Actavis plc has entered into an agreement with Noven Pharmaceuticals Inc. to settle patent litigation related to Actavis' generic version of Daytrana.


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Actavis readies Daytrana generic following patent settlement

March 19th, 2014

DUBLIN, Ireland – Actavis plc has entered into an agreement with Noven Pharmaceuticals Inc. to settle patent litigation related to Actavis' generic version of Daytrana.

Actavis said Wednesday that under the settlement, Noven will grant Actavis a nonexclusive, royalty-bearing license to market its generic Daytrana starting on Sept. 1, 2015, or earlier under certain circumstances.

Other terms of the settlement agreement weren't disclosed.

A central nervous system stimulant delivered via a patch, Daytrana (methylphenidate transdermal system) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children (ages 6-12) and adolescents (ages 13-17).

Actavis said that the launch of its product is contingent upon receiving final approval from the Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for generic Daytrana.

The company added that it believes it may be a first applicant to file an ANDA for the generic version of Daytrana and, if its ANDA is approved, may be entitled to 180 days of generic market exclusivity.

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

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