WILMINGTON, Del.—AstraZeneca has announced that the U.S. District Court forthe District of Columbia issued an opinion and order in AstraZeneca's lawsuitagainst the U.S. Food and Drug Administration (FDA) regarding final marketingapproval of generic quetiapine.
The Court denied the company's request for apreliminary injunction and dismissed the lawsuit without prejudice.
AstraZeneca notes, thought, that "Notwithstanding the court's decision, the companycontinues to believe strongly in the merits of its position and is evaluatingits options."
The litigation was, essentially, a
last-ditch effort by AstraZeneca to fend off generic competition forits top-selling antipsychotic drug Seroquel (quetiapine) and to "vigorouslydefend its legal rights" to a product that generated $5.83 billion for itlast year. The goal of the litigation, which many analysts called a long shot, was to maintain market exclusivity until December.
Specifically, the lawsuit sought to overturn the FDA's denialon March 7, 2012 of the company's Citizen Petitions with regard to Seroqueltablets and Seroquel XR extended release tablets. In the Citizen Petitions,AstraZeneca raised what it said were "important issues regarding labelingrequirements for generic copies of innovative medicines, as well as dataexclusivity rights granted to innovative companies that conduct new clinicaltrials."
On Sept. 9, 2011, AstraZeneca had filed the Citizen Petitionwith the FDA for both Seroquel products, requesting the FDA withhold finalapproval of any generic quetiapine product that omits from its labeling certainwarning 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 ruledfinally this March that generic copies of the antidepressant drug would nothave to carry the same warnings about possible side effects—such as suicidalthoughts and high blood sugar levels--that the FDA has required AstraZeneca toput on the branded product.
AstraZeneca said it was seeking an injunction "barring the FDAfrom 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 toreview imminent FDA action regarding the pending generic marketingapplications."
Generic copies of the original instant-release form ofSeroquel had been due to hit the U.S. market on March 26.