AstraZeneca is to face a crucial court battle over one of its biggest brands, Seroquel.
Generics companies Teva and Sandoz are challenging the drug's US patent, which runs until 2011, and an August date for the challenge has now been set.
Loss of Seroquel revenues would be a major blow to AZ's portfolio if New Jersey's US District Court rules in favour of the challengers.
Teva and Sandoz may launch a generic version ahead of a ruling as early as April, although this would mean they would have to pay damages should the judge uphold AZ's patent.
Earning global sales of $4 billion last year Seroquel is one of the company's most profitable medicines, and analysts believe AstraZeneca has a strong defence. An AZ spokesman said: "We remain confident in the validity and enforceability of the Seroquel patent and that AstraZeneca will prevail at trial."
Meanwhile, the company is seeking to extend the indications for the drug, asking US and European regulators for permission to sell it as a treatment for bipolar disorder as well.
AstraZeneca's biggest selling drug Nexium is also under attack, but analysts are less confident the company can repel a challenge on its patent.
More at Pharmafocus
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