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]

Core Insights - Windtree Therapeutics is advancing istaroxime, a potential treatment for cardiogenic shock, which may receive New Chemical Entity designation from the FDA, providing 7.5 years of U.S. exclusivity if approved [1][3] - Istaroxime has existing patents protecting its method of use until 2039 and a pending patent extending protection until 2043 [2] - The company is focused on the development of istaroxime, with an interim analysis of its Phase 2 study planned for Q3 2025 [3] Company Overview - Windtree Therapeutics is a biotechnology company aiming to generate revenue through innovative therapies for critical conditions, with istaroxime being a key candidate in its portfolio [5] - Istaroxime is a first-in-class dual-mechanism therapy designed to enhance both systolic and diastolic cardiac function, showing significant improvements in cardiac function and blood pressure in Phase 2 studies [4]