The drug is protected by patents and other exclusivity rights that range from March 2012 to November 2017. Nevertheless, Handa announced on 13 December 2010 that its abbreviated new drug application, seeking approval for a generic version of extended-release quetiapine fumarate, had received tentative approval from the FDA. Handa further announced that they believed they are the first applicant to file for 50, 150, 200 and 300 mg tablets and, that they will be entitled to 180 days of marketing exclusivity for these tablet strengths upon receipt of final regulatory approval. So, AstraZeneca started patent infringement litigation against the California-based company.

Under the terms of the settlements, Accord, Handa and Intas do not dispute that both patents asserted by AstraZeneca in the US litigation are valid and enforceable. However, they have been granted licences to enter the US market with generic forms of quetiapine fumarate on 1 November 2016, or earlier upon certain circumstances.

Mr David Brennan, CEO of AstraZeneca, commented that these agreements reaffirmed AstraZeneca’s intellectual property rights and were the right business decision for AstraZeneca at this time. He added ‘Seroquel XR remains an important part of our company’s portfolio benefiting patients and physicians throughout the world.’

There is much at stake here. Seroquel is included in the list of the 10-best-selling medicines, with global sales in 2010 of US$6.7 million [1]. With the first patents on Seroquel’s set to expire in 2012 generics companies will be lining up to grab a piece of this lucrative pie [2].

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References

1. GaBI Online - Generics and Biosimilars Initiative. The market for global and European biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 10]. Available from: www.gabionline.net/Biosimilars/Research/The-market-for-global-and-European-biosimilars

2. GaBI Online - Generics and Biosimilars Initiative. 2012’s biggest patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 10]. Available from: www.gabionline.net/Policies-Legislation/2012-s-biggest-patent-expiries