On January 14, 2026, Scienture Holdings, Inc. announced that the U.S. Patent and Trademark Office granted U.S. Patent No. 12,514,854 B2, an Orange Book‑listable patent covering its 10 mg naloxone HCl nasal spray, REZENOPY®. The patent became effective on January 6, 2026 and is scheduled to expire on February 5, 2041, giving the company a 15‑year intellectual‑property shield that extends beyond the standard 20‑year term for drug patents.
The patent is the result of a partnership in which Summit Biosciences, a subsidiary of Kindeva Drug Delivery, will manufacture and supply REZENOPY®, while Scienture retains ownership of the new drug application and controls U.S. sales, marketing, and distribution. Summit’s expertise in nasal drug delivery and Kindeva’s recent acquisition of Summit in January 2024 provide a robust manufacturing backbone for the product.
REZENOPY® is the highest‑dosage FDA‑approved naloxone nasal spray, approved on April 19, 2024. The U.S. naloxone market was valued at roughly $154 million in 2025, with 9.3 million units sold, and is expected to grow as opioid overdose rates rise. The new patent protects the product’s unique 10 mg formulation, which is designed to counter the potency of modern synthetic opioids and gives Scienture a competitive moat in a market that is both life‑saving and highly regulated.
Financially, Scienture reported gross profit margins of 88.5% in the last twelve months, a figure that reflects the high‑margin nature of the naloxone product and the low cost of goods sold. However, the company also posted negative free cash flow of $11.1 million, driven by significant capital expenditures on manufacturing capacity and marketing initiatives aimed at expanding market share. The high margin offsets the cash burn, but the negative free cash flow signals that the company is investing heavily to secure its long‑term position.
Management emphasized the strategic importance of the patent. President and co‑CEO Narasimhan Mani said the issuance “strengthens the intellectual property supporting REZENOPY and reinforces the value of our exclusive commercialization rights.” Executive Chairman and co‑CEO Shankar Hariharan added that the patent “positions Scienture to drive meaningful impact while building long‑term shareholder value” in a growing naloxone market.
The Orange Book‑listable patent extends Scienture’s exclusive rights for 15 years, providing a durable competitive advantage and a clear revenue‑generation window for a high‑margin, life‑saving product. The combination of regulatory approval, robust manufacturing partnerships, and extended IP protection positions Scienture to capture a larger share of the expanding naloxone market and to generate sustainable cash flows as the product gains broader adoption.
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