Sandoz makes deal with Shire for authorized Adderall XR generic

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Sandoz makes deal with Shire for authorized Adderall XR generic

Genéricos/Novedades | Posted 13/12/2013 0 Post your comment

Shire announced on 2 December 2013 that its subsidiary Shire US had entered into an agreement to supply an authorized generic version of its attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine, dextroamphetamine mixed salts) to Sandoz.

Under the terms of the agreement, Sandoz, the generics unit of Swiss pharma giant Novartis, will exclusively sell an authorized generic version of Adderall XR supplied by Shire as of 1 July 2016. The agreement between the two companies will run for five years from the effective date of 1 December 2013.

Shire, which is UK’s third largest pharmaceutical company, will manufacture and supply Sandoz with all dosage strengths of the authorized generic drug product. Sandoz will distribute the product in the US and Shire will receive a royalty from the sales.

ADHD affects 3–4% of children globally, with 30–50% of those individuals diagnosed in childhood continuing to have symptoms into adulthood. Symptoms include problems paying attention and hyperactivity.

There are already two authorized generics of Shire’s Adderall XR on the market, produced under licence by Israel’s Teva Pharmaceuticals and US-based Impax Laboratories. The US Food and Drug Administration (FDA) also approved an abbreviated new drug application (ANDA) from Actavis for the ADHD drug on 22 June 2012. The approval came despite the fact that Shire had petitioned the agency to block the approval, arguing that Adderall XR is a complex controlled-release product and that any ANDAs should include bioequivalence data using partial area under the curve measurements at five hours and beyond five hours for both the d- and l- amphetamine [1].

Despite generics competition Adderall XR still generated sales of US$81.4 million for the third quarter of 2013.

Reference

1. GaBI Online - Generics and Biosimilars Initiative. Generic Adderall XR approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Dec 13]. Available from: www.gabionline.net/Generics/News/Generic-Adderall-XR-approved-in-the-US

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Source: Reuters, Shire