Amerigen joins Bystolic patent challenge
NEW YORK — Another generic drug maker has joined efforts to challenge the patent on a drug made by Forest Labs for treating hypertension.
East Brunswick, N.J.-based Amerigen Pharmaceuticals announced that it had filed with the Food and Drug Administration for approval of a generic version of Bystolic (nebivolol). Amerigen's announcement followed news that Forest and Johnson & Johnson subsidiary Janssen Pharmaceutica NV had sued Glenmark Generics, Hetero USA, Torrent Pharmaceuticals and Watson Labs on Tuesday over their filing for approval of their own versions. Watson also confirmed Wednesday that it had challenged Forest's patent on Bystolic and sought to market a generic version of the drug in the 2.5 mg, 5 mg, 10 mg and 20 mg strengths.
Forest alleged that the companies named in the suit had infringed U.S. Patent No. 6,545,040, which is scheduled to expire in December 2021. Bystolic had sales of $391 million during the 12-month period ended in January, according to IMS Health.