DUBLIN - Actavis plc (NYSE: ACT) today 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 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 December 31, 2013, Daytrana@ had total U.S. sales of approximately $98 million, according to IMS Health data.