FDA Orange Book · active-ingredient family
Mefenamic acid
Mefenamic acid: 1 brand, 5 generics; first approved Nov 19, 2010; 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
- AVION PHARMSNDA 015034—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB
Generic (ANDA) products (5)
Abbreviated applications
- MEFENAMIC ACIDCHARTWELL RXANDA 2092092020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — - MEFENAMIC ACIDAJENAT PHARMSANDA 0916082014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MEFENAMIC ACIDMPP PHARMAANDA 0903592013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — - MEFENAMIC ACIDLUPIN LTDANDA 0913222011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - MEFENAMIC ACIDMICRO LABSANDA 0905622010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG 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
16 yr 1 mo ago
Most recent approval
6 yr 2 mo ago
Approvals span 2010–2020 across 6 FDA applications.
Brand (NDA) 117%
Generic (ANDA) 583%
Mefenamic acid: 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.
