Court decision inches generic Augmentin forward

Drug Store News, June 17, 2002

A federal district court's ruling May 23 declared three GlaxoSmithKline's U.S. patents for the antibiotic Augmentin (amoxicillin & potassium clavulanate) invalid, further clearing the way for generic drug makers Geneva, Teva and Ranbaxy to sell it. The patents that the court ruled invalid are due to expire in June, July and December 2002.

GSK plans to appeal these rulings and previous rulings from the same court on Augmentin patents that are set to ex ire in 2017 and 2018, but generic drug makers could launch versions of the drug before GSK appeals.

Augmentin is GSK's second-highest selling drug, pulling in $2 billion in worldwide sales last year. In an earnings per share guidance issued on the day of the ruling, GSK stated that 2002 growth projections could drop from the mid-teens to 10 percent and 2003 earnings could dip from the low-teens to "the high single digits" if generic Augmentin were launched.

"GSK is unable to assess the likelihood or timing of a generic version of Augmentin entering the U.S. market," according to a company statement. "If a generic version of Augmentin were to be launched prior to the outcome of the appeal and GSK is successful in its appeal, GSK would seek to recover damages for its lost profits."