After a nervous few hours, Ranbaxy Laboratories has received final approval in the USA to sell its generic version of Pfizer's cholesterol blockbuster Lipitor.
The US Food and Drug Administration has given the Indian drugmaker the green light to market generic Lipitor (atorvastatin), the world's biggest-selling which has just gone off-patent across the Atlantic. Ranbaxy can now take advantage of its 180-day exclusivity to sell its copy, ending doubts as to whether the firm's long-running dispute with the agency over manufacturing violations at its Dewas and Paonta Sahib facilities in India would limit its first-to-file advantage.
That problem seems to have been overcome as the FDA says that Ranbaxy's generic atorvastatin tablets in 10mg, 20 mg, 40 mg and 80 mg strengths will be manufactured by the company's Ohm Laboratories unit in New Brunswick, New Jersey.
Deal with Teva
Ranbaxy also announced a deal with Teva Pharmaceutical Industries, which will see the Israeli group bank a portion of theprofits from sales of atorvastatin duringthe 180-day exclusivity period. Terms of the agreement were not be disclosed, so it is not clear whether the firms have signed a marketing or distribution pact or whether Teva is involved in manufacturing.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation andResearch, said that "this medication is widely used by people who mustmanage their high cholesterol over time, so it is important to haveaffordable treatment options”. She added that “we are working very hardto get generic drugs to people as soon as the law will allow".
The approval is a great relief for Ranbaxy, seeing as Watson Laboratories has already begun shipping its authorised generic under a deal with Pfizer. That version does not require approval from the FDA.
Indeed, Pfizer is fighting hard to maintain a healthy portion of the huge revenues generated by Lipitor - about $7.8 billion in the USA alone in the year to September. As well as the Watson pact, through which it will receive royalties, agreements are in place with a number of pharmacy benefit managers and health plans in the USA to offer the drug at heavily-discounted prices.
Nevertheless, Ranbaxy is likely to grab significant market share and analysts believe the company could bank in the region of $700 million in the six-month exclusivity period.
Indeed the approval, announced in the early hours of the morning UK time, had a touch of drama about it. FDA spokesman Sandy Walsh told PharmaTimes World News that an error was made earlier by the agency's newswire vendor, which sent out a press release prematurely. The latter had to ask reporters to disregard it but the official corrected version came through minutes later.