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Perrigo settles suit
ALLEGAN — Perrigo Co. announced today that all litigation relating to Desloratadine tablets has been settled, with Perrigo taking a license under all relevant patents. Perrigo was sued for patent infringement of three U.S. patents based upon its filing of an abbreviated new drug application containing a Paragraph IV certification, which certifies that the listed patents are invalid or will not be infringed upon by the proposed generic drug.
Under the terms of the settlement, Perrigo can commercially launch its generic Desloratadine product on July 1, 2012, or earlier in certain circumstances. The new product may be a prescription or over-the-counter product depending on its status at the time of launch. The Perrigo product is awaiting FDA approval and seeks a rating equivalent to Schering-Plough’s Clarinex tablets, 5 mg, which is used to treat seasonal allergic rhinitis and perennial allergic rhinitis.
Sales for the brand were approximately $300 million, according to Wolters Kluwer data for the 12 months ending October 2008.