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news.Impax Laboratories, a specialty pharmaceutical company, and Teva Pharmaceuticals have entered into a settlement agreement related to Concerta litigation with Janssen Pharmaceuticals and ALZA.
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The pending US litigation is concerned with the production and sale of generic formulations of Concerta (methylphenidate hydrochloride extended release tablets, 18mg, 27mg, 36mg, and 54mg).
Pursuant to the agreement, ALZA will grant a license to sell generic versions of Concerta on 14 July 2013 or earlier under certain circumstances to Impax and Teva.
Impax’s generic Concerta products are part of the company’s strategic alliance agreement with Teva, which has the right to commercialize the products pursuant to the license agreement with the ANDA approval from FDA.
Concerta is indicated to treat Attention Deficit Hyperactivity Disorder in children six years of age and older, adolescents and adults up to the age of 65.
The US brand and generic sales of Concerta were approximately $1.2bn for the 12 months ended July 2012, according to Wolters Kluwer Health.