Drug major Ranbaxy Laboratories could suffer a potential revenue loss to the tune of Rs 300 crore due to delay in receiving approval from the US Food and Drug Administration (FDA) for generic version of GSK's anti-migraine medicine Imitrex, according to analysts.
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," Angel Broking Pharma Anal Sarvajeet Kaur said.
Ranbaxy in January last year had said that it expected to launch in December 2008 the 25 mg, 50 mg and 100 mg strengths of generic Imitrex in the US with an exclusivity period of 180 days after settling a patent litigation with GlaxoSmithKline (GSK).
However, it has not been able to launch the drug due to delay in getting approval from the USFDA. Industry estimates put Imitrex total annual sales at around one billion dollars.
"Since, Ranbaxy has not been able to launch the drug in 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," Prabhudas Liladhar research head (Pharma) Ranjit Kapadia said.
When contacted, a Ranbaxy spokesperson said "The company is waiting for USFDA approval for launching the drug in the US." The spokesperson, however, declined to give any other detail.
In September last year, the USFDA has imposed an import ban on 30 drugs manufactured at two of its plants located in Dewas, Madhya Pradesh and Poanta Sahib in Himachal Pradesh.
However, according to the company sources, Imitrex is not in the list of banned drugs and neither the drug is produced in these manufacturing units.