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Generated: June 27, 2017
What are the generic sources for rufinamide and what is the scope of rufinamide freedom to operate?
Rufinamide is the generic ingredient in two branded drugs marketed by Eisai Inc, Glenmark Pharms Ltd, West-ward Pharms Int, and Mylan Pharms Inc, and is included in five NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 4 |
| Applicants: | 4 |
| NDAs: | 5 |
| Drug Master File Entries: see list | 6 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 67 |
| Clinical Trials: see list | 10 |
| Patent Applications: see list | 495 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | rufinamide at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | DISCN | Yes | No | 7,750,028*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Glenmark Pharms Ltd | RUFINAMIDE | rufinamide | TABLET;ORAL | 205075-001 | May 16, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-002 | Nov 14, 2008 | AB | RX | Yes | No | 7,750,028*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | AB | RX | Yes | Yes | 7,750,028*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Eisai Inc | BANZEL | rufinamide | SUSPENSION;ORAL | 201367-001 | Mar 3, 2011 | RX | Yes | Yes | 7,750,028*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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