Details for New Drug Application (NDA): 205837
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The generic ingredient in BRIVIACT is brivaracetam. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.
Summary for 205837
| Tradename: | BRIVIACT |
| Applicant: | Ucb Inc |
| Ingredient: | brivaracetam |
| Patents: | 1 |
Pharmacology for NDA: 205837
| Mechanism of Action | Epoxide Hydrolase Inhibitors |
Suppliers and Packaging for NDA: 205837
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIVIACT | brivaracetam | SOLUTION;INTRAVENOUS | 205837 | NDA | UCB, Inc. | 50474-970 | 50474-970-75 | 10 VIAL, GLASS in 1 CARTON (50474-970-75) / 5 mL in 1 VIAL, GLASS (50474-970-63) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/5ML (10MG/ML) | ||||
| Approval Date: | May 12, 2016 | TE: | AP | RLD: | Yes | ||||
| Patent: | 6,911,461 | Patent Expiration: | Feb 21, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PARTIAL ONSET SEIZURES IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY | ||||||||
| Patent: | 6,911,461 | Patent Expiration: | Feb 21, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY | ||||||||
Expired US Patents for NDA 205837
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;INTRAVENOUS | 205837-001 | May 12, 2016 | 6,784,197 | ⤷ Start Trial |
| Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;INTRAVENOUS | 205837-001 | May 12, 2016 | 6,911,461 | ⤷ Start Trial |
| Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;INTRAVENOUS | 205837-001 | May 12, 2016 | 8,492,416 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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