Regulators gave 13 manufacturers approval to market the first generic versions of Sanofi-Aventis SA's Ambien, a sleeping pill with $2.2 billion in U.S. sales last year.
The manufacturers include Dr. Reddy's Laboratories Ltd., Mylan Laboratories Inc., Ranbaxy Laboratories Ltd., Teva Pharmaceutical Industries Ltd. and Watson Pharmaceuticals Inc., the Food and Drug Administration said today in a statement.
Companies had been given preliminary approval before the patent expired April 21. Ambien tablets had U.S. sales of $2.2 billion last year in the two approved strengths, five milligrams and 10 milligrams, Mylan reported separately, citing figures from the research firm IMS Health.
Sanofi-Aventis, based in Paris, is France's largest drugmaker. The company has failed to attract enough patients to a newer version of Ambien.
Other companies winning approval are Boehringer Ingelheim GmbH's Roxane Laboratories Inc., Apotex Inc., Synthon BV, Genpharm Inc., Mutual Pharmaceutical Co., Caraco Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc., and Lek Pharmaceuticals.