RedHill Biopharma announces FDA grant of 5-year market exclusivity for Talicia

RedHill Biopharma announced that the U.S. FDA has granted five years’ market exclusivity for Talicia under the Generating Antibiotic Incentives Now Act Qualified Infectious Disease Product designation, as recommended by the FDA Exclusivity Board. This grant is on top of three years’ exclusivity granted for the approval of Talicia under section 505(b)(2). Talicia is protected by its broad intellectual property suite to 2034. “Talicia is the only FDA-approved rifabutin-based therapy for the eradication of H. pylori. Its components and formulation are optimized to provide patients with the necessary medications for successful H. pylori eradication, an innovation rewarded by this market exclusivity and other IP, providing protection to 2034,” said Patricia Anderson, RedHill’s Senior Vice President of Regulatory Affairs. “With significant concerns around maintaining effective therapeutic options for infectious diseases in the face of growing microbial resistance, it is vital that the most effective options are utilized first line. Talicia’s favorable efficacy, tolerability, and resistance profile, in the only all-in-one formulation available, provides potential advantages over clarithromycin-based regimens for most patients.” The FDA recently approved a supplemental new drug application for Talicia, allowing a change to a more flexible three times daily, taken at least 4 hours apart with food, dosing regimen for H. pylori eradication enabling patients to follow a convenient “breakfast, lunch and dinner” dosing routine, which may support increased patient adherence and optimize the potential for successful H. pylori eradication.