Because there are patents that have not yet expired for Xolegel (ketoconazole gel), companies are not allowed to make generic versions of this skin medication. However, this may change after the first patent expires in December 2018. After this date, it may be possible for a generic Xolegel product to be manufactured, unless new patents, lawsuits, or other factors delay or shorten the exclusivity period.
Can I Buy Generic Xolegel?
Xolegel® (ketoconazole gel) is a prescription skin medication. It is a topical, antifungal medication (an antifungal that is applied to the skin) that is applied once a day for two weeks. It is used for treating seborrhea.
Xolegel is made by DPT Laboratories, Ltd., for Aqua Pharmaceuticals. The drug is protected against generic competition by patents, and no generic Xolegel products are available in the United States.
When Will a Generic Version Be Available?
The first patents for Xolegel are set to expire in December 2018. This is the earliest predictable date that a generic version of the drug could become available.
However, other circumstances could come up to delay or shorten the exclusivity period. This could include things such as other patents for new Xolegel uses or lawsuits.
Is Ketoconazole a Generic Version of Xolegel?
No -- ketoconazole is the active ingredient in Xolegel (as well as several other prescription medications), but is 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, the original medicine must have gone off-patent, and another company besides the original manufacturer must make the product.
There are currently no generic ketoconazole gel products available in the United States.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Xolegel [package insert]. West Chester, PA: Aqua Pharmaceuticals;2012 May.
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 May 29, 2012.
eMedTV serves only as an informational resource. This site does not dispense medical advice or advice of any kind.
Site users seeking medical advice about their specific situation should consult with their own physician. Click