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US court rules AstraZeneca’s Seroquel XR patent is valid

Finds Mylan, Anchen, Osmotica and Torrent infringed the extended release anti-psychotic's exclusivity

A US court has found AstraZeneca's formulation patent for Seroquel XR (quetiapine fumarate) valid after several generics companies had challenged its exclusivity.

The ruling means that Anchen Pharmaceuticals, Osmotica Pharmaceutical, Torrent Pharmaceuticals and Mylan have all infringed the patent of the drug with their generic versions of Seroquel XR, which is an extended release version of AstraZeneca's huge-selling antipsychotic treatment Seroquel.

The paediatric patent for Seroquel expired on March 26, 2012, but AstraZeneca had attempted to extend the life of the franchise by protecting exclusivity of the extended release formulation until 2017.

Several companies, including Mylan, Teva, Dr Reddy's and Sun Pharma, have already released their own versions of regular Seroquel onto the US market for use in the treatment of schizophrenia and bipolar disorder.

These cheaper generic products will take an enormous amount from AZ's revenues for the drug, which had US sales of around $4.6bn during 2011.

The court win regarding Seroquel XR will soften the blow for the pharma firm, with AZ able to protect sales of the extended release version of the drug. Last year this brought in $779m in US sales.

AstraZeneca said it was "pleased with the US District Court's decision, which the company believes underlines the strength of its patents".

The US legal decision follows less fortunate news for the company from the UK last week, where the High Court ruled that Seroquel XR's patent was invalid.

This paved the way for Teva to launch its own generic Seroquel XR product just days later.

Meanwhile, Actavis yesterday launched its generic version of Seroquel in Denmark, the UK, Germany, Italy, Ireland, the Netherlands and Romania, and said it would bring its generic drug to market in Sweden at the end of this week.

AstraZeneca had also attempt to prolong the exclusivity of regular Seroquel further in the US, 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 was declined by the US Food and Drug Administration (FDA), a decision later upheld by a US District Court which rejected AstraZeneca's lawsuit challenging the FDA's stance.

30th March 2012

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