There are currently no approved generic versions of Femtrace available in the United States. This medication is protected by patents until December 2021, which prevents manufacturers from making generic Femtrace. Once the first patent expires, several companies may manufacture a generic version of the drug. However, lawsuits or other patents for specific uses of the medication may change the date of when a generic version of Femtrace becomes available.
Femtrace Generic: An Overview
Femtrace® (estradiol acetate) is a prescription estrogen hormone replacement medication that is approved to treat night sweats and hot flashes due to menopause.
Femtrace is made by Warner Chilcott. It is currently under the protection of a patent that prevents any generic versions of Femtrace from being manufactured or sold in the United States.
When Will Generic Femtrace Be Available?
The first patent for Femtrace currently expires in December 2021. This is the earliest expected date that a generic version of Femtrace could become available. However, there are other circumstances that could come up to extend or shorten the exclusivity period of Femtrace. This could include such things as lawsuits or other patents for specific Femtrace uses. Once Femtrace goes off patent, there may be several companies that manufacture a generic Femtrace drug.
Is Estradiol a Generic for Femtrace?
No -- estradiol is the active ingredient in Femtrace (as well as several other hormone therapy products), but it is not a generic version of Femtrace. What can be confusing is that, oftentimes, the active ingredient of a 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
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Femtrace [package insert]. Rockaway, NJ: Warner Chilcott (US), Inc.;2007 March.
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 16, 2008.
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