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Generated: November 13, 2018

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Details for New Drug Application (NDA): 205836

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NDA 205836 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 205836
Tradename:BRIVIACT
Applicant:Ucb Inc
Ingredient:brivaracetam
Patents:3
Generic Entry Opportunity Date for 205836
Generic Entry Date for 205836*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
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 ActionEpoxide 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 12, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:May 12, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Feb 21, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
Patent:➤ Try a Free TrialPatent Expiration:Feb 21, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Cerilliant
Harvard Business School
Julphar
Fuji
Johnson and Johnson
US Department of Justice
Accenture

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