The pharma giant announced on 13 March 2012 that it had filed the lawsuit in an attempt to overturn FDA’s decision on 7 March 2012 to deny the company’s citizen petitions regarding labelling requirements.

The citizen petitions from AstraZeneca had requested that FDA withholds final approval of any generic quetiapine product with labelling that omits certain hyperglycaemia warning language that FDA had required AstraZeneca to include in the labelling for Seroquel and Seroquel XR (quetiapine fumarate).

In its legal action against FDA, AstraZeneca is seeking ‘an injunction barring FDA from granting final marketing approval of generic quetiapine until 2 December 2012 when regulatory exclusivity expires on important clinical trial data, or alternatively, at least until a federal court has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications.’

The patent covering quetiapine ran out in September 2011 and paediatric exclusivity will expire on 26 March 2012. Seroquel XR is covered by a formulation patent, including paediatric exclusivity, that expires in November 2017.

In October 2011, AstraZeneca reached a settlement with Accord Healthcare, Handa Pharmaceuticals and Intas Pharmaceuticals regarding its generic version of Seroquel XR. The settlement prevents the generics companies from selling a generic form until November 2016 [1].

There is no wonder AstraZeneca is willing to fight for Seroquel. The drug, which is used to treat schizophrenia and bipolar disorders, is in the top ten best-selling drugs in the world, and in 2010 had worldwide sales of US$5.3 billion, or 16% of AstraZeneca’s revenues [2].

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References

1.  GaBI Online - Generics and Biosimilars Initiative. AstraZeneca settles patent dispute over Seroquel XR [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 23]. Available from: www.gabionline.net/Generics/News/AstraZeneca-settles-patent-dispute-over-Seroquel-XR

2.  GaBI Online - Generics and Biosimilars Initiative. 2012’s biggest patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 23]. Available from: www.gabionline.net/Policies-Legislation/2012-s-biggest-patent-expiries