FDA Orange Book · active-ingredient family
Bexarotene
Bexarotene: 2 brands, 9 generics; first approved Dec 29, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
9
Listed patents
0
Presentations
11
Brand (NDA) products
Originator applications
Generic (ANDA) products (9)
Abbreviated applications
- BEXAROTENECIPLAANDA 2103522024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Discontinued — - BEXAROTENEASCENT PHARMS INCANDA 2086282024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Rx AB - BEXAROTENEAMNEALANDA 2153982022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% GEL TOPICAL Rx AB - BEXAROTENETEVA PHARMS USAANDA 2099312021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Rx AB - BEXAROTENEHIKMAANDA 2036632020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Rx AB - BEXAROTENEAMNEAL PHARMS NYANDA 2101052018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Rx AB - BEXAROTENEUPSHER SMITH LABSANDA 2098862018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Rx AB - BEXAROTENEANI PHARMSANDA 2098612018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Rx AB - BEXAROTENEBIONPHARMAANDA 2031742014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
27 yr ago
Most recent approval
1 yr 8 mo ago
Approvals span 1999–2024 across 11 FDA applications.
Brand (NDA) 218%
Generic (ANDA) 982%
Bexarotene: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
