AstraZeneca gets six months' Prilosec grace

AstraZeneca has been granted a six-month additional period of marketexclusivity in the USA for Prilosec (omeprazole), calling a halt to generics firms' attempts to tap into the lucrative US market for the proton pump inhibitor until October. The extension has been given in accordance with the Federal Food, Drug and Cosmetics Act, which awards extra exclusivity periods to companies which conduct clinical studies in children.

Aside from maintaining Prilosec's franchise without competition for an extra six months, the extension gives AstraZeneca a valuable window of opportunity to continue building a market for its new-generation PPI Nexium (esomeprazole), which has advantages over omeprazole and has been launched at a discount to its parent (Marketletters passim).

Over the last year, a number of legal challenges to Prilosec's intellectual property have been made by generics companies, with several firms poised to market competing products should AstraZeneca's patents on the drug be overturned. In the latest development, reported shortly after the market exclusivity extension, the company noted that the US District Court for the Southern District of New York had denied a summary judgement motion, filed by Indian-owned generics firm Reddy-Cheminor, alleging the invalidity of US patent No 4,255,431.