Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that on November 11, 2010 it received notice from Actavis South Atlantic LLC advising that Actavis has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 150 and 300 mg generic versions of OLEPTRO™ (trazodone hydrochloride extended-release 150 and 300 mg tablets) in the United States.
Under the Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Act), OLEPTRO™ has a new dosage form market exclusivity period that prevents final approval of Actavis' ANDA until the exclusivity period expires on February 2, 2013.
Activis' ANDA includes a paragraph IV patent certification to obtain approval to manufacture, use, or sell its generic versions before the expiration of Patent # 6,607,748, which is owned by Labopharm Inc., in June 2020. The patent is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluation (the "Orange Book").
Labopharm is currently reviewing the notice letter to determine next steps in this matter.