AstraZeneca files lawsuit against FDA to delay generic competition

The move is seen as a long shot, but it could pay off well for AstraZeneca even if it can only buy itself a couple more months of patent exclusivity

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WILMINGTON, Del.—In a last-ditch effort to fendoff 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 hasfiled 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 maintainmarket exclusivity until December.
Specifically, the lawsuit seeks to overturn theFDA's denial on March 7, 2012 of the company's Citizen Petitions with regard toSeroquel tablets and Seroquel XR extended release tablets. In the CitizenPetitions, AstraZeneca raised what it said were "important issues regardinglabeling requirements for generic copies of innovative medicines, as well asdata exclusivity rights granted to innovative companies that conduct newclinical trials."
On Sept. 9, 2011, AstraZeneca had filed theCitizen Petition with the FDA for both Seroquel products, requesting the FDAwithhold final approval of any generic quetiapine product that omits from itslabeling certain warning language that FDA required AstraZeneca to include inthe labeling for Seroquel. At issue—and providing the hook for this lawsuit now—is thatthe FDA had ruled finally this March that generic copies of the antidepressantdrug would not have to carry the same warnings about possible side effects—suchas suicidal thoughts and high blood sugar levels--that the FDA has required AstraZenecato put on the branded product.
AstraZeneca said it "seeks an injunction barringthe 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 opportunityto review imminent FDA action regarding the pending generic marketingapplications." 
Generic copies of the original instant-release formof Seroquel had been due to hit the U.S. market on March 26.
Analysts view the lawsuit as a long shot, but somehave also noted that AstraZeneca has a strong track record of protecting itsintellectual property (IP).
As it stands right now, AstraZeneca is budgetingfor a 2012 revenue drop of more than 10 percent, in large part due to the lossof patent exclusivity on Seroquel in both the United States and Europe.
Savvas Neophytou, an analyst at Panmure Gordon, hasnoted that every month AstraZeneca can fend off the generic competition, itstands to boost earning per share by about 2 percent, which could translateinto around a boost of 15 percent if it gets the delay until Dec. 2 that itseeks—an amount that he says some would view as a "windfall."
"Obviously this aggressive stance is not withoutrisk," Neophytou said, "as the agency may decide the company is being frivolousin its defence of its patents, but AstraZeneca has a very good track record ofdefending its IP so [the] lawsuit would have been examined carefully."
In the end, though, he says that overturning theFDA ruling is a "low-probability event."
The FDA has declined all comment on the pendinglitigation.
The patent covering the active ingredient in Seroqueland Seroquel XR expired in September 2011, with pediatric exclusivity expiringon March 26, 2012. Seroquel XR is covered by a formulation patent that expiresin May 2017, with pediatric exclusivity expiring in November 2017.

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