EPO revokes a Symbicort patent

A European combination patent covering the use of Anglo-Swedish drug major AstraZeneca's Symbicort (budesonide/formoterol fumarate dihydrate) inhalation aerosol for chronic obstructive pulmonary disease has been revoked as a result of an appeal by US generic drugmaker Ivax and a UK unit of Germany's Merck KgaA

However, the $1.58 billion-a-year drug, which is also approved for asthma, is still protected by European data exclusivity patents until 2010, as well as by patents on the device used to administer the active ingredients, which do not expire until 2019. Last week, AstraZeneca submitted a supplemental New Drug Application to the US Food and Drug Administration seeking approval for a new indication for Symbicort for the treatment of patients with chronic obstructive pulmonary disease (Marketletter May 5).