Details for New Drug Application (NDA): 205837
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NDA 205837 describes BRIVIACT, which is a drug marketed by Ucb Inc and is included in three NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the BRIVIACT profile page.
The generic ingredient in BRIVIACT is brivaracetam. One supplier is listed for this compound. Additional details are available on the brivaracetam profile page.
The generic ingredient in BRIVIACT is brivaracetam. One supplier is 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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 27, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;INTRAVENOUS | 205837-001 | May 12, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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