Perrigo announced that Sun Pharmaceutical and MiCal Pharmaceuticals 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.
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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.
"This first-to-file Paragraph IV ANDA is another example of making long-term investments in our extended topicals strategy,” Perrigo Executive Vice President and President Rx Pharmaceuticals John Wesolowski said. “The Rx team continues to invest in bringing important products to market that provide savings to patients and the healthcare system."