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Brivaracetam - Generic Drug Details

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What are the generic sources for brivaracetam and what is the scope of brivaracetam freedom to operate?

Brivaracetam is the generic ingredient in one branded drug marketed by Ucb Inc and is included in three NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brivaracetam has one hundred and forty-four patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for brivaracetam

International Patents:	144
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	23
Clinical Trials:	30
Patent Applications:	445
DailyMed Link:	brivaracetam at DailyMed

Pharmacology for brivaracetam

Mechanism of Action

Epoxide Hydrolase Inhibitors

Synonyms for brivaracetam

(2S)-2-((4R)-2-oxo-4-n-propyl-1-pyrrolidinyl)butanamide

(2S)-2-((4R)-2-Oxo-4-propylpyrrolidin-1-yl)butanamide

(2S)-2-[(4R)-2-oxo-4-propyl-pyrrolidin-1-yl]butanamide

(2s)-2-[(4r)-2-oxo-4-propylpyrrolidin-1-yl]butanamide

(S)-2-((R)-2-Oxo-4-propylpyrrolidin-1-yl)butanamide

1-Pyrrolidineacetamide, alpha-ethyl-2-oxo-4-propyl-, (alphaS,4R)-

2-(2-oxo-4-propylpyrrolidin-1-yl)butanamide

2(s)-[2-oxo-4(r)-propylpyrrolidin-1-yl]butyramide

357336-20-0

AK317303

AKOS027324306

AN-16688

BDBM50422531

Brivaracetam (USAN/INN)

Brivaracetam [USAN:INN]

Briviact

Briviact (TN)

CHEBI:133013

CHEMBL607400

compound 83alpha

CS-3418

D08879

D0CT4D

DB05541

FT-0700965

GTPL9041

HY-14449

MFCD25976668

MSYKRHVOOPPJKU-BDAKNGLRSA-N

Rikelta

SCHEMBL122081

U863JGG2IA

UCB 34714

UCB-34714

UCB34714

UNII-U863JGG2IA

ZINC3979899

US Patents and Regulatory Information for brivaracetam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016		RX	Yes	No			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	May 12, 2016		RX	Yes	No			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016		RX	Yes	Yes

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Non-Orange Book US Patents for brivaracetam

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,713,635	2-oxo-1-pyrrolidine derivatives, process for preparing them and their uses
6,806,287	2-oxo-1-pyrrolidine derivatives, process for preparing them and their uses
6,858,740	2-oxo-1-pyrrolidine derivatives, process for preparing them and their uses

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International Patents for brivaracetam

Country	Document Number	Estimated Expiration
Denmark	1452524
Germany	60119397
Australia	5214401

Supplementary Protection Certificates for brivaracetam

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90009-4	Sweden		PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073 20150114
2016013,C1265862	Lithuania		PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114
2016013	Lithuania		PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114