Because certain exclusivity rights are in place until February 2018, companies are currently not allowed to make a generic version of Osphena (ospemifene). However, after these rights expire, a generic product may become available. Certain circumstances may come up, such as lawsuits or patents for new uses, that may delay the availability of this product.
Can I Buy Generic Osphena?
Osphena™ (ospemifene) is a prescription medication approved for treating painful sexual intercourse due to menopause. It belongs to a group of medicines known as selective estrogen receptor modulators (SERMs).
Osphena is made by Penn Pharmaceutical Services, Ltd., for Shionogi, Inc. The drug is currently protected by exclusivity rights that prevent any generic versions from being sold in the United States.
When Will a Generic Version Be Available?
Shionigi, Inc., holds the exclusive rights to market Osphena in the United States until February 2018. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to delay or shorten this exclusivity period, including things such as lawsuits or other patents for new Osphena uses. Once the exclusivity rights expire, there may be several companies that manufacture a generic Osphena drug.
Is Ospemifene a Generic Form of Osphena?
No -- ospemifene is the active ingredient in Osphena, 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, 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
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Osphena [package insert]. Florham Park, NJ: Shionogi, Inc.;2013 February.
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 March 16, 2013.
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