AZ’s Nexium faces generic competition in the UK
pharmafile | September 6, 2011 | News story | | Nexium, Ranbaxy, generics
Generic specialist Ranbaxy has launched its version of AstraZeneca’s anti-ulcer blockbuster Nexium in the UK.
It will be available in 20 mg and 40 mg tablets to treat peptic ulcer disease and is licensed to treat gastroesophageal reflux disease and Zollinger-Ellison syndrome.
“We are committed to bringing high quality, affordable medicines for the benefit of patients and healthcare systems worldwide and in Europe,” said Debashis Dasgupta, Ranbaxy Europe’s regional director.
“The introduction of esomeprazole, in the UK, is an important and significant step in this direction,” Dasgupta added. It is the first approved generic bio-equivalent of the product to be made available in this country.
Launched in Europe in 2000 and in 2001 in the US, Nexium was AstraZeneca’s biggest brand, and still achieved almost $5 billion in sales last year despite patent expiration and the onset of generic competition.
Ranbaxy and AstraZeneca have previously wrangled over US patents, after a submission was made to the FDA for a generic version of Nexium.
That case was settled in 2008 with an agreement that the Indian company could sell a generic version under licence in the US from May 2014.
Ranbaxy has also provided some of AZ’s US supply of Nexium from May 2010, and has been manufacturing some esomeprazole magnesium from May 2009.
In June this year, AstraZeneca sought European approval for a new version of Nexium (under the proposed brand name Axanum) which includes a low-dose of aspirin (acetylsalicylic acid or ASA) and esomeprazole.
It is aimed at preventing cardio- and cerebrovascular events, such as myocardial infarction or stroke, in patients who have continuous ASA treatment and are at risk of developing ulcers.
Adam Hill
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