AstraZeneca's ($AZN) last-ditch effort to hold off generic Seroquel has failed. A U.S. judge denied the drugmaker's request for a preliminary injunction that would delay copycat rivals, saying the company didn't prove that it qualified.
The company had aimed to keep the Seroquel market to itself until December. That's when exclusivity expires on safety data that, AstraZeneca argued, should be included in any generic drug label. The company sued the FDA over the labeling issue, after the agency denied its internal request.
So, as the Seroquel patent expires today, generic versions will roll onto the market. Several billion in annual sales are up for grabs; Leerink Swann's Seamus Fernandez sees a dropoff of $3.9 billion in the first 9 months of generic competition. And as the Wall Street Journal points out, Seroquel's patent expiration is just the first of three biggies over the next 5 years.
"This is a company that is probably facing one of the worst patent cliffs in the industry," Morningstar analyst Damien Conover told the Delaware News Journal. "That, coupled with a pipeline that hasn't produced enough offsetting new products, has really put the company in a challenging spot."
AstraZeneca says it's weighing its options in the FDA lawsuit. Meanwhile, it's cutting costs, pushing hard to boost sales of existing drugs, looking for strategic acquisitions and scrambling to develop new drugs, an effort that has hit some big snags recently. Despite CEO David Brennan's repeated assurances to the contrary, analysts are playing name-that-potential-AstraZeneca-buyout, tagging such companies as Shire and Amylin Pharmaceuticals as likely prospects. But spokesman Tony Jewell says AstraZeneca will succeed by sticking to the knitting it has already begun: "We knew this was coming, and we have a business strategy," Jewell told the News Journal.