Group IP and API Strategy Director, Merck Generics, Generics [UK] Ltd, Albany Gate, Potters Bar, EN6 1AG, UK, Tel: +44 (0)1707 853014, Fax: +44 (0)1707 646299, Email: Howard.Rosenberg@mguk.co.uk

Revised 23 December 2003.

Abstract

This paper looks at the history, consequences and current situation with respect to marketing a generic omeprazole product in the EU. In 1997, Astra (now AstraZeneca) took the disruptive strategy of limiting or avoiding generics competition, by withdrawing their capsule reference product and replacing it with a tablet product prior to generics registration being approved.