Ranbaxy on Thursday announced that it has launched the generic version of blockbuster drug Lipitor in the US market. This comes after the company received final approval from the US Food and Drug Administration to manufacture and market the drug.

The drug generated total annual sales of $7.89 billion in the United States through September 2011. Analysts expect Ranbaxy to corner 30 per cent of this as it has a 180-day exclusivity to market this drug in the US.

Chemically known as Atorvastatin, the drug is a cholesterol-reducing medicine, the generic equivalent of Pfizer's Lipitor. Ranbaxy will manufacture the drug at its Ohm Laboratories unit in New Brunswick, New Jersey. The company has clinched approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths.

Mr Arun Sawhney, CEO & Managing Director, Ranbaxy, stated, “Atorvastatin helps millions of Americans manage healthy cholesterol levels, and we are pleased to have received US FDA approval to manufacture and market a safe, effective, affordable and accessible alternative to branded Lipitor. We are committed to continuing to expand our portfolio of products offered in the US market for the benefit of patients, prescribers and the US healthcare system.” The company’s shares zoomed 10 per cent as soon as the news came in the morning.

Pursuant to an agreement between Ranbaxy and Teva Pharmaceuticals USA, Inc., a portion of the profits from sales of Atorvastatin during Ranbaxy’s 180-day first-to-file exclusivity period will be paid to Teva. Terms of the agreement have not been disclosed.

Not a smooth ride

This comes as major relief to the Indian drug maker as it was counting on this product to revive its business in the US market. But the path to the launch has not been smooth with the company facing a number of blocks over the past 3 years. First, it was Pfizer which challenged Ranbaxy’s copy. Then, in 2008, Ranbaxy reached an agreement with Pfizer to sell generic version of the drug in the US market beginning November 30, 2011. Ranbaxy had said it is entitled to 180 days of marketing exclusivity as a reward for agreeing to withdraw all litigation contesting the validity of Pfizer's patents in specified countries, including the US.

Then, earlier this year, US-based pharmaceutical company Mylan Inc. sued the US Food and Drug Administration, seeking to block the Indian drug maker's exclusive rights to sell a generic version of blockbuster anti-cholesterol drug Lipitor. Mylan, in a complaint filed on March 18 in a federal court in Washington, said it and other generic drug makers should be allowed to enter the market as soon as Lipitor's patent expires later this year. But much to the relief of Ranbaxy the court ruled in its favour.

But the biggest blow came in 2009 when the USFDA banned 30 drugs being manufactured by the company at its plant in Paonta Sahib for failing to meet good manufacturing practice. Since then Ranbaxy has been trying to persuade the FDA that its copy of Lipitor shouldn’t be thwarted because of the violations. While the USFDA has finally given its approval, concerns over the earlier ban still remain.

Meanwhile, Pfzier has strengthened its marketing strategy to counter Ranbaxy's entry. "More than one-third of patients currently taking Lipitor would like to stay on Lipitor," Mr David Simmons, President of emerging markets and established products for Pfizer, said on Tuesday, citing internal company research. Another generic drug maker Watson Pharmaceuticals Inc has also started selling copy of the drug, with an estimated 70 per cent of its sales going to Pfizer. Watson said early on Wednesday it has begun shipping the pills, calling it the "largest generic product launch in US history".

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