Actavis Reaches Agreement With Janssen On Concerta - Quick Facts

(RTTNews) - Actavis Plc. (ACT) said it has reached an agreement with Janssen Pharmaceuticals, Inc. or JPI to continue supplying the authorized generic version of JPI's Concerta or methylphenidate hydrochloride extended-release tablets.

Under the terms of the extended exclusive supply and distribution agreement, JPI will continue to manufacture and supply Actavis with all dosage strengths of the authorized generic product. Actavis will continue to market and distribute the product in the U.S.

JPI will receive 50 percent of the net sales from Actavis' product. The extended agreement runs until December 31, 2017. The agreement was first reached by the companies in November 2010 and is due to expire on December 31, 2014.

During the term of the agreement, Actavis may continue to pursue U.S. Food and Drug Administration approval of its abbreviated new drug application 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 or ADHD in children aged 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, Concerta had total U.S. brand and generic sales of about $1.4 billion, according to IMS Health data.