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Mylan’s attempt to stop Ranbaxy’s Lipitor exclusivity fails Posted 20/05/2011

On 2 May 2011 a federal judge dismissed Mylan’s attempt to block rival generic company Ranbaxy Laboratories from launching a generic version of Pfizer’s blockbuster cholesterol-lowering drug Lipitor (atorvastatin) and trying to terminate Ranbaxy’s rights to sell generic atorvastatin in the US on an exclusive basis for six months.

Mylan was trying to do this by forcing the FDA to make a decision on a pending abbreviated new drug application (ANDA) for atorvastatin from India-based Ranbaxy.

This is a landmark decision as it could signal when drug makers can successfully bring lawsuits against the agency. Judge Mr James Boasberg ruled that Mylan lacked standing in its lawsuit against the FDA in federal court in Washington DC, USA. He found that Mylan had neither tentative approval for its ANDA nor first-to-file status for generic atorvastatin, which belongs to Ranbaxy.

In 2008, Pfizer reached an agreement with Indian generics manufacturer Ranbaxy Laboratories, giving it a license to sell atorvastatin in the US as of 30 November 2011.

However, Mylan sued the FDA, back in March 2011 seeking to terminate Ranbaxy’s exclusive marketing rights to sell atorvastatin for 180 days in the US before other drug makers can enter the market.

Mylan’s case was based on the claim that Ranbaxy was not eligible for the marketing exclusivity because of ‘false and unreliable data’ from its manufacturing site in Paonta Sahib, India, which was used in Ranbaxy’s application for generic atorvastatin. It also accused the FDA of unreasonably delaying its decision on Ranbaxy’s exclusivity.

This is a bitter blow for Mylan, as there is much at stake. Lipitor (atorvastatin) has been the worlds ‘best-selling drug’ for the last 10 years, and in 2010 had sales of US$10.8 billion.

‘Nothing prevents Mylan from seeking judicial recourse’ the judge added in his ruling, ‘if and when the FDA renders a final exclusivity decision that is not to Mylan’s liking’.

Meanwhile, Ranbaxy awaits an FDA decision. If the agency fails to grant approval for a November 2011 launch, though Pfizer and Watson (who has an authorised generic) will have the market to themselves, since other generic drugmakers will be prevented from selling atorvastatin until the Ranbaxy exclusivity period ends.

This would be good news for Pfizer and Watson, but bad news for patients, as it’s would surely mean that price reductions expected in November 2011 would not happen until six months later.

Related article

Mylan tries to block Ranbaxy’s Lipitor exclusivity

Source: Bloomberg, Mylan/FDA ruling, The Economic Times

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