The European patent for Pfizer's blockbuster cholesterol drug, Lipitor (atorvastatin), could be extended by six months due to new paediatric data concerning the treatment.
According to the Financial Times, the extended exclusivity to May 2012 for what is currently the company's largest selling therapy could earn Pfizer $800m.
Pfizer has said it plans to launch a chewable grape-flavoured version of Lipitor for children in the EU by November 2011.
The launch would coincide with the expiration of Lipitor's patent, when the opening of the market to generic competition would be expected to have a dramatic effect on the drug's current £11bn annual revenue.
However, Pfizer has requested a supplementary protection certificate across the EU, which would extend the company's control over supplies and pricing of Lipitor a further six months.
The certificate is part of EU regulations designed to encourage paediatric research regarding medicines.
Lipitor is usually prescribed to adults with high levels of cholesterol, however it can be given to children with the condition familial hypercholesterolaemia - a specific type of inherited high cholesterol that runs in the family.
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