Although all of the patents for Azelex (azelaic acid cream) have expired, no generic versions are available. It is not known why a generic Azelex product has not been manufactured, and it is unclear when a generic version might become available. In the meantime, do not buy anything claiming to be "generic Azelex," as you may not be getting a genuine product.
Can I Buy Generic Azelex?
Azelex® (azelaic acid cream) is a prescription skin medication approved for the treatment of acne. It is unlike any other medications used to treat acne, and is (at least in that sense) in a class by itself.
Azelex cream is made by Allergan, Inc. There are no generic versions of Azelex approved in the United States. However, if you search the Internet for "generic Azelex," you may find a number of companies selling it.
The fact is that these medicines may be fake, substandard, and potentially dangerous. There may be a generic version available from another country, but there is really no way of knowing if you are getting a genuine product or not. You should not buy any generic Azelex until an approved generic version is available.
When Will a Generic Version Be Available?
It is difficult to predict when a generic version of Azelex may become available. All of the patents for the medication listed with the United States Food and Drug Administration (FDA) have expired. It is unclear why no generic companies have chosen to make a generic Azelex.
Is Azelaic Acid a Generic Azelex?
No -- azelaic acid is the active ingredient in Azelex (as well as in Finacea® gel, a prescription rosacea medication), not a generic version of it. What can be confusing is that the active ingredient of a 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
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 January 26, 2011.
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