Actavis in Daytrana patent settlement

Generic drugs major Actavis (NYSE: ACT) has entered into an agreement with Noven Pharmaceuticals, a subsidiary of Japan’s Hisamitsu Pharmaceutical (TYO: 4530),to settle all outstanding patent litigation related to Actavis' generic version of Daytrana (methylphenidate transdermal system), a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder.

Under the terms of the agreement, Noven will grant Actavis a non-exclusive, royalty-bearing license to market its generic Daytrana beginning on September 1, 2015, or earlier under certain circumstances. Other details of the settlement were not disclosed.

Launch of Actavis' product is contingent the firm receiving final approval from the US Food and Drug Administration on its Abbreviated New Drug Application for generic Daytrana. Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Daytrana and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.