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Serving leading biopharmaceutical companies globally:

Cerilliant
Cantor Fitzgerald
Farmers Insurance
Cipla
Daiichi Sankyo
Harvard Business School
US Department of Justice
Medtronic
Colorcon
AstraZeneca

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202429

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NDA 202429 describes ZELBORAF, which is a drug marketed by Hoffmann La Roche and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ZELBORAF profile page.

The generic ingredient in ZELBORAF is vemurafenib. One supplier is listed for this compound. Additional details are available on the vemurafenib profile page.
Summary for 202429
Tradename:ZELBORAF
Applicant:Hoffmann La Roche
Ingredient:vemurafenib
Patents:6
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 202429
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZELBORAF vemurafenib TABLET;ORAL 202429 NDA Genentech, Inc. 50242-090 50242-090-01 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-01) > 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ZELBORAF vemurafenib TABLET;ORAL 202429 NDA Genentech, Inc. 50242-090 50242-090-02 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) > 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength240MG
Approval Date:Aug 17, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 31, 2019
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Aug 17, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 17, 2018
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

Express Scripts
US Army
Accenture
Cerilliant
Dow
Deloitte
McKesson
Colorcon
Citi

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.

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