There is currently no generic Premarin Vaginal Cream (conjugated estrogens vaginal cream) approved in the United States. Although all the patents for the cream have expired, no generic versions are expected to become available any time soon. The medication contains a complex mixture of natural estrogens, which would be difficult to duplicate in a generic Premarin Vaginal Cream.
Premarin Vaginal Cream is a complex natural product. It contains several different estrogens in various amounts. For this reason, it would be difficult to create a generic medication that is exactly like Premarin Vaginal Cream. The U.S. Food and Drug Administration (FDA) will not approve any generic versions of Premarin Vaginal Cream until several requirements are met. Most importantly, the exact composition of the cream must be fully evaluated. This is difficult, because it is not clear which components of Premarin Vaginal Cream are "active" ingredients and which are not. Any potential generics must be shown to be identical to Premarin Vaginal Cream in terms of the content, dose, and absorption of these active components.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Premarin Vaginal Cream [package insert]. New York, NY: Pfizer Inc.;2012 February.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA statement on generic Premarin Vaginal Cream (5/5/1997). FDA Web site. Available at: http://www.fda.gov/cder/news/cepressrelease.htm. Accessed April 1, 2008.
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