Brivaracetam - Generic Drug Details
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What are the generic drug sources for brivaracetam and what is the scope of patent protection?
Brivaracetam
is the generic ingredient in two branded drugs marketed by Ucb Inc, Aurobindo Pharma Ltd, Lupin Ltd, Sunshine, and Zydus Pharms, and is included in seven 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 six tentative approvals for this compound.
Summary for brivaracetam
International Patents: | 173 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 43 |
Clinical Trials: | 44 |
Patent Applications: | 1,276 |
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 |
---|---|
University of California, Los Angeles | Phase 1/Phase 2 |
University of Minnesota | Phase 3 |
Overseas Pharmaceuticals, Ltd. | Phase 1 |
Generic filers with tentative approvals for BRIVARACETAM
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 100mg | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 75mg | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 50mg | TABLET; 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 Action | Epoxide 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-004 | May 12, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Zydus Pharms | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214501-003 | Oct 3, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Lupin Ltd | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214918-001 | Dec 20, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;ORAL | 205838-001 | May 12, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Ucb Inc | BRIVIACT | brivaracetam | TABLET;ORAL | 205836-004 | May 12, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Ucb Inc | BRIVIACT | brivaracetam | SOLUTION;INTRAVENOUS | 205837-001 | May 12, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
San Marino | T201400155 | Composizioni farmaceutiche comprendenti derivati di 2-osso-1-pirrolidina | ⤷ Sign Up |
Iceland | 6472 | ⤷ Sign Up | |
Hong Kong | 1052695 | ⤷ Sign Up | |
South Korea | 20050090090 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for brivaracetam
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1452524 | 16C1001 | France | ⤷ Sign Up | PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160118 |
1452524 | 2016/011 | Ireland | ⤷ Sign Up | PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: EU/1/15/1073 20160114 |
1452524 | CA 2016 00013 | Denmark | ⤷ Sign Up | PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118 |
1452524 | 530 | Finland | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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