WASHINGTON, March 23 (Reuters) - A U.S. judge on
Friday refused to grant a preliminary injunction AstraZeneca
sought to delay the market entry of generic versions of its
top-selling anti-psychotic drug Seroquel, saying the company
failed to make a clear showing that it was entitled to one.
The London-headquartered pharmaceutical company earlier this
month sought an injunction to bar the U.S. Food and Drug Administration from granting final marketing approval of generic
forms of Seroquel until December 2012.
"Because the court finds that AstraZeneca has failed to make
a clear showing that it is entitled to the extraordinary remedy
of a preliminary injunction, its application shall be denied,"
U.S. District Judge Judge Colleen Kollar-Kotelly wrote in a
The company failed to prove that it would succeed in its
court battle to extend its exclusivity for the drug or that the
economic harm it described as a result of the generic versions
was likely, the judge said.
A spokesman for AstraZeneca was not immediately available
Generic copies of the original instant-release form of
Seroquel are due to hit the U.S. market on March 26 when
AstraZeneca's patent expires - an event that will have a
significant impact on both sales and profits.
AstraZeneca is currently budgeting for a 2012 revenue fall
at the group level of more than 10 percent, in large part as a
result of loss of exclusivity on Seroquel in both the United
States and Europe.
The case is AstraZeneca Pharmaceuticals LP v Food and Drug
Administration et al in U.S. District Court for the District of
Columbia, No. 12-cv-388.
For AstraZeneca: Timothy Hester of Covington and Burling.
For the FDA: Gerald Kell of the U.S. Department of Justice.
(Reporting by Jeremy Pelofsky; additional reporting by Ben
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