Pfizer’s ageing blockbuster Lipitor wins $770m paediatric boost
pharmafile | July 11, 2011 | News story | Sales and Marketing | Lipitor, Pfizer, paediatric trials
Pfizer has been given more time to sell its anti-cholesterol treatment Lipitor exclusively in Europe as a quid pro quo for making a different version of the drug available for children.
By developing a paediatric version of the drug Pfizer can extend patent protection – due to come to an end soon – for Lipitor (atorvastatin) by six months in some EU countries, taking it up to May next year.
The European Commission has approved the new chewable formulation of Lipitor for children who are ten or older and who have high levels of LDL, or “bad”, cholesterol.
Lipitor also gains an indication for children with high triglycerides caused by the inherited disorder familial hypercholesterolemia.
The licenses are expected to be lucrative for Pfizer: figures from healthcare data consultancy IMS, quoted in the Financial Times, say the top five European markets account for 14% of Lipitor’s annual sales of $11 billion.
This suggests the six-month extension to Lipitor’s patent could be worth as much as $770m.
Anything that prolongs its exclusivity will be a significant bonus for the company – the drug has long been its biggest-seller and the impending loss of sales is one of the main reasons the manufacturer is currently restructuring its operations.
Making available a six-month extension to an existing patent is part of a package of incentives which the EU put in place to encourage pharma companies to invest in clinical trials in children.
The decision represents the fruits of Pfizer’s labour after it filed a paediatric investigation plan (PIP) with the European Medicines Agency in November 2009 to secure a supplementary protection certificate (SPC).
In March this year, the Committee for Medicinal Products for Human Use recommended that the paediatric indication be made – a move now formalised by the European Commission.
Lipitor has been approved for use in children with heterozygous familial hypercholesterolemia in the US since 2002.
Adam Hill
Related Content
NICE recommends Pfizer’s new once-weekly treatment for haemophilia B on NHS
Walton Oaks, 21st May 2025 – Pfizer Ltd announced today that the National Institute for Health and Care …
Pfizer releases results for severe RSV-associated LRTD treatment study
US-based Pfizer have announced results from its substudy B of the ongoing phase 3 clinical …
New Real-World Data Published in Journal of Cardiac Failure on Effectiveness
Patients treated with tafamidis were associated with greater rates of survival compared with patients untreated …
