There are currently no generic Estrasorb products available in the U.S. This is because the brand-name medication is under the protection of a patent that prevents any generic versions from being manufactured. Circumstances could arise to shorten or extend the exclusivity period of Estrasorb, but the earliest possible date that generic Estrasorb could become available is January 2015.
Generic Estrasorb: An Overview
Estrasorb® (estradiol emulsion) is a prescription hormone replacement medication. It is approved for treating moderate to severe vasomotor menopause symptoms (such as hot flashes and night sweats). It contains an estrogen that is identical to one of the estrogens the body makes naturally. It comes as an emulsion (lotion) that is applied to the skin of the legs.
Estrasorb is manufactured by Graceway Pharmaceuticals. It is currently under the protection of a patent that prevents any generic Estrasorb from being manufactured in the United States.
When Will Generic Estrasorb Be Available?
The patent for Estrasorb currently expires in January 2015. This is the earliest predictable date that a generic version of Estrasorb could become available. However, there are other circumstances that could come up to extend or shorten the exclusivity period of Estrasorb. This could include such things as lawsuits or other patents for new Estrasorb uses. Once Estrasorb goes off patent, there may be several companies that will begin manufacturing a generic Estrasorb drug.
Is Estradiol a Generic Estrasorb?
The answer is no. Estradiol is the active ingredient in Estrasorb (as well as numerous other medications) but is not a generic version of the medicine. 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 April 23, 2008.
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