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Last Updated: November 22, 2019

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
Generic Entry Opportunity Date for 202429
Generic Entry Date for 202429*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 50242-090-02 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) > 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ZELBORAF vemurafenib TABLET;ORAL 202429 NDA Genentech, Inc. 50242-090 50242-090-86 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-86) > 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: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 31, 2019
Regulatory Exclusivity Use:UPDATES MADE TO THE LABELING TO INCLUDE INFORMATION FROM STUDY MO25743 ON THE ANTI-TUMOR ACTIVITY OF VEMURAFENIB IN THE TREATMENT OF PATIENTS WITH BRAF V600E MUTATION-POSITIVE MELANOMA WITH BRAIN METASTASES

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