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Details for Generic Name: vorinostat

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

This ingredient has one hundred and fifty-seven patent family members in thirty-seven countries.

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

Summary for Generic Name: vorinostat

Drug Master File Entries: see list2
Suppliers / Packaging: see list1
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: vorinostat

Clinical Trials for: vorinostat

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

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

A Pilot Study of Oral Vorinostat Plus Oral Eltrombopag Support in Patients With Lymphoma (VEIL)
Status: Terminated Condition: Follicular Lymphoma; Marginal Zone Lymphoma; Mantle Cell Lymphoma

Study of Vorinostat (MK-0683) an HDAC Inhibitor, or Placebo in Combination With Bortezomib in Patients With Multiple Myeloma (MK-0683-088 AMN)
Status: Completed Condition: Multiple Myeloma

Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients With Brain Metastases
Status: Active, not recruiting Condition: Brain Metastases

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

Hydroxychloroquine + Vorinostat in Advanced Solid Tumors
Status: Recruiting Condition: Malignant Solid Tumour

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

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

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

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, 2006RXYes8,067,472<disabled> <disabled>
CAPSULE;ORAL021991-001Oct 6, 2006RXYes8,093,295<disabled>Y <disabled>
CAPSULE;ORAL021991-001Oct 6, 2006RXYes7,851,509<disabled>Y <disabled>
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Non-Orange Book Patents for Generic Ingredient: vorinostat

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 Ingredient: vorinostat

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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