Osteoporosis and ADHD generics launched in USA

Generics/News | Posted 12/06/2015 post-comment0 Post your comment

On 1 and 2 June 2015, Israeli generics giant Teva Pharmaceutical Industries (Teva), launched its latest osteoporosis and ADHD generics, respectively.

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Teva launched its generic equivalent of osteoporosis treatment Actonel (risedronate), in tablet form, in dosages of 5, 30 and 35 mg, in the US on 1 June 2015. Teva believes it was the ‘first-to-file’, making the product eligible for 180 days of market exclusivity.

Risedronate belongs to a group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractures. The drug is indicated for the treatment or prevention of osteoporosis in men and women. It is also used to treat Paget’s disease of bone. Approximately 54 million Americans have low bone mass and osteoporosis, a condition that causes the bones to become weak and brittle. The condition is most common in older women and patients taking specific medications.

Risedronate is the second osteoporosis product in Teva’s generics portfolio. Teva Generics received approval from the European Medicines Agency for its zoledronic acid generic on 27 March 2014 [1].

Actonel tablets marketed by Actavis had 2014 sales of approximately US$157 million in the US, according to IMS data.

On 2 June 2015, Teva launched a generic version of Shire Pharmaceutical’s Intuniv (guanfacine) extended-release tablets in dosages of 1, 2, 3 and 4 mg, in the US. Guanfacine is a non-stimulant medication for the treatment of attention deficit hyperactivity disorder (ADHD) that can be used alone, or as an add-on to stimulant medications. Guanfacine joins Teva’s current generic line of seven ADHD products.

ADHD is the most common neurobehavioral 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$804 million in the US, according to IMS data as of March 2015.

1.   GaBI Online - Generics and Biosimilars Initiative. Generics applications under review by EMA – April 2014 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 12]. Available from: www.gabionline.net/Generics/General/Generics-applications-under-review-by-EMA-April-2014 

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Source: Teva

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