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Details for New Drug Application (NDA): 205838

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NDA 205838 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.

Summary for NDA: 205838

Tradename:
BRIVIACT
Applicant:
Ucb Inc
Ingredient:
brivaracetam
Patents:3

Pharmacology for NDA: 205838

Mechanism of ActionEpoxide Hydrolase Inhibitors

Suppliers and Packaging for NDA: 205838

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIVIACT
brivaracetam
SOLUTION;ORAL 205838 NDA UCB, Inc. 50474-870 50474-870-15 1 BOTTLE in 1 CARTON (50474-870-15) > 300 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:May 12, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:May 12, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:6,784,197Patent Expiration:Feb 21, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY
Patent:6,911,461Patent Expiration:Feb 21, 2021Product Flag?YSubstance Flag?YDelist 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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