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Last Updated: May 20, 2022

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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 21, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 three 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

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BRIVIACT
Generic Entry Dates for BRIVIACT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS
Generic Entry Dates for BRIVIACT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL
Generic Entry Dates for BRIVIACT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BRIVIACT

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

SponsorPhase
UCB Biopharma SRLPhase 1
University of MinnesotaPhase 1/Phase 2
UCB Biopharma SRLPhase 2/Phase 3

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BRIVIACT is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting BRIVIACT

Pharmaceutical compositions comprising 2-oxo-1-pyrrolidine derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-005 May 12, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-001 May 12, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam SOLUTION;ORAL 205838-001 May 12, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-003 May 12, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-005 May 12, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-001 May 12, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam SOLUTION;ORAL 205838-001 May 12, 2016 See Plans and Pricing See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam SOLUTION;INTRAVENOUS 205837-001 May 12, 2016 See Plans and Pricing See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-003 May 12, 2016 See Plans and Pricing See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-005 May 12, 2016 See Plans and Pricing See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-002 May 12, 2016 See Plans and Pricing See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-004 May 12, 2016 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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: See Plans and Pricing

Brazil

Patent: 1007161
Estimated Expiration: See Plans and Pricing

Canada

Patent: 47395
Estimated Expiration: See Plans and Pricing

China

Patent: 2292071
Estimated Expiration: See Plans and Pricing

Patent: 4083328
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0141006
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15673
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 91349
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2057
Estimated Expiration: See Plans and Pricing

Patent: 1101116
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 91349
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 61988
Estimated Expiration: See Plans and Pricing

Patent: 98287
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3545
Estimated Expiration: See Plans and Pricing

Japan

Patent: 76401
Estimated Expiration: See Plans and Pricing

Patent: 12516302
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 11007267
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 927
Estimated Expiration: See Plans and Pricing

Poland

Patent: 91349
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 91349
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01400155
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 554
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 91349
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1640164
Estimated Expiration: See Plans and Pricing

Patent: 120008022
Estimated Expiration: See Plans and Pricing

Spain

Patent: 11047
Estimated Expiration: See Plans and Pricing

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
China 1404470 See Plans and Pricing
Japan 2003523996 See Plans and Pricing
Czech Republic 304420 2-Oxo-1-pyrrolidinové deriváty, způsob jejich přípravy a jejich použití (2-Oxo-1-pyrrolidine derivatives, process of their preparation and their use) See Plans and Pricing
China 1740150 See Plans and Pricing
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) See Plans and Pricing
Iceland 7919 See Plans and Pricing
Iceland 6472 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRIVIACT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1452524 10/2016 Austria See Plans and Pricing PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 (MITTEILUNG) 20160118
2391349 C20160006 00188 Estonia See Plans and Pricing PRODUCT NAME: BRIVARATSETAAM;REG NO/DATE: EU/1/15/1073 18.01.2016
1265862 PA2016013,C1265862 Lithuania See Plans and Pricing PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524 530 Finland See Plans and Pricing
1452524 C01452524/01 Switzerland See Plans and Pricing PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65830 06.10.2016
1452524 16C1001 France See Plans and Pricing PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118
1452524 300815 Netherlands See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Johnson and Johnson
McKinsey
Moodys
AstraZeneca

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.