Last Updated: September 24, 2026

Details for New Drug Application (NDA): 203388

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NDA 203388 describes ERIVEDGE, which is a drug marketed by Genentech and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ERIVEDGE profile page.

The generic ingredient in ERIVEDGE is vismodegib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.

Summary for 203388

Tradename:	ERIVEDGE
Applicant:	Genentech
Ingredient:	vismodegib
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 203388

Generic Entry Date for 203388^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 7,888,364 Dosage: CAPSULE;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: 203388

Mechanism of Action	Smoothened Receptor Antagonists

Suppliers and Packaging for NDA: 203388

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERIVEDGE	vismodegib	CAPSULE;ORAL	203388	NDA	Genentech, Inc.	50242-140	50242-140-01	1 BOTTLE, PLASTIC in 1 CARTON (50242-140-01) / 28 CAPSULE in 1 BOTTLE, PLASTIC
ERIVEDGE	vismodegib	CAPSULE;ORAL	203388	NDA	Genentech, Inc.	50242-140	50242-140-86	1 BOTTLE, PLASTIC in 1 CARTON (50242-140-86) / 28 CAPSULE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Jan 30, 2012	TE:		RLD:	Yes
Patent:	7,888,364	Patent Expiration:	Nov 11, 2028	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	9,278,961	Patent Expiration:	Dec 15, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF USING VISMODEGIB TO TREAT CANCER IN A MAMMAL

Expired US Patents for NDA 203388

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012	9,790,183	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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