Ranbaxy gets approval to launch generic Lipitor in US
India's biggest drugmaker, Ranbaxy, has won an approval from authorities to sell its version of the world's best-selling medicine in the US.
The US Food and Drug Administration (FDA) has granted it permission to sell a generic version of anti-cholestrol drug Lipitor.
Lipitor, manufactured by Pfizer, has sales in excess of $10bn (£6bn) a year, almost 70% of which come from the US.
The approval came after Pfizer lost a patent protection on the drug.
"This medication is widely used by people who must manage their high cholesterol over time," Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
"So it is important to have affordable treatment options.
"We are working very hard to get generic drugs to people as soon as the law will allow."
Allaying fears
There had been fears that the FDA may hold back on the approval due to issues over quality control at some of Ranbaxy's manufacturing facilities in India.
The agency had previously taken action against Ranbaxy, barring the company from importing as many as 30 different drugs into the US.
However, the FDA clarified that the generic version of Lipitor will be manufactured at Ranbaxy's US unit, Ohm Laboratories.
"This finally puts an end to years of speculation around the approval of this product, following significant regulatory issues that the company has been facing," investment bank UBS said in a note.
At the same time, Ranbaxy said it had entered into a partnership with Teva, the world's largest generic drugmaker.
Though the company did not disclose the exact details of its association, analysts said Ranbaxy was likely to benefit from the Israeli firm's strong distribution network.
"It looks like a marketing and distribution tie-up with Teva," said Deepak Malik, an analyst with brokerage Emkay.
"Ranbaxy will be able to fight off competition from Pfizer and Watson better and gain a higher market share with Teva," he added.
Exclusivity period
Ranbaxy was also given exclusive rights by the FDA to sell the generic version of Lipitor for 180 days.
It plans to introduce its version of the drug in 10, 20, 40 and 80 milligram tablets.
According to some estimates, the Indian pharmaceutical giant may generate as much as $650m in sales for the drug during the period.
UBS bank said sales during the exclusivity period may add up to 30 rupees ($0.50; £0.37) to Ranbaxy's earnings per share.
Ranbaxy has not said when it will start sales in the US.
BBC News - Ranbaxy gets approval to launch generic Lipitor in US
India's biggest drugmaker, Ranbaxy, has won an approval from authorities to sell its version of the world's best-selling medicine in the US.
The US Food and Drug Administration (FDA) has granted it permission to sell a generic version of anti-cholestrol drug Lipitor.
Lipitor, manufactured by Pfizer, has sales in excess of $10bn (£6bn) a year, almost 70% of which come from the US.
The approval came after Pfizer lost a patent protection on the drug.
"This medication is widely used by people who must manage their high cholesterol over time," Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
"So it is important to have affordable treatment options.
"We are working very hard to get generic drugs to people as soon as the law will allow."
Allaying fears
There had been fears that the FDA may hold back on the approval due to issues over quality control at some of Ranbaxy's manufacturing facilities in India.
The agency had previously taken action against Ranbaxy, barring the company from importing as many as 30 different drugs into the US.
However, the FDA clarified that the generic version of Lipitor will be manufactured at Ranbaxy's US unit, Ohm Laboratories.
"This finally puts an end to years of speculation around the approval of this product, following significant regulatory issues that the company has been facing," investment bank UBS said in a note.
At the same time, Ranbaxy said it had entered into a partnership with Teva, the world's largest generic drugmaker.
Though the company did not disclose the exact details of its association, analysts said Ranbaxy was likely to benefit from the Israeli firm's strong distribution network.
"It looks like a marketing and distribution tie-up with Teva," said Deepak Malik, an analyst with brokerage Emkay.
"Ranbaxy will be able to fight off competition from Pfizer and Watson better and gain a higher market share with Teva," he added.
Exclusivity period
Ranbaxy was also given exclusive rights by the FDA to sell the generic version of Lipitor for 180 days.
It plans to introduce its version of the drug in 10, 20, 40 and 80 milligram tablets.
According to some estimates, the Indian pharmaceutical giant may generate as much as $650m in sales for the drug during the period.
UBS bank said sales during the exclusivity period may add up to 30 rupees ($0.50; £0.37) to Ranbaxy's earnings per share.
Ranbaxy has not said when it will start sales in the US.
BBC News - Ranbaxy gets approval to launch generic Lipitor in US
