Patent Issued for Rezenopy, the Highest Dosage Naloxone Nasal Spray Approved by the FDA

The United States Patent and Trademark Office has issued patent number 12,514,854 B2, an Orange Book-listable patent, for Scienture Holdings’ naloxone HCl (Rezenopy) nasal spray 10 mg, the highest naloxone HCl nasal spray approved by the US Food and Drug Administration (FDA) for life-saving opioid overdose emergency treatment.¹

Rezenopy received approval from the FDA back on April 19, 2024.² Rezenopy leverages the proven naloxone hydrochloride molecule and familiar nasal spray form, while delivering increased effectiveness against potent opioids. It is intended for immediate administration as emergency therapy in settings where opioids may be present.

“This patent issuance is an important milestone that strengthens the intellectual property supporting Rezenopy and reinforces the value of our exclusive commercialization rights,” said Narasimhan Mani, the president and co-CEO of Scienture. “Orange Book-listable patents are a critical component of product lifecycle management, and this development further supports our long-term commercial strategy.”

The newly issued patent is effective January 6, 2026, with an expiry date of February 5, 2041, and, if listed, may provide additional intellectual property protection supporting the product’s US commercialization.

“Rezenopy addresses a critical public health need with a differentiated, high dosage formulation designed to combat today’s more potent opioids,” said Shankar Hariharan, the executive chairman and co-CEO of Scienture. “With a sizable and growing naloxone market, strong FDA approval status, and additional IP protection, we believe Scienture is well positioned to drive meaningful impact while building long-term shareholder value.”

The patent was issued to Summit Biosciences Inc, a subsidiary of Kindeva Drug Delivery LP. In March 2025, Scienture entered into a definitive agreement with Summit for the exclusive US commercialization rights to Rezenopy. Under the terms of the agreement, Summit will manufacture and commercially supply Rezenopy. Pending certain commercial obligations, Scienture will own the new drug application for Rezenopy in its name and be responsible for the sales, marketing, and distribution of the product in the US through Scienture’s commercial operations infrastructure.

“This patent issuance reinforces the differentiated nature of Rezenopy and the role innovation in drug delivery can play in addressing today’s opioid crisis. With over 50+ years of experience in delivering effective drug delivery solutions, Kindeva is proud to support Scienture in bringing this high dosage naloxone option to market to help address a critical public health need,” said Simon Scholte, the vice president and general manager for the Lexington Site at Kindeva.

References

1. 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. News release. January 14, 2026. Accessed January 14, 2026. https://finance.yahoo.com/news/scienture-announces-issuance-orange-book-130500882.html

2. Ernst D. High-dose naloxone nasal spray Rezenopy gets FDA approval. Medical Professionals Reference. April 24, 2024. Accessed January 14, 2026. https://www.empr.com/home/news/high-dose-naloxone-nasal-spray-rezenopy-gets-fda-approval/