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Perrigo Confirms Filing for Generic Version of Taclonex® Ointment and Announcement of Lawsuit by Leo Pharma
Date:2/22/2011

ALLEGAN, Mich., Feb. 22, 2011 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has filed an Abbreviated New Drug Application 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 February 14, 2011, 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.

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

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients (API) 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 lo
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