Phathom Pharmaceuticals, a biopharmaceutical company specializing in gastrointestinal (GI) treatments, announced a significant update regarding its flagship drug, VOQUEZNA (vonoprazan). The U.S. Food and Drug Administration (FDA) has officially corrected its "Orange Book," which lists approved drug products, to confirm that VOQUEZNA 10 mg and 20 mg tablets are entitled to the full 10-year period of New Chemical Entity (NCE) regulatory exclusivity. This means VOQUEZNA is now protected from generic competition until May 3, 2032.

This crucial update aligns the FDA's listing with statutory requirements, providing Phathom with a reinforced long-term commercial runway for VOQUEZNA. The drug, a first-in-class potassium-competitive acid blocker (PCAB), is already marketed in the U.S. for various GI conditions. These include the relief of heartburn associated with Non-Erosive GERD, the healing and maintenance of healing for Erosive GERD (including associated heartburn), and as part of combination therapies like VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK for the treatment of H. pylori infection in adults. This confirmed extended exclusivity is vital for Phathom as it secures the market position for this novel treatment in the competitive GI landscape.