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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 one branded drug marketed by Ucb Inc and is included in three NDAs. There are four 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.
Summary for brivaracetam
International Patents: | 173 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 3 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 31 |
Clinical Trials: | 37 |
Patent Applications: | 929 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for brivaracetam |
What excipients (inactive ingredients) are in brivaracetam? | brivaracetam excipients list |
DailyMed Link: | brivaracetam at DailyMed |
Recent Clinical Trials for brivaracetam
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
UCB Biopharma SRL | Phase 3 |
UCB Biopharma SRL | Phase 2/Phase 3 |
University of Minnesota | Phase 1/Phase 2 |
Pharmacology for brivaracetam
Mechanism of Action | Epoxide Hydrolase Inhibitors |
Paragraph IV (Patent) Challenges for BRIVARACETAM
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 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 | 205836-002 | May 12, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-002 | May 12, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-005 | May 12, 2016 | RX | Yes | Yes | Start Trial | Start Trial | 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 |
Expired US Patents for brivaracetam
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-001 | May 12, 2016 | Start Trial | Start Trial |
Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | Start Trial | Start Trial |
Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;INTRAVENOUS | 205837-001 | May 12, 2016 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for brivaracetam
Country | Patent Number | Estimated Expiration |
---|---|---|
China | 1208319 | Start Trial |
Australia | 2005200718 | Start Trial |
Russian Federation | 2005125569 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for brivaracetam
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1452524 | C01452524/01 | Switzerland | Start Trial | PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65830 06.10.2016 |
1452524 | CA 2016 00013 | Denmark | Start Trial | PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118 |
1265862 | PA2016013 | Lithuania | Start Trial | PRODUCT NAME: BRIVARACETAMAS; REGISTRATION NO/DATE: EU/1/15/1073 20160114 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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