Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201367

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NDA 201367 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 201367
Applicant:Eisai Inc
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201367
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BANZEL rufinamide SUSPENSION;ORAL 201367 NDA Eisai Inc. 62856-584 62856-584-46 1 BOTTLE in 1 CARTON (62856-584-46) > 460 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 201367
Tradename Dosage Ingredient NDA Submissiondate
BANZEL SUSPENSION;ORAL rufinamide 201367

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Mar 3, 2011TE:ABRLD: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?

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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