Details for New Drug Application (NDA): 205836
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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 205836
| Tradename: | BRIVIACT |
| Applicant: | Ucb Inc |
| Ingredient: | brivaracetam |
| Patents: | 2 |
Pharmacology for NDA: 205836
| Mechanism of Action | Epoxide Hydrolase Inhibitors |
Suppliers and Packaging for NDA: 205836
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIVIACT | brivaracetam | TABLET;ORAL | 205836 | NDA | UCB, Inc. | 50474-370 | 50474-370-66 | 1 BOTTLE in 1 CARTON (50474-370-66) / 60 TABLET, FILM COATED in 1 BOTTLE |
| BRIVIACT | brivaracetam | TABLET;ORAL | 205836 | NDA | UCB, Inc. | 50474-470 | 50474-470-09 | 100 BLISTER PACK in 1 CARTON (50474-470-09) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 12, 2016 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 9, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| 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 | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | May 12, 2016 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 9, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 205836
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-004 | May 12, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-003 | May 12, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-001 | May 12, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-005 | May 12, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-002 | May 12, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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