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US court rejects AstraZeneca’s Seroquel lawsuit against FDA

Another blow in pharma firm’s attempt to extend life of the anti-psychotic

The US District Court has dismissed AstraZeneca's (AZ) lawsuit against the US Food and Drug Administration (FDA) regarding generic versions of its anti-psychotic Seroquel (quetiapine).

The pharma firm had issued a case claiming that clinical data used on the drug's label to provide warnings for suicide and hyperglycaemia was protected by marketing exclusivity until December 2, 2012.

This would delay the launch of any generic versions of the drug, which is due to lose paediatric patent exclusivity today, as they would need to include these warnings on their labels.

However, according to AZ, the US Court 'denied the company's request for a preliminary injunction and dismissed the lawsuit without prejudice'.

The suit had followed two 'citizen petitions' filed by AZ on September 9, 2011 for Seroquel and Seroquel XR requesting that the FDA withhold finally approving any generic versions of the drugs that do not carry the suicide and hyperglycaemia warnings.

The FDA denied both petitions, however, prompting AZ to take action.The company said it 'continues to believe strongly in the merits of its position and is evaluating its options'.

It is the second major blow for AZ regarding its Seroquel franchise in recent days, with the UK high court rejecting the patent of Seroquel XR, an extended release version of the drug.

The company is seeking patent protection of Seroquel XR's formula until 2017 in territories across the world as it attempts to overcome the loss of exclusivity for one its biggest products, with Seroquel making total global sales of $4.34bn during 2012. Seroquel XR made $1.49bn.

There are several similar court cases ongoing around the globe regarding the patent of Seroquel XR, with decisions on concluded trials pending in both the US and Spain.

26th March 2012

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