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news.Actavis has extended its exclusive supply and distribution agreement with Janssen Pharmaceuticals to continue supplying the authorized generic version of JPI's Concerta (methylphenidate hydrochloride extended-release tablets).
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The supply and distribution agreement was first agreed to by the companies in November 2010 and is due to expire on 31 December 2014.
As part of the deal, JPI will continue to manufacture and supply Actavis with all dosage strengths of the authorized generic product, while Actavis will continue to market and distribute the product in the US.
In exchange, JPI will receive 50% of the net sales from Actavis’ product.
According to the company, the extended agreement runs until 31 December 2017.
During the term of the agreement, Actavis may continue to pursue FDA approval of its abbreviated new drug application (ANDA) for a generic version of Concerta and may launch its own ANDA product at the conclusion of the exclusive supply agreement.
Concerta is approved to treat attention deficit hyperactivity disorder (ADHD) in children ages six to 17 and in adults 18 to 65, as part of a total treatment program that may include counseling or other therapies.