At this time, Xtandi (enzalutamide) capsules are available in brand-name form only. After the first patent for the drug expires in August 2027, however, companies may be allowed to manufacture a generic Xtandi product. Although enzalutamide is considered the "generic name" for Xtandi, it is simply the active ingredient in the drug and not a generic version of it.
Can I Buy Generic Xtandi?
Xtandi® (enzalutamide) is a prescription medication used in the treatment of prostate cancer. It belongs to a group of medicines known as androgen receptor inhibitors.
Xtandi is made by Catalent Pharma Solutions, LLC, for Astellas Pharma US, Inc., and Medivation, Inc. It is currently under the protection of patents that prevent any generic versions of the medication from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent for Xtandi is set to expire in August 2027. 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 Xtandi uses. Once the patent expires, there may be several companies that manufacture a generic Xtandi drug.
Is Enzalutamide a Generic Xtandi?
No -- enzalutamide is the active ingredient in Xtandi, 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
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 September 28, 2012.
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