MUMBAI: Ranbaxy Laboratories received 180-day exclusive marketing rights to sell the 80 mg generic version of Bristol-Myers Squibb's cholesterol-lowering drug Pravachol from the US Food and Drug Administration.
India's largest drugmaker already has approvals to sell pravastatin (the drug that's branded as Pravachol) in the 10mg, 20 mg and 40 mg dosage forms. Pravachol notches up sales of $1.2 billion a year for Bristol-Myers. Of this, the 80mg dosage of pravastatin draws one-sixth, or $209 million in the US.
The gains for Ranbaxy from this, however, may not be much because its other dosage forms cannibalise and competing drug simvastatin also provides an alternative.
Citigroup analysts Prashant Nair and Chirag Dagli, in a note to clients on Wednesday, said the approval is likely to have only marginal impact on earnings. But more than this win, what matters is that some of the major concerns related to Ranbaxy's US facilities are put to rest, Nair and Dagli said.
The New Jersey headquarters of Ranbaxy, and the Ohm Labs facility in New Brunswick (which Ranbaxy had acquired some time back), were raided by USFDA on Febuary 13. Since then little is known on what had spurred the raids, what transpired during and after the event, and what is the situation now. The FDA approval sets to rest rumours that the raids were triggered by serious manufacturing and/or compliance-related issues.
The development is also seen as a good offset to the delays that Ranbaxy faces in getting FDA approval for its dosage forms facility at Paonta Sahib in Himachal Pradesh.
The good thing is that that Ranbaxy has been working around this obstacle, the analysts pointed out.
It has been refilling products where approvals could get stalled from other facilities (such as Ohm for pravastatin) and tying up with generics rivals such as Ipca Labs for certain products. Citigroup maintains a buy on the share,stating it continues to be one of the few diversified generic companies.


