Watson Reaches Settlement with Mallinckrodt Over Exalgo
Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc.- Florida has reached a settlement with Mallinckrodt Inc. on outstanding patent litigation related to Watson's generic versions of Mallinckrodt's Exalgo® (Hydromorphone Hydrochloride Extended-Release ) tablets. Mallinckrodt filed its lawsuit on December 10, 2010 in the United States District Court for the District of New Jersey following Watson's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its product in the 8 mg, 12 mg, and 16 mg dosage strengths.
Under terms of the settlement agreement, Mallinckrodt has granted Watson a royalty-free license to U.S. patents relating to Exalgo®. Watson will have the right to launch its bioequivalent products on November 15, 2013. Other details of the settlement were not disclosed.
