Imitrex generic, a consolation prize for Ranbaxy

GlaxoSmithKline’s (GSK) migraine and headache brand Imitrex (generic name sumatriptan) might have worked as the much needed balm for Indian drugmaker Dr Reddy’s Laboratories (DRL) improving its third quarter numbers.

An authorised copycat version of the drug launched by it in the US late November netted the Hyderabad-based company a whopping $73 million in just about a month.

But the drug may fail to work the same wonders for its Delhi-based rival Ranbaxy Laboratories, which finally received the US Food and Drug Administration (FDA) approval this week to sell its own copycat version.

Imitrex had sales of $1 billion in 2008, shows IMS Health data. DRL had settled with GSK on sumatriptan succinate in October 2006, bagging the right to sell the generic version in the three strengths before the expiration of the patent.

Ranbaxy, too, had settled in January 2008 a patent litigation in the US relating to Imitrex, enabling it to market the generic sumatripatan succinate tablets in the 25 mg, 50 mg and 100 mg strengths with an expected launch date in December the same year.

But the launch was delayed with FDA banning the export of 30-odd drugs manufactured at its Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh plants. While DRL was first off the block with its authorised generic in three dosage forms and has been able to garner almost 65% market share at considerably attractive pricing,

Ranbaxy will have to fight it out with four other players. Israeli generic giant Teva Pharma too received the FDA approval for its abbreviated new drug application (ANDA), with a 180 days exclusivity.

According to market sources, there will be at least one more authorised seller for Imitrex, most probably Canadian drug-maker Cobalt Pharmaceuticals. Moreover, the approval may not mean much in revenues even though the 110 mg dosage approval for Ranbaxy accounts for almost 50% of the market with sales of $650 million last year.

DRL, on the contrary, is selling the drug in three dosages. “The situation does not look very bright for Ranbaxy,” said First Global analyst Kavita Thomas, adding the margins too would be under pressure for the Delhi-based company.

Given that Ranbaxy’s FDA problems still persist and it will manufacture sumatriptan at a facility in the US, its costs are likely to be somewhat higher, observed another analyst. Arvind Bothra, analyst with Merrill Lynch, said in a note to clients on Wednesday that given these factors the opportunity may contribute only $11-13 million to the topline with a gross margins of 60-65%.