FDA Orange Book · active-ingredient family
Leflunomide
Leflunomide: 1 brand, 12 generics; first approved Sep 10, 1998; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
12
Listed patents
0
Presentations
27
Brand (NDA) products
Originator applications
- ARAVARLDSANOFI AVENTIS USNDA 02090519983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 100MG TABLET ORAL Discontinued —
Generic (ANDA) products (12)
Abbreviated applications
- LEFLUNOMIDEAET PHARMAANDA 21349720212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - LEFLUNOMIDEAUROBINDO PHARMAANDA 21365220212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - LEFLUNOMIDELUPINANDA 21186320202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - LEFLUNOMIDEABHAI LLCANDA 21245320192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - LEFLUNOMIDEZYDUS LIFESCIENCESANDA 21230820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - LEFLUNOMIDEALEMBIC PHARMS LTDANDA 09136920112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - LEFLUNOMIDEAPOTEXANDA 07709020052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - LEFLUNOMIDEBARRANDA 07708320052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - LEFLUNOMIDEFOSUN WANBANGANDA 07708720052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - LEFLUNOMIDEHERITAGEANDA 07708620052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - LEFLUNOMIDESANDOZANDA 07708520052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - LEFLUNOMIDETEVA PHARMSANDA 07708420052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET 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
28 yr 6 mo ago
Most recent approval
5 yr 6 mo ago
Approvals span 1998–2021 across 13 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1292%
Leflunomide: 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.
