At this time, an unexpired patent is probably preventing the introduction of generic Zolinza (vorinostat). This patent is scheduled to expire in July 2015, which would be the earliest date that a generic version could become available. However, lawsuits or other patents for new uses of the drug could change this date.
Can I Buy Generic Zolinza?
Zolinza® (vorinostat) is a prescription medication used to treat people with a certain cancer of the immune system known as cutaneous T-cell lymphoma. It belongs to a group of drugs called histone deacetylase inhibitors.
Zolinza is made by Patheon, Inc., for Merck Sharp and Dohme Corp. It is currently protected from generic competition by patents and exclusivity rights that prevent any generic Zolinza from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent for Zolinza expired in October 2011, and exclusivity rights for the drug have also expired, in October 2013. Yet, no generic versions are available. This suggests that the medication is still currently protected by other patents, the next of which is set to expire in July 2015. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to delay or shorten the exclusivity period. This could include such things as lawsuits or patents for new Zolinza uses. Once the patent expires, there may be several companies that manufacture a generic Zolinza drug.
Is Vorinostat a Generic Zolinza?
No -- vorinostat is the active ingredient in Zolinza, but is not a generic version of it. What can be confusing is that the active ingredient of a drug is often referred to as the "generic name."
The generic name is different from a generic version of a medicine. In order for there to be a generic version, the original medicine must have gone off-patent and another company besides the original manufacturer must make the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Zolinza [package insert]. White House Station, NJ: Merck Sharp & Dohme Corp.;2011 November.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed December 3, 2013.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA approved drug products. FDA Web site. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed February 5, 2012.
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