There is currently no generic Vagifem (estradiol vaginal tablets) approved in the United States, and no generic versions are expected to become available any time soon. There may be companies out there claiming to sell generic Vagifem, but be advised that these products may be fake, substandard, and potentially dangerous.
Generic Vagifem: An Overview
Vagifem® (estradiol vaginal tablets) is a prescription hormone replacement medication used to treat vaginal menopause symptoms, such as vaginal dryness, itching, or burning. Although it comes in tablet form, the drug is taken vaginally using single-use, disposable applicators, not by mouth.
Vagifem is made by Novo Nordisk. No generic versions of the medication have been approved in the United States. However, if you search the Internet for "generic Vagifem," you may find a number of companies selling it. These medicines may be fake, substandard, and potentially dangerous. Generic Vagifem products may be available from another country, but there is no way of knowing if you are getting genuine Vagifem or not. Therefore, you should not buy any generic Vagifem until an approved generic version is available.
When Will Generic Vagifem Available?
The first patent for Vagifem currently expires in September 2022. This is the earliest predictable date that a generic version of Vagifem could become available.
However, there are other circumstances that could come up to extend or shorten the exclusivity period of Vagifem. This could include such things as lawsuits or other patents for specific Vagifem uses. Once Vagifem goes off-patent, there may be several companies that manufacture a generic Vagifem drug.
Is Estradiol a Generic Version of Vagifem?
Estradiol is the active ingredient in Vagifem (as well as in several other medications) but is not a generic version of Vagifem. What can be confusing is that the active ingredient of any 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 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):
Vagifem [package insert]. Princeton, NJ: Novo Nordisk, Inc.;2012 April.
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 7 2008.
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