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 two 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 205837

Tradename:	BRIVIACT
Applicant:	Ucb Inc
Ingredient:	brivaracetam
Patents:	1

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)

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:	Aug 27, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:	⤷ Sign Up	Patent Expiration:	Feb 21, 2026	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:	⤷ Sign Up	Patent Expiration:	Feb 21, 2026	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016	⤷ Sign Up	⤷ Sign Up
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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