Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Methylphenidate Hydrochloride for Extended-release Oral Suspension, 5 mg/mL. Actavis' ANDA product is a generic version of Pfizer and Tris Pharma's Quillivant XR®, which is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder.
Tris Pharma, Inc. filed suit against Actavis on October 15, 2014 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. Patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Quillivant XR® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending June 30, 2014, Quillivant XR® had total U.S. sales of approximately $52 million, according to IMS Health data.