06/16/2025 | Press release | Distributed by Public on 06/16/2025 06:06
Item 8.01 |
Other Events. |
On June 16, 2025, Phathom Pharmaceuticals, Inc. ("Phathom" or the "Company"), announced that the U.S. Food and Drug Administration ("FDA") has updated the Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") to accurately reflect the full 10-yearperiod of non-patentNew Chemical Entity ("NCE") exclusivity for VOQUEZNA (vonoprazan) 10 mg and 20 mg tablets. The corrected Orange Book listing confirms that VOQUEZNA is entitled to NCE regulatory exclusivity through May 3, 2032, aligning with statutory requirements and reinforcing the long-term commercial runway for the first-in-classproduct.