BRIVARACETAM Drug Patent Profile
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Which patents cover Brivaracetam, and when can generic versions of Brivaracetam launch?
Brivaracetam is a drug marketed by Aurobindo Pharma Ltd, Lupin Ltd, Sunshine, and Zydus Pharms. and is included in four NDAs.
The generic ingredient in BRIVARACETAM is brivaracetam. One supplier is listed for this compound. Additional details are available on the brivaracetam profile page.
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Summary for BRIVARACETAM
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 43 |
| Clinical Trials: | 44 |
| Patent Applications: | 815 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRIVARACETAM |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214848-001 | Jan 6, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lupin Ltd | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214918-005 | Dec 20, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lupin Ltd | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214918-002 | 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 | ||||
| Sunshine | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214748-001 | Jun 9, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214501-004 | Oct 3, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214501-002 | 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 |
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 |
