This is the first approved generic bioequivalent version of AstraZeneca’s blockbuster stomach-acid-relief drug, Nexium, in the UK. This presents a major opportunity for Ranbaxy, but bad news for AstraZeneca, which will lose further sales of its major revenue generator. Between the launch of esomeprazole in 2001 and 2005, the drug netted approximately US$ 14.4 billion for AstraZeneca [1] and still raked in US$5 million during 2010 despite patent expiries. According to IMS Health data from June 2011 sales of Nexium in the UK were GBP 60 million annually.

Commenting on the development, Regional Director of Ranbaxy Europe, Mr Debashis Dasgupta, said ‘we are committed to bringing high quality, affordable medicines for the benefit of patients and healthcare systems worldwide and in Europe. The introduction of esomeprazole, in the UK, is an important and significant step in this direction.’

Esomeprazole is a proton pump inhibitor used in the treatment of dyspepsia, peptic ulcers, gastroesophageal reflux and Zollinger-Ellison syndrome.

Ranbaxy and AstraZeneca have clashed in the past over generic esomeprazole in the US, but eventually reached an agreement in 2008 which will allow Ranbaxy to launch its generic version, with 180-day exclusivity, in May 2014, when the first patents on Nexium will start to expire.

To counter some of its losses AstraZeneca has come up with a combined esomeprazole and aspirin (acetylsalicylic acid) pill. This treatment is indicated to prevent heart attack or stroke in high-risk patients in need of daily low-dose aspirin treatment and who are at risk of stomach ulcers.

The combination, called Axanum, consists of a fixed dose combination of 81 mg low dose acetylsalicylic acid and 20 mg esomeprazole and received approval in 23 EU member countries and in Norway in August 2011.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Astra Zeneca losing generic esomeprazole battle [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 08]. Available from: www.gabionline.net/Generics/News/Astra-Zeneca-losing-generic-esomeprazole-battle