Pfizer seeks 6-month paediatric exclusivity for Lipitor

Generics/News | Posted 26/08/2011 post-comment0 Post your comment

Pfizer is poised for a Lipitor (atorvastatin) reprieve in Europe. The company has asked for six months of additional exclusivity in most EU countries under regulations designed to promote drug trials for children. The extension could be worth almost US$800 million as it staves off generic competition until May 2012.


Lipitor should normally lose patent protection in most of Europe in November 2011. Pfizer now intends to launch a chewable grape-flavoured low-dose version of its blockbuster cholesterol drug in November 2011 for treatment of children who have an inherited condition called familial hypercholesterolaemia.

The supplementary protection certificates for paediatric exclusivity in Europe, which were instigated in 2007, are meant to encourage research into children’s diseases that would not have been conducted otherwise. However, this recent development in the case of Lipitor has created some debate around both the profits involved and the fact that the new paediatric version will be provided to just a few thousand children.

Although Pfizer has already lost its patent protection on Lipitor in some European countries, such as Finland, Norway and Spain, the company has won or is seeking 6-month extensions in at least 11 other markets, including France, Germany and the UK.

In 2010, Lipitor had worldwide sales of US$13 billion [1], accounting for 15.8% of Pfizer’s total revenue [2]. IMS Health estimate that, considering the top five European markets alone (France, Germany, Italy, Spain and the UK), a 6-month extension is worth US$770 million. Therefore, this is good news for Pfizer, but not such good news for generics manufacturers and patients, who will have to wait a further six months for generic atorvastatin to enter the market.

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1. Sheppard A. Biological/Biotechnological and Biosimilars market: the global outlook. 9th EGA International Symposium on Biosimilar Medicines. 2011 Apr 14–15; London.

2. GaBI Online - Generics and Biosimilars Initiative. 2011’s biggest patent expiries []. Mol, Belgium: Pro Pharma Communications International; [cited 2011 August 26]. Available from:

Source: Financial Times

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