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Monday, June 16, 2025

Phathom: FDA Confirms 10 Years of Regulatory Exclusivity for VOQUEZNA

Phathom Pharmaceuticals (NASDAQ: PHAT) announced that the FDA has corrected the Orange Book listing for VOQUEZNA® (vonoprazan) tablets, confirming its 10-year New Chemical Entity (NCE) exclusivity period through May 3, 2032. VOQUEZNA, a first-in-class potassium-competitive acid blocker (PCAB), is approved for treating heartburn associated with Non-Erosive GERD and Erosive GERD in adults. The product is also available as VOQUEZNA TRIPLE PAK and DUAL PAK for H. pylori infection treatment. This correction reinforces the long-term commercial potential for this novel GI treatment, ensuring market protection for the full statutory period.

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