Ranbaxy's Lipitor generic may miss Dec deadline for return to US market
Ranbaxy's generic version of Lipitor, which faced recall from the US market last month, could remain missing at the beginning of 2013, if the company fails to resume supplies of the drug by the end of December.
The firm had earlier indicated it expected to resume production and supply of the drug in December. It had not been able to meet the deadline so far, though investigation into the matter was over, sources said.
A detailed query sent to Ranbaxy on this did not elicit any response.
"The investigation is over but the company is yet to restore supplies of atorvastatin (Lipitor generic) in the US... The reasons for the delay are not known; it is possible there are serious concerns the company is taking time to address," a source said.
According to another source, there is also a process involving US drug authorities that Ranbaxy will have to follow to resume supplies. "It is likely the company is yet to get a go-ahead from the US Food and Drug Administration (USFDA) to resume supplies," he said.
In November, Ranbaxy had voluntarily recalled 41 batches of its generic version of cholestrol-lowering drug Lipitor from the US market after it suspected possible contamination with very small glass particles (less than 1 mm in size).
Due to this, Ranbaxy, which used to manufacture its generic version of Lipitor from two of its facilities - US-based Ohm Laboratories and its new facility in Mohali in India - also stopped production of the medicine until the cause was thoroughly investigated and corrective measures taken. The company, however, did not disclose the manufacturing location of the recalled batches.
During an interview with Business Standard last month, Ranbaxy CEO & managing director Arun Sawhney had said the company expected to resume supplies of its Lipitor generic in December.
According to analysts, the recall has also escalated over the past month the drop in the company's share in sales of the drug in the US market.
"There was already a dip in the market share due to penetration of new entrants in the segment, after the company's 180-day exclusivity ended in May. The recall has escalated the fall significantly since November," said Nirmal Bang senior analyst Praful Bohra.
According to Bohra, data show that Ranbaxy's market share for Lipitor has dropped from 42 per cent in the week ended November 9 to 17 per cent in the week ended December 17. From May to September, the company commanded a 45 per cent share for the drug in the US market.
Analyst estimates show, after the end of the exclusive marketing period, Ranbaxy's revenues from atorvastatin could be at $60-65 million. The drug, which contributed around $600 million during the exclusivity period, is still a major revenue earner for the company.
At present, Lipitor generic accounts for 20 per cent of Ranbaxy's total base revenues in the US. The company might see some financial impact due to the recall in the current quarter, analysts said.