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Last Updated: March 28, 2024

Brivaracetam - Generic Drug Details


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What are the generic drug sources for brivaracetam and what is the scope of freedom to operate?

Brivaracetam is the generic ingredient in two branded drugs marketed by Ucb Inc, Aurobindo Pharma Ltd, Lupin Ltd, Sunshine, and Zydus Pharms, and is included in seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound. There are five tentative approvals for this compound.

Summary for brivaracetam
Recent Clinical Trials for brivaracetam

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

SponsorPhase
University of California, Los AngelesPhase 1/Phase 2
University of MinnesotaPhase 3
Overseas Pharmaceuticals, Ltd.Phase 1

See all brivaracetam clinical trials

Generic filers with tentative approvals for BRIVARACETAM
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial100mgTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial75mgTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial50mgTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for brivaracetam
Mechanism of ActionEpoxide Hydrolase Inhibitors
Paragraph IV (Patent) Challenges for BRIVARACETAM
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 brivaracetam

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 TABLET;ORAL 205836-003 May 12, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-002 May 12, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-002 May 12, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms BRIVARACETAM brivaracetam TABLET;ORAL 214501-003 Oct 3, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-001 May 12, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Aurobindo Pharma Ltd BRIVARACETAM brivaracetam TABLET;ORAL 214848-001 Jan 6, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms BRIVARACETAM brivaracetam TABLET;ORAL 214501-004 Oct 3, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 brivaracetam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-003 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-001 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 205836-004 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-004 May 12, 2016 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-002 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 brivaracetam

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 brivaracetam

Country Patent Number Title Estimated Expiration
Serbia 53554 FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE 2-OKSO-1-PIROLIDIN DERIVATE (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES) ⤷  Try a Trial
Yugoslavia 63102 ⤷  Try a Trial
Russian Federation 2005125645 ⤷  Try a Trial
Romania 121559 DERIVAŢI DE 2-OXO-1-PIROLIDINĂ, PROCEDEU DE PREPARARE A ACESTORA ŞI UTILIZĂRILE LOR (2-OXO-1-PYRROLIDINE DERIVATIVES, PROCESS FOR PREPARING THE SAME AND THEIR USES) ⤷  Try a Trial
Montenegro 01927 FARMACEUTSKE KOMPOZICIJE KOJE SADRZE 2-OKSO-1-PIROLIDIN DERIVATE (PHARMACEUTICAL COMPOSITIONS COMPRISING 2-OXO-1-PYRROLIDINE DERIVATIVES) ⤷  Try a Trial
European Patent Office 1265862 DERIVES DE 2-OXO-1-PYRROLIDINE, PROCEDES DE PREPARATION ET UTILISATIONS DESDITS DERIVES (2-OXO-1-PYRROLIDINE DERIVATIVES, PROCESSES FOR PREPARING THEM AND THEIR USES) ⤷  Try a Trial
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) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for brivaracetam

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1265862 PA2016013,C1265862 Lithuania ⤷  Try a Trial PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524 CA 2016 00013 Denmark ⤷  Try a Trial PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118
1452524 300815 Netherlands ⤷  Try a Trial PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118
1452524 1690009-4 Sweden ⤷  Try a Trial PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073 20150114
1452524 2016/011 Ireland ⤷  Try a Trial PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524 10/2016 Austria ⤷  Try a Trial PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 (MITTEILUNG) 20160118
1452524 16C1001 France ⤷  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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