The patent for Fanapt (iloperidone) currently expires in November 2016. This is the earliest possible date that a generic Fanapt could become available. However, other circumstances (such as lawsuits or other patents for specific Fanapt uses) could come up to extend the exclusivity period beyond that time. It is important to note that iloperidone is the "generic name" for Fanapt; it is not a "generic version" of the drug.
Fanapt is manufactured by Vanda Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic versions of Fanapt from being manufactured in the United States.
When Will a Generic Version of Fanapt Be Available?
The first patent for Fanapt currently expires in November 2016, which is the earliest predictable date that a generic version of Fanapt could become available. However, there are other circumstances that could come up to extend or shorten the exclusivity period of Fanapt. This could include such things as lawsuits or other Fanapt patents. Once Fanapt goes off patent, there may be several companies that manufacture a generic Fanapt drug.
Is Iloperidone a Generic Fanapt?
No -- iloperidone is the active ingredient in Fanapt, but it is not a generic version of Fanapt. What can be confusing is that, oftentimes, the active ingredient of a drug is referred to as the "generic name." The generic name is different than 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 would 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 February 9, 2012.
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