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 four 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 205838

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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for 205838

Generic Entry Date for 205838^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial Dosage: SOLUTION;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: 205838

Mechanism of Action	Epoxide 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

Paragraph IV (Patent) Challenges for 205838

Tradename	Dosage	Ingredient	NDA	Submissiondate
BRIVIACT	SOLUTION;ORAL	brivaracetam	205838	2020-05-12

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	May 12, 2016	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 12, 2021
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	Start Trial	Patent Expiration:	Feb 21, 2021	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
Patent:	Start Trial	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 205838

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016	Start Trial	Start Trial
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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