A patent currently prevents any generic Asmanex from being manufactured in the United States. The earliest date that a generic version of Asmanex could become available is December 2012. However, certain circumstances (such as lawsuits or other patents for specific uses of Asmanex) could potentially extend that date beyond 2012.
Asmanex is manufactured by the Schering-Plough Corporation. It is currently under the protection of a patent that prevents any generic Asmanex from being manufactured in the United States.
When Will Generic Asmanex Be Available?
The first patent for Asmanex currently expires in December 2012. Although initially set to expire in June 2012, an additional six months of patent protection were awarded in return for the manufacturer performing much-needed studies in children. This is the earliest possible date that a generic version of Asmanex could become available.
However, there are circumstances that could come up to extend the exclusivity period of Asmanex beyond 2012. These circumstances could include things such as other patents for specific Asmanex uses or lawsuits. Once Asmanex goes off patent, there may be several companies that manufacture a generic Asmanex product.
Is Mometasone a Generic Asmanex?
The answer is no. Mometasone furoate is the active ingredient in Asmanex (as well as other medications), but it is not a generic version of Asmanex. What can be confusing is that, oftentimes, the active ingredient of a drug is referred to as its "generic name." The generic name of a medicine is different from a generic version of it. 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 have made 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 June 28, 2012.
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