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Last Updated: June 14, 2024

BRIVIACT Drug Patent Profile


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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

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Drug patent expirations by year for BRIVIACT
Drug Prices for BRIVIACT

See drug prices for BRIVIACT

Recent Clinical Trials for BRIVIACT

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

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

See all BRIVIACT clinical trials

Pharmacology for BRIVIACT
Mechanism of ActionEpoxide Hydrolase Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for BRIVIACT
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

Pharmaceutical compositions comprising 2-oxo-1-pyrrolidine derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY

2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PARTIAL ONSET SEIZURES IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY

2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER

FDA Regulatory Exclusivity protecting BRIVIACT

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-005 May 12, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-001 May 12, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ucb Inc BRIVIACT brivaracetam SOLUTION;ORAL 205838-001 May 12, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-003 May 12, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BRIVIACT

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 10215646
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 1007161
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 47395
Estimated Expiration: ⤷  Sign Up

China

Patent: 2292071
Estimated Expiration: ⤷  Sign Up

Patent: 4083328
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0141006
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 15673
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 91349
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 2057
Estimated Expiration: ⤷  Sign Up

Patent: 1101116
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 91349
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 61988
Estimated Expiration: ⤷  Sign Up

Patent: 98287
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 3545
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 76401
Estimated Expiration: ⤷  Sign Up

Patent: 12516302
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 11007267
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 927
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 91349
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 91349
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01400155
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 554
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 91349
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1640164
Estimated Expiration: ⤷  Sign Up

Patent: 120008022
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 11047
Estimated Expiration: ⤷  Sign Up

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
Japan 5576401 ⤷  Sign Up
Spain 2355140 ⤷  Sign Up
Israel 170181 (4R) AND (4S)-DIASTEREOISOMERS OF (2S)-2-[OXY-4-PROPYLPYRROLIDINYL]BUTANAMIDE, PHARMACEUTICAL COMPOSITIONS COMPRISING THEM AND THEIR USE FOR PREPARING MEDICAMENTS ⤷  Sign Up
Slovenia 2391349 ⤷  Sign Up
South Korea 100681580 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRIVIACT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1452524 122016000030 Germany ⤷  Sign Up PRODUCT NAME: BRIVARACETAM ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524 C01452524/01 Switzerland ⤷  Sign Up PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65830 06.10.2016
1452524 CR 2016 00013 Denmark ⤷  Sign Up PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118
1452524 10/2016 Austria ⤷  Sign Up PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 (MITTEILUNG) 20160118
2391349 C20160006 00188 Estonia ⤷  Sign Up PRODUCT NAME: BRIVARATSETAAM;REG NO/DATE: EU/1/15/1073 18.01.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.