The United States Patent and Trademark Office has issued U.S. Patent No. 12,514,854 B2, an Orange Book-listable patent covering Rezenopy (naloxone HCl) Nasal Spray 10 mg.

The company on Wednesday said the patent is effective January 6, 2026, with an expiry date of February 5, 2041.

The patent was issued to Summit Biosciences Inc., a subsidiary of Kindeva Drug Delivery L.P.

Background

In March 2025, Scienture LLC, a wholly owned subsidiary of Scienture Holdings Inc. (NASDAQ:SCNX), inked a commercialization pact with Summit for the exclusive U.S. rights to Rezenopy.

Under the terms of the collaboration, Summit will manufacture and commercially supply Rezenopy.

Pending certain commercial obligations, Scienture will own the new drug application (NDA) for Rezenopy in its name and be responsible for the sales, marketing, and distribution of the product in the U.S. through Scienture's commercial operations infrastructure.

The U.S. Food and Drug Administration (FDA) approved Rezenopy in April 2024. Rezenopy is the highest dosage of naloxone HCl nasal spray approved by the FDA.

What Is Rezenopy?

Rezenopy (naloxone HCl) Nasal Spray 10mg is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients.

It is intended for immediate administration as emergency therapy in settings where opioids may be present.

Rezenopy nasal spray is for intranasal use only and is supplied as a carton containing two blister packages, each with a single spray device.

The newly issued patent is eligible for listing in the FDA's Orange Book and, if listed, may provide additional intellectual property protection supporting the product's U.S. commercialization.

The product leverages the proven naloxone hydrochloride molecule and familiar nasal spray form factor, while delivering increased effectiveness against potent opioids.

According to IQVIA data, total annual U.S. naloxone sales reached approximately $154 million, with unit volume of 9.3 million units, underscoring the significant and growing market opportunity.

Scienture reported that third quarter net revenue increased from approximately $65 thousand to $590 thousand, while gross profit increased from roughly $4 thousand to $575 thousand.

In November 2025, Scienture announced that Arbli (losartan potassium) Oral Suspension, 10 mg/mL, has been added to the formularies of key national payors, expanding access through both multiple commercial coverage and Medicare supplement plans.

Arbli is the first FDA-approved, ready-to-use oral suspension formulation of losartan potassium, designed to provide a safe, consistent, and convenient therapeutic option for patients requiring an alternative to solid dosage forms.

SCNX Price Action: Scienture Holdings shares were up 0.13% at $0.54 during premarket trading on Wednesday. The stock is trading near its 52-week low of $0.46, according to Benzinga Pro data.

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