Perrigo confirms first to file patent challenge for generic Ultravate lotion

DublinTuesday, May 15, 2018, 17:00 Hrs  [IST]

Perrigo Company plc announced that Sun Pharmaceutical Industries, Inc. and MiCal Pharmaceuticals LLC initiated patent litigations on May 9 and 10, 2018, in the US District Court for the District of Delaware and in the US 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.