The US Food and Drug Administration (FDA) can take more time to approve Ranbaxy's generic version of GSK's anti-migraine medicine, Imitrex. The delay may cause potential loss of Rs 300 crore to the drug major. Research Analyst Ranjit Kapadia said, "Since, Ranbaxy has not been able to launch the drug in the US and patent for the drug is also going to expire in February 2009, the company may have to suffer a potential revenue loss of Rs 240-250 crore in the current year."  

The company holds considerable share of the US market and it has been selling various generic and anti-infection drugs in the US. The company had planned to launch Imitrex in December 2008 in the 25 mg, 50 mg and 100 mg strengths in the US, after getting approval from USFDA but sources said that its launch would take some time.  

It is recalled that the USFDA had imposed an import ban in September on 30 drugs after noting defects at Ranbaxy’s plants located at Dewas, Madhya Pradesh and Poanta Sahib in Himachal Pradesh. But Imitrex is not manufactured at these plants and does not come under the ban by the US authorities as per the company sources.  

Angel Broking Pharm’s Sarvajeet Kaur said, "Ranbaxy is likely to suffer a potential revenue loss of up to Rs 300 crore as it has not been able to meet the deadline of the fourth quarter for launching Imitrex in the US market." the spokesperson of company said that it is waiting for approval from the US health authorities.

India's second largest drug maker, Dr Reddy's Laboratories also has some market share in US generic market. It sells the drugs by GSK in the US and its margin is lower than Ranbaxy.