Firms set for Simvastatin launch in US

With the 180-day market exclusivity in the US for Ranbaxy's Simvastatin getting over this week, generic companies are all set to launch the entire strength of bioequivalent versions of Simvastatin in the world's largest market.

While Ranbaxy has already received the final marketing approval for five different strengths of the drug, Dr Reddy's has got a tentative approval for four strengths. Sandoz, the generics arm of Swiss major Novartis, is another company that is expecting final approval any day now.

Ranbaxy "� whose Simvastatin 80 mg was the only generic drug other than the authorised generic marketed by Dr Reddy's and the branded version of Merck (Zocor) during this period "� is ready with all strengths of the drug.

It received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Simvastatin Tablets of 5 mg, 10 mg, 20 mg and 40 mg. Dr Reddy's has received tentative approval from the USFDA for Simvastatin tablets of 10 mg, 20 mg, 40 mg and 80mg.

The total annualised market sales for Simvastatin are $4.8 billion, of which $4.2 billion are for the 5 mg, 10 mg, 20 mg and 40 mg tablets (IMS-MAT: September 2006).

Simvastatin tablets are indicated in the treatment of patients with coronary heart disease (CHD) or those at high risk of CHD, reductions in risk of CHD mortality and cardiovascular disorders, patients with hypercholesterolemia requiring modifications of lipid profiles and adolescent patients with Heterozygous Familial Hypercholesterolemia (HeFH).

A Simvastatin regimen can be started simultaneously with diet.