Barr Starts Process to Sell Generic Ambien
April 6, 2007
U.S. generic drug maker Barr said Friday it has initiated a patent challenge to Sanofi-Aventis’s sleep drug Ambien.
The company said it filed an application with the Food and Drug Administration in December for approval of a generic version of Ambien controlled-release tablets, and received notification from the agency in February that the application had been accepted for review.
In response to that filing, Sanofi-Aventis filed suit in the U.S. District Court of New Jersey to try to stop Barr from marketing a generic version of its top-selling insomnia treatment.
Barr estimated U.S. sales of Ambien CR at approximately $659 million in the 12 months ended February 2007, quoting IMS data.