A patent and exclusivity rights currently prevent a generic Gleevec (sunitinib) from being manufactured in the United States. The first patent is expected to expire in February 2021, which would be the earliest date that a generic version might become available. However, certain circumstances, such as lawsuits or other patents for new uses of the drug, could delay this date.
Can I Buy Generic Gleevec?
Gleevec® (imatinib mesylate) is a prescription medication used in the treatment of certain types of cancer. It belongs to a group of chemotherapy drugs called tyrosine kinase inhibitors.
Gleevec is made by Novartis Pharmaceuticals Corporation. It is currently protected from generic competition by patents and exclusivity rights that have yet to expire.
When Will Generic Gleevec Be Available?
The first patent for Gleevec expires in July 2015. This is the earliest predictable date that a generic version could become available.
However, there are other circumstances that could come up to extend or shorten this exclusivity period of Gleevec. This includes such things as lawsuits or other patents for specific Gleevec uses. Once Gleevec goes off-patent, there may be several companies that manufacture a generic Gleevec drug.
Is Imatinib a Generic Gleevec?
No -- imatinib is the active ingredient in Gleevec, but is not a generic version of it. What can be confusing is that the active ingredient of any 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 of a medicine, the original medicine must have gone off-patent and another company besides the original manufacturer would make the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Gleevec [package insert]. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation;2013 February.
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 October 12, 2011.
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