RedHill's Talicia Granted 5-year Market Exclusivity By FDA

(RTTNews) - RedHill Biopharma Ltd. (RDHL) Monday announced that the U.S. FDA has granted five years' market exclusivity for Talicia under the Generating Antibiotic Incentives Now or GAIN Act Qualified Infectious Disease Product designation. This is based on the recommendation by the FDA Exclusivity Board.

Talicia is a fixed-dose, all-in-one oral capsule combination of two antibiotics and a proton pump inhibitor, approved by the U.S. FDA for the treatment of H. pylori infection in adults.

The company said the grant is on top of three years' exclusivity granted for the approval of Talicia under section 505(b)(2).

Patricia Anderson, RedHill's Senior Vice President said "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."