Details for New Drug Application (NDA): 202429

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 202429

Constraining patent/regulatory exclusivity:

9,447,089

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.

Pharmacology for NDA: 202429

Mechanism of Action

Cytochrome P450 1A2 Inhibitors P-Glycoprotein Inhibitors Protein Kinase Inhibitors

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	240MG
Approval Date:	Aug 17, 2011	TE:		RLD:	Yes
Patent:	7,504,509	Patent Expiration:	Oct 22, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	7,863,288	Patent Expiration:	Jun 20, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	8,143,271	Patent Expiration:	Jun 21, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?

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