INDIA BUSINESS WORLD - JANUARY 16^th - JANUARY 31^st - 2008

RANBAXY, GSK SETTLE IMITREX ROW

Ranbaxy Laboratories has reached an out-of-court settlement with UK's pharma major GlaxoSmithKline to market generic copies of the latter's $1 billion migraine headache drug Imitrex in the US. The company plans to launch its generic copies with 180-day marketing exclusivity in December this year.

The Gurgaon-based company said it has settled all matters relating to possible patent litigation with GSK regarding Sumatriptan Succinate tablets, the generic version of Imitrex. The Indian company has the first to file application for the drug. Although it is common for innovator companies to sue generic pharma companies for patent infringement to prevent them from launching generic copies, GSK did not file any litigation against the Indian company.

Under the terms of the agreement, Ranbaxy will be able to market 25 mg, 50 mg and 100 mg dosages of the drug in the US with no competition from any generic company. According to IMS figures, Imitrex had annual sales of $985 million in 2007, a Ranbaxy Laboratories release said. Other details of the settlement were not disclosed. According to sources, the settlement could rake in $90-$100 million during the 6 month period for Ranbaxy Laboratories. The patent for Imitrex expires in March 2009, however GSK has additional patents covering for the drug which will extend its patent till June, sources added. This is the second out-of-court settlement with GSK following a similar settlement for another billion drug Valacyclovir in July 2007.