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 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 205836

Tradename:	BRIVIACT
Applicant:	Ucb Inc
Ingredient:	brivaracetam
Patents:	2

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

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:	Aug 27, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:	10,729,653	Patent Expiration:	Apr 9, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	6,911,461	Patent Expiration:	Feb 21, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER

Expired US Patents for NDA 205836

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016	6,784,197	⤷ Subscribe
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016	6,784,197	⤷ Subscribe
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016	6,784,197	⤷ Subscribe
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	May 12, 2016	6,784,197	⤷ Subscribe
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016	8,492,416	⤷ Subscribe
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	May 12, 2016	8,492,416	⤷ Subscribe
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016	8,492,416	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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