FDA Orange Book
Generic for Arava
Arava contains leflunomide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Arava is leflunomide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Arava products the Orange Book lists.
Run it in Rivvi
Map Arava and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Arava products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 20MG | Marketed (Rx) | AB | 9 | AB |
NDA 020905, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic leflunomide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 077090 | AB (A-rated, therapeutically equivalent) | September 13, 2005 | 10MG, 20MG |
| FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO LTD | 077087 | AB (A-rated, therapeutically equivalent) | September 13, 2005 | 10MG, 20MG |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 077086 | AB (A-rated, therapeutically equivalent) | September 13, 2005 | 10MG, 20MG |
| ALEMBIC PHARMACEUTICALS LTD | 091369 | AB (A-rated, therapeutically equivalent) | November 21, 2011 | 10MG, 20MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 212308 | AB (A-rated, therapeutically equivalent) | April 24, 2019 | 10MG, 20MG |
| ABHAI LLC | 212453 | AB (A-rated, therapeutically equivalent) | June 3, 2019 | 10MG, 20MG |
| LUPIN LTD | 211863 | AB (A-rated, therapeutically equivalent) | February 4, 2020 | 10MG, 20MG |
| AUROBINDO PHARMA LTD | 213652 | AB (A-rated, therapeutically equivalent) | March 29, 2021 | 10MG, 20MG |
| AET PHARMA US INC | 213497 | AB (A-rated, therapeutically equivalent) | May 10, 2021 | 10MG, 20MG |
Arava NDC codes
Questions
Is there a generic for Arava?
Yes. The generic name for Arava is leflunomide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Arava products the Orange Book lists.
What is the generic name for Arava?
The active ingredient in Arava is leflunomide, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.