FDA Orange Book · active-ingredient family
Rufinamide
Rufinamide is approved as 2 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BANZEL · NDA 201367
2
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BANZELRLD | EISAI INC | NDA 201367 | AB | Mar 03, 2011 | |
| BANZELRLD×3 | EISAI INC | NDA 021911 | — | Nov 14, 2008 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RUFINAMIDE | MSN | ANDA 214817 | AB | Apr 15, 2025 | |
| RUFINAMIDE | HETERO LABS LTD III | ANDA 216841 | AB | Dec 05, 2023 | |
| RUFINAMIDE×2 | AUROBINDO PHARMA | ANDA 217230 | AB | Jun 16, 2023 | |
| RUFINAMIDE×2 | MICRO LABS | ANDA 216688 | AB | May 15, 2023 | |
| RUFINAMIDE | CHARTWELL RX | ANDA 214009 | AB | Nov 07, 2022 | |
| RUFINAMIDE | AUROBINDO PHARMA | ANDA 216549 | AB | Oct 26, 2022 | |
| RUFINAMIDE×3 | LUPIN | ANDA 204964 | — | Aug 17, 2022 | |
| RUFINAMIDE×2 | HETERO LABS LTD III | ANDA 204993 | AB | May 11, 2021 | |
| RUFINAMIDE | ALKEM LABS LTD | ANDA 213410 | AB | Feb 23, 2021 | |
| RUFINAMIDE | LUPIN | ANDA 213457 | AB | Dec 18, 2020 | |
| RUFINAMIDE | BIONPHARMA | ANDA 211388 | AB | Apr 23, 2019 | |
| RUFINAMIDE | HIKMA | ANDA 207363 | AB | Apr 23, 2019 | |
| RUFINAMIDE×2 | GLENMARK PHARMS LTD | ANDA 205075 | AB | May 16, 2016 | |
| RUFINAMIDE×2 | HIKMA | ANDA 204988 | AB | May 16, 2016 | |
| RUFINAMIDE×2 | PHARMOBEDIENT | ANDA 205095 | AB | May 16, 2016 |
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.
Rufinamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
