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ZOLINZA Drug Patent Profile

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Which patents cover Zolinza, and what generic alternatives are available?

Zolinza is a drug marketed by Msd Sub Merck and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in ZOLINZA is vorinostat. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the vorinostat profile page.

DrugPatentWatch^® Generic Entry Outlook for Zolinza

Zolinza was eligible for patent challenges on October 6, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 11, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZOLINZA

International Patents:	131
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	161
Patent Applications:	4,651
Drug Prices:	Drug price information for ZOLINZA
What excipients (inactive ingredients) are in ZOLINZA?	ZOLINZA excipients list
DailyMed Link:	ZOLINZA at DailyMed

Drug patent expirations by year for ZOLINZA

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

Generic Entry Date for ZOLINZA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 021991 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 ZOLINZA

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

Sponsor	Phase
OHSU Knight Cancer Institute	Phase 1
Prospect Creek Foundation	Phase 1
Oregon Health and Science University	Phase 1

See all ZOLINZA clinical trials

Pharmacology for ZOLINZA

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Histone Deacetylase Inhibitors

US Patents and Regulatory Information for ZOLINZA

ZOLINZA is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZOLINZA 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 ZOLINZA

Methods of treating cancer with HDAC inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (CTCL)

Polymorphs of suberoylanilide hydroxamic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Polymorphs of suberoylanilide hydroxamic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (CTCL)

Formulations of suberoylanilide hydroxamic acid and methods for producing the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Formulations of suberoylanilide hydroxamic acid and methods for producing same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (CTCL)

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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		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
>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 ZOLINZA

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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 ZOLINZA

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

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Country	Patent Number	Title	Estimated Expiration
Portugal	1663194		⤷ Sign Up
South Africa	200601757	Methods of inducing terminal differentiation	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006127321		⤷ Sign Up
Israel	173846		⤷ Sign Up
Australia	2009201668	Methods of Treating Cancer with HDAC Inhibitors	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration