Perrigo Confirms Filing for Generic Version of Taclonex

Allegan-based Perrigo Co. (Nasdaq: PRGO) announced that it has filed an Abbreviated New Drug Application with the United States Food and Drug Administration for calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment, a generic form of Taclonex Ointment.

Another generic company is the first to file on this product.

Taclonex (Calcipotriene and Betamethasone) ointment is indicated for the topical treatment of psoriasis vulgaris in adults 18 years of age and older. According to Wolters Kluwer Health, sales for Taclonex Ointment for the 12 month period ending November 2010 were $135 million.

Perrigo filed its ANDA containing a paragraph IV certification with the U.S. Food & Drug Administration and notified Leo Pharma Inc., the New Drug Application holder for Taclonex Ointment, of its filing. On Feb. 14, Leo filed suit alleging patent infringement in the United States District Court for the Southern District of New York to prevent Perrigo from proceeding with the commercialization of this product. This action formally initiates the process under the Hatch-Waxman Act.

"This filing is another example of our investment in new products and focus on the extended topical generic space," said Perrigo chairman and CEO Joseph C. Papa. "As always, Perrigo is committed to making quality healthcare more affordable for our customers and drive value for our shareholders."

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. Perrigo's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.

More at www.perrigo.com.