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J&J files new Concerta suit against Impax

Impax Laboratories has been sued for the second time by Johnson & Johnson in connection with a generic version of the attention deficit hyperactivity disorder drug Concerta

Impax Laboratories has been sued for the second time by Johnson & Johnson (J&J), the maker of Concerta (methylphenidate hydrochloride), in connection with the generic company's plans to market a low-cost copy of the blockbuster attention deficit hyperactivity disorder (ADHD) drug.

J&J's Alza Corporation has filed suit against Impax in the US District Court for the District of Delaware for infringement of the patents on extended-release 18mg, 27mg and 36mg Concerta tablets. The new litigation follows a lawsuit filed against Impax by J&J's Ortho-McNeil-Janssen Pharmaceutical division in late 2010 over the 54mg tablet version  of the drug.

The suits were spurred by Impax's filing of marketing applications for the generic products with the US Food and Drug Administration (FDA). If the applications are approved, the Impax generics will be commercialised by Teva under a Strategic Alliance Agreement between the two companies.

Concerta is indicated for the treatment of ADHD in children six years of age and older, adolescents, and adults up to the age of 65. Sales of the four dosage strengths combined were about $1.4bn in the US for the 12 months ended February 2011.

The new lawsuit comes on the heels of Watson Pharmaceuticals' launch this month of an authorised generic version of Concerta, which is being supplied to Watson by Ortho-McNeil-Janssen in return for a percentage of revenues.

The supply and distribution agreement between Watson and Ortho-McNeil covers the 18mg, 27mg, 36mg, and 54mg formulations of Concerta and is in effect until the end of 2014.

9th May 2011

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