Perrigo Company has filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) for ingenol mebutate gel (0.015% and 0.05%), the generic versions of Picato® gel (0.015% and 0.05%). Perrigo has notified Leo Pharma A/S and Leo Laboratories, Ltd., the owners of the New Drug Applications (NDAs) and patents listed in FDA's Orange Book, of its filings.
On June 10, 2016, Leo Pharma A/S, Leo Laboratories Limited and Leo Pharma, Inc. filed suit in the United States District Court for the District of Delaware alleging patent infringement. This action formally initiates the litigation process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, making it eligible for 180 days of generic exclusivity.
Picato® gel (ingenol mebutate gel) is a prescription medicine indicated for the topical treatment of actinic keratosis. Branded sales for the twelve months ending April 2016 were approximately $69 million.
Perrigo's CEO John T. Hendrickson stated, "This filing illustrates Perrigo's commitment to providing Quality Affordable Healthcare Products®. The Rx team continues to invest in the development of important products that strengthen our extended topicals portfolio and drive savings for our customers and consumers."