FDA Orange Book · active-ingredient family
Leflunomide
Leflunomide is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ARAVA · NDA 020905
1
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ARAVARLD×3 | SANOFI AVENTIS US | NDA 020905 | AB | Sep 10, 1998 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEFLUNOMIDE×2 | AET PHARMA | ANDA 213497 | AB | May 10, 2021 | |
| LEFLUNOMIDE×2 | AUROBINDO PHARMA | ANDA 213652 | AB | Mar 29, 2021 | |
| LEFLUNOMIDE×2 | LUPIN | ANDA 211863 | AB | Feb 04, 2020 | |
| LEFLUNOMIDE×2 | ABHAI LLC | ANDA 212453 | AB | Jun 03, 2019 | |
| LEFLUNOMIDE×2 | ZYDUS LIFESCIENCES | ANDA 212308 | AB | Apr 24, 2019 | |
| LEFLUNOMIDE×2 | ALEMBIC PHARMS LTD | ANDA 091369 | AB | Nov 21, 2011 | |
| LEFLUNOMIDE×2 | APOTEX | ANDA 077090 | AB | Sep 13, 2005 | |
| LEFLUNOMIDE×2 | BARR | ANDA 077083 | — | Sep 13, 2005 | |
| LEFLUNOMIDE×2 | FOSUN WANBANG | ANDA 077087 | AB | Sep 13, 2005 | |
| LEFLUNOMIDE×2 | HERITAGE | ANDA 077086 | AB | Sep 13, 2005 | |
| LEFLUNOMIDE×2 | SANDOZ | ANDA 077085 | — | Sep 13, 2005 | |
| LEFLUNOMIDE×2 | TEVA PHARMS | ANDA 077084 | — | Sep 13, 2005 |
Listed patents
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.
Leflunomide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
