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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Medtronic
Mallinckrodt
Dow
McKesson

Last Updated: November 28, 2021

DrugPatentWatch Database Preview

BANZEL Drug Patent Profile


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When do Banzel patents expire, and what generic alternatives are available?

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. Seven 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.

  Free Forever Trial

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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 Nov 14, 2008 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-001 Nov 14, 2008 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-002 Nov 14, 2008 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 SUSPENSION;ORAL 201367-001 Mar 3, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-002 Nov 14, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-002 Nov 14, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 Nov 14, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for BANZEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0994863 SPC026/2007 Ireland ⤷  Free Forever Trial SPC026/2007: 20071026, EXPIRES: 20220115
0994863 SPC/GB07/041 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
0994863 300284 Netherlands ⤷  Free Forever Trial 300284, 20180608, EXPIRES: 20220115
0994864 SPC/GB07/041 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Mallinckrodt
Medtronic
Boehringer Ingelheim
AstraZeneca

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