Details for New Drug Application (NDA): 205838
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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 205838
| Tradename: | BRIVIACT |
| Applicant: | Ucb Inc |
| Ingredient: | brivaracetam |
| Patents: | 1 |
Pharmacology for NDA: 205838
| Mechanism of Action | Epoxide Hydrolase Inhibitors |
Suppliers and Packaging for NDA: 205838
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838 | NDA | UCB, Inc. | 50474-870 | 50474-870-15 | 1 BOTTLE in 1 CARTON (50474-870-15) / 300 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | May 12, 2016 | TE: | AA | RLD: | Yes | ||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 21, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER | ||||||||
Expired US Patents for NDA 205838
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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