At this time, exclusivity rights and a patent prevent a generic Nexavar (sorafenib) from being manufactured in the United States. The patent is scheduled to expire in January 2020, which is the earliest date that a generic version might become available. However, lawsuits, other patents for new uses of the drug, or various other circumstances could change this date.
Nexavar is made by Onyx Pharmaceuticals, Inc., for Bayer HealthCare Pharmaceuticals, Inc. It is currently under the protection of a patent and exclusivity rights that prevent any generic Nexavar from being manufactured in the United States.
When Will a Generic Version Be Available?
The patent for Nexavar is set to expire in January 2020. 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 includes such things as lawsuits or other patents for new Nexavar uses. Once the patent and exclusivity rights expire, several companies may begin manufacturing a generic Nexavar drug.
Is Sorafenib a Generic Nexavar?
No, sorafenib is the active ingredient in Nexavar, 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 October 26, 2011.
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