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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 three 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: | 3 |
Generic Entry Opportunity Date for 205837
Generic Entry Date for 205837*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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) |
Paragraph IV (Patent) Challenges for 205837
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BRIVIACT | SOLUTION;INTRAVENOUS | brivaracetam | 205837 | 2020-05-12 |
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: | May 12, 2021 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Feb 21, 2021 | 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: | Start Trial | Patent Expiration: | Feb 21, 2021 | 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 | ||||||||
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