USPTO issues new patent covering Talicia[1] as a method for eradicating H. pylori regardless of patient Body Mass Index (BMI)[2], supporting Talicia protection until May 2042
The patent is supported by previously published pooled data from two Phase 3 studies showing Talicia’s efficacy was unaffected by presence of elevated BMI[3]
The U.S. FDA recently granted five years’ market exclusivity for Talicia under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, additional to the three years’ exclusivity granted for the approval of Talicia under section 505(b)(2)
Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[4] for eradication of H. pylori – a bacterial infection that affects approximately 35% of the U.S. adult population[5]
TEL AVIV, Israel and RALEIGH, N.C., Jan. 25, 2024 /PRNewswire/ — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the U.S. Patent and Trademark Office (USPTO) issued a new patent, U.S. Patent No. 11,878,011, covering Talicia as a method for eradicating Helicobacter pylori (H. pylori) regardless of patient Body Mass Index (BMI). This new patent is expected to provide protection for Talicia until May 2042.
“Rates of obesity continue to rise in the U.S., with over 70% of the population being overweight or obese[6], and published data have shown that obesity has been associated with failure of clarithromycin-based therapies for the treatment of H. pylori infection. This patent acknowledges the novelty of the data demonstrating Talicia’s ability to remain effective regardless of patient BMI, awarding this clinically important innovation with expected patent protection for Talicia until May 2042″ said Gilead Raday, RedHill’s Chief Operating Officer, and Head of R&D.
SHARE
