Brivaracetam - Generic Drug Details

What are the generic drug 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, Sunshine, and Zydus Pharms, and is included in five 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 eight tentative approvals for this compound.

Summary for brivaracetam

International Patents:	173
US Patents:	2
Tradenames:	2
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	41
Patent Applications:	737
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 Rochester	Early Phase 1
UCB Biopharma SRL	Phase 1
University of Minnesota	Phase 1/Phase 2

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

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
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016	AB	RX	Yes	No			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016	AB	RX	Yes	No			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016		RX	Yes	Yes			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016	AB	RX	Yes	Yes			Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	May 12, 2016	AB	RX	Yes	No			Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-004	May 12, 2016	AB	RX	Yes	No			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	May 12, 2016	AB	RX	Yes	No

Expired US Patents for brivaracetam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	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	205836-002	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	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
Spain	2231501
Iceland	7923
Luxembourg	92993
Hungary	0204526
Russian Federation	2291860	ПРОИЗВОДНЫЕ 2-ОКСО-1-ПИРРОЛИДИНА, СПОСОБ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ
Australia	5214401
China	1404470

Supplementary Protection Certificates for brivaracetam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1265862	PA2016013	Lithuania		PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	C01452524/01	Switzerland		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65830 06.10.2016
1452524	122016000030	Germany		PRODUCT NAME: BRIVARACETAM ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	CR 2016 00013	Denmark		PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118
1452524	CA 2016 00013	Denmark		PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118
1452524	10/2016	Austria		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 (MITTEILUNG) 20160118
1452524	132016000045699	Italy		PRODUCT NAME: BRIVARACETAM(BRIVIACT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1073, 20160118