Generic atorvastatin partnership

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Generic atorvastatin partnership

Generics/News | Posted 18/11/2011 0 Post your comment

In early November 2011, there has been speculation that Ranbaxy Laboratories and Teva are about to join in manufacturing generic atorvastatin, better known as Lipitor, in the US.

This may happen because Ranbaxy has been struggling to win FDA clearance for its Indian Dewas and Paonta Sahib manufacturing facilities that failed inspections in 2009. About 30 Ranbaxy products have been under an import alert ever since [1]. Nevertheless, they have the all-important 180-day exclusivity for atorvastatin. So they might announce in a few weeks that they will go ahead themselves, as soon as their patent settlement with Pfizer allows. There has already been a failed legal attempt in May 2011 by competitor Mylan to force FDA action on pending applications, which argued that Ranbaxy should be forced to forfeit its exclusivity period [2] for violating the FDA’s application integrity policy.

But if Ranbaxy cannot manufacture generic atorvastatin, Teva might make the atorvastatin and market it in the US in partnership with Ranbaxy. The possible deal has been reported in the Israeli news site Ynet and discussed by analysts for Bloomberg. Teva has the capability to manufacture atorvastatin, and is poised to start marketing it in the UK in May 2012.

Ranbaxy’s scheduled end November 2011 launch of the drug has been clouded by speculation that regulatory troubles could prevent it from launching on time, and there has even been talk of the company selling its atorvastatin exclusivity [3]. However, representatives of the company have insisted that there is no change to the timetable and maybe this deal is the reason for that certainty [4].

Ranbaxy would prefer to launch atorvastatin on its own, but teaming up with Teva might allow it to maximise its earnings on sales of the drug. It is unclear at this point how the partnership would be structured – or whether it is a real deal at all.

Related articles

Mylan tries to block Ranbaxy’s Lipitor exclusivity

Ranbaxy launches generic atorvastatin in South Africa

References

1. 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 November 18]. Available from: www.gabionline.net/Pharma-News/Ranbaxy-to-pay-FDA-to-end-impasse-on-manufacturing-ban

2. 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 November 18]. Available from: www.gabionline.net/Generics/News/Mylan-s-attempt-to-stop-Ranbaxy-s-Lipitor-exclusivity-fails

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 November 18]. Available from: www.gabionline.net/Generics/News/Ranbaxy-may-sell-its-generic-atorvastatin-exclusivity

4. 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 18]. Available from: www.gabionline.net/Generics/News/Ranbaxy-to-launch-generic-atorvastatin-on-time

Source: Bloomberg, Ynet