Ranbaxy loses market share in the wake of generic atorvastatin withdrawal
Now commands less than 8% of the market following glass contamination risk
India-based Ranbaxy Pharmaceuticals, the largest producer of the generic version of Lipitor (atorvastatin), has halted production of the drug. The company, which had voluntarily recalled more than 40 lots of its generic version of the cholesterol lowering drug from the US market in November 2012, after finding batches containing small glass particles, appears to have lost its lead in the generic Lipitor market as a consequence.
Generic majors and competitors Mylan and Apotex look to have taken advantage of this recall and have already garnered more than a 20% share in the global market. From a 42.1% market share last year, Ranbaxy Pharma now commands just 7.7% of the market for generic Lipitor at US$150m.
The product has been one of the biggest earners for Ranbaxy, bringing in $600m between December 2011 and May 2012, when the company monetised its exclusivity opportunity in the US. Lipitor was the world’s top selling drug for years until its patent expired in November 2011.
In November 2012, Ranbaxy Pharmaceuticals halted all production of generic Lipitor as it investigated how tiny glass particles got into dozens of batches of the drug. The recall affected 41 batches of the company’s product having expiry dates between July and August 2014, and covered 10, 20 and 40 milligram doses.
In a statement at the time, Ranbaxy said: ‘The company is taking this voluntary action as a precautionary measure due to the fact that we cannot exclude the possibility that the affected lots may contain very small glass particles resembling a fine grain of sand (less than 1mm in size).’
This is the second time the company has come under scrutiny from the US Food and Drug Administration. In September 2008, the FDA stopped production at Ranbaxy’s plants in Paonta Sahib and Dewas near New Delhi, following manufacturing issues.
