RedHill: FDA Grants 5-Year U.S. Market Exclusivity for Talicia® with IP Protection to 2034

 The U.S. FDA has granted five years' market exclusivity for Talicia under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) 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 leading branded first-line therapy prescribed by U.S. gastroenterologists1 for eradication of H. pylori - a bacterial infection that affects approximately 35% of the U.S. adult population

https://www.prnewswire.com/news-releases/redhill-biopharma-announces-fda-grant-of-5-year-us-market-exclusivity-for-talicia-with-ip-protection-running-to-2034-301997828.html