At this time, Apriso is not available as a generic. Apriso is currently under the protection of a patent that prevents any drug companies from manufacturing a generic version of the medication. As soon as this patent expires in April 2018, however, a number of companies are expected to begin producing generic versions.
Apriso is manufactured by Catalent Pharma Solutions for Salix Pharmaceuticals, Inc.
When Will a Generic Version Be Available?
The patent for Apriso is currently set to expire in April 2018. This is the earliest predictable date that a generic version of Apriso could become available. However, there are other circumstances that could come up to extend or shorten the exclusivity period of Apriso. This could include such things as lawsuits or other patents for specific Apriso uses. Once Apriso goes off patent, there may be several companies that will manufacture a generic Apriso drug.
Is Mesalamine a Generic Apriso?
The answer is no. Mesalamine is the active ingredient in Apriso (as well as several other medications) but is not a generic version of the drug. 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 May 27, 2010.
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