Perrigo Company plc (NYSE; TASE: PRGO) today announced that Sun Pharmaceutical Industries, Inc. and MiCal Pharmaceuticals LLC initiated patent litigations on May 9 and 10, 2018, in the U.S. District Court for the District of Delaware and in the U.S. District Court for the Western District of Michigan regarding Perrigo’s Paragraph IV Abbreviated New Drug Application for halobetasol propionate lotion, 0.05% (a generic version of Ultravate® Lotion), asserting a patent listed in the Orange Book for Ultravate® Lotion. This action formally initiates the litigation process under the Hatch-Waxman Act.
Ultravate® Lotion, 0.05% is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. Annual market sales for the 12 months ending March 2018 were $17 million as measured by IQVIA.
Perrigo Executive Vice President and President Rx Pharmaceuticals John Wesolowski stated, “This first-to-file Paragraph IV ANDA is another example of making long-term investments in our extended topicals strategy. The Rx team continues to invest in bringing important products to market that provide savings to patients and the healthcare system.”
Perrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by providing Quality Affordable Healthcare Products®. Founded in 1887 as a packager of home remedies, Perrigo has built a unique business model that is best described as the convergence of a fast-moving consumer goods company, a high-quality pharmaceutical manufacturing organization and a world-class supply chain network. Perrigo is one of the world’s largest manufacturers of over-the-counter (“OTC”) healthcare products and suppliers of infant formulas for the store brand market. The Company also is a leading provider of branded OTC products throughout Europe and the U.S., as well as a leading producer of “extended topical” prescription drugs. Perrigo, headquartered in Ireland, sells its products primarily in North America and Europe, as well as in other markets, including Australia, Israel and China.