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Last Updated: September 26, 2022

Brivaracetam - Generic Drug Details


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What are the generic 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 and Sunshine, and is included in four 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 eight tentative approvals for this compound.

Summary for brivaracetam
Recent Clinical Trials for brivaracetam

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

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

See all brivaracetam clinical trials

Generic filers with tentative approvals for BRIVARACETAM
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing50MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing25MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing10MGTABLET;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
Anatomical Therapeutic Chemical (ATC) Classes for brivaracetam
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
Sunshine BRIVARACETAM brivaracetam TABLET;ORAL 214748-001 Jun 9, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-003 May 12, 2016 AB RX Yes No 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 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sunshine BRIVARACETAM brivaracetam TABLET;ORAL 214748-005 Jun 9, 2022 AB RX No 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 brivaracetam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 205836-004 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
>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
South Korea 20050090090 See Plans and Pricing
Germany 60140222 See Plans and Pricing
Russian Federation 2355680 ПРОИЗВОДНЫЕ 2-ОКСО-1-ПИРРОЛИДИНА, СПОСОБ ИХ ПОЛУЧЕНИЯ (2-OXO-1-PYRROLIDINE DERIVATIVES, METHOD OF OBTAINMENT) See Plans and Pricing
Czech Republic 20022849 See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524 C01452524/01 Switzerland See Plans and Pricing PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65830 06.10.2016
1452524 530 Finland See Plans and Pricing
1452524 1690009-4 Sweden See Plans and Pricing PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073 20150114
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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