The two generic drug manufacturers have agreed that the patent on Crestor (rosuvastatin calcium) is valid, enforceable and would be infringed by Actavis’ generic rosuvastatin zinc and rosuvastatin calcium products.

Crestor had worldwide sales of US$6.25 billion in 2012. The substance patent protecting the cholesterol-lowering blockbuster expires on 8 January 2016 and the paediatric exclusivity period expires on 8 July 2016.

The settlement agreement allows Actavis to start selling its generic rosuvastatin calcium and rosuvastatin zinc products as of 2 May 2016, and will have to pay a fee of 39% of net sales of these products to AstraZeneca until the end of paediatric exclusivity on 8 July 2016.

This is not the first time AstraZeneca has had to defend its patent on Crestor. Back in 2007, nine generic drug manufacturers claimed that the Crestor patent was invalid on the grounds that it was an obvious invention. A US court, however, dismissed the claims [1].

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References

1.  GaBI Online - Generics and Biosimilars Initiative. Generics lose battle against AstraZeneca’s Crestor (rosuvastatin) [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 19]. Available from: www.gabionline.net/Generics/News/Generics-lose-battle-against-AstraZeneca-s-Crestor-rosuvastatin

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