Patents and exclusivity rights prevent the manufacturing of any generic version of Zytiga (abiraterone) at this time. The first patent is scheduled to expire in February 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 may delay the manufacturing of a generic Zytiga.
Can I Buy Generic Zytiga?
Zytiga™ (abiraterone acetate) is a prescription medication used in the treatment of advanced prostate cancer that is resistant to certain other medical and surgical treatments. It is used in combination with prednisone.
Zytiga is made by Patheon, Inc., for Centocor Ortho Biotech, Inc. It is protected from generic competition by patents and exclusivity rights that have not yet expired.
When Will a Generic Version Be Available?
The first Zytiga patent is set to expire in February 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 Zytiga uses. Once the patent expires, there may be several companies that manufacture a generic Zytiga drug.
Is Abiraterone a Generic Zytiga?
No -- abiraterone is the active ingredient in Zytiga, but it 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 June 17, 2011.
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