Vismodegib - Generic Drug Details

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What are the generic sources for vismodegib and what is the scope of freedom to operate?

Vismodegib is the generic ingredient in one branded drug marketed by Genentech and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vismodegib has fifty-four patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for vismodegib

International Patents:	54
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	77
Patent Applications:	3,554
What excipients (inactive ingredients) are in vismodegib?	vismodegib excipients list
DailyMed Link:	vismodegib at DailyMed

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

Generic Entry Date for vismodegib^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 vismodegib

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

Sponsor	Phase
Sun Pharmaceutical Industries Limited	Phase 2
Genentech, Inc.	Early Phase 1
H. Lee Moffitt Cancer Center and Research Institute	Early Phase 1

See all vismodegib clinical trials

Pharmacology for vismodegib

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for vismodegib

L01XJ	Hedgehog pathway inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for vismodegib

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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	Y	Y		⤷ Sign Up
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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 vismodegib

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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 vismodegib

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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 vismodegib

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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

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