Core Insights - The U.S. naloxone market has annual sales of approximately $154 million, with a unit volume of 9.3 million units, indicating a significant and growing market opportunity for naloxone products [4]. Company Overview - Scienture Holdings, Inc. is a holding company focused on developing, commercializing, and distributing novel specialty pharmaceutical products to address unmet market needs [1][10]. - Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, has entered into an agreement with Summit Biosciences for the exclusive U.S. commercialization rights to REZENOPY, a naloxone HCl nasal spray [2]. Product Details - REZENOPY is the highest dosage naloxone HCl nasal spray approved by the FDA, designed to effectively combat potent opioids [4]. - The product received FDA approval on April 19, 2024, and is indicated for emergency treatment of known or suspected opioid overdose [3][6]. Intellectual Property - The U.S. Patent and Trademark Office issued U.S. Patent No. 12,514,854 B2 for REZENOPY, effective January 6, 2026, with an expiry date of February 5, 2041, providing additional intellectual property protection [1][3]. - The patent is eligible for listing in the FDA's Orange Book, which may further support the product's commercialization in the U.S. [3]. Market Strategy - The patent issuance is viewed as a critical milestone that strengthens the intellectual property supporting REZENOPY and reinforces the value of Scienture's exclusive commercialization rights [5]. - Scienture aims to leverage the growing naloxone market and strong FDA approval status to drive meaningful impact and build long-term shareholder value [5].
SCIENTURE Announces Issuance of Orange Book-Listable Patent Covering REZENOPY™, the Highest Dosage Naloxone HCl Nasal Spray Approved by the FDA for Life-Saving Opioid Overdose Emergency Treatment