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14 May 2014Americas

Janssen sues to halt Mylan’s Concerta generic

Johnson & Johnson’s pharmaceuticals subsidiary Janssen has sued Mylan to stop it launching a generic version of Concerta (methylphenidate hydrochloride).

Janssen’s Concerta is used to treat patients with attention deficit hyperactivity disorder. In 2013, it generated sales of $782 million worldwide. Methylphenidate hydrochloride is also marketed under the brand name Ritalin by Novartis.

The patent at issue, 8,163,798, is held by ALZA Corporation, another Johnson & Johnson-owned pharmaceutical company. It covers “methods and devices for providing prolonged drug therapy”, and expires in July 2017.

Janssen launched the case after Mylan filed an Abbreviated New Drug Application with the US Food and Drug Administration for approval to make and sell a generic version of Concerta before ALZA’s patent expires.

In the complaint, filed on May 12 at the US District Court for the District of Delaware, Janssen and ALZA claim that Mylan intends to and will actively induce infringement of the ‘798 patent.

They asked that the court find the ’798 patent to be valid and enforceable, and for a permanent injunction enjoining Mylan from making and selling generic copies of Concerta in 18 mg, 27 mg, 36 mg and 54 mg dosage strengths.

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