FDA Orange Book · active-ingredient family
Acitretin
Acitretin: 1 brand, 7 generics; first approved Oct 28, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
23
Brand (NDA) products
Originator applications
- SORIATANERLDSTIEFEL LABS INCNDA 01982119964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — 25MG CAPSULE ORAL Discontinued — 17.5MG CAPSULE ORAL Discontinued — 22.5MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (7)
Abbreviated applications
- ACITRETINALEMBICANDA 21777420243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 17.5MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - ACITRETINIMPAX LABS INCANDA 20255220154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 17.5MG CAPSULE ORAL Rx AB 22.5MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - ACITRETINMYLANANDA 20214820152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - ACITRETINMYLANANDA 20370720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17.5MG CAPSULE ORAL Discontinued — 22.5MG CAPSULE ORAL Discontinued — - ACITRETINSIGMAPHARM LABS LLCANDA 20463320154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 17.5MG CAPSULE ORAL Rx AB 22.5MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - ACITRETINBARR LABS INCANDA 09145520132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - ACITRETINTEVA PHARMS USAANDA 20289720132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 17.5MG CAPSULE ORAL Rx AB 22.5MG 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
30 yr 3 mo ago
Most recent approval
2 yr 1 mo ago
Approvals span 1996–2024 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Acitretin: 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.
