OTC-listed biotech company TAHO Pharmaceuticals announced on October 1 that it submitted a New Drug Application (NDA) for its globally first-of-its-kind oral antithrombotic film, TAH3311, to the U.S. Food and Drug Administration (FDA) on September 30 (U.S. time). The company aims to launch the product in the U.S. by the second half of next year, targeting a market worth $26.1 billion annually.
Chairman Li Shih-Jen stated that this NDA submission marks a critical milestone for TAHO in developing 505(b)(2) new formulation drugs and advancing them toward commercialization. The company plans to continue pursuing drug approvals in Europe and other regions according to its development timeline.
TAH3311 is the world’s first oral dissolving film (ODF) formulation containing Apixaban, a 505(b)(2) new formulation drug. While Apixaban is the best-selling anticoagulant globally, tablets remain its only dosage form. Each year, approximately 15 million new stroke patients are diagnosed worldwide, with about 50% experiencing swallowing difficulties during hospitalization, and 13% developing long-term dysphagia. These patients currently must crush tablets and mix them with water twice daily—a time-consuming, inconvenient process that risks inaccurate dosing, choking, and aspiration pneumonia.
The TAH3311 film utilizes TAHO’s proprietary Transepithelial Delivery System (TDS) for trans-mucosal drug delivery. Placed on the tongue, it dissolves within minutes without water, significantly addressing unmet clinical needs and reducing the burden on both patients and caregivers.
According to IQVIA, Apixaban tablets in the U.S. generated $26.1 billion in sales in 2024. The global antithrombotic market is projected to grow at a CAGR of 9.5% from 2023 to 2032. Following NDA submission, the review under the Prescription Drug User Fee Act (PDUFA) is expected to take approximately one year, though final approval timing depends on the FDA.
TAHO Pharmaceuticals is actively seeking global partners to jointly plan local pricing and marketing strategies, accelerating TAH3311’s entry into international markets and providing patients worldwide with a more convenient anticoagulant therapy option.
Resource: 泰合抗血栓口溶膜新藥 TAH3311 向美國提新藥查驗登記申請 拚明年上市
