Qualaquin® (quinine sulfate) is our first internally developed branded product and the only FDA approved version of quinine sulfate. Qualaquin® was approved with Orphan Drug Exclusivity for the treatment of malaria in August, 2005.
URL Pharma has a comprehensive life-cycle management program for quinine sulfate, which includes a project to improve the safety profile of quinine sulfate. In conjunction with these improvements, we have filed multiple patent applications and expect to receive regulatory exclusivities. As such, URL Pharma expects to have patent and regulatory exclusivity well past the expiration of the Orphan Drug exclusivity in 2012.