TWi Pharmaceuticals, Inc. (4180.TT) today announced that it has received final approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for megestrol acetate 125mg/ml oral suspension, the generic equivalent to Par Pharmaceutical's Megace® ES. TWi is the first-to-file and under Hatch Waxman rules, it will be entitled to 180 days of marketing exclusivity. TWi has completed the pre-launch preparation of the generic drug. However, the launch of the product has been enjoined by Par's posting of a US$10 million bond with the District Court of Maryland pending Par's appeal to the US Court of Appeals for the Federal Circuit. TWi has filed a motion in the Federal Circuit Court to dissolve the injunction. If TWi succeeds on its motion to dissolve the injunction or the Federal Circuit rejects Par's appeal, the product can be launched immediately.
Megace® ES is indicated for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients. It is a reformulation of megestrol acetate oral suspension and is prescribed for AIDS patients to help improve appetite and gain weight. According to IMS Health, a market research firm, the total annual sales of the megestrol acetate products in U.S. were approximately $57 million for the twelve months ending June 30, 2014.
TWi Pharmaceuticals, Inc.