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Last Updated: November 21, 2019

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Details for New Drug Application (NDA): 021911

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NDA 021911 describes BANZEL, which is a drug marketed by Eisai Inc and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the BANZEL profile page.

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.
Summary for 021911
Tradename:BANZEL
Applicant:Eisai Inc
Ingredient:rufinamide
Patents:2
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021911
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BANZEL rufinamide TABLET;ORAL 021911 NDA Eisai Inc. 62856-582 62856-582-04 4 TABLET, FILM COATED in 1 BOTTLE (62856-582-04)
BANZEL rufinamide TABLET;ORAL 021911 NDA Eisai Inc. 62856-582 62856-582-52 120 TABLET, FILM COATED in 1 BOTTLE (62856-582-52)
Paragraph IV (Patent) Challenges for 021911
Tradename Dosage Ingredient NDA Submissiondate
BANZEL TABLET;ORAL rufinamide 021911 2012-11-14

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 14, 2008TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 14, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Apr 19, 2019Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Nov 14, 2008TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:May 14, 2023Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021911

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc BANZEL rufinamide TABLET;ORAL 021911-001 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 021911-003 Nov 14, 2008   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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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