Ranbaxy to benefit from 180-day US market exclusivity for its pravastatin

Ranbaxy Laboratories today announced that its wholly owned subsidiary, Ranbaxy Pharmaceuticals Inc. (RPI), has launched pravastatin sodium 80mg tablets in the US healthcare system.

Being the first-to-file, it will enjoy a 180-day exclusivity for and benefit from the commercial gains during this period. The annual sales for Pravastatin 80mg are $209 million, according to IMS: MAT (December 2006).

Pravastatin is indicated in the treatment of primary prevention of coronary events such as in hypercholesterolemic patients without clinically evident coronary heart disease. The drug is also indicated in the reduction of the risk of myocardial infarction, reduction in the risk of undergoing myocardial revascularisation procedures and reduction in 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 stroke / transient ischemic attack (TIA), and slow the progression of coronary atherosclerosis.

"We will make Pravastatin Sodium 80mg tablets available to all classes of trade immediately, and our sales and distribution teams will be doing everything to have the product in the hands of our customers as quickly as possible," said Jim Meehan, vice president, sales and marketing, RPI. "We are delighted to have this product formulation as an addition to our ever expanding product portfolio of affordable generic alternatives," Meecham added.