Patents and exclusivity rights currently prevent the manufacturing of a generic version of Torisel (temsirolimus). The first patent is scheduled to expire in April 2014, 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 Torisel?
Torisel® (temsirolimus) is a prescription medication used in the treatment of kidney cancer. It comes in the form of a liquid solution that is given as a slow injection into a vein (an intravenous, or IV, infusion).
Torisel is made by Pfizer Inc., and distributed by Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer Inc. It is currently under the protection of a patent and exclusivity rights that prevent any generic versions of Torisel from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent is set to expire in April 2014. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to extend or shorten this exclusivity period. This could include such things as lawsuits or other patents for new Torisel uses. Once the drug goes off-patent, there may be several companies that manufacture a generic Torisel drug.
Is Temsirolimus a Generic Torisel?
No -- temsirolimus is the active ingredient in Torisel, 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 of a medicine, 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
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 4, 2011.
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