BANZEL Drug Patent Profile
Which 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.
The generic ingredient in BANZEL is rufinamide. Twelve suppliers are listed for this compound. Additional details are available on the rufinamide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Banzel
A generic version of BANZEL was approved as rufinamide by GLENMARK PHARMS LTD on May 16th, 2016.
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Summary for BANZEL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BANZEL |
Paragraph IV (Patent) Challenges for BANZEL
| 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 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 | ⤷ Start Trial | |||
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-003 | Nov 14, 2008 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-001 | Nov 14, 2008 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Eisai Inc | BANZEL | rufinamide | TABLET;ORAL | 021911-002 | Nov 14, 2008 | AB | RX | Yes | 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 |
International Patents for BANZEL
See the table below for patents covering BANZEL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 012945 | FORMAS CRISTALINAS B Y C DEL COMPUESTO 1-(2,6-DIFLUORBENCIL)-1H-1,2,3- TRIAZOL-4 CARBOXAMIDA, UN PREPARADO FARMACEUTICO Y USO PARA LA OBTENCIONDEL MISMO Y PARA LA MANUFACTURA DE UN MEDICAMENTO | ⤷ Start Trial |
| Argentina | 012946 | FORMA CRISTALINA A DE 1-(2,6-DIFLUORBENCIL)-1H-1,2,3-TRIAZOL-4-CARBOXAMIDA, PREPARACIONES FARMACEUTICAS QUE LOS CONTIENEN Y SU USO PARA LA PREPARACION DE MEDICAMENTOS | ⤷ Start Trial |
| Argentina | 061004 | FORMAS CRISTALINAS B Y C DEL COMPUESTO 1-(2,6-DIFLUOROBENCIL)-1H-1,2,3-TRIAZOL-4- CARBOXAMIDA, UN PREPARADO FARMACEUTICO Y USO PARA LA OBTENCION DEL MISMO Y PARA LA MANUFACTURA DE UN MEDICAMENTO | ⤷ Start Trial |
| Argentina | 061005 | FORMA CRISTALINA A DE 1-(2,6- DIFLUOROBENCIL)-1H-1,2,3- TRIAZOL-4-CARBOXAMIDA, PREPARACIONES FARMACEUTICAS QUE LAS CONTIENEN Y SU USO PARA LA PREPARACION DE MEDICAMENTOS | ⤷ Start Trial |
| Austria | 232852 | ⤷ Start Trial | |
| Austria | 237599 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BANZEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | SPC026/2007 | Ireland | ⤷ Start Trial | SPC026/2007: 20071026, EXPIRES: 20220115 |
| 0994863 | 300284 | Netherlands | ⤷ Start Trial | 300284, 20180608, EXPIRES: 20220115 |
| 0994863 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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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