VORINOSTAT - Generic Drug Details

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

Vorinostat is the generic ingredient in one branded drug marketed by Msd Sub Merck and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vorinostat has one hundred and thirty-one patent family members in thirty-five countries.

There are two drug master file entries for vorinostat. One supplier is listed for this compound.

Summary for VORINOSTAT

International Patents:	131
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	280
Patent Applications:	7,387
What excipients (inactive ingredients) are in VORINOSTAT?	VORINOSTAT excipients list
DailyMed Link:	VORINOSTAT at DailyMed

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

Generic Entry Date for VORINOSTAT^: ⤷ 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 VORINOSTAT

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

Sponsor	Phase
Washington State University	Early Phase 1
Lucile Packard Children's Hospital Foundation	Phase 1/Phase 2
Amgen	Phase 1/Phase 2

See all VORINOSTAT clinical trials

Pharmacology for VORINOSTAT

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Histone Deacetylase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VORINOSTAT

L01XH	Histone deacetylase (HDAC) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for VORINOSTAT

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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
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	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

Expired US Patents for VORINOSTAT

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for VORINOSTAT

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Country	Patent Number	Title	Estimated Expiration
Norway	20061348		⤷ Sign Up
Norway	332749		⤷ Sign Up
South Korea	100924737		⤷ Sign Up
Russian Federation	2394022	СПОСОБЫ ИНДУКЦИИ КОНЕЧНОЙ ДИФФЕРЕНЦИРОВКИ (METHOD OF INDUCING TERMINAL DIFFERENTIATION)	⤷ Sign Up
European Patent Office	2229941	Formulations d'acide suberoylanilide hydroxamique et leurs procedes de production (Formulations of suberoylanilide hydroxamic acid and methods for producing same)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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