Generic Drugs for Restless Leg Syndrome to Hit Market Soon

Sleep Disorders

Generic Drugs for Restless Leg Syndrome to Hit Market Soon

May 2008 - The Food and Drug Administration (FDA) said that it would allow four companies to market the first generic kind of the restless legs syndrome drug Requip (Ropinirole). Patients who have restless leg syndrome experience excessive twitching in their legs, which compels them to move around and can interfere with sleep.

Requip works by stimulating the dopamine receptors in the brain that control a person’s ability to move his or her body. After Requip is ingested, patients regain control of their legs and experience fewer twitches. (Medline Plus Summary.) Although Requip is also approved to combat Parkinson’s disease, the FDA didn’t extend that use to the generic drugs as the patent on Parkinson’s treatment does not expire until later in the month. Once the patent expires, however, it is expected that the companies will apply for FDA approval of that use

The four companies that received the approval are Par Pharmaceuticals Inc., Roxane Laboratories Inc., Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA. The FDA approved six different dosing levels of the drug, which range from as much as 4 milligrams to 0.25 milligrams. Since the side effects are the same, these generic versions will share the same warnings as Requip. Dangers of the drug can include falling asleep while driving.

According to IMS Health, a pharmaceutical statistics firm, last year alone Requip generated $518 million in sales in the United States. GlaxoSmithKline, the company that produces Requip, still has the sole ownership of doses ranging from 4 to 5 milligrams of the drug.