J&J Resolves ADHD Lawsuit with Impax Labs and Teva

Johnson & Johnson (J&J) have established a new deal to settle a patent disagreement regarding their attention-deficit hyperactivity disorder (ADHD) drug, Concerta.

Impax Laboratories and partner Teva Pharmaceutical Industries launched a lawsuit against Johnson & Johnson’s Janssen Pharmaceuticals and Alza Corp units.  Impax Laboratories announced on Friday that the lawsuit has now been settled after J&J granted the organisations a licence to sell their copies of Concerta (methylphenidate) by July 14th next year.

The generic version of Concerta is part of the strategic alliance Impax has with Teva.  Teva are currently waiting for their version to be approved by the US Food and Drug Administration (FDA).  Once the Abbreviated New Drug Application is approved by the FDA, Teva has the right to commercialise the products under the license arrangement.

Concerta has been a big earner for Johnson & Johnson, with US brand and generic sales of the medication at roughly $1.20 billion for the 12 months ending July 2012, according to data from Wolters Kluwer Health.

However, this demonstrates a potential problem for Impax and Teva when gaining market share next summer.  An authorised generic of the ADHD drug was launched last year by Watson Pharmaceuticals after an agreement was signed with J&J in 2010, which allows the healthcare giant to supply generic Concerta and take a cut of the profits.

Concerta is specified for ADHD in children aged six years or over, as well as for adults up to the age of 65.


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