Perrigo Company plc announced it has received tentative approval from the U.S. Food and Drug Administration for the first to file generic version of Ultravate® Lotion (halobetasol propionate) 0.05%. Perrigo previously announced a patent litigation suit with Sun Pharmaceutical Industries, Inc. and MiCal Pharmaceuticals LLC for this product.
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 September 2018 were approximately $17 million as measured by IQVIA™.
Perrigo Executive Vice President and President Rx Pharmaceuticals Sharon Kochan stated, "Our R&D team continues its efforts to secure regulatory approvals for important new products. This tentative approval reflects our continued dedication to developing extended topical products for patients and further illustrates our commitment to advancing our new product pipeline."