Allegan-based Perrigo Co. (Nasdaq: PRGO) announced its filing with the United States Food and Drug Administration for its Abbreviated New Drug Application for clobetasol propionate shampoo, 0.05 percent, and notified Galderma, the listed patent owner.

On Aug. 17, Galderma filed suit alleging patent infringement in the United States District Court for the Northern District of Texas to prevent Perrigo from proceeding with the commercialization of this product. This action formally initiates the process under the Hatch-Waxman Act.

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The product is substitutable to Galderma’s Clobex Shampoo, 0.05 percent, a topical corticosteroid indicated for the treatment of moderate to severe psoriasis of the scalp. Sales for the brand were approximately $53 million, according to Wolters Kluwer data for the twelve months ending June 2010.

Said Perrigo chairman and CEO Joseph C. Papa: “This filing reflects our razor focused strategy of bringing new extended topical products to market and making quality healthcare more affordable for our customers.”

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Perrigo develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients and pharmaceutical and medical diagnostic products. The company is the world’s largest store brand manufacturer of OTC pharmaceutical products and infant formulas. The company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.

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