AstraZeneca loses US plea to delay market entry of generic Seroquel

26 March 2012

Astra

A US court has denied AstraZeneca's request for a preliminary injunction which would have delayed the market entry of generic versions of its anti-psychotic drug Seroquel.

US District Judge Colleen Kollar-Kotelly of the District Court of Columbia wrote in a 33-page decision that the company failed to make a clear showing that it was entitled to an injunction.

AstraZeneca filed a lawsuit against the US Food and Drug Administration earlier this month in a bid to overturn the agency's rejection of its Citizen Petitions which requested that generic copies of its Seroquel (quetiapine) come with warnings about high blood sugar and suicidal tendencies.

A decision in favour of the Anglo-Swedish company would have barred the FDA from granting final marketing approval of generic version of Seroquel until December 2, 2012.

Instead, copies of the drug will hit the US market today, when AstraZeneca's patent expires.

Caption: AstraZeneca hoped the FDA would delay the release of generic versions of Seroquel until December 2. Credit: AstraZeneca.