In the latest saga of the Seroquel story, a ruling from the UK High Court on 22 March 2012 has invalidated the patent on the extended-release version (Seroquel XR) of the antipsychotic.

The formulation patent on Seroquel XR was due to expire in November 2017. The patent had already been challenged by Accord Healthcare (Accord), Intas Pharmaceuticals (Intas), Hexal, Sandoz and Teva Pharmaceutical Industries [1].

AstraZeneca points out that ‘the High Court decision is limited to the UK and is not binding in other countries,’ and in fact on 7 March 2012 the patent protecting Seroquel XR in The Netherlands was found to be valid by the District Court in The Hague.

The company also added that it ‘is engaged in numerous other proceedings regarding Seroquel XR related patents and regulatory exclusivity,’ adding that ‘trials have concluded in Spain and the US and decisions are pending in those jurisdictions.’

AstraZeneca has already made deals with Accord, Handa Pharmaceuticals and Intas, giving them licences to enter the US market with generic forms of extended-release quetiapine fumarate on 1 November 2016, or earlier upon certain circumstances [2].

In more bad news AstraZeneca’s lawsuit filed against FDA regarding final marketing approval of generic quetiapine was also denied on 23 March 2012. The pharma giant had filed the lawsuit in an attempt to overturn FDA’s decision to deny the company’s citizen petitions requiring generics to include hyperglycaemia warnings on their labels [1].

The patent covering quetiapine ran out in September 2011 and paediatric exclusivity expired on 26 March 2012 opening the gates for generics to enter the lucrative antipsychotic market.

AstraZeneca has much to lose when generic quetiapines enter the market. In 2010 worldwide sales of Seroquel, which is used to treat schizophrenia and bipolar disorders, were US$5.3 billion, accounting for almost 16% of AstraZeneca’s annual earnings [3].

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References

1.  GaBI Online - Generics and Biosimilars Initiative. AstraZeneca sues FDA over generic quetiapine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 06]. Available from: www.gabionline.net/Generics/News/AstraZeneca-sues-FDA-over-generic-quetiapine

2.  GaBI Online - Generics and Biosimilars Initiative. AstraZeneca settles patent dispute over Seroquel XR [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 06]. Available from: www.gabionline.net/Generics/News/AstraZeneca-settles-patent-dispute-over-Seroquel-XR

3.  GaBI Online - Generics and Biosimilars Initiative. 2012’s biggest patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 06]. Available from: www.gabionline.net/Policies-Legislation/2012-s-biggest-patent-expiries