.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201367

« Back to Dashboard
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 three 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 six 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 NDA: 201367

Tradename:
BANZEL
Applicant:
Eisai Inc
Ingredient:
rufinamide
Patents:2

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Mar 3, 2011TE:RLD:Yes
Patent:6,740,669*PEDPatent Expiration:May 14, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:7,750,028*PEDPatent Expiration:Apr 19, 2019Product Flag?Substance Flag?Delist Request?Y
Regulatory Exclusivity Expiration:Nov 14, 2015
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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 verifification 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.

`abc