ASTRAZENECA said yesterday it was suing the Food and Drug Administration (FDA) after the US regulator refused to delay the market entry later this month of generic versions of top-selling antipsychotic Seroquel.
The drugmaker is seeking an injunction barring the FDA from granting final marketing approval of generic forms of the drug, whose chemical name is quetiapine, until 2 December 2012, or at least until a federal court has a chance to review the agency’s action.
Last week, the FDA denied AstraZeneca’s Citizen Petitions requesting the agency withhold approving any generic with labelling that did not have certain warning language required for its branded version.
Generic copies of the original instant-release form of Seroquel are due to hit the US market on 26 March when AstraZeneca's patent expires – an event that will have a significant impact on both sales and profits.
AstraZeneca is currently budgeting for a 2012 revenue fall at the group level of more than 10 per cent, in large part as a result of loss of exclusivity on Seroquel in both the US and Europe.
Seroquel is a particularly profitable medicine for the drugmaker and analysts at Berenberg estimate its loss could knock 330 basis points off the group’s pre-R&D margin.
With acid reflux treatment Nexium also facing US generics in 2014 and top-selling cholesterol fighter Crestor losing patent protection in 2016, AstraZeneca is stepping up the drive to buy in replacement products through a series of acquisitions.
Shares in AstraZeneca closed up 0.3 per cent at £23.84 yesterday, valuing the firm at £37.5bn.
City A.M. Reporter