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Phathom Pharmaceuticals Announces FDA Correction to Orange Book Listing, Confirming 10 Years of Regulatory Exclusivity for VOQUEZNA® (vonoprazan) Tablets Through May 3, 2032
Globenewswire· 2025-06-16 12:00
Core Insights - The FDA has updated the Orange Book to confirm that VOQUEZNA® (vonoprazan) is entitled to a full 10-year period of non-patent New Chemical Entity (NCE) exclusivity, extending through May 3, 2032, which supports the long-term commercial potential of the product [1][2] Company Overview - Phathom Pharmaceuticals is focused on developing and commercializing novel treatments for gastrointestinal diseases, with a key product being vonoprazan, marketed as VOQUEZNA® for various GI conditions [3] - VOQUEZNA® is a first-in-class potassium-competitive acid blocker (PCAB) used for the relief of heartburn associated with Non-Erosive GERD and for the treatment of H. pylori infection in adults [3]