ALLEGAN — Perrigo Co. (Nasdaq: PRGO; TASE) announced that it has agreed to settle its Hatch-Waxman litigation relating to Clobetasol propionate emulsion foam, 0.05% brought by Stiefel Research Australia Pty. Ltd., a GSK company.
Under the terms of the settlement, Perrigo can launch in the U.S., a generic version of Olux-E (clobetasol propionate) Foam 0.05% on Feb. 1, 2013, or earlier under certain circumstances. Perrigo was the first applicant to submit a substantially complete ANDA with a paragraph IV certification and is entitled to 180-days of marketing exclusivity upon launch. Perrigo received tentative approval for this ANDA in October 2011 and this product was the result of a collaboration with Cobrek Pharmaceuticals.
Olux-E Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older, and has annual sales of approximately $40 million, as measured by Wolters Kluwer.
“This settlement further proves our commitment to launching new products to consumers,” said Perrigo chairman and CEO Joseph C. Papa. “Perrigo continues its focus on bringing quality, affordable healthcare to the marketplace.”
Perrigo develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients. The company is the world’s largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.