MUMBAI - Four months after the U.S. FDA imposed an import alert on 33 products manufactured by Ranbaxy, the company received a much needed shot in the arm after the drug regulator approved launch of its generic versions of GlaxoSmithKline's migraine drug Imitrex (sumatriptan) 100 mg, which has sales of over $1.1 billion in the U.S. alone.

Ranbaxy filed the abbreviated new drug application for permission to market sumatriptan from its New Jersey-based Ohm Labs facility after the U.S. FDA suspended marketing for products from Ranbaxy's Paonta Sahib and Dewas facility (Also see "U.S. Congress Expands Probe Into Ranbaxy’s AIDS Drugs Supplied To Developing Nations" - Scrip, 20 September, 2008.). Speaking to PharmAsia News, a Ranbaxy spokesperson confirmed the approval for sumatriptan 100 mg though the official FDA website does not show the approval as yet.

Fellow Indian drug maker Dr. Reddy's settled its patent litigation and launched the authorized generic versions of sumatriptan as part of its settlement with GSK in November (Also see "Dr Reddy’s Launches Generic Versions Of GSK’s Imitrex; Ranbaxy May Have To Wait" - Scrip, 25 November, 2008.).

Dr. Reddy's announced during a third quarter earnings call that it has cornered a 19 percent market share of sumatriptan since its November launch (Also see "Generic Imitrex Launch In U.S. Drives Strong Revenue Growth For Dr. Reddy’s" - Scrip, 20 January, 2009.).

According to financial analysts, the upsides for Ranbaxy from sumatriptan will be limited as three to four players, including Teva and Cobalt, are also expected to share the market exclusivity for the next six months, and later the market will be flooded with generic competitors.

An industry source explained that the 100 mg strength for the drug comprises over 60 percent of the total Imitrex market, so Ranbaxy can still reap decent margins. Asked if more big drug approvals are expected for the company, the source clearly stated that the investigations over Ranbaxy's manufacturing deficiencies at Paonta Sahib and Dewas plants in India will continue uninterrupted and the approval process will continue separately.

Ranbaxy management had hinted that the company is looking at FDA approved manufacturing facilities, besides moving some of its products to Ohm Labs, to off-set the losses due to the restrictions on its two plants by U.S. FDA.

- Vikas Dandekar (v.dandekar@elsevier.com)

Ranbaxy Gets U.S. FDA Nod For Imitrex After Four Months Of Waiting

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