Impax Laboratories, Inc.today announced that it and Teva Pharmaceuticals USA, Inc. have reached agreement with Janssen Pharmaceuticals, Inc. and ALZA Corporation (together, “ALZA”) to settle pending U.S. litigation with regard to the production and sale of generic formulations of CONCERTA® (methylphenidate hydrochloride extended release tablets, 18 mg, 27 mg, 36 mg, and 54 mg). Under the terms of the settlement, ALZA has agreed to grant Impax and Teva a license to sell generic versions of CONCERTA® on July 14, 2013 or earlier under certain circumstances.
Impax’s generic CONCERTA® products are part of the Company’s Strategic Alliance Agreement with Teva. Once the ANDA is approved by the U.S. Food and Drug Administration, Teva has the right to commercialize the products pursuant to the license agreement.
CONCERTA® is indicated for the treatment of Attention Deficit Hyperactivity Disorder in children six years of age and older, adolescents and adults up to the age of 65. According to Wolters Kluwer Health, U.S. brand and generic sales of CONCERTA® were approximately $1.2 billion for the 12 months ended July 2012.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals Division and markets branded products through the Impax Pharmaceuticals Division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities.