Perrigo confirms first-to-file patent challenge for generic plaque psoriasis treatment


DUBLIN — Perrigo announced on Monday that Sun Pharmaceutical Industries and MiCal Pharmaceuticals has initiated patent litigations 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.

“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,” stated Perrigo executive vice president and president Rx Pharmaceuticals John Wesolowski.

Annual market sales for the 12 months ended March 2018 were $17 million as measured by IQVIA.


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