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Perrigo files regulatory application for Taclonex generic

ALLEGAN, Mich. — Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

Perrigo announced Tuesday that it had filed an application with the FDA for calcipotriene and betamethasone dipropionate in the 0.005%/0.064% strength. The drug is a generic version of Leo Pharma’s Taclonex and is used to treat psoriasis vulgaris in adults.

Taclonex had sales of $135 million during the 12-month period ended in November 2010, according to Wolters Kluwer Health. Perrigo included in its application a Paragraph IV certification, a legal assertion that the patent covering Taclonex is invalid, unenforceable or won’t be infringed, attracting a patent infringement lawsuit from Leo, though a different generic company was the first to file for approval with the FDA.

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