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Generics of ADHD drug launched in US Posted 26/06/2015

Shire Pharmaceutical’s (Shire’s) blockbuster attention deficit hyperactivity disorder (ADHD) drug Intuniv is now facing competition as four generics of the therapy have been launched on the US market.

On 2 June 2015, Mylan, Par Pharmaceuticals, Sandoz and Teva Pharmaceuticals (Teva) launched generic versions of Intuniv (guanfacine) extended-release tablets in doses of 1, 2, 3 and 4 mg strengths following approval by the US Food and Drug Administration (FDA) of their abbreviated new drug applications (ANDAs). Teva now has eight generic ADHD products.

Although Shire’s patent for Intuniv only expires in September 2015, the company made an agreement with generics maker Actavis in April 2013. The deal allowed Actavis to launch a generic version of the drug in December 2014, with 180 days of marketing exclusivity. Now that the exclusivity period is over, other generics makers can enter the US market.

Guanfacine is a non-stimulant medication for the treatment of ADHD that can be used alone, or as an add-on to stimulant medications.

ADHD is the most common neurobehavioural disorder diagnosed in children in the US. ADHD affects one in 10 US children and half of these children are diagnosed by the age of six.

Intuniv had total market sales of approximately US$800 million in the US, according to IMS data as of March 2015.

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Source: Mylan, Par Pharmaceuticals, Sandoz, Teva

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