Patents currently prevent a generic Zortress (everolimus) from being manufactured in the United States. The first patent is set to expire in March 2014, 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 Zortress?
Zortress® (everolimus) is a prescription medication approved for use in certain people after a kidney or liver transplant. It helps reduce the chance that the body will attack, or reject, the new organ.
Zortress is made by Novartis Pharma Stein AG for Novartis Pharmaceuticals Corporation. Currently, the drug is protected by patents that prevent any generic versions from being sold in the United States.
When Will a Generic Version Be Available?
The first patent was set to expire in September 2013, but this patent was given a six-month extension in exchange for the manufacturer performing much-needed pediatric studies. The first patent is now set to expire in March 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 specific Zortress uses. Once the drug goes off-patent, there may be several companies that manufacture a generic Zortress drug.
Is Everolimus a Generic Form of Zortress?
No -- everolimus is the active ingredient in Zortress, 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.
Zortress contains everolimus, which is also the active ingredient in Afinitor®. Afinitor is available as higher-strength tablets and is approved to treat certain types of cancers and tumors. Afinitor is not a generic version of Zortress.
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
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Zortress [package insert]. East Hanover, NJ: 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 December 3, 2013.
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