You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 25, 2024

BANZEL Drug Patent Profile


✉ Email this page to a colleague

« 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.

The generic ingredient in BANZEL is rufinamide. There are seven drug master file entries for this compound. Eleven 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.

  Try a Trial

Drug patent expirations by year for BANZEL
Drug Prices for BANZEL

See drug prices for BANZEL

Recent Clinical Trials for BANZEL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Eisai Inc.Phase 3

See all BANZEL clinical trials

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 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-003 Nov 14, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-001 Nov 14, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-002 Nov 14, 2008 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-002 Nov 14, 2008 ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-001 Nov 14, 2008 ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-001 Nov 14, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for BANZEL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Eisai GmbH Inovelon rufinamide EMEA/H/C/000660
Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.
Authorised no no no 2007-01-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for BANZEL

See the table below for patents covering BANZEL around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1028031 ⤷  Try a Trial
China 1259127 ⤷  Try a Trial
Slovenia 0994863 ⤷  Try a Trial
Canada 2256013 MODIFICATION CRISTALLINE DE 1-(2,6-DIFLUOROBENZYLE)-1H-1,2,3-TRIAZOLE-4-CARBOXAMIDE ET SON UTILISATION EN TANT QU'ANTI-EPILEPTIQUE (CRYSTAL MODIFICATION OF 1-(2,6-DIFLUOROBENZYL)-1H-1,2,3-TRIAZOLE-4-CARBOXAMIDE AND ITS USE AS ANTIEPILEPTIC) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BANZEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0994863 07C0037 France ⤷  Try a 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
0994863 SPC026/2007 Ireland ⤷  Try a Trial SPC026/2007: 20071026, EXPIRES: 20220115
0994863 303 Finland ⤷  Try a Trial
0994863 C00994863/01 Switzerland ⤷  Try a Trial PRODUCT NAME: RUFINAMID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58097 06.01.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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.