RUFINAMIDE - Generic Drug Details
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What are the generic drug sources for rufinamide and what is the scope of freedom to operate?
Rufinamide
is the generic ingredient in two branded drugs marketed by Eisai Inc, 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 sixteen NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for rufinamide. Eleven suppliers are listed for this compound.
Summary for RUFINAMIDE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 11 |
NDAs: | 16 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 122 |
Clinical Trials: | 12 |
Patent Applications: | 1,609 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for RUFINAMIDE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RUFINAMIDE |
What excipients (inactive ingredients) are in RUFINAMIDE? | RUFINAMIDE excipients list |
DailyMed Link: | RUFINAMIDE at DailyMed |
Recent Clinical Trials for RUFINAMIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Guy's and St Thomas' NHS Foundation Trust | Phase 4 |
The Leeds Teaching Hospitals NHS Trust | Phase 4 |
Cambridge University Hospitals 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | RUFINAMIDE | rufinamide | TABLET;ORAL | 204964-003 | Aug 17, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glenmark Pharms Ltd | RUFINAMIDE | rufinamide | TABLET;ORAL | 205075-002 | May 16, 2016 | 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 |
Expired US Patents for RUFINAMIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-002 | Nov 14, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Eisai Inc | BANZEL | rufinamide | SUSPENSION;ORAL | 201367-001 | Mar 3, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-002 | Nov 14, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |