2010 U.S. sales: $3.107 billion/$4.148 billion global
Impact: 22.63% of U.S. sales
Exclusivity expires: March 2012
(XR versions expected to avoid generic rivals for now, thanks to patent settlements)
Seroquel wasn't the first atypical antipsychotic to hit the market, nor is it the biggest-selling in its class today. But it and its extended-release partner have racked up more indications than their sister drugs, including the most recent nod as an add-on treatment for depression that was gained in 2009. The patent shield was set to disappear on all of that next year--or so analysts thought. A couple of new settlements with generics makers point the way to longer-term exclusivity for Seroquel XR, which means AstraZeneca may not lose its entire franchise all at once. It also means the company can try to convert patients to the extended-release version to keep them in the branded-drug fold.
While AstraZeneca was racking up new uses for Seroquel and Seroquel XR, its marketing caught the eyes of federal prosecutors. The company agreed to pay $520 million in 2010 to settle allegations it promoted the brand for uses that weren't FDA-approved. It also faced more than 26,000 lawsuits filed by patients who claimed the company knew Seroquel could cause diabetes, but didn't do enough to warn about the risk. It has settled most of these cases for upward of $350 million, but 2,600 remained as of March 31. While the company apparently has a chance at continued exclusivity for Seroquel XR, it also has to deal with lingering litigation over the brand.