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PARSIPPANY, N.J. — Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.
Watson announced that one of its subsidiaries had settled with Mallinckrodt over Watson's generic version of Exalgo (hydromorphone hydrochloride) extended-release tablets. Mallinckrodt, a subsidiary of medical products maker Covidien, filed a patent-infringement suit against Watson in December 2010 in the U.S. District Court for the District of New Jersey after Watson sought FDA approval for a generic version of the drug in the 8-mg, 12-mg and 1- mg strengths.
Under the settlement, Watson gets a royalty-free license to patents related to Exalgo and can launch a generic version in November 2013. Other terms of the settlement were not disclosed. Watson said it was probably the first company to seek approval for a generic version, which would entitle it to 180 days of market exclusivity in which to be the sole competitor to Mallinckrodt's product.