Actavis settles with Mallinckrodt over Exalgo 32mg; Teva gains FDA OK for Adderall XR

US generics drug major Actavis (NYSE: ACT) has reached a settlement with Mallinckrodt (NYSE: MKG) on outstanding patent litigation related to Actavis' generic version of the 32mg dosage strength of Mallinckrodt's long-acting prescription pain drug Exalgo (hydromorphone hydrochloride extended-release) tablets.

In January of 2012, Actavis and Mallinckrodt previously settled litigation involving the 8mg, 12mg and 16mg dosage strengths of the product. Mallinckrodt filed its current lawsuit on October 25, 2012, in the US District Court for the District of New Jersey following the Actavis (then still named Watson) filing of an amendment to an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market its product in the 32mg dosage strength.

Under terms of the settlement agreement, Mallinckrodt has granted Actavis a royalty-free license to US patents relating to Exalgo to sell Actavis' 32mg product starting on May 15, 2014. Other details of the settlement were not disclosed.