U.S. Naloxone Market: ~$141 million in annual sales and 9.4 million units annually
COMMACK, NY, June 02, 2026 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization, and distribution of novel specialty products that address unmet market needs, today announced that the United States Patent and Trademark Office has granted U.S. Patent No. 12,622,903 B2, patent covering REZENOPY™ (naloxone HCl) Nasal Spray 10 mg, effective May 12, 2026, with an expiry date of February 5, 2041.
The patent was issued to Summit Biosciences Inc. (“Summit”), a subsidiary of Kindeva Drug Delivery L.P. As previously disclosed, Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., entered into a definitive agreement with Summit in March 2025 for the exclusive U.S. commercialization 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. REZENOPY™ received approval from the U.S. Food and Drug Administration (the “FDA”) on April 19, 2024.
REZENOPY™ is the highest FDA-approved Dose per Nasal spray for Naloxone in the US market, delivering 10 mg of naloxone HCl in a single-use nasal spray device for the emergency treatment of known or suspected opioid overdose. 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 (MAT January 2026), total annual U.S. naloxone sales reached approximately $141 million, with unit volume of 9.4 million units, underscoring the significant and growing market opportunity.
“The issuance of this patent is a substantial milestone for Scienture and a significant validation of our intellectual patent strategy,” commented Narasimhan Mani, President and co-CEO of Scienture. “With intellectual property protection extending through 2041 and our planned commercial launch of REZENOPY™ in mid-July, we are entering an exciting new phase for the product. As the highest-dosage naloxone nasal spray approved by the FDA, REZENOPY™ has the potential to address a critical public health need while creating long-term value for patients, healthcare providers, and our shareholders.”
“This patent enhances the value of REZENOPY™ as we advance toward commercialization and supports our strategy to establish a meaningful presence in the naloxone market,” stated Shankar Hariharan, Executive Chairman and co-CEO of Scienture. “The opioid epidemic continues to evolve with the widespread presence of highly potent synthetic opioids, underscoring the need for effective overdose reversal tools. We believe REZENOPY™ offers a differentiated solution, and we look forward to making it available through our commercial and distribution partners in the coming weeks.”
About 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 (2) blister packages each with a single spray device.
IMPORTANT SAFETY INFORMATION
- Administration: REZENOPY™ nasal spray is for intranasal use only. Seek emergency medical care immediately after use. Administer a single spray into one nostril. If the patient does not respond within 2 to 3 minutes or responds and then relapses into respiratory depression, an additional dose may be given into the other nostril with a new device. Do not administer more than 2 sprays per day. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
- Contraindications: REZENOPY™ nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.
- Warnings and Precautions:
- Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer additional doses as necessary while awaiting emergency medical assistance.
- Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.
- Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid-dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.
- Risk of Cardiovascular Effects: Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular effects. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.
- Adverse Reactions: The following adverse reactions were observed in a REZENOPY™ nasal spray clinical study: upper abdominal pain, nasopharyngitis, and dysgeusia.
- Storage and Handling: Store REZENOPY™ nasal spray in the blister and cartons provided. Store between 2°C to 25°C (36°F to 77°F). Excursions permitted up to 40°C (104°F). Do not freeze or expose to excessive heat above 40°C (104°F). Protect from light. REZENOPY™ nasal spray may freeze at cold temperatures. If this happens, the device will not spray. If REZENOPY™ nasal spray is frozen and is needed in an emergency, do NOT wait for it to thaw; get emergency medical help right away.
For more detailed information, please refer to the full prescribing information provided by the FDA.
About Scienture Holdings, Inc.
SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), through its wholly owned subsidiary, Scienture, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit: www.scientureholdings.com and www.scienture.com.
Cautionary Statements Regarding Forward-Looking Statements
This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, such as REZENOPY™, the success those products may have in the marketplace, and our strategies related to those products. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.
Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.
Contact:
SCIENTURE HOLDINGS, INC.
20 Austin Blvd
Commack, NY 11725
Phone: (866) 468-6535
Email: IR@Scienture.com
