FDA Orange Book · active-ingredient family
Bexarotene
Bexarotene is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TARGRETIN · NDA 021056
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, gel
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TARGRETINRLD | BAUSCH | NDA 021056 | AB | Jun 28, 2000 | |
| TARGRETINRLD | BAUSCH | NDA 021055 | AB | Dec 29, 1999 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BEXAROTENE | CIPLA | ANDA 210352 | — | Dec 10, 2024 | |
| BEXAROTENE | ASCENT PHARMS INC | ANDA 208628 | AB | Sep 06, 2024 | |
| BEXAROTENE | AMNEAL | ANDA 215398 | AB | Apr 27, 2022 | |
| BEXAROTENE | TEVA PHARMS USA | ANDA 209931 | AB | Jan 14, 2021 | |
| BEXAROTENE | HIKMA | ANDA 203663 | AB | Jun 16, 2020 | |
| BEXAROTENE | AMNEAL PHARMS NY | ANDA 210105 | AB | Sep 04, 2018 | |
| BEXAROTENE | UPSHER SMITH LABS | ANDA 209886 | AB | Jul 25, 2018 | |
| BEXAROTENE | ANI PHARMS | ANDA 209861 | AB | May 08, 2018 | |
| BEXAROTENE | BIONPHARMA | ANDA 203174 | AB | Aug 12, 2014 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Bexarotene — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
