FDAnews
www.fdanews.com/articles/63421-dr-reddy-s-gsk-settle-imitrex-suit

DR. REDDY'S, GSK SETTLE IMITREX SUIT

October 19, 2006

Dr. Reddy's Laboratories will begin distributing an authorized generic version of GlaxoSmithKline's (GSK) migraine drug Imitrex in late 2008, under terms of a patent settlement.

Dr. Reddy's will distribute Imitrex (sumatriptan succinate) tablets in 25-, 50-, and 100-mg strengths in the U.S. ahead of the pediatric exclusivity expiration in February 2009. Other settlement terms of the deal, which is still subject to government review, were not disclosed.

In early 2004, GSK sued Dr. Reddy's in the U.S. District Court for the Southern District of New York after Dr. Reddy's filed an abbreviated new drug application challenging four of the five patents on the drug.

Imitrex had U.S. sales of $890 million for the 12 months ending in June of this year, Dr. Reddy's said, citing IMS Health data.