RUFINAMIDE Drug Patent Profile
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Which patents cover Rufinamide, and when can generic versions of Rufinamide launch?
Rufinamide is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Glenmark Pharms Ltd, Micro Labs, and Mylan. and is included in fourteen NDAs.
The generic ingredient in RUFINAMIDE is rufinamide. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the rufinamide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Rufinamide
A generic version of RUFINAMIDE was approved as rufinamide by GLENMARK PHARMS LTD on May 16th, 2016.
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Summary for RUFINAMIDE
Recent Clinical Trials for RUFINAMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Central Manchester University Hospitals NHS Foundation Trust | Phase 4 |
| Sheffield Children's NHS Foundation Trust | Phase 4 |
| Birmingham Women's and Children's NHS Foundation Trust | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for RUFINAMIDE
Paragraph IV (Patent) Challenges for RUFINAMIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BANZEL | Oral Suspension | rufinamide | 40 mg/mL | 201367 | 1 | 2014-06-16 |
| BANZEL | Tablets | rufinamide | 200 mg and 400 mg | 021911 | 5 | 2012-11-14 |
US Patents and Regulatory Information for RUFINAMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | RUFINAMIDE | rufinamide | SUSPENSION;ORAL | 213410-001 | Feb 23, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | RUFINAMIDE | rufinamide | TABLET;ORAL | 204964-003 | Aug 17, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | RUFINAMIDE | rufinamide | SUSPENSION;ORAL | 213457-001 | Dec 18, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | RUFINAMIDE | rufinamide | SUSPENSION;ORAL | 214009-001 | Nov 7, 2022 | AB | RX | 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 RUFINAMIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Eisai GmbH | Inovelon | rufinamide | EMEA/H/C/000660 Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older. |
Authorised | no | no | no | 2007-01-16 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
