The Hindu Business Line : Ranbaxy launches Pravastatin in US

New Delhi June 25 Two months after it finally received the go ahead from the US Food and Drug Administration, Ranbaxy has launched the 80 mg generic version of the cholesterol-lowering drug Pravachol (Pravastatin) with a six-month market exclusivity.

"Our sales and distribution teams will be doing everything to have the product in the hands of our customers as quickly as possible," said Mr Jim Meehan, Vice-President of Sales and Marketing for the company's Florida-based subsidiary Ranbaxy Pharmaceuticals Inc. According to the company, annual sales for the drug for 2006 accounted for $209 million.

Ranbaxy's 180 exclusivity advantage had been expected for a while, however, issues at its Paonta Sahib unit, which still awaits USFDA clearance, had delayed its launch.

A few agencies had written off the commercial gains, arguing that generic versions of Bristol Myers Squibb's Pravachol from Israel's Teva and others, are now selling at almost 90 per cent discount to the original offering.

Lower dosages

Some analysts were also of the opinion that a delay in the launch of the 80 mg strength had seen the demand shift to lower dosages of the drug. Ranbaxy has approval for 10 mg, 20 mg, and 40 mg dosages of Pravastatin but has not indicated the exact date of their launch yet.

Despite the price erosion, the gains from the six-month exclusivity will still be significant, said PricewaterhouseCoopers's Associate Director, Pharmaceutical and Life Sciences, Mr Sujay Shetty.

"The 180 day exclusivity is first of all a great psychological boost, and a legal landmark and could add as much as $50-60 million (or between Rs 200-250 crore) to the company's topline," he said.

Ranbaxy plans to manufacture the drug at its New Jersey facility, Ohm Laboratories.

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