Actavis Settles Daytrana® Patent Litigation

Actavis announced that it signed an agreement with Noven Pharmaceuticals for the settlement of all outstanding patent litigation in connection with Actavis’ generic version of Daytrana (methylphenidate transdermal system), a CNS stimulant used to treat ADHD.

Noven Pharmaceuticals will grant Actavis a non-exclusive, royalty bearing license to market the generic version of the drug starting on September 1, 2015 or earlier under certain conditions.

The company had filed a patent infringement lawsuit against Actavis (then known as Watson Pharmaceuticals) in 2011 as a result of an Abbreviated New Drug Application (ANDA) submission by Watson for the approval of a generic version of Daytrana. Noven insisted that Actavis’ application was illegal because it was made prior to the drug’s scheduled patent expiration in 2018.

“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,” Actavis said in its press release.

Daytrana is the first transdermal patch approved for the treatment of Attention Deficit Hyperactivity Disorder symptoms in pediatric patients 6 to 17 years old. The medication patch contains a prescription central nervous system (CNS) stimulant used to help increase attention and decrease hyperactive and impulsive behavior. Daytrana is recommended as an adjunct treatment to a total therapy program for ADHD.

The ADHD patch is developed and manufactured by Noven and marketed by the CNS unit of its specialty pharmaceuticals subsidiary, Noven Therapeutics, LLC. Daytrana is a controlled substance due to risk of abuse or dependence.

The drug had total U.S. sales of an estimated $98 million, says IMS Health data.