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ZOLINZA Drug Profile

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Zolinza is a drug marketed by Merck and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug.

This drug has one hundred and fifty-nine patent family members in thirty-seven 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.

Summary for Tradename: ZOLINZA

Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: ZOLINZA

Clinical Trials for: ZOLINZA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
ZOLINZA
vorinostat
CAPSULE;ORAL021991-001Oct 6, 2006RXYes7,399,787<disabled> <disabled>
Merck
ZOLINZA
vorinostat
CAPSULE;ORAL021991-001Oct 6, 2006RXYes7,456,219<disabled>Y <disabled>
Merck
ZOLINZA
vorinostat
CAPSULE;ORAL021991-001Oct 6, 2006RXYes8,067,472<disabled> <disabled>
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Expired Patents for Tradename: ZOLINZA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
ZOLINZA
vorinostat
CAPSULE;ORAL021991-001Oct 6, 20066,087,367<disabled>
Merck
ZOLINZA
vorinostat
CAPSULE;ORAL021991-001Oct 6, 2006RE38506<disabled>
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Non-Orange Book Patents for Tradename: ZOLINZA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,148,257Methods of treating mesothelioma with suberoylanilide hydroxamic acid<disabled in preview>
6,087,367 Potent inducers of terminal differentiation and methods of use thereof<disabled in preview>
7,847,122Polymorphs of suberoylanilide hydroxamic acid<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ZOLINZA

Country Document Number Estimated Expiration
BrazilPI0605893<disabled in preview>
BrazilPI0413826<disabled in preview>
Australia692561<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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