At this time, Rapaflo (silodosin) is available as a brand-name drug only, despite the fact that some of its patents and exclusivity rights have expired. The next patent is set to expire in December 2018. It's possible that a generic version could be introduced after this date, barring any lawsuits or other patents for specific uses of the drug.
Is a Generic Version of Rapaflo Available?
Rapaflo™ (silodosin) is a prescription medication that belongs to a group of medications known as alpha-1 blockers. It is approved for treating the symptoms of an enlarged prostate (also known as benign prostatic hyperplasia, or BPH). This medication is not available in generic form.
Brand-name Rapaflo is manufactured by Watson Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic Rapaflo from being manufactured in the United States.
When Will Generic Rapaflo Be Available?
Although some patents and exclusivity rights for Rapaflo expired in October 2013 and November 2013, the drug is not yet available in generic form. This suggests that another patent, set to expire in December 2018, is still protecting the drug from generic competition. This is the earliest predictable date that a generic version of Rapaflo could become available.
However, there are other circumstances that could come up to extend or shorten the exclusivity period of Rapaflo. This could include such things as lawsuits or other patents for specific Rapaflo uses. Once Rapaflo goes off patent, there may be several companies that will begin manufacturing a generic Rapaflo drug.
Is Silodosin a Generic Form of Rapaflo?
The answer is no. Silodosin is the active ingredient in Rapaflo but is not a generic version of the medication. 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 December 3, 2013.
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