To encourage companies to make the investments necessary to conduct these trials, the EU also created certain incentives, including the availability of a six-month extension to an existing patent extension, also known as a supplementary protection certificate (SPC). If Pfizer fulfils all further requirements of the EU Paediatric Medicines Regulation, Pfizer will be eligible and intends to apply for an additional six months of patent/SPC protection for Lipitor in certain EU countries.
Pfizer is committed to improving the lives of all adults and children at risk of cardiovascular disease and will continue to work closely with the EMEA and other regulatory authorities to help address areas of unmet medical need and reduce health inequalities. Lipitor has been approved for use in children (aged 10 to 17 years old) with heterozygous familial hypercholesterolemia in the United States since 2002.
Source Pfizer Inc