First generic atorvastatin launched in Australia and Europe

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First generic atorvastatin launched in Australia and Europe

Generics/News | Posted 16/03/2012 0 Post your comment

On 6 March 2012, Ranbaxy announced that it had obtained, pursuant to a settlement agreement with Pfizer, the rights to an early entry of its generic atorvastatin in Germany, Italy, The Netherlands and Sweden.

In accordance with its settlement agreement with Pfizer, Ranbaxy has introduced the product ahead of the applicable patent expiries. Pfizer’s patent for its brand-name atorvastatin (Sortis/Lipitor) expires in Germany on 7 May 2012, in Italy on 8 May 2012; and in The Netherlands and Sweden on 6 May 2012.

On 21 February 2012, Ranbaxy also launched its branded generic version of atorvastatin under the brand-name Trovas, in Australia, after receiving approval from the Therapeutic Goods Administration, the regulatory authority in Australia.

The drug lost patent protection in the US back in November 2011, which was followed by Ranbaxy launching its generic on 1 December 2011 after finally gaining FDA approval, despite much speculation as to whether the generics giant would be ready in time due to problems at its manufacturing plants [1].

The blockbuster cholesterol-reducing drug 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 [2].

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References

1. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy gets FDA approval and launches generic atorvastatin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 16]. Available from: www.gabionline.net/Generics/News/Ranbaxy-gets-FDA-approval-and-launches-generic-atorvastatin

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 2012 Mar 16]. Available from: www.gabionline.net/Generics/News/Mylan-tries-to-block-Ranbaxy-s-Lipitor-exclusivity

Source: Ranbaxy