Patents currently prevent a generic Staxyn (orally disintegrating vardenafil) product from being manufactured. The earliest predictable date that a generic version of the drug could become available is October 2018, when the first patent expires. However, lawsuits or other patents for specific uses of the drug may delay the manufacturing of a generic product.
Staxyn is made by Bayer HealthCare Pharmaceuticals, Inc. It is marketed by GlaxoSmithKline and distributed by Schering Corporation. Staxyn is protected by patents that prevent a generic version from being manufactured.
When Will a Generic Version Be Available?
The first patent for Staxyn expires in October 2018. This is the earliest predictable date that a generic version could become available.
However, there are other circumstances that could come up to extend or shorten this exclusivity period. This could include such things as lawsuits or other patents for specific Staxyn uses. Once the drug goes off-patent, there may be several companies that manufacture a generic Staxyn drug.
Is Vardenafil a Generic Staxyn?
No -- vardenafil is the active ingredient in Staxyn, but it is not a generic version of it. What can be confusing is that the active ingredient of a drug is often 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 July 22, 2010.
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