Requip now has generic competitors

Chain Drug Review, June 30, 2008

WASHINGTON -- The Food and Drug Administration last month approved the first generic versions of Requip (GlaxoSmithKline PLC) for treating moderate to severe restless leg syndrome. Ropinirole hydrochloride tablets were cleared in 0.25-, 0.5-, 1-, 2-, 3- and 4-mg dosages.

"This generic drug approval is an example of the FDA's efforts to increase access to safe and effective genetic drugs as soon as the law permits," says Gary Buehler, director of the agency's office of genetic grugs.

Among the companies receiving approval to market ropinirole hydrochloride tablets are Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc. and Mylan Pharmaceuticals Inc.

The FDA notes that the labeling of the generic versions may differ from that of the brand name product because some uses of the drug continue to fall under patent protection.

The generic ropinirole hydrochloride tablets will, however, have the same safety warnings as Requip, which cautions about patient reports of falling asleep while engaged in such typical daily activities as operating a vehicle. Although many such patients reported sleepiness while on the medication, others perceived experiencing no such side effect.

According to IMS Health, Requip reaped sales in the United States of about $518 million in 2007 for doses ranging between 0.25 mg and 5 mg.

The drug is reported to stimulate dopamine receptors in the brain that control body movement.

Separately, another generic version of a GlaxoSmithKline drug has been launched. Mylan has rolled out its copy of Paxil CR, an antidepressant.

Last fall Mylan reached a patent settlement with GlaxoSmithKline, gaining licenses and the fight to market genetic versions of all three strengths of the medication.