There are no generic Stivarga (regorafenib) products available at this time. This is because there are certain patents in place that prevent any company from making a generic version of this drug. However, after these patents expire in 2020, companies may be allowed to start making a generic Stivarga product.
Stivarga is manufactured by Bayer HealthCare Pharmaceuticals, Inc. It is currently protected by patents that prevent any generic Stivarga from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent for Stivarga is set to expire in January 2020. This is the earliest predictable date that a generic version could become available.
However, there are other circumstances that could come up to delay or shorten this exclusivity period, such as lawsuits or other patents for new Stivarga uses. Once Stivarga goes off-patent, there may be several companies that manufacture a generic Stivarga medication.
Is Regorafenib a Generic Stivarga?
No -- regorafenib is the active ingredient in Stivarga, 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 January 4, 2013.
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