Actavis, Inc., a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products, has reached a settlement with Mallinckrodt Inc. on outstanding patent litigation related to Actavis' generic version of the 32 mg dosage strength of Mallinckrodt's Exalgo (Hydromorphone Hydrochloride Extended-Release) tablets.
In January of 2012, Actavis and Mallinckrodt previously settled litigation involving the 8 mg, 12 mg and 16 mg 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 Actavis' filing of an Amendment to an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market its product in the 32 mg 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' 32 mg product starting on May 15, 2014. Other details of the settlement were not disclosed.
Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of the 32 mg dosage strength of Exalgo and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.