Astrazeneca Plc has said the US patent on its top-selling drug Nexium had been challenged by India’s Ranbaxy Laboratories, sending its shares down more than 2 per cent.
Industry analysts said a generic challenge to the $4 billion-a-year heartburn and anti-ulcerant pill had long been expected, since Nexium is similar chemically to AstraZeneca’s off-patent Prilosec medicine. But news Ranbaxy had now submitted an abbreviated new drug application in the US hit confidence in the Anglo-Swedish drug maker, which has already suffered setbacks with new products last year.
AstraZeneca management have also warned investors earlier that a generic challenge was to be expected. Still, it intends to defend its position and an early decision on patents surrounding the medicine looks unlikely. “AstraZeneca is evaluating Ranbaxy’s notice and continues to have full confidence in its intellectual property protecting Nexium,” the group said, adding that it has 45 days within which to start a patent infringement lawsuit against Ranbaxy.
Such a move would automatically bar the US FDA from approving Ranbaxy’s application for 30 months or until an adverse court decision. The last of the patents being challenged expires in 2018 but Ranbaxy would not launch its product prior to the expiry of other US patents relating to Nexium, of which the latter expires in October 2007, it said.