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Last Updated: November 29, 2022

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, Sunshine, and Zydus Pharms, and is included in five 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 Pricing100MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing75MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing50MGTABLET;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 205836-001 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 205836-002 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 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 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-004 May 12, 2016 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-004 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 205836-002 May 12, 2016 AB 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 brivaracetam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc BRIVIACT brivaracetam SOLUTION;ORAL 205838-001 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 TABLET;ORAL 205836-004 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 205836-002 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 205836-003 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
Spain 2231501 See Plans and Pricing
Iceland 7923 See Plans and Pricing
Luxembourg 92993 See Plans and Pricing
Hungary 0204526 See Plans and Pricing
Russian Federation 2291860 ПРОИЗВОДНЫЕ 2-ОКСО-1-ПИРРОЛИДИНА, СПОСОБ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ See Plans and Pricing
Australia 5214401 See Plans and Pricing
China 1404470 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 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 122016000030 Germany See Plans and Pricing PRODUCT NAME: BRIVARACETAM ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524 CR 2016 00013 Denmark See Plans and Pricing PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118
1452524 CA 2016 00013 Denmark See Plans and Pricing PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118
1452524 10/2016 Austria See Plans and Pricing PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 (MITTEILUNG) 20160118
1452524 132016000045699 Italy See Plans and Pricing PRODUCT NAME: BRIVARACETAM(BRIVIACT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1073, 20160118
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School

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