At this time, Xalkori (crizotinib) is protected by patents and exclusivity rights that prevent any generic versions from being manufactured in the United States. The earliest predictable date that a generic product might be made is after the first patent expires in February 2025. However, lawsuits, other patents for new uses of the drug, or certain other circumstances could delay this.
Xalkori is made by Pfizer Ireland Pharmaceuticals for Pfizer Labs. It is currently under the protection of patents and exclusivity rights that prevent any generic Xalkori from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent for Xalkori is set to expire in February 2025. 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 Xalkori uses. Once the drug goes off-patent, several companies might start manufacturing a generic Xalkori drug.
Is Crizotinib a Generic Xalkori?
Crizotinib is the active ingredient in Xalkori, 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):
Xalkori [package insert]. New York, NY: Pfizer, Inc.;2013 October.
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 20, 2011.
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