There is currently a patent that prevents any generic Elestrin products from being manufactured in the U.S. The earliest possible date that a generic version of the estrogen gel may be available is June 2022, when the patent expires. Until an approved generic version is available, beware of anything claiming to be "generic Elestrin" -- these products may not be what they claim to be.
Generic Elestrin: An Overview
Elestrin™ (estradiol gel) is a prescription estrogen hormone replacement medication. It comes as a gel that is applied to the skin of the upper arm and shoulder. It is approved for treating moderate to severe vasomotor symptoms of menopause (such as hot flashes and night sweats).
Elestrin is made by Bradley Pharmaceuticals, a division of Nycomed US, Inc. It is currently under the protection of a patent that prevents any generic Elestrin from being manufactured in the United States. Yet, if you search the Internet for "generic Elestrin," you may find a number of companies claiming to sell it. The fact is, these medicines may be fake, substandard, and potentially dangerous. You should not buy any generic Elestrin until there is an approved generic available.
When Will Generic Elestrin Be Available?
The first patent for Elestrin currently expires in June 2022. This is the earliest predictable date that a generic version of Elestrin could become available. However, there are other circumstances that could come up to extend or shorten the exclusivity period of Elestrin. This could include such things as lawsuits or other patents for specific Elestrin uses. Once the medication goes off patent, there may be several companies that will manufacture a generic Elestrin drug.
Is Estradiol a Generic Elestrin?
The answer is no. Estradiol is the active ingredient in Elestrin (as well as numerous other medications) but is not a generic version of Elestrin. 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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