Actavis announced that it has entered into an agreement with Noven Pharmaceuticals Inc. to settle all outstanding patent litigation related to Actavis’ generic version of Daytrana (Methylphenidate Transdermal System). Daytrana is 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 Sept. 1, 2015, or earlier under certain circumstances. Other details of the settlement were not disclosed.

Launch of Actavis’ product is contingent upon Actavis receiving final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) 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.

For the 12 months ending Dec. 31, 2013, Daytrana had total U.S. sales of approximately $98 million, according to IMS Health data.

Date: March 19, 2014

Source: Actavis