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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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