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, 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: | 1,398 |
| 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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin Ltd | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214918-005 | Dec 20, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sunshine | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214748-005 | Jun 9, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214501-001 | Oct 3, 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 | TABLET;ORAL | 205836-002 | 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 | 205836-005 | 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
Supplementary Protection Certificates for brivaracetam
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1452524 | C01452524/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BRIVARACETAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65830 06.10.2016 |
| 1452524 | 132016000045699 | Italy | ⤷ Sign Up | PRODUCT NAME: BRIVARACETAM(BRIVIACT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1073, 20160118 |
| 1452524 | CA 2016 00013 | Denmark | ⤷ Sign Up | PRODUCT NAME: BRIVARACETAM; REG. NO/DATE: EU/1/15/1073/001-022 20160118 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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