Core Viewpoint - Scienture Holdings, Inc. has announced the FDA listing of two patents for its product Arbli, a novel oral liquid formulation of losartan, which is expected to enhance its market position and provide statutory exclusivity under the Hatch-Waxman Act [1][2][6]. Company Overview - Scienture Holdings, Inc. is a holding company focused on developing and distributing specialty pharmaceutical products that address unmet market needs [1][13]. - The company operates through its subsidiary, Scienture, LLC, which is dedicated to bringing unique specialty products to market [13]. Product Details - Arbli is the first FDA-approved ready-to-use oral liquid formulation of losartan, designed for patients over 6 years old, and is indicated for the treatment of hypertension and related conditions [3][4][8]. - The product is available in a 165 mL bottle with a peppermint flavor, has a shelf life of 18 months at room temperature, and does not require refrigeration [7]. Market Position - The patents for Arbli cover stable liquid formulations of losartan and methods of use, reinforcing Scienture's intellectual property position [2]. - Losartan is classified as an angiotensin receptor blocker (ARB) and is one of the most prescribed medications for hypertension, with annual sales of approximately $276 million and a prescription volume of 69 million in the U.S. market as of March 2025 [5]. Regulatory Milestone - The listing of Arbli in the FDA's Orange Book is considered a significant regulatory achievement for Scienture, validating its development efforts and enhancing its commercial pathway in the U.S. market [6][2].