Sumatriptan Generic Space | Ranbaxy's Delay is Dr. Reddy's Gain

In an interesting piece of news reported by Khomba Singh of Economic Times, India’s largest drug manufacturer Ranbaxy has strangely missed their expected December 2008 deadline to launch generic version of Glaxo’s blockbuster anti-migraine drug Imitrex, generically known as Sumatriptan Succinate in the United States. He further reported that delay is likely due to Ranbaxy not yet received the final regulatory approval from the US Food and Drug Administration. Analysts keeping close eyes on the development projected Ranbaxy to suffer a potential loss of up to Rs. 300 crore due to regulatory delay. This seems to be a rare case where a generic manufacturer with 180 days market exclusivity delayed in launching first-time generic due to regulatory process. Last year in January, Ranbaxy settled Imitrex patent litigation with GlaxoSmithKline and announced expected launch of generic Imitrex (25mg, 50mg and 100mg strengths) in December 2008 with 180 days market exclusivity.

Ranbaxy strong business rival Dr. Reddy’s Laboratories was also in race for generic Imitrex space and was sued by GlaxoSmithKline following paragraph IV certification for Imitrex and like Ranbaxy settled patent litigation with Glaxo but in more strategic agreement and importantly before Glaxo-Ranbaxy settlement. Under the terms of agreement, Glaxo allowed Dr. Reddy’s to launch an authorized generic in the last quarter of 2008 before the expiration of the pediatric exclusivity on US5037845. In November 2008, Dr. Reddy’s as per agreement launched the authorized generic of Imitrex tablets 25mg, 50mg and 100mg in the US. Now considering Ranbaxy’s delay in launching generic Imitrex there is no doubt that it is a welcome new year for Dr. Reddy’s (and Glaxo too).