Research & Development
RedHill Biopharma granted five years' market exclusivity for Talicia by US FDA
28 November 2023 -

RedHill Biopharma Ltd. (NASDAQ: RDHL), a US-based specialty biopharmaceutical company, announced on Monday that it has received five years' market exclusivity for Talicia from the US FDA (US Food and Drug Administration).

The exclusivity has been granted under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, as recommended by the FDA Exclusivity Board.

The grant is in addition to the three year's exclusivity granted for the approval of Talicia under section 505(b)(2). The product is protected by its broad intellectual property suite until 2034.

The FDA recently approved a supplemental new drug application (sNDA) for Talicia, allowing a change to a more flexible three times daily (TID), 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 optimise the potential for successful H.pylori eradication.

H. pylori is a bacterial infection that affects approximately 35% of the US population, with an estimated two million patients treated annually.