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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, Bionpharma Inc, Hikma, Glenmark Pharms Ltd, and Mylan, and is included in seven NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Rufinamide has eighty-seven patent family members in thirty-four countries.
There are seven drug master file entries for rufinamide. Three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for rufinamide
| International Patents: | 87 |
| US Patents: | 1 |
| Tradenames: | 2 |
| Applicants: | 5 |
| NDAs: | 7 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 99 |
| Clinical Trials: | 11 |
| Patent Applications: | 1,619 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for rufinamide |
| 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 |
| Birmingham Children's Hospital NHS Foundation Trust | Phase 4 |
| The Leeds Teaching Hospitals NHS Trust | Phase 4 |
Generic filers with tentative approvals for RUFINAMIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 40MG/ML | SUSPENSION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Paragraph IV (Patent) Challenges for RUFINAMIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BANZEL | SUSPENSION;ORAL | rufinamide | 201367 | 2014-06-16 |
| BANZEL | TABLET;ORAL | rufinamide | 021911 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | RUFINAMIDE | rufinamide | SUSPENSION;ORAL | 207363-001 | Apr 23, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Eisai Inc | BANZEL | rufinamide | SUSPENSION;ORAL | 201367-001 | Mar 3, 2011 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Glenmark Pharms Ltd | RUFINAMIDE | rufinamide | TABLET;ORAL | 205075-002 | May 16, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hikma | RUFINAMIDE | rufinamide | TABLET;ORAL | 204988-001 | May 16, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan | RUFINAMIDE | rufinamide | TABLET;ORAL | 205095-001 | May 16, 2016 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan | RUFINAMIDE | rufinamide | TABLET;ORAL | 205095-002 | May 16, 2016 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >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 | Start Trial | Start Trial |
| Eisai Inc | BANZEL | rufinamide | SUSPENSION;ORAL | 201367-001 | Mar 3, 2011 | Start Trial | Start Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | Start Trial | Start Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | Start Trial | Start Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-002 | Nov 14, 2008 | Start Trial | Start Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | Start Trial | Start Trial |
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for rufinamide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 983666 | Start Trial |
| South Africa | 9804967 | Start Trial |
| Czech Republic | 292260 | Start Trial |
| Norway | 983667 | Start Trial |
| Norway | 329315 | Start Trial |
| Spain | 2192779 | Start Trial |
| Slovakia | 109398 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for rufinamide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0994863 | 300284 | Netherlands | Start Trial | 300284, 20180608, EXPIRES: 20220115 |
| 0994863 | SPC026/2007 | Ireland | Start Trial | SPC026/2007: 20071026, EXPIRES: 20220115 |
| 0994863 | CA 2007 00037 | Denmark | Start Trial | PRODUCT NAME: RUFINAMID, KRYSTALMODIFIKATION A |
| 0994863 | SPC/GB07/041 | United Kingdom | Start Trial | PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015 |
| 0994864 | SPC/GB07/041 | United Kingdom | Start Trial | PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015 |
| 0994863 | C00994863/01 | Switzerland | Start Trial | PRODUCT NAME: RUFINAMID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58097 06.01.2009 |
| 0994863 | 91345 | Luxembourg | Start Trial | CERTIFICATE NAME: RUFINAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (INOVELON); FIRST REGISTRATION DATE: 20070116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
