Ranbaxy Laboratories has temporary recalled its cholesterol lowering drug, atorvastatin – the generic version of Pfizer’s Lipitor – from the US market.
The recall will temporarily disrupt supplies of atorvastatin while it conducts an investigation, the company said in a statement.
It did not provide details, but said the investigation is expected to be completed in two weeks, after which it plans to resume supplies.
Lipitor is one of the topmost selling drugs globally and boasted sales of $13 billion a year at one point.
For Ranbaxy, generic Lipitor has been a top-grosser and fetched over $600 million between December last year and this May.
Analysts said it is not possible to gauge the impact yet as the reason for the recall and the quantity of drugs recalled are not known.
“There is no clarity whether the recall has happened due to issues related to manufacturing or because of the product not being stable. Also, there is no word on the number of batches that have been recalled,” said Ranjit Kapadia, senior vice-president, Centrum Broking.
According to experts, if the recall is connected with manufacturing related issues, then Ranbaxy’s plants in Mohali as well as its Ohm Laboratories in the US (from where generic Lipitor is manufactured) can come under USFDA scanner.
As such, two of its plants – in Dewas and Paonta Sahib – have been under USFDA scanner since September 2008.
Some analysts, however, believe the recall won’t dent the company’s atorvastatin prospects much.
“Ranbaxy has managed to get all that it could within the exclusivity period. Since they are saying they would resume supplies after two weeks, the impact should not be severe,” said Sarabjit Kour Nangra, senior vice-president, Angel Broking.
For the record, Ranbaxy was the first generic firm to have successfully challenged the patent held by innovator Pfizer, a status that granted it a six-month exclusivity – a period during which no other generic firm could enter the market.
Significantly, it has continued to enjoy a 40-55% share of the market for this product even after the exclusivity period ended and the market was thrown open to competitors such as Mylan.
Arun Sawhney, Ranbaxy’s CEO and MD, had told analysts during the September quarter earnings call that the firm had a share of about 50% in generic Lipitor in the post-exclusivity period.