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Last Updated: May 27, 2022

BANZEL Drug Patent Profile


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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. Eight 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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Drug patent expirations by year for BANZEL
Drug Prices for BANZEL

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Recent Clinical Trials for BANZEL

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SponsorPhase
Eisai Inc.Phase 3

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Anatomical Therapeutic Chemical (ATC) Classes 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 100 mg, 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 Nov 14, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-001 Nov 14, 2008 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-001 Nov 14, 2008 See Plans and Pricing See Plans and Pricing
Eisai Inc BANZEL rufinamide SUSPENSION;ORAL 201367-001 Mar 3, 2011 See Plans and Pricing See Plans and Pricing
>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 300284 Netherlands See Plans and Pricing 300284, 20180608, EXPIRES: 20220115
0994864 SPC/GB07/041 United Kingdom See Plans and Pricing PRODUCT NAME: CRYSTAL MODIFICATION A OF RUFINAMIDE; REGISTRATION NO/DATE: EU/1/06/378/001 - 015
0994863 C00994863/01 Switzerland See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
McKesson
Dow
Harvard Business School
Medtronic

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