Because the patent for Picato (ingenol mebutate) has not yet expired, manufacturers are not allowed to make a generic version of the drug. After the patent expires in August 2018, a generic Picato product could become available. However, lawsuits, additional patents for new uses of Picato, or other circumstances may delay the availability of a generic version of the drug.
Can I Buy Generic Picato?
Picato® (ingenol mebutate) is a prescription medication approved to treat actinic keratosis, a condition that causes precancerous skin lesions. It is approved in two different strengths (0.015% and 0.05%), with the higher strength for use on the body and the lower strength for use on the face and scalp. Picato is unique among actinic keratosis medications in that it is used for only two or three days, depending on the area of the body being treated.
Picato is made by LEO Pharma, Inc. There are no generic versions of Picato available at this time.
When Will a Generic Version Be Available?
Picato is expected to be protected from generic competition until at least August 2018, when the patent is set to expire. This is the earliest predictable date that a generic version could become available. However, other circumstances could come up to delay or shorten the exclusivity period. This could include such things as lawsuits or patents for new Picato uses.
Is Ingenol Mebutate a Generic Picato?
No -- ingenol mebutate is the active ingredient in Picato, 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.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Picato [package insert]. Parsippany, NJ: LEO Pharma, Inc.;2012 January.
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 March 16, 2012.
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