Phathom Pharmaceuticals Reports BDR Lawsuit Challenging VOQUEZNA Exclusivity

BDR Pharmaceuticals sued the FDA in U.S. District Court for the District of Columbia, seeking an order requiring the agency to accept its ANDA for generic vonoprazan tablets. Phathom Pharmaceuticals is not named in the suit; it said it is reviewing the case and intends to vigorously defend its intellectual property rights in vonoprazan, the active ingredient in its FDA-approved Voquezna products. The article also notes the FDA recently approved Voquezna for heartburn associated with non-erosive GERD in adults.