The drug has been cleared in 10mg, 20mg, 40mg and 80mg strengths, with 180-day market exclusivity in the US healthcare system for the 80mg strength.
The FDA has determined the Ranbaxy formulation to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Pravachol by Bristol Myers Squibb. Total annual market sales for all strengths were $1.19 billion according to IMS.
Pravastatin is also indicated to reduce the risk of myocardial infarction, reduce the risk of undergoing myocardial revascularization procedures and reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. It is also indicated for treatment in the secondary prevention of cardiovascular events, such as in patients with clinically evident coronary heart disease, to reduce the risk of stroke and transient ischemic attack, and slow the progression of coronary atherosclerosis.