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AstraZeneca sues FDA over Seroquel patent exclusivity in US

Company claims trial data used in labeling protects drug from generic competition until December

AstraZeneca has taken legal action against the US Food and Drug Administration (FDA) in an attempt to extend the patent protection for its antipsychotic drug Seroquel (quetiapine fumarate).

The Anglo-Swedish pharma firm wants the FDA to withhold approving any generic Seroquel or Seroquel XR products that don't include suicide and hyperglycaemia warnings.

The company says clinical trial data used in the warnings, which appear in the labeling for both Seroquel and Seroquel XR, is protected by marketing exclusivity until December 2, 2012.

AstraZeneca is seeking an injunction barring the FDA from granting final marketing approval for generic quetiapine until this time, or “at least until a federal court has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications”.

AstraZeneca filed two 'citizen petitions' on September 9, 2011 for Seroquel and Seroquel XR requesting the FDA withhold finally approving any generic versions of the drugs that don't carry the suicide and hyperglycaemia warnings, but last week the FDA denied both petitions.

Generic versions of the drugs are expected to launched in the US on March 26, 2012, when AstraZeneca loses paediatric exclusivity, and will then take a significant chunk from Seroquel's sales, which last year amounted to $4.1bn in the US.

The company will be hit hard by loss of patent exclusivity for key products over the next few years, with acid reflux treatment Nexium (esomeprazole) facing US generic competition in 2014 and Crestor (rosuvastatin), set to lose patent protection in 2016.

These pressures, and the need to improve the efficiency of its operations, have forced a major restructuring at AstraZeneca that will see some 7,300 jobs cut.

Any outcome of the firm's lawsuit against the FDA would also apply to Seroquel XR, although the extended release version of the drug is covered by a formulation patent that expires in May 2017 as well.

AstraZeneca granted both Handa and Accord a licence to enter the US market with their generic versions of Seroquel XR in November 2016.

14th March 2012

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