The United States Patent and Trademark Office has officially granted U.S. Patent No. 12,514,854 B2 to Summit Biosciences Inc., a subsidiary of Kindeva Drug Delivery L.P., covering Rezenopy (naloxone HCl) Nasal Spray 10 mg. This patent provides intellectual property protection that extends from its effective date on January 6, 2026, through to February 5, 2041.
Summit Biosciences serves as the original patent holder for this product, which is notable for being listed in the FDA’s Orange Book—a directory listing drug products approved on the basis of safety and effectiveness. The patent’s inclusion here supports the intellectual property rights crucial for commercial success and competitive market positioning.
Rezenopy stands out as the highest dosage formulation of naloxone hydrochloride nasal spray authorized by the U.S. Food and Drug Administration (FDA), receiving approval in April 2024. Naloxone serves as an opioid antagonist used in emergency treatment scenarios for opioid overdoses, especially where respiratory or central nervous system depression signals such a crisis. The nasal spray form facilitates rapid, non-invasive delivery, making it highly practical in diverse emergency contexts.
In a strategic arrangement solidified in March 2025, Scienture LLC—a wholly owned subsidiary of Scienture Holdings Inc. (NASDAQ:SCNX)—secured exclusive U.S. commercialization rights for Rezenopy from Summit Biosciences. Under this pact, Summit retains manufacturing and supply responsibilities, while Scienture assumes ownership of the new drug application (NDA) for Rezenopy in the U.S. This ownership confers on Scienture the responsibility for sales, marketing, and distribution of the product through its existing commercial infrastructure.
The collaboration model capitalizes on Summit’s expertise in pharmaceutical formulation and production, alongside Scienture’s commercial capabilities tailored to reach U.S. healthcare providers and emergency services. This division is intended to streamline market entry and support the rapid adoption of Rezenopy in addressing the ongoing opioid crisis.
Rezenopy’s formulation consists of a 10 mg dose of naloxone HCl delivered intranasally. The product packaging includes a carton with two blister packages, each containing a single-use spray device, assuring ready access for emergency administration. The drug is indicated for immediate administration upon suspicion or confirmation of opioid overdose in both adult and pediatric populations. The utilization of a nasal delivery system aligns with current emergency medical response practices and eliminates the need for invasive injection routes.
The newly issued patent not only secures proprietary protection over the product through 2041 but may also provide additional layers of exclusivity once listed in the FDA’s Orange Book. This aspect of intellectual property protection is critical to safeguarding market share and deterring generic competition, bolstering the commercial viability of Rezenopy.
Market data underscoring the opportunity for Rezenopy comes from IQVIA, which reports approximately $154 million in total annual U.S. naloxone sales, with about 9.3 million units distributed yearly. These figures reflect both the significant public health need and growing demand for effective opioid overdose treatments.
Financially, Scienture has demonstrated marked growth in its fiscal metrics related to its commercial operations. In the third quarter, net revenue surged from roughly $65,000 to $590,000, while gross profit experienced an increase from approximately $4,000 to $575,000. These improvements suggest rising commercial traction and the productive scaling of its pharmaceutical assets, including projects like Rezenopy.
Additionally, in November 2025, Scienture expanded its portfolio access by securing formulary inclusion for Arbli (losartan potassium) Oral Suspension, 10 mg/mL, across major national payors. Arbli is distinguished as the first FDA-approved oral suspension formulation of losartan potassium, intended to provide a reliable alternative to solid dosage forms for patients with specific therapeutic needs.
Regarding current market performance, Scienture Holdings' stock traded at $0.54 in early premarket activity on Wednesday, reflecting a modest increase of 0.13%. However, the share price hovers close to its 52-week low of $0.46, according to Benzinga Pro data, highlighting the volatility and challenges faced by emerging pharmaceutical companies in capital markets.
The advancements surrounding Rezenopy represent a significant milestone in opioid overdose intervention therapies. The partnership dynamics between Summit and Scienture illustrate a collaborative framework aimed at addressing an urgent public health concern with an innovative pharmaceutical solution backed by strong patent protection and regulatory approval.