Actavis plc has reached an agreement with Janssen Pharmaceuticals, Inc. (JPI) to continue supplying the authorized generic version of JPI's Concerta (methylphenidate hydrochloride extended-release tablets).
Under the terms of the extended exclusive supply and distribution agreement — which was first agreed to by the companies in November 2010 and due to expire on December 31, 2014 — JPI will continue to manufacture and supply Actavis with all dosage strengths of the authorized generic product, and Actavis will continue to market and distribute the product in the United States. JPI will receive 50 percent of the net sales from Actavis' product. The extended agreement runs until December 31, 2017.
During the term of the agreement, Actavis may continue to pursue US Food and Drug Administration approval of its abbreviated new drug application (ANDA) for a generic version of Concerta and may launch its own ANDA product at the conclusion of the exclusive supply agreement. Other terms of the agreement have not been disclosed.
Concerta is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 17 and in adults 18 to 65, as part of a total treatment program that may include counseling or other therapies. For the 12 months ending February 28, 2014, Concerta had total US brand and generic sales of approximately $1.4 billion, according to IMS Health data.
Actavis plc is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Actavis has global headquarters in Dublin, Ireland and US administrative headquarters in Parsippany, New Jersey, USA.