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Profile for Tradename: ZOLINZA

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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-seven 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

Suppliers / Packagers: see list1

Pharmacology for Tradename: ZOLINZA

Clinical Trials for: ZOLINZA

Vorinostat Plus FND in Relapsed or Refractory Mantle Cell Lymphoma
Status: Not yet recruiting Condition: Mantle Cell Lymphoma

Study of Suberoylanilide Hydroxamic Acid (SAHA) With Temsirolimus in Children With Diffuse Intrinsic Pontine Glioma (DIPG)
Status: Recruiting Condition: Diffuse Intrinsic Pontine Glioma

Study of Vorinostat Plus Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer
Status: Active, not recruiting Condition: Gastric Cancer; Histone Deacetylase Inhibitor

Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))
Status: Completed Condition: Multiple Myeloma

MLN9708 and Vorinostat in Patients With Advanced p53 Mutant Malignancies
Status: Recruiting Condition: Advanced Cancers

Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma
Status: Active, not recruiting Condition: Brain Cancer

Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)
Status: Terminated Condition: Brain Cancer; Glioblastoma Multiforme

High-Dose or Low-Dose Vorinostat in Combination With Carboplatin or Paclitaxel in Treating Patients With Advanced Solid Tumors
Status: Active, not recruiting Condition: Adult Solid Neoplasm

A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025)
Status: Terminated Condition: Carcinoma, Non-Small-Cell Lung

SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma
Status: Completed Condition: Lymphoma

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
CAPSULE;ORAL021991-001Oct 6, 2006RXYes7,399,787<disabled> <disabled>
CAPSULE;ORAL021991-001Oct 6, 2006RXYes7,456,219<disabled>Y <disabled>
CAPSULE;ORAL021991-001Oct 6, 2006RXYes8,067,472<disabled> <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>
8,288,440Formulations of suberoylanilide hydroxamic acid and methods for producing same<disabled in preview>
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International Patent Family for Tradename: ZOLINZA

Country Document Number Publication Date
China1901895Jan 24, 2007
Russian Federation2006109467Oct 10, 2007
Norway20044112Nov 30, 2004
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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