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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Harvard Business School
McKesson
Healthtrust
Farmers Insurance
Chubb
Teva
Daiichi Sankyo
Merck

Generated: April 26, 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 N 50242-090-01
ZELBORAF vemurafenib TABLET;ORAL 202429 NDA Genentech, Inc. 50242-090 N 50242-090-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength240MG
Approval Date:Aug 17, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 6, 2020
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH ERDHEIM-CHESTER DISEASE WITH BRAF V600 MUTATION
Regulatory Exclusivity Expiration:Nov 6, 2024
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH ERDHEIM-CHESTER DISEASE WITH BRAF V600 MUTATION
Regulatory Exclusivity Expiration:Aug 17, 2018
Regulatory Exclusivity Use:TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA WITH THE BRAFV600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Fuji
Teva
Argus Health
Federal Trade Commission
Queensland Health
Mallinckrodt
Cipla

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