The soonest a generic version of Atelvia (risedronate delayed-release) could become available is in June 2014. However, other patents or lawsuits could push this date out even further, providing additional protection against generic competition. Contrary to popular belief, risedronate is just the active ingredient in Atelvia. It may be considered the "generic" name, but this is not the same as a "generic version."
Is a Generic Version of Atelvia Available?
Atelvia™ (risedronate delayed-release) is a prescription medication used to treat osteoporosis in postmenopausal women. It is part of a group of medications known as bisphosphonates. The unique delayed-release is designed to eliminate the need to wait to eat or drink until 30 minutes after taking it. In fact, Atelvia is meant to be taken right after breakfast.
Atelvia is made by Norwich Pharmaceuticals, Inc., for Warner Chilcott Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic Atelvia from being manufactured in the United States.
When Will a Generic Be Available?
The first patent for Atelvia currently expires in June 2014. However, other circumstances could come up to extend or shorten the exclusivity period. This includes such things as other patents for specific Atelvia uses or lawsuits. Once the patent expires, several companies will likely begin manufacturing generic Atelvia.
Interestingly, the June 2014 patent for Atelvia is shared by Actonel®, an older medication that contains the same active ingredient, except that it comes in an immediate-release tablet, made by the same company. This suggests that perhaps some of the later-expiring patents for Atelvia will "stand up in court" and will provide protection against generic competition well beyond 2014, since it would be unusual for two medications that were approved 12 years apart to "go generic" at the same time. However, it is too soon to know for sure.
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 February 22, 2011.
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