After all the speculation India-based Ranbaxy Laboratories (Ranbaxy) has resolved all outstanding issues and finally managed to gain approval from FDA for its generic version of the blockbuster cholesterol-reducing drug Lipitor (atorvastatin).
On 1 December 2011 Ranbaxy announced that it had received final approval from FDA to manufacture and market generic atorvastatin and had launched the product in the US market.
The announcement supports the story reported in The Times of India that generics giant Ranbaxy and FDA were making a deal rumoured to be costing Ranbaxy US$350 to 400 million to solve the company’s outstanding regulatory problems and clear the way for FDA approval of Ranbaxy’s generic atorvastatin.
Ranbaxy also said in its statement that a portion of the profits from sales of atorvastatin during Ranbaxy’s 180-day first-to-file exclusivity period will be paid to Teva Pharmaceuticals USA (Teva), however, terms of the agreement were not disclosed. So the rumours about Ranbaxy and generics rival Teva teaming up in order to bring generic atorvastatin to market on time were not far off after all [1].
FDA approval was for products made at Ranbaxy’s New Jersey (USA) manufacturing facility and not at the company’s troubled Dewas and Paonta Sahib (India) manufacturing facilities. According to Bloomberg the approval may also have been contingent on a deal with Teva to provide the atorvastatin ingredients to the New Jersey site.
The Daiichi Sankyo subsidiary’s scheduled November 2011 launch of the drug had been clouded by speculation that regulatory troubles could prevent it from launching on time. Ranbaxy, however, has always reported that it would launch on time and that there would be ‘no change’ to the timetable for generic atorvastatin [2].
‘This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options,’ said Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research. ‘We are working very hard to get generic drugs to people as soon as the law will allow.’
Lipitor had sales of US$10.8 billion in 2010 alone and has been the world’s best-selling drug for the last 10 years, generating 27% of Pfizer’s income in 2010. Ranbaxy, with its 6-month exclusivity due to its first-to-file status, could expect to rake in almost US$600 million in the first six months alone [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Generic atorvastatin partnership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 December 02]. Available from: http://www.gabionline.net/Generics/News/Generic-atorvastatin-partnership
2. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy to launch generic atorvastatin on time [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 December 02]. Available from:www.gabionline.net/Generics/News/Ranbaxy-to-launch-generic-atorvastatin-on-time
3. GaBI Online - Generics and Biosimilars Initiative. Mylan tries to block Ranbaxy’s Lipitor exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 December 02]. Available from:www.gabionline.net/Generics/News/Mylan-tries-to-block-Ranbaxy-s-Lipitor-exclusivity
Source: Bloomberg, FDA, Ranbaxy
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