FDA Orange Book · active-ingredient family
Gemfibrozil
Gemfibrozil: 1 brand, 20 generics; first approved Nov 20, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 20 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
20
Listed patents
0
Presentations
23
Brand (NDA) products
Originator applications
- PFIZER PHARMSNDA 01842219863 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued - 300MG CAPSULE ORAL Discontinued - 600MG TABLET ORAL Rx AB
Generic (ANDA) products (20)
Abbreviated applications
- GEMFIBROZILASCENT PHARMS INCANDA 2146032021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - GEMFIBROZILCADILAANDA 2041892018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued - - GEMFIBROZILCADILA PHARMS LTDANDA 2032662016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - GEMFIBROZILAUROBINDO PHARMA LTDANDA 2027262015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - GEMFIBROZILNORTHSTAR HLTHCAREANDA 0790722010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - GEMFIBROZILHIKMA PHARMSANDA 0785992010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued - - GEMFIBROZILSUN PHARM INDS INCANDA 0792392008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued - - GEMFIBROZILIMPAX PHARMSANDA 0782072007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - GEMFIBROZILEPIC PHARMA LLCANDA 0780122007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - GEMFIBROZILINVAGEN PHARMSANDA 0778362006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - GEMFIBROZILAPOTEXANDA 0750341998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued - - GEMFIBROZILCHARTWELL RXANDA 0746151995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued - - GEMFIBROZILWATSON LABSANDA 0744421995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued - - GEMFIBROZILPHARMOBEDIENTANDA 0744521995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued - - GEMFIBROZILWATSON LABSANDA 0741561994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued - - GEMFIBROZILPUREPAC PHARMANDA 0743601994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued - - GEMFIBROZILTEVAANDA 0742561993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued - - GEMFIBROZILCHARTWELL MOLECULESANDA 0742701993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - GEMFIBROZILPUREPAC PHARMANDA 0729291993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Discontinued - - GEMFIBROZILNATCOANDA 0734661993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG 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 6 mo ago
Most recent approval
5 yr 10 mo ago
Approvals span 1986–2021 across 21 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 2095%
Gemfibrozil: 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.
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