Endo Pharmaceuticals is currently the only maker of Fortesta (testosterone gel). Although no generic versions are available at this time, this could change as early as November 2018, when the drug's first patents expire. Until then, keep in mind that "testosterone gel" is the generic name for Fortesta -- this is not the same as a generic version.
Brand-name Fortesta is made by Endo Pharmaceuticals, Inc. Fortesta is not available in generic form.
When Will Generic Fortesta Be Available?
The first patents for Fortesta are currently set to expire in November 2018. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to extend or shorten the exclusivity period. This could include such things as lawsuits or other patents for specific Fortesta uses. Once the patent expires, there may be several companies that manufacture a generic Fortesta drug.
Is Testosterone Gel a Generic Fortesta?
No -- testosterone gel is the generic name for Fortesta but is not a generic version of it. All medications have generic names, regardless of whether generics are available.
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.
No other testosterone product (generic or not) available at this time is legally interchangeable with Fortesta. If you would like to switch products, you will need a new prescription from your healthcare provider.
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 June 10, 2011.
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