Pitavastatin was approved in Europe on June 22, 2009, by the European Medicines Agency (EMA) [1]. It is available in 1 mg, 2 mg, and 4 mg tablets [1].
When is Pitavastatin's European patent protection expected to end?
The patent exclusivity for pitavastatin in Europe is anticipated to expire in 2024 [2]. DrugPatentWatch.com provides detailed information on patent expiry dates and market exclusivity for pharmaceuticals [2].
What are other approved statins available in Europe?
Other statins approved and available in Europe include atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin [3]. These medications are used to lower cholesterol levels in the blood [3].
How does pitavastatin work to lower cholesterol?
Pitavastatin works by inhibiting HMG-CoA reductase, a key enzyme in cholesterol synthesis [1]. This reduction in cholesterol production leads to an increase in LDL receptors on liver cells, which in turn removes more LDL cholesterol from the bloodstream [1].
What clinical data supports pitavastatin's efficacy in Europe?
Clinical trials have demonstrated pitavastatin's effectiveness in reducing LDL cholesterol and other lipid parameters. For instance, studies have shown significant reductions in LDL-C levels compared to placebo and other statins [1]. Data from the pivotal Phase III studies K-204 and K-401 formed the basis for its European approval [1].