Watson settles over Exalgo; gets favorable news on enoxaparin

29 January 2012

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) says that its subsidiary, Watson Laboratories, has reached a settlement with Mallinckrodt NYSE: MKG) on outstanding patent litigation related to Watson's generic versions of Mallinckrodt's long-acting prescription pain drug Exalgo (hydromorphone hydrochloride) extended-release tablets.

Mallinckrodt filed its law suit on December 10, 2010 in the US District Court for the District of New Jersey following Watson's filing of an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market its product in the 8mg, 12mg, and 16mg dosage strengths.

Under terms of the settlement agreement, Mallinckrodt has granted Watson a royalty-free license to US patents relating to Exalgo. giving Watson the right to launch its bioequivalent products on November 15, 2013. Other details of the settlement were not disclosed.

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