Perrigo Confirms Patent Challenge

Allegan-based Perrigo Co. (Nasdaq: PRGO) announced it had filed an Abbreviated New Drug Application with the United States Food and Drug Administration for Clobetasol Propionate Emulsion Foam, 0.05 percent. The company said it believes it is first to file on this product.

On July 12, Stiefel Research Australia Pty. Ltd., the listed patent owner, filed suit alleging patent infringement in the United States District Court for the District of Delaware to prevent Perrigo from proceeding with the commercialization of this product. This action formally initiates the process under the Hatch-Waxman Act.

The product is equivalent to Stiefel Laboratories' Olux-E Foam, a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand were up 18 percent for the 12 months ending May 2010 to $41.5 million, according to the research firm Wolters Kluwer.

Said Perrigo chairman and CEO Joseph C. Papa: "This filing reflects our strategy to be first to market with the important products that make quality healthcare more affordable for our customers and drive value for our shareholders."

Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, nutritional products, infant formula, active pharmaceutical ingredients and consumer products. The company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The company's primary markets and locations of manufacturing and logistics operations are the U.S., Australia, Israel, Mexico and the United Kingdom.

More at www.perrigo.com.

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