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Last Updated: November 24, 2020

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BRIVIACT Drug 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 four patents protecting this drug.

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.

US ANDA Litigation and 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 May 12, 2021. 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.

Indicators of Generic Entry

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Drug patent expirations by year for BRIVIACT
Drug Prices for BRIVIACT

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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 S.P.R.L.Phase 3
UCB Biopharma S.P.R.L.Phase 2

See all BRIVIACT clinical trials

Pharmacology for BRIVIACT
Mechanism of ActionEpoxide Hydrolase Inhibitors
Paragraph IV (Patent) Challenges for BRIVIACT
Tradename Dosage Ingredient NDA Submissiondate
BRIVIACT TABLET;ORAL brivaracetam 205836 2020-05-12
BRIVIACT SOLUTION;INTRAVENOUS brivaracetam 205837 2020-05-12
BRIVIACT SOLUTION;ORAL brivaracetam 205838 2020-05-12

US Patents and Regulatory Information for BRIVIACT

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 205836-005 May 12, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-004 May 12, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-005 May 12, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ucb Inc BRIVIACT brivaracetam TABLET;ORAL 205836-004 May 12, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for BRIVIACT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1452524 132016000045699 Italy   Start Trial PRODUCT NAME: BRIVARACETAM(BRIVIACT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1073, 20160118
1452524 C01452524/01 Switzerland   Start Trial PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65830 06.10.2016
1265862 PA2016013 Lithuania   Start Trial PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114
1452524 CR 2016 00013 Denmark   Start Trial PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Moodys
Johnson and Johnson
Medtronic
Dow

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