You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
McKesson
Dow
Harvard Business School
Medtronic

Last Updated: July 4, 2020

DrugPatentWatch Database Preview

BANZEL Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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. 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.

  Start 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   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

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
McKesson
Dow
Harvard Business School
Medtronic

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 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.