BRIVIACT Drug Patent Profile

When do Briviact patents expire, and what generic alternatives are available?

Briviact is a drug marketed by Ucb Inc and is included in three NDAs. There are two patents protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in BRIVIACT is brivaracetam. One supplier is listed for this compound. Additional details are available on the brivaracetam profile page.

DrugPatentWatch^® Generic Entry Outlook for Briviact

Briviact was eligible for patent challenges on May 12, 2020.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are five tentative approvals for the generic drug (brivaracetam), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for BRIVIACT

International Patents:	173
US Patents:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	14
Patent Applications:	510
Drug Prices:	Drug price information for BRIVIACT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRIVIACT
What excipients (inactive ingredients) are in BRIVIACT?	BRIVIACT excipients list
DailyMed Link:	BRIVIACT at DailyMed

See drug prices for BRIVIACT

Recent Clinical Trials for BRIVIACT

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

Sponsor	Phase
University of California, Los Angeles	Phase 1/Phase 2
Overseas Pharmaceuticals, Ltd.	Phase 1
GX pharma technology (beijing) Co., Ltd	Phase 1

See all BRIVIACT clinical trials

Pharmacology for BRIVIACT

Mechanism of Action

Epoxide Hydrolase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BRIVIACT

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for BRIVIACT

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 BRIVIACT

BRIVIACT is protected by four US patents and one FDA Regulatory Exclusivity.

Patents protecting BRIVIACT

FDA Regulatory Exclusivity protecting BRIVIACT

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	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016		RX	Yes	Yes			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016		RX	Yes	Yes			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016		RX	Yes	No			Y
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016		RX	Yes	Yes			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	May 12, 2016		RX	Yes	No			Y	Y

Expired US Patents for BRIVIACT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-003	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;INTRAVENOUS	205837-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	SOLUTION;ORAL	205838-001	May 12, 2016

EU/EMA Drug Approvals for BRIVIACT

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 BRIVIACT

When does loss-of-exclusivity occur for BRIVIACT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

Montenegro

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BRIVIACT around the world.

Country	Patent Number	Title	Estimated Expiration
Czech Republic	304702	(4R) a (4S) diastereoizomery (2S)-2-[2-oxo-4-propylpyrrolidinyl] butanamidu, farmaceutická kompozice s jejich obsahem a jejich použití ((4R) and (4S) Diastereoisomers of (2S)-2-[2-oxo-4-propylpyrrolidinyl] butanamide, pharmaceutical composition containing thereof and their use)
Brazil	0108657
Japan	2012516302
Bulgaria	109297
Hungary	230270	(2S)-2-[2-oxo-4-propilpirrolidinil]-butánamid (4R) és (4S) diasztereoizomerjei és gyógyszerészetileg elfogadható sói és ezek gyógyászati alkalmazása ((4r)and(4s)diastereoisomers of (2s)-2-[2-oxo-4-propylpyrrolidinyl]-butaneamide and pharmaceutically acceptable salts of them and their use)

Supplementary Protection Certificates for BRIVIACT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1452524	132016000045699	Italy		PRODUCT NAME: BRIVARACETAM(BRIVIACT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1073, 20160118
1452524	1690009-4	Sweden		PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073 20150114
1452524	16C1001	France		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118
1452524	530	Finland
1265862	PA2016013,C1265862	Lithuania		PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114