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BANZEL Drug Profile
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» See Plans and PricingWhich patents cover Banzel, and when can generic versions of Banzel launch?
Banzel is a drug marketed by Eisai Inc and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.
This drug has eighty-seven patent family members in thirty-four countries.
The generic ingredient in BANZEL is rufinamide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rufinamide profile page.
US ANDA Litigation and Generic Entry Outlook for Banzel
A generic version of BANZEL was approved as rufinamide by GLENMARK PHARMS LTD on May 16th, 2016.
Summary for BANZEL
| International Patents: | 87 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 93 |
| Patent Applications: | 469 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BANZEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BANZEL |
| DailyMed Link: | BANZEL at DailyMed |
Paragraph IV (Patent) Challenges for BANZEL
| 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 BANZEL
| 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 | SUSPENSION;ORAL | 201367-001 | Mar 3, 2011 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 | TABLET;ORAL | 021911-002 | Nov 14, 2008 | AB | RX | Yes | No | Start Trial | Start Trial | Y | 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 BANZEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | SUSPENSION;ORAL | 201367-001 | Mar 3, 2011 | 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 | 021911-001 | Nov 14, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BANZEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1298708 | Start Trial |
| Argentina | 012946 | Start Trial |
| Norway | 983666 | Start Trial |
| Brazil | 9804946 | Start Trial |
| European Patent Office | 0994864 | Start Trial |
| Denmark | 0994863 | Start Trial |
| Netherlands | 300284 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BANZEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0994863 | 91345 | Luxembourg | Start Trial | CERTIFICATE NAME: RUFINAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (INOVELON); FIRST REGISTRATION DATE: 20070116 |
| 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 | CA 2007 00037 | Denmark | Start Trial | PRODUCT NAME: RUFINAMID, KRYSTALMODIFIKATION A |
| 0994863 | C00994863/01 | Switzerland | Start Trial | PRODUCT NAME: RUFINAMID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58097 06.01.2009 |
| 0994863 | 303 | Finland | Start Trial | |
| 0994863 | SPC026/2007 | Ireland | Start Trial | SPC026/2007: 20071026, EXPIRES: 20220115 |
| 0994863 | 07C0037 | France | Start Trial | PRODUCT NAME: MODIFICATION CRISTALLINE A DU RUFINAMIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/378/001 DU 20070116; REGISTRATION NO/DATE AT EEC: EU/1/06/378/001-016 DU 20070116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
