FDA Orange Book · active-ingredient family
Clofibrate
Clofibrate: 1 brand, 5 generics; first approved Jun 16, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
5
Listed patents
0
Presentations
6
Brand (NDA) products
Originator applications
- WYETH AYERSTNDA 016099—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (5)
Abbreviated applications
- CLOFIBRATEBANNER PHARMACAPSANDA 0733961992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Discontinued — - CLOFIBRATETEVAANDA 0726001991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Discontinued — - CLOFIBRATESANDOZANDA 0721911988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Discontinued — - CLOFIBRATEWATSON LABSANDA 0716031987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Discontinued — - CLOFIBRATEUSL PHARMAANDA 0705311986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE ORAL Discontinued —
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
40 yr 9 mo ago
Most recent approval
34 yr 11 mo ago
Approvals span 1986–1992 across 6 FDA applications.
Brand (NDA) 117%
Generic (ANDA) 583%
Clofibrate: 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.
