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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

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U.S. Naloxone Market: ~$154 million in annual sales and 9.3 million units annually COMMACK, NY, Jan....

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U.S. Patent issued for REZENOPY™, covering its commercialization and IP protection. REZENOPY™ is FDA-approved, enhancing market position in growing naloxone sector. U.S. naloxone market size is ~$154 million with 9.3 million units sold annually. Patent reinforces exclusive commercialization rights and product's unique market position. REZENOPY™ effectively addresses opioid overdose response needs in public health.

Sentiment Rationale

The patent affirms SCNX's competitive advantage in a growing market, similar to past successful product launches which often led to stock increases.

Trading Thesis

The patent's long-term protection (until 2041) indicates sustained market presence and profit potential.

Market-Moving

  • U.S. Patent issued for REZENOPY™, covering its commercialization and IP protection.
  • REZENOPY™ is FDA-approved, enhancing market position in growing naloxone sector.
  • U.S. naloxone market size is ~$154 million with 9.3 million units sold annually.

Key Facts

  • U.S. Patent issued for REZENOPY™, covering its commercialization and IP protection.
  • REZENOPY™ is FDA-approved, enhancing market position in growing naloxone sector.
  • U.S. naloxone market size is ~$154 million with 9.3 million units sold annually.
  • Patent reinforces exclusive commercialization rights and product's unique market position.
  • REZENOPY™ effectively addresses opioid overdose response needs in public health.

Companies Mentioned

  • KNDV (KNDV)
  • PFE (PFE)
  • JNJ (JNJ)

Corporate Developments

The patent and market potential are highly relevant to SCNX’s growth trajectory and success in the pharmaceutical sector.

SCIENTURE Announces Issuance of Orange Book-Listable Patent Covering REZENOPY™, the Highest Dosage Naloxone HCl Nasal Spray Approved by the FDA

Commack, NY, Jan. 14, 2026 — SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX) has announced the issuance of U.S. Patent No. 12,514,854 B2 for its innovative naloxone HCl nasal spray, REZENOPY™. This patent grants significant intellectual property rights as part of the company’s commitment to enhancing treatment options in the life-saving opioid overdose market.

Patent Issuance Details

This newly issued patent, covering REZENOPY™, is effective from January 6, 2026, and will expire on February 5, 2041. The patent was granted by the United States Patent and Trademark Office to Summit Biosciences Inc., a subsidiary of Kindeva Drug Delivery L.P., which holds a pivotal role in the product's manufacturing and commercialization process.

As part of a definitive agreement reached in March 2025, Scienture, LLC, the wholly-owned subsidiary of Scienture Holdings, Inc., secured exclusive U.S. commercialization rights for REZENOPY™. Under this agreement, Scienture plans to oversee the sales, marketing, and distribution of the product through its robust commercial infrastructure.

Market Opportunity and Product Effectiveness

According to IQVIA data, the total annual U.S. naloxone market is currently valued at approximately $154 million with a volume of 9.3 million units sold. The approval of REZENOPY™ by the U.S. Food and Drug Administration (FDA) on April 19, 2024, compliments this market potential, which is further supported by the newly issued patent eligible for the FDA’s Orange Book.

REZENOPY™ is distinguished as the highest dosage naloxone HCl nasal spray approved by the FDA. It utilizes a proven naloxone hydrochloride formula and familiar delivery method, aiming to increase effectiveness against potent opioids.

Statements from Leadership

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

Shankar Hariharan, Executive Chairman and co-CEO of Scienture, added, “REZENOPY™ addresses a critical public health need with a differentiated, high dosage formulation designed to combat today’s more potent opioids. 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.”

Simon Scholte, Vice President & General Manager at Kindeva, also acknowledged, “This patent issuance reinforces the differentiated nature of REZENOPY™ and the role innovation in drug delivery can play in addressing today’s opioid crisis.”

About REZENOPY™ and Safety Information

REZENOPY™ (naloxone HCl) Nasal Spray 10mg is an opioid antagonist intended for the emergency treatment of known or suspected opioid overdose. The product is designed for immediate administration in environments where opioid exposure may occur.

Administration details for REZENOPY™ include a single spray into one nostril, while emergency medical care must be sought immediately after use. It is critical to monitor patients for continued respiratory depression due to the potential overlap in the duration of action with opioids.

About Scienture Holdings, Inc.

SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX) is committed to developing specialty pharmaceutical products that elevate patient care. Through Scienture, LLC, the company focuses on addressing unmet market needs and enhancing value to patients, physicians, and caregivers through innovative therapies.

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