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Details for New Drug Application (NDA): 205836
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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 205836
Tradename: | BRIVIACT |
Applicant: | Ucb Inc |
Ingredient: | brivaracetam |
Patents: | 4 |
Generic Entry Opportunity Date for 205836
Generic Entry Date for 205836*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*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: 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 |
Paragraph IV (Patent) Challenges for 205836
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
BRIVIACT | TABLET;ORAL | brivaracetam | 205836 | 2020-05-12 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | May 12, 2016 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | May 12, 2021 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Patent: | Start Trial | Patent Expiration: | Apr 9, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Feb 21, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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