Court orders withdrawal of generic Lipitor in Denmark
pharmafile | March 2, 2007 | News story | Sales and Marketing |Â Â Â
Pfizer has gained a court injunction ordering the withdrawal of a generic version of its top-seller Lipitor (atorvastatin).
Indian generics company Ranbaxy launched its copy of the world's biggest selling drug in Denmark on 12 February, but the court order blocked its sale just 11 days later.
The Danish launch of generic atorvastatin was the first in the western world, and Ranbaxy launched the drug 'at risk' knowing that the court could intervene shortly afterwards.
Pfizer and Ranbaxy are awaiting a definitive court ruling on the drugs patent in Denmark, but the generic company had seized an opportunity to launch its product ahead of the verdict.
Ranbaxy had gambled on the pre-emptive launch helping it to seize market share, but it may ultimately have to pay damages to Pfizer if it loses the case.
"This ruling is another significant milestone in our defence of Lipitor patents around the world," said Pfizer senior vice president and general counsel Allen Waxman. "And it's an important outcome for Pfizer and other medical innovators who invest in high-risk research to develop life-saving medicines for millions of patients," added Karin Verland, country manager of Pfizer Denmark.
Ranbaxy has already launched its atorvastatin product in India and some other emerging markets, but the company hopes Denmark will be the first of many mature markets to which it can gain entry.
Analysts say the small size of the Danish market – which spends an estimated $30 million on Lipitor a year – makes it a good test market, with fewer risks attached.
Ranbaxy is one of a handful of major generics companies now challenging the industry's top sellers, but it has had limited success in challenging Lipitor patents so far. But favourable verdicts in Norwegian, Australian and Canadian courts have boosted Ranbaxy's belief that eventually it will be able to market atorvastatin on a permanent basis.
Speaking on the day of its launch in Denmark in early February, Malvinder Mohan Singh, chief executive of Ranbaxy, said: "The introduction of atorvastatin in Denmark is a significant milestone in Ranbaxy's atorvastatin strategy and heralds the beginning of the company's determined efforts to bring affordable atorvastatin to patients in Europe and other parts of the world."
He continued: "Generic atorvastatin will bring significant and immediate cost benefits to the Danish healthcare system."
So far, Pfizer has been very successful in defending its patents on Lipitor in the major markets around the world, including the US and the UK.
Pfizer has another four years before its basic European patent on Lipitor expires in 2011, and will fight to maintain its grip on the drug, which is the mainstay of its sales.
Lipitor earned sales of $13 billion worldwide in 2006, representing more than a quarter of Pfizer's total sales.
