Patent Challenge Filed for Generic Version Of Soolantra Cream


Perrigo Company plc's subsidiary has filed a Paragraph IV Abbreviated New Drug Application with the FDA 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.

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