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^® Litigation and Generic Entry Outlook for Briviact

A generic version of BRIVIACT was approved as brivaracetam by LUPIN LTD on December 20^th, 2022.

Summary for BRIVIACT

International Patents:	173
US Patents:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	13
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
GX pharma technology (beijing) Co., Ltd	Phase 1
Overseas Pharmaceuticals, Ltd.	Phase 1
UCB Biopharma SRL	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	AB	RX	Yes	Yes			Y	Y
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-001	May 12, 2016	AB	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	AB	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	SOLUTION;ORAL	205838-001	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-005	May 12, 2016
Ucb Inc	BRIVIACT	brivaracetam	TABLET;ORAL	205836-002	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

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
Romania	121597	DERIVATI DE 2-OXO-1-PIROLIDINA, COMPOZITII FARMACEUTICE SI UTILIZAREA LOR (2-OXO-PYRROLIDINE DERIVATIVES, PHARMACEUTICAL COMPOSITIONS AND USE THEREOF)
New Zealand	520448	2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Iceland	2176
Austria	488500
Montenegro	00595	2-OKSO-1-PIROLIDINSKI DERIVATI, POSTUPCI ZA NJIHOVO DOBIJANJE I NJIHOVE PRIMENE (2-OXO-1-PYRROLIDINE DERIVATIVES, PROCESSES FOR PREPARING THEM AND THEIR USES)

Supplementary Protection Certificates for BRIVIACT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122016000030	Germany		PRODUCT NAME: BRIVARACETAM ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524	C01452524/01	Switzerland		PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65830 06.10.2016
1265862	PA2016013	Lithuania		PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114