Phathom Pharmaceuticals submits Citizen Petition to FDA

Phathom Pharmaceuticals (PHAT) announced it has submitted a Citizen Petition, CP, with the U.S. Food and Drug Administration, FDA. The petition formally requests correction of the Orange Book listings for VOQUEZNA 10 mg and 20 mg tablets to accurately reflect the full 10-year NCE exclusivity period until May 3, 2032. The update would align the VOQUEZNA tablets Orange Book listings to reflect the same period of NCE exclusivity that was granted upon approval of vonoprazan-based VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK in May 2022. The statutory 10-year exclusivity period encompasses the five-year standard exclusivity period for NCEs as extended by the additional five years by operation of the Generating Antibiotic Incentives Now, GAIN, Act. As VOQUEZNA tablet products contain the same drug substance with the active moiety, vonoprazan, they should be entitled to the same protection.