Germany dismisses Seroquel XR
pharmafile | November 14, 2012 | News story | Sales and Marketing | AstraZeneca, FDA, Germany, Seroquel XR
AstraZeneca has received another dent in its international attempts to keep the money-spinning antipsychotic Seroquel going in a new form.
The company was hoping to preserve its rights on that drug by creating an extended-release version – called Seroquel XR – to expire in May 2017.
But the Federal Patent Court in Germany is the latest to find that the formulation patent for Seroquel XR (quetiapine fumarate) prolonged-release tablets is invalid.
AstraZeneca said it was ‘disappointed’ with the court’s decision and insisted: “The company remains committed to defending its intellectual property protecting Seroquel XR.”
Marketed as Seroquel Prolong in Germany, the drug had sales of $82 million for the ten months ending on 31 October in the country.
The court’s decision is not binding in other states but the problem for AstraZeneca extends beyond Europe as it battles to hold onto rights to the drug.
Seroquel – AstraZeneca’s second-best seller behind cholesterol drug Crestor, accounting for 17% of the company’s $33.6 billion sales last year – lost patent protection in March.
A British High Court has already ruled that the patent on Seroquel XR is invalid, while AstraZeneca was suing the FDA after it denied the firm’s request to withhold approving any generic form of its drug with labelling that excludes warnings required for Seroquel and Seroquel XR.
Teva has launched a generic version in the UK, making quetiapine – indicated for schizophrenia and the treatment of moderate to severe manic episodes – and quietiapine XL – approved for schizophrenia and bipolar disorder – available in generic form for the first time.
AstraZeneca is under ongoing legal pressure from generics firms challenging the patent, including Teva, Accord Healthcare and Sandoz. Health authorities will welcome the significant savings from generic quetiapine tablets over the coming years.
Adam Hill
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