Ranbaxy may settle with FDA for generic atorvastatin launch

Genéricos/Novedades | Posted 16/12/2011 post-comment

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According to The Times of India, generics giant Ranbaxy Laboratories and FDA are getting closer to reaching an agreement to solve the Indian drugmaker’s regulatory troubles.

The agreement could allow Ranbaxy to launch its generic version of the blockbuster cholesterol-lowering drug Lipitor (atorvastatin) on time. Ranbaxy has a license from Pfizer, the originator company, to sell atorvastatin in the US once the patent expires on 30 November 2011 [1]. The Daiichi Sankyo subsidiary will also have exclusivity for 180 days before other drugmakers can enter the market due to its first-to-file status with FDA.

Ranbaxy’s scheduled November 2011 launch of the drug has, however, been clouded by speculation that regulatory troubles could prevent it from launching on time. Ranbaxy has been struggling to win FDA clearance for its Indian Dewas and Paonta Sahib manufacturing facilities that failed inspections in 2009, causing about 30 Ranbaxy products to be under a US import alert ever since [2]. Due to these problems, there have been rumours of Ranbaxy selling its rights to make generic atorvastatin [3] or that the company may even enter into a partnership with generics rival Teva Pharmaceutical Industries [4]. Ranbaxy, however, has always reported that it would launch on time and that there would be ‘no change’ to the timetable for generic atorvastatin [5].

But now, according to The Times of India, Ranbaxy and FDA are close to 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. The company is reported to be likely to move manufacturing of generic atorvastatin to New Jersey away from the troubled plants [5].

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 [6].

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References

1. GaBI Online - Generics and Biosimilars Initiative. Mylan’s attempt to stop Ranbaxy’s Lipitor exclusivity fails [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 December 16]. Available from: www.gabionline.net/Generics/News/Mylan-s-attempt-to-stop-Ranbaxy-s-Lipitor-exclusivity-fails

2. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy to pay FDA to end impasse on manufacturing ban [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 December 16]. Available from: www.gabionline.net/Pharma-News/Ranbaxy-to-pay-FDA-to-end-impasse-on-manufacturing-ban

3. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy may sell its generic atorvastatin exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 December 16]. Available from: www.gabionline.net/Generics/News/Ranbaxy-may-sell-its-generic-atorvastatin-exclusivity

4. GaBI Online - Generics and Biosimilars Initiative. Generic atorvastatin partnership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 December 16]. Available from: http://www.gabionline.net/Generics/News/Generic-atorvastatin-partnership

5. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy to launch generic atorvastatin on time [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 November 29]. Available from: www.gabionline.net/Generics/News/Ranbaxy-to-launch-generic-atorvastatin-on-time

6. 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 16]. Available from: www.gabionline.net/Generics/News/Mylan-tries-to-block-Ranbaxy-s-Lipitor-exclusivity

Source: The Economic Times India

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Novedades

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