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news.Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has reached a settlement with Mallinckrodt on outstanding patent litigation related to Watson's generic versions of Mallinckrodt's Exalgo (Hydromorphone Hydrochloride Extended-Release ) tablets.
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As per the settlement agreement, Mallinckrodt has granted Watson a royalty-free license to US patents relating to Exalgo.
Watson will have the right to launch its bioequivalent products on 15 November 2013. Other details of the settlement were not disclosed.
Mallinckrodt has filed its lawsuit in US District Court for the District of New Jersey following Watson’s filing of an ANDA with the FDA seeking approval to market its product.
Watson has filed to market the product in 8mg, 12mg, and 16mg dosage strengths.