Perrigo Company plc, a leading global healthcare company, announced that its subsidiary has filed a Paragraph IV Abbreviated New Drug Application with the US Food and Drug Administration for a generic version of Soolantra (ivermectin) cream, 1%.
Following notification from Perrigo, Galderma Laboratories, L.P., Galderma S.A., and Nestle Skin Health S.A., filed a patent litigation suit asserting patents listed in the Orange Book for Soolantra in the United States District Court for the Northern District of Texas on July 13, 2017. This action formally initiates the litigation process under the Hatch-Waxman Act.
Soolantra (ivermectin) cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Annual market sales for the 12 months ending May 2017 were $87 million.
Perrigo executive vice president and president Rx Pharmaceuticals John Wesolowski stated, "This filing is another example of the hard work done by our R&D and legal teams to develop new generic products that lower the cost of healthcare for consumers."