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ERIVEDGE Drug Patent Profile

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When do Erivedge patents expire, and when can generic versions of Erivedge launch?

Erivedge is a drug marketed by Genentech and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-four patent family members in twenty-four countries.

The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.

DrugPatentWatch^® Generic Entry Outlook for Erivedge

Erivedge was eligible for patent challenges on January 30, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 11, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ERIVEDGE

International Patents:	54
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	46
Patent Applications:	1,329
Drug Prices:	Drug price information for ERIVEDGE
What excipients (inactive ingredients) are in ERIVEDGE?	ERIVEDGE excipients list
DailyMed Link:	ERIVEDGE at DailyMed

Drug patent expirations by year for ERIVEDGE

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

Generic Entry Date for ERIVEDGE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 203388 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.

Recent Clinical Trials for ERIVEDGE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
H. Lee Moffitt Cancer Center and Research Institute	Early Phase 1
Genentech, Inc.	Early Phase 1
Ronald Buckanovich	Phase 2

See all ERIVEDGE clinical trials

Pharmacology for ERIVEDGE

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

US Patents and Regulatory Information for ERIVEDGE

ERIVEDGE is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ERIVEDGE is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ERIVEDGE

Pyridyl inhibitors of hedgehog signalling
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pyridyl inhibitors of hedgehog signalling
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF USING VISMODEGIB TO TREAT CANCER IN A MAMMAL

Pyridyl inhibitors of hedgehog signalling
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF USING VISMODEGIB TO TREAT BASAL CELL CARCINOMA

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for ERIVEDGE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Erivedge	vismodegib	EMEA/H/C/002602 Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy	Authorised	no	no	no	2013-07-12	2013-04-26
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ERIVEDGE

See the table below for patents covering ERIVEDGE around the world.

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Country	Patent Number	Title	Estimated Expiration
South Korea	101225018		⤷ Sign Up
Ukraine	96565	ПИРИДИЛЬНЫЕ ИНГИБИТОРЫ ХЕДЖХОГОВСКОЙ ПЕРЕДАЧИ СИГНАЛА;ПІРИДИЛЬНІ ІНГІБІТОРИ ХЕДЖХОГІВСЬКОЇ ПЕРЕДАЧІ СИГНАЛУ (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)	⤷ Sign Up
Canada	2579002	INHIBITEURS PYRIDYLES DE LA SIGNALISATION HEDGEHOG (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ERIVEDGE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1789390	C01789390/01	Switzerland	⤷ Sign Up	PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: SWISSMEDIC 62497 30.05.2013
1789390	2014/002	Ireland	⤷ Sign Up	PRODUCT NAME: ERIVEDGE-VISMODEGIB OR A SALT OR SOLVATE THEREOF; NAT REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION NO/DATE: 62497 01 20130530
1789390	2013C/071	Belgium	⤷ Sign Up	PRODUCT NAME: VISMODEGIB; AUTHORISATION NUMBER AND DATE: EU/1/13/84/001 20130715
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description