Patent challenge

Atorvastatin
Carcinogenesis, mutagenesis, impairment of fertility
Patent challenge
Dosage and administration
How supplied
Available forms
Mechanism of action
Pharmacokinetics and drug metabolism
Clinical use

 

The size of the market for atorvastatin has prompted the generic drug manufacturing company Ranbaxy to challenge the validity of some of Pfizer's patents in patent courts across the world. As of March 2007, courts had mostly upheld the validity of Pfizer's original patent for atorvastatin, which is due to expire in European territories in 2011 (but 2007 in Canada). However a later patent for the specific enantiomer of the atorvastatin formula that is medically useful, which would have given Pfizer longer protection, has fared less well. Although upheld in the United States, Spain, and Ecuador, the enantiomer patent has been declared invalid by courts in Austria, Australia, Canada, the Netherlands and the United Kingdom.
Pfizer fight against simvastatin alternative

After doctors and patients began switching to a cheaper generic alternative drug called simvastatin in the tens of thousands, Pfizer launched a campaign including advertisements, lobbying efforts, and a paid speaking tour by Dr. Louis W. Sullivan, a former secretary of the federal Department of Health and Human Services, to discourage the trend.

An independent analysis showed that, at commonly prescribed doses, atorvastatin and simvastatin have no statistically significant differences in reducing cardiovascular morbidity and mortality.