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AstraZeneca files lawsuit against FDA to delay generic competition
WILMINGTON, Del.—In a last-ditch effort to fend off generic competition for its top-selling antipsychotic drug Seroquel (quetiapine) and to "vigorously defend its legal rights" to a product that generated $5.83 billion for it last year, AstraZeneca has filed a lawsuit against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia—with the goal being to maintain market exclusivity until December.
Specifically, the lawsuit seeks to overturn the FDA's denial on March 7, 2012 of the company's Citizen Petitions with regard to Seroquel tablets and Seroquel XR extended release tablets. In the Citizen Petitions, AstraZeneca raised what it said were "important issues regarding labeling requirements for generic copies of innovative medicines, as well as data exclusivity rights granted to innovative companies that conduct new clinical trials."
On Sept. 9, 2011, AstraZeneca had filed the Citizen Petition with the FDA for both Seroquel products, requesting the FDA withhold final approval of any generic quetiapine product that omits from its labeling certain warning language that FDA required AstraZeneca to include in the labeling for Seroquel. At issue—and providing the hook for this lawsuit now—is that the FDA had ruled finally this March that generic copies of the antidepressant drug would not have to carry the same warnings about possible side effects—such as suicidal thoughts and high blood sugar levels--that the FDA has required AstraZeneca to put on the branded product.
AstraZeneca said it "seeks an injunction barring the FDA from granting final marketing approval of generic quetiapine until Dec. 2, 2012, when regulatory exclusivity expires on important clinical trial data, or, alternatively, at least until a federal court has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications."
Generic copies of the original instant-release form of Seroquel had been due to hit the U.S. market on March 26.
Analysts view the lawsuit as a long shot, but some have also noted that AstraZeneca has a strong track record of protecting its intellectual property (IP).
As it stands right now, AstraZeneca is budgeting for a 2012 revenue drop of more than 10 percent, in large part due to the loss of patent exclusivity on Seroquel in both the United States and Europe.
Savvas Neophytou, an analyst at Panmure Gordon, has noted that every month AstraZeneca can fend off the generic competition, it stands to boost earning per share by about 2 percent, which could translate into around a boost of 15 percent if it gets the delay until Dec. 2 that it seeks—an amount that he says some would view as a "windfall."
"Obviously this aggressive stance is not without risk," Neophytou said, "as the agency may decide the company is being frivolous in its defence of its patents, but AstraZeneca has a very good track record of defending its IP so [the] lawsuit would have been examined carefully."
In the end, though, he says that overturning the FDA ruling is a "low-probability event."
The FDA has declined all comment on the pending litigation.
The patent covering the active ingredient in Seroquel and Seroquel XR expired in September 2011, with pediatric exclusivity expiring on March 26, 2012. Seroquel XR is covered by a formulation patent that expires in May 2017, with pediatric exclusivity expiring in November 2017.