FDA Disputes AstraZeneca's Seroquel Exclusivity Claims

Law360, New York (April 12, 2012, 2:41 PM EDT) -- The U.S. Food and Drug Administration said Wednesday that there was no legal basis to AstraZeneca PLC's bid to overturn approval of generic versions of its antipsychotic Seroquel on grounds that they violate the drugmaker's exclusivity rights, and urged a judge to toss AstraZeneca's suit.

“For over 14 years, AstraZeneca has enjoyed a monopoly for this product, which the company seeks to perpetuate with this lawsuit,” said the FDA's summary judgment motion, filed in Washington federal court.

AstraZeneca, whose patent for Seroquel expired last month, contends...
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