Brivaracetam - Generic Drug Details

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

Brivaracetam is the generic ingredient in two branded drugs marketed by Ucb Inc, Aurobindo Pharma Ltd, Lupin Ltd, Sunshine, and Zydus Pharms, and is included in seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brivaracetam has one hundred and seventy-three patent family members in forty-five countries.

One supplier is listed for this compound. There are five tentative approvals for this compound.

Summary for brivaracetam

International Patents:	173
US Patents:	2
Tradenames:	2
Applicants:	5
NDAs:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	44
Patent Applications:	1,276
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for brivaracetam
What excipients (inactive ingredients) are in brivaracetam?	brivaracetam excipients list
DailyMed Link:	brivaracetam at DailyMed

Recent Clinical Trials for brivaracetam

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of California, Los Angeles	Phase 1/Phase 2
University of Minnesota	Phase 3
Overseas Pharmaceuticals, Ltd.	Phase 1

See all brivaracetam clinical trials

Generic filers with tentative approvals for BRIVARACETAM

Applicant	Application No.	Strength	Dosage Form
		100mg	TABLET; ORAL
		75mg	TABLET; ORAL
		50mg	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for brivaracetam

Mechanism of Action

Epoxide Hydrolase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for brivaracetam

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for BRIVARACETAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BRIVIACT	Tablets	brivaracetam	10 mg, 25 mg, 50 mg, 75 mg and 100 mg	205836	7	2020-05-12
BRIVIACT	Injection	brivaracetam	50 mg/5 mL	205837	2	2020-05-12
BRIVIACT	Oral Solution	brivaracetam	10 mg/mL	205838	1	2020-05-12

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
Lupin Ltd	BRIVARACETAM	brivaracetam	TABLET;ORAL	214918-001	Dec 20, 2022		DISCN	No	No
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016		RX	Yes	No
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	May 12, 2016		RX	Yes	No
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016		RX	Yes	Yes			Y	Y
Zydus Pharms	BRIVARACETAM	brivaracetam	TABLET;ORAL	214501-004	Oct 3, 2022		DISCN	No	No
Sunshine	BRIVARACETAM	brivaracetam	TABLET;ORAL	214748-003	Jun 9, 2022		DISCN	No	No
Aurobindo Pharma Ltd	BRIVARACETAM	brivaracetam	TABLET;ORAL	214848-002	Jan 6, 2023		DISCN	No	No

Expired US Patents for brivaracetam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016

EU/EMA Drug Approvals for brivaracetam

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma SA	Briviact (in Italy: Nubriveo)	brivaracetam	EMEA/H/C/003898 Briviact is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy.	Authorised	no	no	no	2016-01-13

International Patents for brivaracetam

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2005125645
Mexico	PA02008056	DERIVADOS DE 2-OXO-1 PIRROLIDINA, PROCESO PARA PREPARARLOS Y SUS APLICACIONES. (2 OXO 1 PYRROLIDINE DERIVATIVES, PROCESSES FOR PREPARING THEM AND THEIR USES.)
Australia	2001252144
Japan	2003528828
Poland	213669
South Africa	200205671	2-oxo-1-pyrrolidine derivatives, process for preparing them and their uses.
Iceland	2119

Supplementary Protection Certificates for brivaracetam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1452524	2016/011	Ireland		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1265862	PA2016013	Lithuania		PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114
2391349	C20160006	Estonia		PRODUCT NAME: BRIVARATSETAAM; NATIONAL AUTHORISATION NUMBER: EMA/CHMP/1199/2023 13.03.2023
1452524	10/2016	Austria		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 (MITTEILUNG) 20160118
1452524	122016000030	Germany		PRODUCT NAME: BRIVARACETAM ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	530	Finland
1265862	PA2016013,C1265862	Lithuania		PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114