US 10,154,990, use patent
patent.txt lines 5,895, 5,903- Flags
- use code U-2620
- Product numbers
- 001, 002
10 Jan 2026 · NDA 214133 · LEVOKETOCONAZOLE
US 10,098,877, use patent
patent.txt line 15,556- Flags
- use code U-3283
- Product numbers
- 001
10 Jan 2026 · NDA 214133 · LEVOKETOCONAZOLE
US 10,517,868, use patent
patent.txt line 15,557- Flags
- use code U-3283
- Product numbers
- 001
10 Jan 2026 · NDA 214133 · LEVOKETOCONAZOLE
US 10,835,530, use patent
patent.txt line 15,558- Flags
- use code U-3283
- Product numbers
- 001
10 Jan 2026 · NDA 214133 · LEVOKETOCONAZOLE
US 11,478,471, use patent
patent.txt line 15,561- Flags
- use code U-3283
- Product numbers
- 001
11 Jan 2026 · NDA 204168 · LEVOMILNACIPRAN HYDROCHLORIDE
US RE43879, use patent
patent.txt lines 4,339, 4,342, 4,345, 4,348- Flags
- use code U-839
- Product numbers
- 001, 002, 003, 004
12 Jan 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,609,863, product patent
patent.txt lines 1,366, 1,383- Flags
- product
- Product numbers
- 001, 002
12 Jan 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,791,270, product and use patent
patent.txt lines 1,370, 1,387, 1,400, 1,406- Flags
- product use code U-1542
- Product numbers
- 001, 002, 003, 004
12 Jan 2026 · NDA 022249 · BENDAMUSTINE HYDROCHLORIDE
US 8,895,756, product patent
patent.txt lines 1,374, 1,391- Flags
- product
- Product numbers
- 001, 002
12 Jan 2026 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 8,791,270, product and use patent
patent.txt line 5,676- Flags
- product use code U-1971
- Product numbers
- 001
12 Jan 2026 · NDA 205580 · BENDAMUSTINE HYDROCHLORIDE
US 8,791,270, product and use patent
patent.txt line 5,677- Flags
- product use code U-1972
- Product numbers
- 001
12 Jan 2026 · NDA 208194 · BENDAMUSTINE HYDROCHLORIDE
US 8,791,270, product and use patent
patent.txt line 8,312- Flags
- product use code U-1790
- Product numbers
- 001
13 Jan 2026 · NDA 201292 · AFATINIB DIMALEATE
US RE43431, substance patent
patent.txt lines 2,407, 2,417, 2,427- Flags
- substance
- Product numbers
- 001, 002, 003
16 Jan 2026 · NDA 022560 · RISEDRONATE SODIUM
US 8,246,989, product patent
patent.txt line 2,088- Flags
- product
- Product numbers
- 001
17 Jan 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 8,461,187, product patent
patent.txt lines 1,560, 1,574- Flags
- product
- Product numbers
- 001, 002
17 Jan 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 9,238,029, product patent
patent.txt lines 1,564, 1,578- Flags
- product
- Product numbers
- 001, 002
17 Jan 2026 · NDA 208056 · DEXLANSOPRAZOLE
US 8,461,187, product patent
patent.txt line 8,043- Flags
- product
- Product numbers
- 001
17 Jan 2026 · NDA 208056 · DEXLANSOPRAZOLE
US 9,238,029, product patent
patent.txt line 8,047- Flags
- product
- Product numbers
- 001
18 Jan 2026 · NDA 202860 · NITRIC OXIDE
US 8,057,742, use patent
patent.txt line 3,417- Flags
- use code U-3037
- Product numbers
- 001
19 Jan 2026 · NDA 021395 · TIOTROPIUM BROMIDE
US 8,022,082, product and use patent
patent.txt line 596- Flags
- product use code U-1186
- Product numbers
- 001
19 Jan 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,211,889, substance patent
patent.txt lines 10,042, 10,056- Flags
- substance
- Product numbers
- 001, 002
19 Jan 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 9,266,912, use patent
patent.txt lines 10,049, 10,063- Flags
- use code U-2294
- Product numbers
- 001, 002
19 Jan 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US RE48898, product patent
patent.txt lines 10,051, 10,065- Flags
- product
- Product numbers
- 001, 002
20 Jan 2026 · NDA 022088 · TEMSIROLIMUS
US 8,026,276, product patent
patent.txt line 1,047- Flags
- product
- Product numbers
- 001
20 Jan 2026 · NDA 209637 · SEMAGLUTIDE
US 10,357,616, product patent
patent.txt lines 10,688, 10,704, 10,721, 10,739- Flags
- product delist requested
- Product numbers
- 001, 002, 003, 004
20 Jan 2026 · NDA 209637 · SEMAGLUTIDE
US 10,376,652, product patent
patent.txt lines 10,689, 10,705, 10,722, 10,740- Flags
- product delist requested
- Product numbers
- 001, 002, 003, 004
20 Jan 2026 · NDA 209637 · SEMAGLUTIDE
US 9,108,002, product patent
patent.txt lines 10,694, 10,712, 10,729, 10,747- Flags
- product delist requested
- Product numbers
- 001, 002, 003, 004
20 Jan 2026 · NDA 209637 · SEMAGLUTIDE
US 9,616,180, product patent
patent.txt lines 10,697, 10,715, 10,732, 10,750- Flags
- product delist requested
- Product numbers
- 001, 002, 003, 004
20 Jan 2026 · NDA 209637 · SEMAGLUTIDE
US 9,861,757, product patent
patent.txt lines 10,700, 10,718, 10,735, 10,753- Flags
- product delist requested
- Product numbers
- 001, 002, 003, 004
24 Jan 2026 · NDA 204824 · METHOTREXATE
US 11,446,441, product patent
patent.txt lines 5,062, 5,077, 5,092, 5,107, 5,122, 5,137, 5,152, 5,167- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
24 Jan 2026 · NDA 204824 · METHOTREXATE
US 8,562,564, product patent
patent.txt lines 5,068, 5,083, 5,098, 5,113, 5,128, 5,143, 5,158, 5,173- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
24 Jan 2026 · NDA 204824 · METHOTREXATE
US 9,533,102, product patent
patent.txt lines 5,073, 5,088, 5,103, 5,118, 5,133, 5,148, 5,163, 5,178- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
24 Jan 2026 · NDA 204824 · METHOTREXATE
US 9,629,959, product patent
patent.txt lines 5,074, 5,089, 5,104, 5,119, 5,134, 5,149, 5,164, 5,179- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
24 Jan 2026 · NDA 209863 · TESTOSTERONE ENANTHATE
US 10,478,560, product patent
patent.txt lines 10,919, 10,942, 10,965- Flags
- product
- Product numbers
- 001, 002, 003
24 Jan 2026 · NDA 209863 · TESTOSTERONE ENANTHATE
US 11,446,441, product patent
patent.txt lines 10,927, 10,950, 10,973- Flags
- product
- Product numbers
- 001, 002, 003
24 Jan 2026 · NDA 209863 · TESTOSTERONE ENANTHATE
US 8,562,564, product patent
patent.txt lines 10,933, 10,956, 10,979- Flags
- product
- Product numbers
- 001, 002, 003
24 Jan 2026 · NDA 209863 · TESTOSTERONE ENANTHATE
US 9,180,259, product patent
patent.txt lines 10,934, 10,957, 10,980- Flags
- product
- Product numbers
- 001, 002, 003
24 Jan 2026 · NDA 209863 · TESTOSTERONE ENANTHATE
US 9,533,102, product patent
patent.txt lines 10,935, 10,958, 10,981- Flags
- product
- Product numbers
- 001, 002, 003
24 Jan 2026 · NDA 209863 · TESTOSTERONE ENANTHATE
US 9,629,959, product patent
patent.txt lines 10,936, 10,959, 10,982- Flags
- product
- Product numbers
- 001, 002, 003
26 Jan 2026 · NDA 205920 · EPINEPHRINE
US 8,367,734, product patent
patent.txt line 6,039- Flags
- product
- Product numbers
- 001
27 Jan 2026 · NDA 022225 · SUGAMMADEX SODIUM
US RE44733, substance and product and use patent
patent.txt lines 1,353, 1,355- Flags
- substance product use code U-1794
- Product numbers
- 001, 002
27 Jan 2026 · NDA 214965 · CYCLOSPORINE
US 11,612,658, use patent
patent.txt line 16,396- Flags
- use code U-3560
- Product numbers
- 001
27 Jan 2026 · NDA 214965 · CYCLOSPORINE
US 7,973,081, product patent
patent.txt line 16,397- Flags
- product
- Product numbers
- 001
27 Jan 2026 · NDA 214965 · CYCLOSPORINE
US 8,524,779, product patent
patent.txt line 16,399- Flags
- product
- Product numbers
- 001
27 Jan 2026 · NDA 214965 · CYCLOSPORINE
US 9,220,694, product patent
patent.txt line 16,401- Flags
- product
- Product numbers
- 001
27 Jan 2026 · NDA 214965 · CYCLOSPORINE
US 9,956,289, product patent
patent.txt line 16,402- Flags
- product
- Product numbers
- 001
28 Jan 2026 · NDA 214621 · RELUGOLIX
US 8,058,280, substance and product patent
patent.txt line 15,891- Flags
- substance product
- Product numbers
- 001
28 Jan 2026 · NDA 214846 · ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
US 8,058,280, substance and product patent
patent.txt line 16,243- Flags
- substance product
- Product numbers
- 001
1 Feb 2026 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 9,278,182, product patent
patent.txt line 5,888- Flags
- product
- Product numbers
- 001
1 Feb 2026 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 9,278,182, product patent
patent.txt line 10,912- Flags
- product
- Product numbers
- 001
2 Feb 2026 · NDA 211288 · DACOMITINIB
US 10,596,162, use patent
patent.txt lines 12,675, 12,678, 12,681- Flags
- use code U-3338
- Product numbers
- 001, 002, 003
2 Feb 2026 · NDA 211288 · DACOMITINIB
US 10,603,314, use patent
patent.txt lines 12,676, 12,679, 12,682- Flags
- use code U-3337
- Product numbers
- 001, 002, 003
4 Feb 2026 · NDA 215168 · FLURPIRIDAZ F-18
US 9,161,997, substance and product and use patent
patent.txt line 16,510- Flags
- substance product use code U-4011
- Product numbers
- 001
6 Feb 2026 · NDA 013217 · METAXALONE
US 7,122,566, use patent
patent.txt line 132- Flags
- use code U-915
- Product numbers
- 003
6 Feb 2026 · NDA 211150 · PITOLISANT HYDROCHLORIDE
US 8,354,430, use patent
patent.txt lines 12,481, 12,486- Flags
- use code U-1101
- Product numbers
- 001, 002
6 Feb 2026 · NDA 211150 · PITOLISANT HYDROCHLORIDE
US 8,354,430, use patent
patent.txt lines 12,482, 12,487- Flags
- use code U-1102
- Product numbers
- 001, 002
19 Feb 2026 · NDA 021985 · ALISKIREN HEMIFUMARATE
US 8,617,595, product patent
patent.txt lines 866, 868- Flags
- product
- Product numbers
- 001, 002
21 Feb 2026 · NDA 021660 · PACLITAXEL
US 7,758,891, use patent
patent.txt line 660- Flags
- use code U-1434
- Product numbers
- 001
21 Feb 2026 · NDA 021660 · PACLITAXEL
US 8,268,348, use patent
patent.txt line 664- Flags
- use code U-1290
- Product numbers
- 001
21 Feb 2026 · NDA 021660 · PACLITAXEL
US 9,101,543, use patent
patent.txt line 666- Flags
- use code U-1434
- Product numbers
- 001
21 Feb 2026 · NDA 205836 · BRIVARACETAM
US 6,911,461, substance and product and use patent
patent.txt lines 5,976, 5,978, 5,980, 5,982, 5,984- Flags
- substance product use code U-2295
- Product numbers
- 001, 002, 003, 004, 005
21 Feb 2026 · NDA 205837 · BRIVARACETAM
US 6,911,461, substance and product and use patent
patent.txt line 5,985- Flags
- substance product use code U-1815
- Product numbers
- 001
21 Feb 2026 · NDA 205837 · BRIVARACETAM
US 6,911,461, substance and product and use patent
patent.txt line 5,986- Flags
- substance product use code U-2130
- Product numbers
- 001
21 Feb 2026 · NDA 205838 · BRIVARACETAM
US 6,911,461, substance and product and use patent
patent.txt line 5,987- Flags
- substance product use code U-2295
- Product numbers
- 001
22 Feb 2026 · NDA 203567 · EFINACONAZOLE
US 7,214,506, use patent
patent.txt line 4,097- Flags
- use code U-281
- Product numbers
- 001
22 Feb 2026 · NDA 204417 · LEVETIRACETAM
US 8,425,938, product patent
patent.txt lines 4,677, 4,682- Flags
- product
- Product numbers
- 001, 002
22 Feb 2026 · NDA 204417 · LEVETIRACETAM
US 8,535,717, product patent
patent.txt lines 4,680, 4,685- Flags
- product
- Product numbers
- 001, 002
22 Feb 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,361,649, substance and product and use patent
patent.txt lines 6,411, 6,419- Flags
- substance product use code U-1694
- Product numbers
- 001, 002
22 Feb 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,361,650, substance and product and use patent
patent.txt lines 6,413, 6,421- Flags
- substance product use code U-1694
- Product numbers
- 001, 002
22 Feb 2026 · NDA 206143 · IVABRADINE HYDROCHLORIDE
US 7,879,842, substance and product and use patent
patent.txt lines 6,417, 6,425- Flags
- substance product use code U-1694
- Product numbers
- 001, 002
22 Feb 2026 · NDA 209964 · IVABRADINE
US 7,361,649, substance and product and use patent
patent.txt line 11,085- Flags
- substance product use code U-1694
- Product numbers
- 001
22 Feb 2026 · NDA 209964 · IVABRADINE
US 7,361,650, substance and product and use patent
patent.txt line 11,086- Flags
- substance product use code U-1694
- Product numbers
- 001
22 Feb 2026 · NDA 209964 · IVABRADINE
US 7,879,842, substance and product and use patent
patent.txt line 11,088- Flags
- substance product use code U-1694
- Product numbers
- 001
23 Feb 2026 · NDA 206099 · SUMATRIPTAN SUCCINATE
US 11,571,531, use patent
patent.txt line 6,280- Flags
- use code U-1809
- Product numbers
- 001
24 Feb 2026 · NDA 022287 · DEXLANSOPRAZOLE
US 9,011,926, product patent
patent.txt lines 1,562, 1,576- Flags
- product
- Product numbers
- 001, 002
24 Feb 2026 · NDA 202236 · AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
US 8,168,620, product patent
patent.txt line 2,957- Flags
- product
- Product numbers
- 001
24 Feb 2026 · NDA 208056 · DEXLANSOPRAZOLE
US 9,011,926, product patent
patent.txt line 8,046- Flags
- product
- Product numbers
- 001
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 10,703,763, use patent
patent.txt line 559- Flags
- use code U-2848
- Product numbers
- 001
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 10,703,763, use patent
patent.txt line 569- Flags
- use code U-1708
- Product numbers
- 002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 10,703,763, use patent
patent.txt line 570- Flags
- use code U-2847
- Product numbers
- 002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 8,518,949, product patent
patent.txt lines 562, 581- Flags
- product
- Product numbers
- 001, 002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 8,741,904, substance and product and use patent
patent.txt line 563- Flags
- substance product use code U-2848
- Product numbers
- 001
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 8,741,904, substance and product and use patent
patent.txt line 583- Flags
- substance product use code U-1707
- Product numbers
- 002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 8,741,904, substance and product and use patent
patent.txt line 584- Flags
- substance product use code U-1708
- Product numbers
- 002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 8,741,904, substance and product and use patent
patent.txt line 585- Flags
- substance product use code U-2847
- Product numbers
- 002
27 Feb 2026 · NDA 021361 · RIFAXIMIN
US 9,271,968, product patent
patent.txt lines 564, 589- Flags
- product
- Product numbers
- 001, 002
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 10,022,344, product and use patent
patent.txt line 773- Flags
- product use code U-1731
- Product numbers
- 001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 10,022,344, product and use patent
patent.txt line 774- Flags
- product use code U-1732
- Product numbers
- 001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 10,028,925, product and use patent
patent.txt line 775- Flags
- product use code U-1731
- Product numbers
- 001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 10,028,925, product and use patent
patent.txt line 776- Flags
- product use code U-1732
- Product numbers
- 001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 11,090,280, product and use patent
patent.txt line 777- Flags
- product use code U-1731
- Product numbers
- 001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 11,090,280, product and use patent
patent.txt line 778- Flags
- product use code U-1732
- Product numbers
- 001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 9,693,978, product patent
patent.txt line 779- Flags
- product
- Product numbers
- 001
3 Mar 2026 · NDA 021920 · NAPROXEN SODIUM
US 9,693,979, product patent
patent.txt line 780- Flags
- product
- Product numbers
- 001
7 Mar 2026 · NDA 202317 · MECHLORETHAMINE HYDROCHLORIDE
US 7,838,564, product patent
patent.txt line 3,041- Flags
- product
- Product numbers
- 001
7 Mar 2026 · NDA 202317 · MECHLORETHAMINE HYDROCHLORIDE
US 8,450,375, product patent
patent.txt line 3,043- Flags
- product
- Product numbers
- 001
7 Mar 2026 · NDA 202317 · MECHLORETHAMINE HYDROCHLORIDE
US 8,501,818, product patent
patent.txt line 3,044- Flags
- product
- Product numbers
- 001
7 Mar 2026 · NDA 202317 · MECHLORETHAMINE HYDROCHLORIDE
US 8,501,819, use patent
patent.txt line 3,045- Flags
- use code U-1427
- Product numbers
- 001
7 Mar 2026 · NDA 202317 · MECHLORETHAMINE HYDROCHLORIDE
US 9,382,191, product patent
patent.txt line 3,046- Flags
- product
- Product numbers
- 001
13 Mar 2026 · NDA 021821 · TIGECYCLINE
US 10,588,975, product patent
patent.txt line 702- Flags
- product
- Product numbers
- 001
13 Mar 2026 · NDA 021821 · TIGECYCLINE
US 9,254,328, product patent
patent.txt line 706- Flags
- product
- Product numbers
- 001
13 Mar 2026 · NDA 021821 · TIGECYCLINE
US 9,694,078, product patent
patent.txt line 707- Flags
- product
- Product numbers
- 001
13 Mar 2026 · NDA 213756 · SELUMETINIB SULFATE
US 8,178,693, substance and product patent
patent.txt lines 15,259, 15,267- Flags
- substance product
- Product numbers
- 001, 002
13 Mar 2026 · NDA 219943 · SELUMETINIB SULFATE
US 8,178,693, substance and product patent
patent.txt lines 22,065, 22,069- Flags
- substance product
- Product numbers
- 001, 002
20 Mar 2026 · NDA 209637 · SEMAGLUTIDE
US 8,536,122, substance and product and use patent
patent.txt lines 10,692, 10,710- Flags
- substance product use code U-2202
- Product numbers
- 001, 002
20 Mar 2026 · NDA 209637 · SEMAGLUTIDE
US 8,536,122, substance and product and use patent
patent.txt line 10,727- Flags
- substance product use code U-3355
- Product numbers
- 003
20 Mar 2026 · NDA 209637 · SEMAGLUTIDE
US 8,536,122, substance and product and use patent
patent.txt line 10,745- Flags
- substance product use code U-3469
- Product numbers
- 004
20 Mar 2026 · NDA 213051 · SEMAGLUTIDE
US 8,536,122, substance and product and use patent
patent.txt lines 14,592, 14,607, 14,622, 14,632, 14,641, 14,650- Flags
- substance product use code U-2628
- Product numbers
- 001, 002, 003, 004, 005, 006
20 Mar 2026 · NDA 215256 · SEMAGLUTIDE
US 8,536,122, substance and product patent
patent.txt lines 16,609, 16,617, 16,625, 16,633, 16,643- Flags
- substance product
- Product numbers
- 001, 002, 003, 004, 005
20 Mar 2026 · NDA 218316 · SEMAGLUTIDE
US 8,536,122, substance and product patent
patent.txt lines 20,940, 20,948, 20,956, 20,965- Flags
- substance product
- Product numbers
- 001, 002, 003, 004
28 Mar 2026 · NDA 021986 · DASATINIB
US 7,491,725, substance and product patent
patent.txt lines 870, 872, 874, 876, 878, 880- Flags
- substance product
- Product numbers
- 001, 002, 003, 004, 005, 006
28 Mar 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 7,538,108, substance and use patent
patent.txt lines 10,039, 10,053- Flags
- substance use code U-2294
- Product numbers
- 001, 002
31 Mar 2026 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 8,926,594, product patent
patent.txt line 5,884- Flags
- product
- Product numbers
- 001
31 Mar 2026 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 8,926,594, product patent
patent.txt line 10,908- Flags
- product
- Product numbers
- 001
1 Apr 2026 · NDA 217388 · EPLONTERSEN SODIUM
US 8,101,743, substance and product patent
patent.txt line 19,899- Flags
- substance product
- Product numbers
- 001
4 Apr 2026 · NDA 209310 · MOMETASONE FUROATE
US 9,585,681, use patent
patent.txt line 10,077- Flags
- use code U-2272
- Product numbers
- 001
5 Apr 2026 · NDA 022051 · FLUTICASONE FUROATE
US 8,062,264, product patent
patent.txt line 976- Flags
- product
- Product numbers
- 002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt lines 1,091, 1,099- Flags
- substance product use code U-1064
- Product numbers
- 001, 002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt lines 1,092, 1,100- Flags
- substance product use code U-1960
- Product numbers
- 001, 002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt lines 1,093, 1,101- Flags
- substance product use code U-1961
- Product numbers
- 001, 002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt lines 1,094, 1,102- Flags
- substance product use code U-1962
- Product numbers
- 001, 002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt lines 1,095, 1,103- Flags
- substance product use code U-1963
- Product numbers
- 001, 002
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt line 1,107- Flags
- substance product use code U-1893
- Product numbers
- 003
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 7,741,358, substance and product and use patent
patent.txt line 1,108- Flags
- substance product use code U-1966
- Product numbers
- 003
6 Apr 2026 · NDA 022117 · ASENAPINE MALEATE
US 8,022,228, substance and product patent
patent.txt lines 1,097, 1,105, 1,110- Flags
- substance product
- Product numbers
- 001, 002, 003
9 Apr 2026 · NDA 204326 · AMPHETAMINE
US 8,840,924, product patent
patent.txt lines 4,477, 4,482, 4,487, 4,492, 4,497, 4,502- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006
11 Apr 2026 · NDA 022399 · GABAPENTIN ENACARBIL
US 8,114,909, use patent
patent.txt lines 1,776, 1,780- Flags
- use code U-1231
- Product numbers
- 001, 002
11 Apr 2026 · NDA 202343 · SIMVASTATIN; SITAGLIPTIN PHOSPHATE
US 7,326,708, substance and product and use patent
patent.txt lines 3,072, 3,074, 3,076, 3,078, 3,080, 3,082- Flags
- substance product use code U-1188
- Product numbers
- 001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 8,349,840, product and use patent
patent.txt lines 5,310, 5,323, 5,336, 5,349, 5,362, 5,373- Flags
- product use code U-1529
- Product numbers
- 001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 8,618,109, use patent
patent.txt lines 5,312, 5,325, 5,338, 5,351, 5,364, 5,375- Flags
- use code U-3281
- Product numbers
- 001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 8,618,109, use patent
patent.txt lines 5,313, 5,326, 5,339, 5,352, 5,365, 5,376- Flags
- use code U-543
- Product numbers
- 001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 9,839,637, product and use patent
patent.txt lines 5,315, 5,328, 5,341, 5,354, 5,367, 5,378- Flags
- product use code U-1529
- Product numbers
- 001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 9,839,637, product and use patent
patent.txt lines 5,316, 5,329, 5,342, 5,355, 5,368, 5,379- Flags
- product use code U-3281
- Product numbers
- 001, 002, 003, 004, 005, 006
12 Apr 2026 · NDA 205422 · BREXPIPRAZOLE
US 9,839,637, product and use patent
patent.txt lines 5,317, 5,330, 5,343, 5,356, 5,369, 5,380- Flags
- product use code U-543
- Product numbers
- 001, 002, 003, 004, 005, 006
14 Apr 2026 · NDA 206089 · TESTOSTERONE UNDECANOATE
US 11,179,402, substance and product patent
patent.txt lines 6,239, 6,250, 6,261- Flags
- substance product
- Product numbers
- 001, 002, 003
21 Apr 2026 · NDA 022416 · ESLICARBAZEPINE ACETATE
US 9,206,135, substance patent
patent.txt lines 1,817, 1,825, 1,833, 1,841- Flags
- substance
- Product numbers
- 001, 002, 003, 004
21 Apr 2026 · NDA 022416 · ESLICARBAZEPINE ACETATE
US 9,643,929, product patent
patent.txt lines 1,819, 1,827, 1,835, 1,843- Flags
- product
- Product numbers
- 001, 002, 003, 004
21 Apr 2026 · NDA 205874 · FERRIC CITRATE
US 8,093,423, use patent
patent.txt line 5,997- Flags
- use code U-1577
- Product numbers
- 001
25 Apr 2026 · NDA 021669 · CHLORHEXIDINE GLUCONATE
US 7,427,574, product patent
patent.txt line 673- Flags
- product
- Product numbers
- 001
25 Apr 2026 · NDA 205755 · CERITINIB
US 7,893,074, substance and product patent
patent.txt line 5,852- Flags
- substance product
- Product numbers
- 001
25 Apr 2026 · NDA 211225 · CERITINIB
US 7,893,074, substance and product patent
patent.txt line 12,548- Flags
- substance product
- Product numbers
- 001
27 Apr 2026 · NDA 203496 · TREPROSTINIL DIOLAMINE
US 9,393,203, product and use patent
patent.txt lines 3,952, 3,962, 3,971, 3,980, 3,988- Flags
- product use code U-1877
- Product numbers
- 001, 002, 003, 004, 005
28 Apr 2026 · NDA 207202 · ARIPIPRAZOLE
US 11,476,952, product patent
patent.txt lines 7,066, 7,093, 7,120, 7,147, 7,174, 7,201- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005, 006
28 Apr 2026 · NDA 212887 · CABOTEGRAVIR SODIUM
US 10,927,129, substance and product patent
patent.txt line 14,474- Flags
- substance product
- Product numbers
- 001
28 Apr 2026 · NDA 212888 · CABOTEGRAVIR; RILPIVIRINE
US 10,927,129, substance and product patent
patent.txt lines 14,476, 14,486- Flags
- substance product
- Product numbers
- 001, 002
28 Apr 2026 · NDA 215499 · CABOTEGRAVIR
US 10,927,129, substance and product patent
patent.txt line 17,408- Flags
- substance product
- Product numbers
- 001
9 May 2026 · NDA 210884 · SUMATRIPTAN
US 8,268,791, product patent
patent.txt line 12,377- Flags
- product
- Product numbers
- 001
9 May 2026 · NDA 210884 · SUMATRIPTAN
US 8,440,631, product and use patent
patent.txt line 12,378- Flags
- product use code U-1719
- Product numbers
- 001
9 May 2026 · NDA 210884 · SUMATRIPTAN
US 9,283,280, product patent
patent.txt line 12,380- Flags
- product
- Product numbers
- 001
12 May 2026 · NDA 022063 · AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
US 9,173,857, use patent
patent.txt lines 983, 985, 987, 989- Flags
- use code U-2025
- Product numbers
- 001, 002, 003, 004
13 May 2026 · NDA 022252 · DIENOGEST; ESTRADIOL VALERATE
US 8,071,577, product and use patent
patent.txt line 1,407- Flags
- product use code U-1
- Product numbers
- 001
15 May 2026 · NDA 203415 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt line 3,867- Flags
- use code U-1588
- Product numbers
- 001
15 May 2026 · NDA 203415 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt line 3,868- Flags
- use code U-2345
- Product numbers
- 001
15 May 2026 · NDA 203415 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt line 3,869- Flags
- use code U-2708
- Product numbers
- 001
15 May 2026 · NDA 203415 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt line 3,870- Flags
- use code U-3763
- Product numbers
- 001
15 May 2026 · NDA 209279 · BOSENTAN
US 8,309,126, product patent
patent.txt line 10,024- Flags
- product
- Product numbers
- 001
15 May 2026 · NDA 213674 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt lines 15,174, 15,192- Flags
- use code U-2345
- Product numbers
- 001, 002
15 May 2026 · NDA 213674 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt lines 15,175, 15,193- Flags
- use code U-2708
- Product numbers
- 001, 002
15 May 2026 · NDA 213674 · ENZALUTAMIDE
US 9,126,941, use patent
patent.txt lines 15,176, 15,194- Flags
- use code U-3763
- Product numbers
- 001, 002
16 May 2026 · NDA 021991 · VORINOSTAT
US 8,093,295, product patent
patent.txt line 882- Flags
- product
- Product numbers
- 001
16 May 2026 · NDA 214520 · HEPARIN SODIUM; TAUROLIDINE
US 7,696,182, substance and product and use patent
patent.txt lines 15,868, 15,870- Flags
- substance product use code U-3774
- Product numbers
- 001, 002
17 May 2026 · NDA 208073 · LIFITEGRAST
US 8,084,047, substance and product patent
patent.txt line 8,085- Flags
- substance product
- Product numbers
- 001
17 May 2026 · NDA 208073 · LIFITEGRAST
US 8,592,450, use patent
patent.txt line 8,088- Flags
- use code U-1880
- Product numbers
- 001
21 May 2026 · NDA 021539 · ACETYLCYSTEINE
US 8,148,356, product patent
patent.txt line 628- Flags
- product
- Product numbers
- 001
26 May 2026 · NDA 022563 · CALCIPOTRIENE
US 8,629,128, product and use patent
patent.txt line 2,094- Flags
- product use code U-1280
- Product numbers
- 001
26 May 2026 · NDA 022563 · CALCIPOTRIENE
US 8,629,128, product and use patent
patent.txt line 2,095- Flags
- product use code U-1767
- Product numbers
- 001
26 May 2026 · NDA 022563 · CALCIPOTRIENE
US 8,629,128, product and use patent
patent.txt line 2,096- Flags
- product use code U-2662
- Product numbers
- 001
26 May 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 8,729,085, product patent
patent.txt lines 2,246, 2,257, 2,268, 2,279, 2,290- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
26 May 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 8,883,794, product patent
patent.txt lines 2,248, 2,259, 2,270, 2,281, 2,292- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
26 May 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 9,555,027, product and use patent
patent.txt lines 2,251, 2,262, 2,273, 2,284, 2,295- Flags
- product use code U-543
- Product numbers
- 001, 002, 003, 004, 005
26 May 2026 · NDA 200603 · LURASIDONE HYDROCHLORIDE
US 9,907,794, product patent
patent.txt lines 2,255, 2,266, 2,277, 2,288, 2,299- Flags
- product
- Product numbers
- 001, 002, 003, 004, 005
26 May 2026 · NDA 204141 · DESOXIMETASONE
US 8,715,624, product and use patent
patent.txt line 4,332- Flags
- product use code U-1408
- Product numbers
- 001
26 May 2026 · NDA 215168 · FLURPIRIDAZ F-18
US 7,344,702, substance patent
patent.txt line 16,507- Flags
- substance
- Product numbers
- 001
30 May 2026 · NDA 217424 · BERDAZIMER SODIUM
US 8,282,967, substance patent
patent.txt line 19,938- Flags
- substance
- Product numbers
- 001
30 May 2026 · NDA 217424 · BERDAZIMER SODIUM
US 8,956,658, substance patent
patent.txt line 19,939- Flags
- substance
- Product numbers
- 001
1 Jun 2026 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 7,731,686, product patent
patent.txt line 10,900- Flags
- product
- Product numbers
- 001
2 Jun 2026 · NDA 022504 · TESTOSTERONE
US 8,993,520, use patent
patent.txt line 2,010- Flags
- use code U-1390
- Product numbers
- 001
2 Jun 2026 · NDA 022504 · TESTOSTERONE
US 9,180,194, use patent
patent.txt line 2,011- Flags
- use code U-1390
- Product numbers
- 001
2 Jun 2026 · NDA 202799 · PEGINESATIDE ACETATE
US 7,550,433, use patent
patent.txt lines 3,234, 3,236, 3,238, 3,240, 3,242, 3,244, 3,246, 3,248- Flags
- use code U-1238
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
2 Jun 2026 · NDA 202799 · PEGINESATIDE ACETATE
US 7,919,461, use patent
patent.txt lines 3,235, 3,237, 3,239, 3,241, 3,243, 3,245, 3,247, 3,249- Flags
- use code U-1238
- Product numbers
- 001, 002, 003, 004, 005, 006, 007, 008
5 Jun 2026 · NDA 205489 · METHYLPHENIDATE
US 8,840,924, product patent
patent.txt lines 5,440, 5,444, 5,448- Flags
- product
- Product numbers
- 001, 002, 003
7 Jun 2026 · NDA 022020 · PANTOPRAZOLE SODIUM
US 7,544,370, product patent
patent.txt line 911- Flags
- product
- Product numbers
- 001
7 Jun 2026 · NDA 209401 · CYTARABINE; DAUNORUBICIN
US 8,518,437, product patent
patent.txt line 10,339- Flags
- product
- Product numbers
- 001
7 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 10,351,517, use patent
patent.txt lines 12,558, 12,600- Flags
- use code U-2548
- Product numbers
- 001, 002
7 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 11,753,368, use patent
patent.txt lines 12,567, 12,608- Flags
- use code U-2548
- Product numbers
- 001, 002
7 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 12,209,059, use patent
patent.txt lines 12,591, 12,632- Flags
- use code U-2548
- Product numbers
- 001, 002
7 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 8,877,806, use patent
patent.txt lines 12,597, 12,636- Flags
- use code U-2548
- Product numbers
- 001, 002
7 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
US 9,604,917, use patent
patent.txt lines 12,598, 12,637- Flags
- use code U-2548
- Product numbers
- 001, 002
10 Jun 2026 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 7,731,686, product patent
patent.txt line 5,876- Flags
- product
- Product numbers
- 001
12 Jun 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 7,989,448, substance and use patent
patent.txt lines 10,040, 10,054- Flags
- substance use code U-2294
- Product numbers
- 001, 002
13 Jun 2026 · NDA 021937 · EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 9,018,192, use patent
patent.txt line 817- Flags
- use code U-1170
- Product numbers
- 001
13 Jun 2026 · NDA 021937 · EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 9,018,192, use patent
patent.txt line 818- Flags
- use code U-750
- Product numbers
- 001
13 Jun 2026 · NDA 021937 · EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 9,545,414, product and use patent
patent.txt line 819- Flags
- product use code U-1170
- Product numbers
- 001
13 Jun 2026 · NDA 021937 · EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
US 9,545,414, product and use patent
patent.txt line 820- Flags
- product use code U-750
- Product numbers
- 001
16 Jun 2026 · NDA 022058 · HISTRELIN ACETATE
US 8,062,652, use patent
patent.txt line 980- Flags
- use code U-1197
- Product numbers
- 001
16 Jun 2026 · NDA 022165 · DICLOFENAC POTASSIUM
US 7,759,394, substance and product and use patent
patent.txt line 1,134- Flags
- substance product use code U-436
- Product numbers
- 001
16 Jun 2026 · NDA 022165 · DICLOFENAC POTASSIUM
US 8,097,651, substance and product and use patent
patent.txt line 1,135- Flags
- substance product use code U-436
- Product numbers
- 001
16 Jun 2026 · NDA 022165 · DICLOFENAC POTASSIUM
US 8,927,604, use patent
patent.txt line 1,136- Flags
- use code U-436
- Product numbers
- 001
16 Jun 2026 · NDA 022165 · DICLOFENAC POTASSIUM
US 9,827,197, product patent
patent.txt line 1,137- Flags
- product
- Product numbers
- 001
17 Jun 2026 · NDA 204447 · VORTIOXETINE HYDROBROMIDE
US 7,144,884, substance and product and use patent
patent.txt lines 4,699, 4,719, 4,739, 4,759- Flags
- substance product use code U-1439
- Product numbers
- 001, 002, 003, 004
17 Jun 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,163,902, substance and use patent
patent.txt lines 10,041, 10,055- Flags
- substance use code U-2294
- Product numbers
- 001, 002
17 Jun 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,445,485, product patent
patent.txt lines 10,044, 10,058- Flags
- product
- Product numbers
- 001, 002
17 Jun 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 8,912,170, use patent
patent.txt lines 10,047, 10,061- Flags
- use code U-2294
- Product numbers
- 001, 002
17 Jun 2026 · NDA 209299 · FOSTAMATINIB DISODIUM
US 9,283,238, use patent
patent.txt lines 10,050, 10,064- Flags
- use code U-2294
- Product numbers
- 001, 002
21 Jun 2026 · NDA 202429 · VEMURAFENIB
US 8,143,271, substance and product patent
patent.txt line 3,089- Flags
- substance product
- Product numbers
- 001
25 Jun 2026 · NDA 205787 · NALOXONE HYDROCHLORIDE
US 10,960,155, product patent
patent.txt line 5,874- Flags
- product
- Product numbers
- 001
25 Jun 2026 · NDA 209862 · NALOXONE HYDROCHLORIDE
US 10,960,155, product patent
patent.txt line 10,898- Flags
- product
- Product numbers
- 001
26 Jun 2026 · NDA 205494 · ELIGLUSTAT TARTRATE
US 7,196,205, substance patent
patent.txt line 5,458- Flags
- substance
- Product numbers
- 001
26 Jun 2026 · NDA 210655 · RISPERIDONE
US 10,406,160, product and use patent
patent.txt lines 12,066, 12,076- Flags
- product use code U-2608
- Product numbers
- 001, 002
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,241,805, product patent
patent.txt lines 1,055, 1,063, 1,071- Flags
- product
- Product numbers
- 001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,569,610, use patent
patent.txt lines 1,056, 1,064, 1,072- Flags
- use code U-997
- Product numbers
- 001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,572,935, product patent
patent.txt lines 1,057, 1,065, 1,073- Flags
- product
- Product numbers
- 001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,585,897, product patent
patent.txt lines 1,058, 1,066, 1,074- Flags
- product
- Product numbers
- 001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,645,802, product patent
patent.txt lines 1,059, 1,067, 1,075- Flags
- product
- Product numbers
- 001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,649,019, product patent
patent.txt lines 1,060, 1,068, 1,076- Flags
- product
- Product numbers
- 001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,662,407, product patent
patent.txt lines 1,061, 1,069, 1,077- Flags
- product
- Product numbers
- 001, 002, 003
27 Jun 2026 · NDA 022108 · BUPROPION HYDROBROMIDE
US 7,671,094, product patent
patent.txt lines 1,062, 1,070, 1,078- Flags
- product
- Product numbers
- 001, 002, 003
Pediatric exclusivity, as listed (39)
13 Jan 2026 · NDA 022291 · ELTROMBOPAG OLAMINE
US 7,547,719 with pediatric exclusivity, as listed
patent.txt lines 1,579, 1,584, 1,590, 1,596, 1,601- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
13 Jan 2026 · NDA 207027 · ELTROMBOPAG OLAMINE
US 7,547,719 with pediatric exclusivity, as listed
patent.txt lines 6,995, 7,000- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
13 Feb 2026 · NDA 022341 · LIRAGLUTIDE
US 8,114,833 with pediatric exclusivity, as listed
patent.txt line 1,721- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
13 Feb 2026 · NDA 206321 · LIRAGLUTIDE
US 8,114,833 with pediatric exclusivity, as listed
patent.txt line 6,470- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
7 Mar 2026 · NDA 022512 · DABIGATRAN ETEXILATE MESYLATE
US 7,932,273 with pediatric exclusivity, as listed
patent.txt lines 2,013, 2,017, 2,021- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
7 Mar 2026 · NDA 214358 · DABIGATRAN ETEXILATE MESYLATE
US 7,932,273 with pediatric exclusivity, as listed
patent.txt lines 15,715, 15,717, 15,719, 15,721, 15,723, 15,725- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005, 006
11 Mar 2026 · NDA 022012 · CARVEDILOL PHOSPHATE
US 8,101,209 with pediatric exclusivity, as listed
patent.txt lines 901, 903, 905, 907- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
1 Apr 2026 · NDA 205832 · NINTEDANIB ESYLATE
US 6,762,180 with pediatric exclusivity, as listed
patent.txt lines 5,896, 5,904- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
2 Apr 2026 · NDA 021926 · NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
US 7,332,183 with pediatric exclusivity, as listed
patent.txt lines 804, 806- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
4 Apr 2026 · NDA 022200 · EXENATIDE SYNTHETIC
US 6,515,117 with pediatric exclusivity, as listed
patent.txt lines 1,242, 1,278- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
4 Apr 2026 · NDA 202293 · DAPAGLIFLOZIN
US 6,515,117 with pediatric exclusivity, as listed
patent.txt lines 2,977, 3,015- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
4 Apr 2026 · NDA 205649 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US 6,515,117 with pediatric exclusivity, as listed
patent.txt lines 5,710, 5,720, 5,730, 5,740, 5,750- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004, 005
4 Apr 2026 · NDA 209091 · DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US 6,515,117 with pediatric exclusivity, as listed
patent.txt lines 9,657, 9,673- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
4 Apr 2026 · NDA 209210 · EXENATIDE SYNTHETIC
US 6,515,117 with pediatric exclusivity, as listed
patent.txt line 9,875- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
4 Apr 2026 · NDA 210874 · DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
US 6,515,117 with pediatric exclusivity, as listed
patent.txt lines 12,274, 12,284, 12,294, 12,304- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
24 Apr 2026 · NDA 206947 · LENVATINIB MESYLATE
US 7,253,286 with pediatric exclusivity, as listed
patent.txt lines 6,889, 6,910- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
30 Apr 2026 · NDA 021445 · EZETIMIBE
US 7,612,058 with pediatric exclusivity, as listed
patent.txt line 614- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
30 Apr 2026 · NDA 207500 · ISAVUCONAZONIUM SULFATE
US 6,812,238 with pediatric exclusivity, as listed
patent.txt lines 7,264, 7,270- Flags
- substance pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
30 Apr 2026 · NDA 207501 · ISAVUCONAZONIUM SULFATE
US 6,812,238 with pediatric exclusivity, as listed
patent.txt line 7,272- Flags
- substance pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
1 May 2026 · NDA 022334 · EVEROLIMUS
US 8,410,131 with pediatric exclusivity, as listed
patent.txt lines 1,708, 1,711, 1,714, 1,717- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
1 May 2026 · NDA 203441 · TEDUGLUTIDE
US 7,847,061 with pediatric exclusivity, as listed
patent.txt line 3,871- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
1 May 2026 · NDA 203441 · TEDUGLUTIDE
US 9,060,992 with pediatric exclusivity, as listed
patent.txt line 3,873- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
16 May 2026 · NDA 022181 · SAPROPTERIN DIHYDROCHLORIDE
US 7,566,462 with pediatric exclusivity, as listed
patent.txt line 1,138- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
16 May 2026 · NDA 022181 · SAPROPTERIN DIHYDROCHLORIDE
US 8,003,126 with pediatric exclusivity, as listed
patent.txt line 1,140- Flags
- pediatric, as listed by FDA
- Product numbers
- 001
26 May 2026 · NDA 201280 · LINAGLIPTIN
US 8,883,805 with pediatric exclusivity, as listed
patent.txt line 2,340- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
26 May 2026 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,883,805 with pediatric exclusivity, as listed
patent.txt lines 2,356, 2,374, 2,392- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
26 May 2026 · NDA 206073 · EMPAGLIFLOZIN; LINAGLIPTIN
US 8,883,805 with pediatric exclusivity, as listed
patent.txt lines 6,201, 6,233- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 May 2026 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,883,805 with pediatric exclusivity, as listed
patent.txt lines 7,980, 7,999- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
26 May 2026 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
US 8,883,805 with pediatric exclusivity, as listed
patent.txt lines 14,249, 14,279, 14,309, 14,338- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
5 Jun 2026 · NDA 204410 · MACITENTAN
US 7,094,781 with pediatric exclusivity, as listed
patent.txt line 4,668- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
5 Jun 2026 · NDA 218490 · MACITENTAN; TADALAFIL
US 7,094,781 with pediatric exclusivity, as listed
patent.txt lines 21,094, 21,100- Flags
- substance product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
8 Jun 2026 · NDA 203214 · TOFACITINIB CITRATE
US RE41783 with pediatric exclusivity, as listed
patent.txt lines 3,671, 3,673- Flags
- substance pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
8 Jun 2026 · NDA 208246 · TOFACITINIB CITRATE
US RE41783 with pediatric exclusivity, as listed
patent.txt lines 8,380, 8,389- Flags
- substance pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
8 Jun 2026 · NDA 213082 · TOFACITINIB CITRATE
US RE41783 with pediatric exclusivity, as listed
patent.txt line 14,660- Flags
- substance pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
10 Jun 2026 · NDA 201023 · CABAZITAXEL
US 7,241,907 with pediatric exclusivity, as listed
patent.txt line 2,318- Flags
- substance pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
11 Jun 2026 · NDA 203341 · BOSUTINIB MONOHYDRATE
US 7,417,148 with pediatric exclusivity, as listed
patent.txt lines 3,773, 3,784, 3,795- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
11 Jun 2026 · NDA 203341 · BOSUTINIB MONOHYDRATE
US 7,919,625 with pediatric exclusivity, as listed
patent.txt lines 3,779, 3,790, 3,801- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003
11 Jun 2026 · NDA 217729 · BOSUTINIB MONOHYDRATE
US 7,417,148 with pediatric exclusivity, as listed
patent.txt lines 20,342, 20,352- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
11 Jun 2026 · NDA 217729 · BOSUTINIB MONOHYDRATE
US 7,919,625 with pediatric exclusivity, as listed
patent.txt lines 20,347, 20,357- Flags
- product pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
Non-patent exclusivity (127)
10 Jan 2026 · NDA 214070 · ALBUTEROL SULFATE; BUDESONIDE
NP exclusivity
exclusivity.txt line 1,297- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
13 Jan 2026 · NDA 210922 · PATISIRAN SODIUM
M-270 exclusivity
exclusivity.txt line 927- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
14 Jan 2026 · NDA 208692 · CABOZANTINIB S-MALATE
ODE-227 exclusivity
exclusivity.txt lines 738, 741, 744- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
18 Jan 2026 · NDA 215309 · RUXOLITINIB PHOSPHATE
PED exclusivity
exclusivity.txt line 1,520- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
19 Jan 2026 · NDA 213217 · ZANUBRUTINIB
I-817 exclusivity
exclusivity.txt line 1,161- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
19 Jan 2026 · NDA 213411 · TUCATINIB
I-906 exclusivity
exclusivity.txt lines 1,218, 1,221- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
19 Jan 2026 · NDA 214377 · VERICIGUAT
NCE exclusivity
exclusivity.txt lines 1,323, 1,325, 1,327- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
19 Jan 2026 · NDA 218785 · ZANUBRUTINIB
I-817 exclusivity
exclusivity.txt line 2,195- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
20 Jan 2026 · NDA 208288 · CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
M-292 exclusivity
exclusivity.txt line 702- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
21 Jan 2026 · NDA 212887 · CABOTEGRAVIR SODIUM
NCE exclusivity
exclusivity.txt line 1,127- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
21 Jan 2026 · NDA 212888 · CABOTEGRAVIR; RILPIVIRINE
NCE exclusivity
exclusivity.txt lines 1,128–1,129- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002
21 Jan 2026 · NDA 215499 · CABOTEGRAVIR
NCE exclusivity
exclusivity.txt line 1,584- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
22 Jan 2026 · NDA 213716 · VOCLOSPORIN
NCE exclusivity
exclusivity.txt line 1,246- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
27 Jan 2026 · NDA 214846 · ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
M-289 exclusivity
exclusivity.txt line 1,410- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
28 Jan 2026 · NDA 206192 · COBIMETINIB FUMARATE
PED exclusivity
exclusivity.txt line 554- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
31 Jan 2026 · NDA 021845 · SILDENAFIL CITRATE
M-287 exclusivity
exclusivity.txt line 131- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
31 Jan 2026 · NDA 022473 · SILDENAFIL CITRATE
M-287 exclusivity
exclusivity.txt line 198- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
31 Jan 2026 · NDA 203109 · SILDENAFIL CITRATE
M-287 exclusivity
exclusivity.txt line 302- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
3 Feb 2026 · NDA 214096 · TEPOTINIB HYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 1,302- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
5 Feb 2026 · NDA 213176 · UMBRALISIB TOSYLATE
NCE exclusivity
exclusivity.txt line 1,159- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
8 Feb 2026 · NDA 215014 · PEGCETACOPLAN
M-288 exclusivity
exclusivity.txt line 1,459- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
9 Feb 2026 · NDA 213871 · ABROCITINIB
NPP exclusivity
exclusivity.txt lines 1,271, 1,273, 1,275- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
12 Feb 2026 · NDA 214200 · TRILACICLIB DIHYDROCHLORIDE
NCE exclusivity
exclusivity.txt line 1,315- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
13 Feb 2026 · NDA 208711 · TRICLABENDAZOLE
ODE-228 exclusivity
exclusivity.txt line 751- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
15 Feb 2026 · NDA 206947 · LENVATINIB MESYLATE
PED exclusivity
exclusivity.txt lines 566, 570- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
22 Feb 2026 · NDA 207981 · TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
ODE-229 exclusivity
exclusivity.txt lines 676–677- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
22 Feb 2026 · NDA 217171 · PEGCETACOPLAN
NP exclusivity
exclusivity.txt line 1,843- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
24 Feb 2026 · NDA 205552 · IBRUTINIB
PED exclusivity
exclusivity.txt lines 504, 508- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
24 Feb 2026 · NDA 210563 · IBRUTINIB
PED exclusivity
exclusivity.txt lines 891, 895, 899, 903- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
24 Feb 2026 · NDA 217003 · IBRUTINIB
PED exclusivity
exclusivity.txt line 1,833- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
25 Feb 2026 · NDA 213026 · CASIMERSEN
NCE exclusivity
exclusivity.txt line 1,144- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
26 Feb 2026 · NDA 214018 · FOSDENOPTERIN HYDROBROMIDE
NCE exclusivity
exclusivity.txt line 1,292- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
1 Mar 2026 · NDA 205625 · FLUTICASONE FUROATE
M-290 exclusivity
exclusivity.txt line 514- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 003
1 Mar 2026 · NDA 209471 · ACETAMINOPHEN; IBUPROFEN
NP exclusivity
exclusivity.txt line 787- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
7 Mar 2026 · NDA 208969 · NALOXONE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 758- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
10 Mar 2026 · NDA 212904 · TIVOZANIB HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 1,130–1,131- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002
13 Mar 2026 · NDA 201532 · ERIBULIN MESYLATE
PED exclusivity
exclusivity.txt line 224- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
13 Mar 2026 · NDA 214662 · MARALIXIBAT CHLORIDE
NPP exclusivity
exclusivity.txt line 1,349- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001
16 Mar 2026 · NDA 202806 · DABRAFENIB MESYLATE
I-908 exclusivity
exclusivity.txt lines 286, 290- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
16 Mar 2026 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE
I-908 exclusivity
exclusivity.txt lines 368, 372, 376- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
16 Mar 2026 · NDA 217513 · TRAMETINIB DIMETHYL SULFOXIDE
NP exclusivity
exclusivity.txt line 1,883- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
16 Mar 2026 · NDA 217514 · DABRAFENIB MESYLATE
NP exclusivity
exclusivity.txt line 1,887- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
18 Mar 2026 · NDA 213498 · PONESIMOD
NCE exclusivity
exclusivity.txt lines 1,227–1,228- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 010
22 Mar 2026 · NDA 214231 · DASIGLUCAGON HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 1,316, 1,318- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002
24 Mar 2026 · NDA 204168 · LEVOMILNACIPRAN HYDROCHLORIDE
M-304 exclusivity
exclusivity.txt lines 380–383- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
28 Mar 2026 · NDA 214028 · PILOCARPINE HYDROCHLORIDE
D-187 exclusivity
exclusivity.txt line 1,294- Definition
- New dosing schedule (to be checked against FDA's list)
- Product numbers
- 001
29 Mar 2026 · NDA 202408 · ACYCLOVIR
ODE-235 exclusivity
exclusivity.txt line 275- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
2 Apr 2026 · NDA 211964 · VILOXAZINE HYDROCHLORIDE
NCE exclusivity
exclusivity.txt lines 1,005–1,007- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
3 Apr 2026 · NDA 207695 · CRISABOROLE
D-191 exclusivity
exclusivity.txt line 623- Definition
- New dosing schedule (to be checked against FDA's list)
- Product numbers
- 001
14 Apr 2026 · NDA 020263 · LEUPROLIDE ACETATE
NS exclusivity
exclusivity.txt line 107- Definition
- New strength (to be checked against FDA's list)
- Product numbers
- 009
15 Apr 2026 · NDA 214154 · DROSPIRENONE; ESTETROL
NCE exclusivity
exclusivity.txt line 1,310- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
17 Apr 2026 · NDA 215206 · ATOGEPANT
I-909 exclusivity
exclusivity.txt lines 1,491, 1,493, 1,495- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
20 Apr 2026 · NDA 212028 · LEMBOREXANT
M-293 exclusivity
exclusivity.txt lines 1,018–1,019- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
22 Apr 2026 · NDA 209964 · IVABRADINE
ODE-234 exclusivity
exclusivity.txt line 842- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
22 Apr 2026 · NDA 214787 · REMDESIVIR
PED exclusivity
exclusivity.txt lines 1,394, 1,400- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
26 Apr 2026 · NDA 021196 · SODIUM OXYBATE
PED exclusivity
exclusivity.txt line 118- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001
26 Apr 2026 · NDA 217660 · ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
NP exclusivity
exclusivity.txt lines 1,901, 1,905- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002
28 Apr 2026 · NDA 022253 · LACOSAMIDE
D-188 exclusivity
exclusivity.txt lines 176–179- Definition
- New dosing schedule (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
28 Apr 2026 · NDA 022254 · LACOSAMIDE
D-188 exclusivity
exclusivity.txt line 180- Definition
- New dosing schedule (to be checked against FDA's list)
- Product numbers
- 001
28 Apr 2026 · NDA 022255 · LACOSAMIDE
D-188 exclusivity
exclusivity.txt line 181- Definition
- New dosing schedule (to be checked against FDA's list)
- Product numbers
- 001
28 Apr 2026 · NDA 213586 · RISPERIDONE
NP exclusivity
exclusivity.txt lines 1,232–1,238- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
29 Apr 2026 · NDA 207925 · IVACAFTOR
ODE-236 exclusivity
exclusivity.txt lines 627, 633, 639- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
30 Apr 2026 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
ODE-232 exclusivity
exclusivity.txt line 776- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
30 Apr 2026 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR
ODE-233 exclusivity
exclusivity.txt line 777- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
1 May 2026 · NDA 214755 · SODIUM OXYBATE
NP exclusivity
exclusivity.txt lines 1,370, 1,373, 1,376, 1,379- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
2 May 2026 · NDA 211192 · IVOSIDENIB
ODE-242 exclusivity
exclusivity.txt line 943- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
3 May 2026 · NDA 207925 · IVACAFTOR
NPP exclusivity
exclusivity.txt lines 645, 651- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 004, 005
3 May 2026 · NDA 211996 · TAFAMIDIS MEGLUMINE
ODE-237 exclusivity
exclusivity.txt line 1,014- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
3 May 2026 · NDA 212161 · TAFAMIDIS
ODE-237 exclusivity
exclusivity.txt line 1,027- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
5 May 2026 · NDA 215352 · PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE
NP exclusivity
exclusivity.txt line 1,534- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
7 May 2026 · NDA 212994 · DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
NCE exclusivity
exclusivity.txt lines 1,134–1,136- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
8 May 2026 · NDA 202293 · DAPAGLIFLOZIN
M-298 exclusivity
exclusivity.txt lines 267, 271- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
10 May 2026 · NDA 205422 · BREXPIPRAZOLE
I-913 exclusivity
exclusivity.txt lines 450, 455, 460, 465, 470, 475- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
11 May 2026 · NDA 022348 · IBUPROFEN
NPP exclusivity
exclusivity.txt lines 192–194- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
12 May 2026 · NDA 021323 · ESCITALOPRAM OXALATE
NPP exclusivity
exclusivity.txt lines 119–121- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
12 May 2026 · NDA 021365 · ESCITALOPRAM OXALATE
NPP exclusivity
exclusivity.txt line 122- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001
13 May 2026 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
NPP exclusivity
exclusivity.txt line 384- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001
13 May 2026 · NDA 204275 · FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
NS exclusivity
exclusivity.txt line 386- Definition
- New strength (to be checked against FDA's list)
- Product numbers
- 003
14 May 2026 · NDA 215014 · PEGCETACOPLAN
NCE exclusivity
exclusivity.txt line 1,460- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
14 May 2026 · NDA 217171 · PEGCETACOPLAN
NCE exclusivity
exclusivity.txt line 1,842- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
15 May 2026 · NDA 208573 · VENETOCLAX
ODE-239 exclusivity
exclusivity.txt lines 718–720- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
16 May 2026 · NDA 203441 · TEDUGLUTIDE
ODE-240 exclusivity
exclusivity.txt line 322- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
17 May 2026 · NDA 211321 · MIDAZOLAM
ODE-243 exclusivity
exclusivity.txt line 951- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
18 May 2026 · NDA 211675 · UPADACITINIB
I-919 exclusivity
exclusivity.txt lines 983, 989, 993- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
22 May 2026 · NDA 212608 · AVAPRITINIB
I-912 exclusivity
exclusivity.txt line 1,096- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 004
22 May 2026 · NDA 217470 · NALMEFENE HYDROCHLORIDE
NP exclusivity
exclusivity.txt line 1,882- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
23 May 2026 · NDA 210136 · BUPRENORPHINE
NP exclusivity
exclusivity.txt lines 847–853- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006, 007
24 May 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
ODE-238 exclusivity
exclusivity.txt lines 238, 244, 250, 256, 262- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005
26 May 2026 · NDA 214793 · PIFLUFOLASTAT F-18
NCE exclusivity
exclusivity.txt line 1,403- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
26 May 2026 · NDA 220089 · PIFLUFOLASTAT F-18
NCE exclusivity
exclusivity.txt line 2,374- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
28 May 2026 · NDA 021880 · LENALIDOMIDE
ODE-241 exclusivity
exclusivity.txt lines 133, 135, 137, 139, 141, 143- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
28 May 2026 · NDA 021880 · LENALIDOMIDE
ODE-245 exclusivity
exclusivity.txt lines 134, 136, 138, 140, 142, 144- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
28 May 2026 · NDA 213378 · OLANZAPINE; SAMIDORPHAN L-MALATE
NCE exclusivity
exclusivity.txt lines 1,214–1,217- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
28 May 2026 · NDA 214622 · INFIGRATINIB PHOSPHATE
NCE exclusivity
exclusivity.txt lines 1,343, 1,345- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002
28 May 2026 · NDA 214665 · SOTORASIB
NCE exclusivity
exclusivity.txt lines 1,359, 1,363, 1,367- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
30 May 2026 · NDA 217469 · CYCLOSPORINE
NP exclusivity
exclusivity.txt line 1,881- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
31 May 2026 · NDA 203565 · FERRIC CARBOXYMALTOSE
I-915 exclusivity
exclusivity.txt lines 336–339- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
31 May 2026 · NDA 208558 · OLAPARIB
I-914 exclusivity
exclusivity.txt lines 712, 715- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
1 Jun 2026 · NDA 214900 · IBREXAFUNGERP CITRATE
NCE exclusivity
exclusivity.txt line 1,412- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001
5 Jun 2026 · NDA 209939 · LETERMOVIR
I-916 exclusivity
exclusivity.txt lines 819, 825- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
5 Jun 2026 · NDA 209940 · LETERMOVIR
I-916 exclusivity
exclusivity.txt lines 831, 837- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002
5 Jun 2026 · NDA 211580 · INDOCYANINE GREEN
I-911 exclusivity
exclusivity.txt line 965- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
7 Jun 2026 · NDA 208684 · DEFLAZACORT
ODE-252 exclusivity
exclusivity.txt lines 733–736- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
7 Jun 2026 · NDA 208685 · DEFLAZACORT
ODE-252 exclusivity
exclusivity.txt line 737- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
12 Jun 2026 · NDA 202811 · LINACLOTIDE
I-921 exclusivity
exclusivity.txt lines 294, 297- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 003
13 Jun 2026 · NDA 215498 · ODEVIXIBAT
I-918 exclusivity
exclusivity.txt lines 1,568, 1,572, 1,576, 1,580- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
15 Jun 2026 · NDA 205551 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
M-294 exclusivity
exclusivity.txt line 500- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
15 Jun 2026 · NDA 214998 · MAVACAMTEN
M-297 exclusivity
exclusivity.txt lines 1,446, 1,449, 1,452, 1,455- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
15 Jun 2026 · NDA 215344 · MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE
NP exclusivity
exclusivity.txt line 1,533- Definition
- New product (to be checked against FDA's list)
- Product numbers
- 001
15 Jun 2026 · NDA 215413 · ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
NPP exclusivity
exclusivity.txt line 1,561- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001
17 Jun 2026 · NDA 211230 · SOLRIAMFETOL HYDROCHLORIDE
ODE-254 exclusivity
exclusivity.txt lines 946–947- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
18 Jun 2026 · NDA 210251 · BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
ODE-256 exclusivity
exclusivity.txt line 861- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
19 Jun 2026 · NDA 202192 · RUXOLITINIB PHOSPHATE
PED exclusivity
exclusivity.txt lines 240, 246, 252, 258, 264- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005
20 Jun 2026 · NDA 201280 · LINAGLIPTIN
M-295 exclusivity
exclusivity.txt line 215- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001
20 Jun 2026 · NDA 201281 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
M-295 exclusivity
exclusivity.txt lines 217, 219, 221- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
20 Jun 2026 · NDA 204629 · EMPAGLIFLOZIN
NPP exclusivity
exclusivity.txt lines 438, 440- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
20 Jun 2026 · NDA 206111 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
NPP exclusivity
exclusivity.txt lines 544, 546, 548, 550- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
20 Jun 2026 · NDA 208026 · LINAGLIPTIN; METFORMIN HYDROCHLORIDE
M-295 exclusivity
exclusivity.txt lines 678, 680- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
20 Jun 2026 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
M-296 exclusivity
exclusivity.txt lines 725, 727, 729, 731- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
20 Jun 2026 · NDA 211651 · TALAZOPARIB TOSYLATE
I-920 exclusivity
exclusivity.txt lines 976–978- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 003, 005
20 Jun 2026 · NDA 217439 · TALAZOPARIB TOSYLATE
I-920 exclusivity
exclusivity.txt lines 1,878–1,880- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001, 002, 004
21 Jun 2026 · NDA 021986 · DASATINIB
PED exclusivity
exclusivity.txt lines 146, 148, 150, 152, 154, 156- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
21 Jun 2026 · NDA 210491 · IVACAFTOR; IVACAFTOR, TEZACAFTOR
ODE-247 exclusivity
exclusivity.txt lines 876, 878- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
26 Jun 2026 · NDA 210238 · AVATROMBOPAG MALEATE
ODE-246 exclusivity
exclusivity.txt line 857- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
28 Jun 2026 · NDA 019569 · TIOPRONIN
ODE-267 exclusivity
exclusivity.txt line 106- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
28 Jun 2026 · NDA 211843 · TIOPRONIN
ODE* exclusivity
exclusivity.txt lines 1,003–1,004- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
29 Jun 2026 · NDA 206229 · LEVONORGESTREL
I-917 exclusivity
exclusivity.txt line 555- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001