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Details for New Drug Application (NDA): 205837
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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 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 205837
Generic Entry Date for 205837*:
Constraining patent/regulatory exclusivity:
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 |
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 | Start Trial | Start Trial |
Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;INTRAVENOUS | 205837-001 | May 12, 2016 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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