The delay in Ranbaxy Laboratories getting approval from the USFDA for launching generic version of GlaxoSmithKline's (GSK) migraine and headache drug Imitrex could turn out to be a gain for Hyderabad-based Dr Reddy's Laboratories, which has already launched the drug in the US.
According to analysts, Dr Reddy's (DRL) could end up gaining a major chunk of the estimated 80 million dollars sales from the drug by Ranbaxy in the first year of launch in the US.
Dr Reddy's, which is the authorised generic manufacturers from GSK had already launched the drug in November last year.
"Ranbaxy was expecting a sale of up to 80 million dollars from generic Imitrex but now DRL is the only generic manufacturer of the drug," Pharma Analyst of Angel Broking, Sarvajit Kaur, said, adding that the advantage is with DRL to garner a large chunk if Ranbaxy failed to launch the drug anytime soon.
Ranbaxy has not got approval from the USFDA for launching the generic copy of Imitrex after it came under the scanner of the health regulator, which last year banned 30 of its generic drugs produced at Dewas and Poanta Sahib units.
On the other hand, DRL launched the generic version of Imitrex in November last year after settling patent litigation with GSK, thus becoming the first company to launch an authorised generic version of the drug.
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.
"As Ranbaxy may not be able to launch the drug in US whose patent is going to expire February 2009, so, Ranbaxy's loss would be a gain for the DRL as it is the only generic manufacturer of Imitrex in US (as of now),"Prabhudas Liladhar Head Research Pharma Ranjit Kapadia said.
When contacted DRL officials refused to comment on the projected revenues from generic Imitrex sales.