Patent Law Practice Center

Actavis Announces Daytrana® Patent Challenge Settlement

On March 19, 2014, Actavis plc (NYSE: ACT) announced that it 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. For the 12 months ending December 31, 2013, Daytrana® had total U.S. sales of approximately $98 million, according to IMS Health data.

The ultimate launch of Actavis’ product is, however, contingent upon Actavis receiving final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for generic Daytrana®.

This patent dispute in fact arose out of the filing of the ANDA by Actavis. An ANDA applicant must make one of four certifications regarding each patent that applies to the drug for which approval is being sought: (I) no such patent information has been submitted to the FDA; (II) the patent has expired; (III) the patent is set to expire on a certain date; or (IV) the patent is invalid or will not be infringed by the drug covered in the ANDA.

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