FDA Orange Book · active-ingredient family
Clocortolone pivalate
Clocortolone pivalate: 1 brand, 1 generic; first approved Apr 21, 2020; generic available.
Generic available
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
0
Presentations
2
Brand (NDA) products
Originator applications
- LEGACYNDA 017765—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL Rx AB
Generic (ANDA) products (1)
Abbreviated applications
- CLOCORTOLONE PIVALATETAROANDA 2063702020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL 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
6 yr 5 mo ago
Most recent approval
6 yr 5 mo ago
All 2 applications were approved in 2020.
Brand (NDA) 150%
Generic (ANDA) 150%
Clocortolone pivalate: 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.
