On March 7, 2012 the FDA shot down AstraZeneca‘s bid to stall generic versions of the antipsychotic drug Seroquel. In an effort to prolong what seems to be the inevitable, the drugmaker fired back with a lawsuit, seeking an injunction to block Seroquel copies at least until a court can review its claims. But, the stakes are huge: Seroquel IR’s exclusive hold on the market is set to lapse later this month, and it’s a multibillion-dollar drug, with $3.3 billion in U.S. sales in 2011.
AstraZeneca is seeking a ruling keeping the FDA from granting final marketing approval of generic Quetiapine until December 2, 2012 when regulatory exclusivity expires on important clinical trial data.
If the drugmaker could delay copycat Seroquel until December, the branded version would have more than 8 additional months to dominate the market. That could translate into $650 million in Seroquel sales otherwise lost to generic competition, give or take a hundred million or so, depending on uptake.
AstraZeneca is currently budgeting for a 2012 revenue fall at the group level of more than 10 percent, in large part as a result of loss of exclusivity on Seroquel in both the United States and Europe.
The unexpected lawsuit was seen by analysts as a long shot, but if successful the move could postpone a major generic hit for Britain’s second biggest drugmaker.