Ranbaxy’s scheduled November 2011 launch of the drug has been clouded by speculation that regulatory troubles could prevent it from launching on time. However, Dr Tsutomu Une, Chairman of the Board for the Indian generics manufacturer, said there is ‘no change’ to the timetable.

Dr Une also dismissed speculation by Credit Suisse analysts that Ranbaxy might sell its rights to make generic atorvastatin, should it look unlikely to gain FDA approval in time for the planned November 2011 launch.

Ranbaxy has a licence from Pfizer (the originator company) to sell atorvastatin in the US as of 30 November 2011 [1]. The Daiichi Sankyo subsidiary will also have 180-days market exclusivity before other drugmakers can enter the market due to its first-to-file with the FDA status.

Whether or not Ranbaxy would actually received approval for its abbreviated new drug application (ANDA) for generic atorvastatin has been under discussion for some time. The problem is caused by good manufacturing practice (GMP) problems identified by FDA at its Dewas and Paonta Sahib manufacturing plants in India.

Due to these GMP violations, FDA introduced a US import ban on 30 products from Ranbaxy in 2008. Then in early 2009, FDA halted review of drug applications for drugs manufactured at the Paonta Sahib plant in India, alleging Ranbaxy had falsified data.

The stakes are high. 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 the income for Pfizer [2]. The US patent on Lipitor will expire in November 2011, opening the market up to generic versions of the blockbuster medicine [3]. 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 [2].

Annoyed by the delay and anxious to sell its own version of the drug, rival generics manufacturer Mylan sued FDA in March 2011 for not making a decision on Ranbaxy’s ANDA for generic atorvastatin. Mylan said that Ranbaxy wasn’t eligible for the marketing exclusivity because of ‘false and unreliable data’ from its two Indian manufacturing sites [2]. Luckily for Ranbaxy, however, a federal judge dismissed Mylan’s case in May 2011 [4].

A dispute settlement costing Ranbaxy more than US$1 billion has also been reported to be under discussion with FDA [5]. Dr Une, however, told the Nikkei that the actual figure would likely be lower based on past cases. Fines of US$1 billion ‘would hurt Ranbaxy severely and the impact on Daiichi Sankyo will be large as well,’ he said. This settlement could, however, provide the light at the end of the tunnel for Ranbaxy, lifting restrictions on the troubled Indian plants and clearing the way for the November 2011 launch of its generic atorvastatin.

Daiichi Sankyo is working with FDA to resolve outstanding issues related to Ranbaxy’s plants in India and to get an approval to market the drug in the US, spokeswoman Ms Michiko Harada told Bloomberg. The company has also stated that it intends to move manufacturing of generic atorvastatin to New Jersey, USA, away from the troubled plants [2].

Ranbaxy already markets generic atorvastatin in Canada and South Africa [3].

Related articles

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Ranbaxy to pay FDA to end impasse on manufacturing ban,

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 September 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. Mylan tries to block Ranbaxy’s Lipitor exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 16]. Available from: www.gabionline.net/Generics/News/Mylan-tries-to-block-Ranbaxy-s-Lipitor-exclusivity

3. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy launches generic atorvastatin in South Africa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 16]. Available from: www.gabionline.net/Generics/News/Ranbaxy-launches-generic-atorvastatin-in-South-Africa

4. 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 September 16]. Available from: www.gabionline.net/Generics/News/Mylan-s-attempt-to-stop-Ranbaxy-s-Lipitor-exclusivity-fails

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