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12 January 2017Americas

Shire and Actavis sued in competition case over ADHD drug

Rochester Drug Co-operative, a wholesaler serving community retail pharmacy and home healthcare dealers, has filed a class action complaint against Shire and Actavis in a competition case centring on ADHD drug Intuniv (guanfacine hydrochloride).

According to the complaint, filed yesterday, January 11 in the US District Court for the District of Massachusetts, Shire allegedly entered into an unlawful reverse payment  agreement with Actavis in April 2013.

Under the agreement, Actavis allegedly agreed to delay marketing its less expensive, generic version of Intuniv until December 2014, in return for payment. Intuniv is made by Shire.

Following the agreement, Actavis allegedly did not bring its generic to market until December 2014, even though the company was granted Food and Drug Administration approval in October 2012.

Rochester is seeking damages arising from the alleged unlawful conduct between the two companies within the first 180 days of generic marketing.

In a patent settlement agreement between Actavis and Shire which took place in 2013 before the US District Court for the District of Delaware, Actavis agreed to provide Shire with a 25% portion of Actavis’s gross profits during the 180-day exclusivity period.

Rochester stated in its complaint: “By paying Actavis to delay its launch using the no-AG [authorised generic] promise … Shire was able to continue to reap monopoly profits on branded Intuniv until December 1, 2014.

“In addition, the no-AG promise allowed Actavis to garner higher prices and double its sales during its 180-day exclusivity period, after its delayed launch.”

A spokesperson from Shire said: “The allegations are without merit, and Shire will vigorously defend against these claims.”

In the complaint, which was filed “on behalf of itself and all others similarly situated”, Rochester has demanded a jury trial and damages to be determined at trial.

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