Currently, Abraxane is not available as a generic. Abraxane's next unexpired patent is expected to expire in 2016, however, which means that other drug companies could begin manufacturing generic Abraxane products at that time, provided that Abraxane's exclusivity period is not extended.
Abraxane is made by Abraxis BioScience, Inc. It is currently under the protection of a patent that prevents any generic Abraxane from being manufactured in the United States.
When Will Generic Abraxane Be Available?
The first several patents for Abraxane expired in February 2013 and March 2013. Yet, no generic versions are available. This strongly suggests that other, later-expiring patents are still providing patent protection for the drug. The next patent set to expire will do so in August 2016. This is the earliest possible date that a generic version of Abraxane could become available.
However, circumstances could arise to extend this exclusivity period beyond 2016. This could include such things as other patents for specific Abraxane uses or lawsuits. Once the patent expires, several companies will likely begin manufacturing generic Abraxane.
Is Paclitaxel a Generic Abraxane?
No -- paclitaxel is the active ingredient in Abraxane but is not a generic version of the medication. Additionally, "regular" paclitaxel (which is available as a generic) is not equivalent to protein-bound paclitaxel (Abraxane). What can be confusing is that, oftentimes, the active ingredient of any drug is 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 March 25, 2013.
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