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Last Updated: May 18, 2024

BRIVIACT Drug Patent Profile


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When do Briviact patents expire, and when can generic versions of Briviact launch?

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

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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-005 May 12, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-001 May 12, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam SOLUTION;ORAL 205838-001 May 12, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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 205836-002 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam SOLUTION;ORAL 205838-001 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam SOLUTION;INTRAVENOUS 205837-001 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-003 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Brazil

Patent: 1007161
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 47395
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2292071
Estimated Expiration: ⤷  Try a Trial

Patent: 4083328
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0141006
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 15673
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 91349
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 2057
Estimated Expiration: ⤷  Try a Trial

Patent: 1101116
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 91349
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 61988
Estimated Expiration: ⤷  Try a Trial

Patent: 98287
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3545
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 76401
Estimated Expiration: ⤷  Try a Trial

Patent: 12516302
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 11007267
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 927
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 91349
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 91349
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01400155
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 554
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 91349
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1640164
Estimated Expiration: ⤷  Try a Trial

Patent: 120008022
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 11047
Estimated Expiration: ⤷  Try a Trial

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
Germany 60140222 ⤷  Try a Trial
Iceland 2754 ⤷  Try a Trial
Hong Kong 1198287 包含 -氧代- -吡咯烷衍生物的藥物組合物 (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES 2--1-) ⤷  Try a Trial
San Marino T201400155 Composizioni farmaceutiche comprendenti derivati di 2-osso-1-pirrolidina ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRIVIACT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2391349 C20160006 00188 Estonia ⤷  Try a Trial PRODUCT NAME: BRIVARATSETAAM;REG NO/DATE: EU/1/15/1073 18.01.2016
1452524 CA 2016 00013 Denmark ⤷  Try a Trial PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118
1452524 1690009-4 Sweden ⤷  Try a Trial PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073 20150114
1452524 300815 Netherlands ⤷  Try a Trial PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118
>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.