FDA Orange Book · active-ingredient family
Brivaracetam
Brivaracetam is approved as 3 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BRIVIACT · NDA 205837
3
Brand (NDA)
15
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRIVIACTRLD | UCB INC | NDA 205837 | AP | May 12, 2016 | |
| BRIVIACTRLD | UCB INC | NDA 205838 | AA | May 12, 2016 | |
| BRIVIACTRLD×5 | UCB INC | NDA 205836 | AB | May 12, 2016 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRIVARACETAM | HAINAN POLY | ANDA 218249 | AP | Feb 23, 2026 | |
| BRIVARACETAM | MICRO LABS | ANDA 214880 | AP | Feb 23, 2026 | |
| BRIVARACETAM | MSN | ANDA 214924 | AP | Feb 23, 2026 | |
| BRIVARACETAM | ALKEM LABS LTD | ANDA 219772 | AA | Feb 23, 2026 | |
| BRIVARACETAM | LUPIN | ANDA 220164 | AA | Feb 23, 2026 | |
| BRIVARACETAM | REGCON HOLDINGS | ANDA 220385 | AA | Feb 23, 2026 | |
| BRIVARACETAM | ZHEJIANG POLY PHARM | ANDA 218494 | AA | Feb 23, 2026 | |
| BRIVARACETAM×5 | APOTEX | ANDA 214875 | AB | Feb 23, 2026 | |
| BRIVARACETAM×5 | CENTAUR PHARMS PVT | ANDA 220470 | AB | Feb 23, 2026 | |
| BRIVARACETAM | MSN | ANDA 214922 | AA | Feb 19, 2026 | |
| BRIVARACETAM×5 | MSN | ANDA 214921 | AB | Nov 13, 2025 | |
| BRIVARACETAM×2 | AUROBINDO PHARMA LTD | ANDA 214848 | AB | Jan 06, 2023 | |
| BRIVARACETAM×5 | LUPIN | ANDA 214918 | — | Dec 20, 2022 | |
| BRIVARACETAM×5 | ZYDUS PHARMS | ANDA 214501 | AB | Oct 03, 2022 | |
| BRIVARACETAM×5 | SUNSHINE | ANDA 214748 | AB | Jun 09, 2022 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 6911461 | Feb 21, 2026 | 4 mo ago | SubstanceProductU-1815 |
| 10729653 | Apr 09, 2030 | in 3 yr 10 mo | Product |
Brivaracetam — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
