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

Rhea-AI Summary

SCIENTURE (NASDAQ: SCNX) announced issuance of U.S. Patent No. 12,514,854 B2, an Orange Book-listable patent covering REZENOPY™ (naloxone HCl) Nasal Spray 10 mg, effective Jan 6, 2026 and expiring Feb 5, 2041. Scienture holds exclusive U.S. commercialization rights under a March 2025 agreement with Summit, which will manufacture and supply the product. REZENOPY™ received FDA approval on Apr 19, 2024 and is the highest-dosage FDA-approved naloxone nasal spray. IQVIA (MAT Sep 2025) reports U.S. naloxone sales of approximately $154 million and 9.3 million units, highlighting the market opportunity.

Positive

• Issued Orange Book-listable patent (U.S. No. 12,514,854 B2) effective Jan 6, 2026
• Patent term through Feb 5, 2041 provides extended IP protection
• Exclusive U.S. commercialization rights under March 2025 agreement with Summit
• Product has FDA approval (Apr 19, 2024) and is highest-dosage naloxone nasal spray
• IQVIA market data: $154M annual sales and 9.3M units (MAT Sep 2025)

Negative

• Ownership of the NDA is contingent on pending commercial obligations, creating timing/conditional risk
• Commercial supply and manufacturing depend on Summit, creating third-party operational risk

News Market Reaction

-4.51% 19.6x vol

20 alerts

-4.51% News Effect

+20.6% Peak Tracked

-13.3% Trough Tracked

-$1M Valuation Impact

$22M Market Cap

19.6x Rel. Volume

On the day this news was published, SCNX declined 4.51%, reflecting a moderate negative market reaction. Argus tracked a peak move of +20.6% during that session. Argus tracked a trough of -13.3% from its starting point during tracking. Our momentum scanner triggered 20 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $1M from the company's valuation, bringing the market cap to $22M at that time. Trading volume was exceptionally heavy at 19.6x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

U.S. naloxone market sales: $154 million U.S. naloxone units: 9.3 million units Patent number: U.S. Patent No. 12,514,854 B2 +4 more

7 metrics

U.S. naloxone market sales $154 million Annual U.S. naloxone sales (IQVIA MAT Sep 2025)

U.S. naloxone units 9.3 million units Annual U.S. naloxone unit volume (IQVIA MAT Sep 2025)

Patent number U.S. Patent No. 12,514,854 B2 Orange Book-listable patent covering REZENOPY™

REZENOPY™ dose strength 10 mg Naloxone HCl nasal spray dosage

Patent effective date January 6, 2026 Effective date of issued patent for REZENOPY™

Patent expiry February 5, 2041 Expiration of Orange Book-listable patent

FDA approval date April 19, 2024 U.S. FDA approval of REZENOPY™

Market Reality Check

Price: $0.4330 Vol: Volume 320,889 is light v...

low vol

$0.4330 Last Close

Volume Volume 320,889 is light vs 20-day average of 849,880 (about 0.38x average activity). low

Technical Shares at $0.5394 are trading below the $1.01 200-day moving average and 89.54% below the 52-week high.

Peers on Argus

SCNX was nearly flat at -0.13% pre-news with subdued volume, while tracked peers...

1 Down

SCNX was nearly flat at -0.13% pre-news with subdued volume, while tracked peers showed mixed moves (e.g., SSY up 9.31%, WGRX down 4.24%). Momentum scans only flagged NBY, down 4.06% without news, suggesting today’s setup was stock-specific rather than a coordinated sector move.

Historical Context

5 past events · Latest: Dec 22 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 22	Launch update	Positive	-8.6%	Updated timing for REZENOPY® commercial launch and market sizing details.
Dec 10	Strategic partnership	Positive	-2.9%	BlinkRx collaboration to expand national access to Arbli™ suspension.
Dec 02	Investor conference	Neutral	+0.1%	Participation in iAccess Alpha virtual conference and investor meetings.
Nov 13	Earnings update	Positive	-5.5%	Q3 2025 results highlighting Arbli™ launch and strong revenue growth.
Nov 04	Formulary expansion	Positive	+15.3%	Arbli™ added to major health plan formularies, expanding covered lives.

Pattern Detected

Recent history shows SCNX often trading lower on fundamentally positive or growth-oriented news, with several divergences between upbeat headlines and negative price reactions.

Recent Company History

Over the last few months, SCIENTURE has focused on building a specialty pharma platform. Key steps included adding Arbli™ to major formularies and reporting Q3 2025 revenue growth to $590K and expanded gross profit. The company announced a REZENOPY® commercial launch timeline and a BlinkRx collaboration to broaden access. Despite these seemingly constructive milestones, three of the last five news events saw negative 24-hour price reactions, underscoring market skepticism toward the growth strategy and financing needs that frame today’s patent announcement.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-08-01

The company has an active Form S-3 shelf filed on 2025-08-01 that remains in effect through 2028-08-01. It is noted as not yet effective in the context provided but has already been used multiple times, as indicated by at least 4 related prospectus supplements, including filings on 2025-11-07 and 2025-10-24. This framework provides flexibility for additional capital raises.

Market Pulse Summary

This announcement highlights a new Orange Book-listable patent for REZENOPY™ effective January 6, 20...

Analysis

This announcement highlights a new Orange Book-listable patent for REZENOPY™ effective January 6, 2026 and expiring in 2041, strengthening intellectual property around the highest-dosage FDA-approved naloxone nasal spray. In a U.S. naloxone market of about $154 million and 9.3 million units annually, added exclusivity supports the product’s U.S. commercialization strategy. Investors may watch how this IP position translates into launch execution, revenue traction, and how it intersects with the company’s existing S-3 capital-raising capacity.

Key Terms

orange book-listable patent, orange book, nda, fda, +2 more

6 terms

orange book-listable patent regulatory

"has issued U.S. Patent No. 12,514,854 B2, an Orange Book-listable patent covering"

An Orange Book-listable patent is a drug-related patent that the U.S. regulator allows to be recorded in its official list tied to an approved prescription medicine. Being listed is like putting a lock on a public registry that alerts potential generic makers and can trigger formal patent challenges and regulatory delays; for investors it signals legal protection around sales and helps predict when competition and revenue changes may occur.

orange book regulatory

"The newly issued patent is eligible for listing in the FDA’s Orange Book and, if listed,"

A publicly maintained FDA database that lists approved prescription drugs and notes which versions are considered interchangeable with brand-name products, along with key patent and exclusivity dates. Think of it as a product roster plus an expiration calendar: investors use it to see when a drug’s protection ends and generic competition can enter, which can directly affect a company’s sales, future revenue and stock value.

nda regulatory

"Scienture will own the new drug application (NDA) for REZENOPY™ in its name"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

fda regulatory

"REZENOPY™ received approval from the U.S. Food and Drug Administration (the “FDA”) on April 19, 2024."

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

naloxone medical

"REZENOPY™ (naloxone HCl) Nasal Spray 10 mg, effective January 6, 2026"

Naloxone is a fast-acting medication that temporarily reverses the life-threatening effects of opioid overdose by blocking opioids’ effects on the brain, like an emergency master key that unlocks someone from a dangerous drug-induced shutdown. It matters to investors because demand, pricing, regulatory approvals, product formulations (injectable, nasal spray), and government purchasing programs can drive sales, affect company valuations, and influence litigation and public-health-related revenue streams.

opioid medical

"designed to combat today’s more potent opioids,” stated Shankar Hariharan"

An opioid is a type of drug that reduces pain by binding to receptors in the nervous system; it includes prescription painkillers and some illegal substances. Investors care because opioids carry medical benefit but also risks—addiction, heavy regulation, litigation and changing prescribing practices—that can affect sales, legal costs, reputations and future product approvals, much like how a product recall or safety scandal can quickly change a company’s value.

AI-generated analysis. Not financial advice.

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

COMMACK, NY, Jan. 14, 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 issued U.S. Patent No. 12,514,854 B2, an Orange Book-listable patent covering REZENOPY^™ (naloxone HCl) Nasal Spray 10 mg, effective January 6, 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. 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.

REZENOPY^™ is the highest dosage naloxone HCl nasal spray approved by the FDA. 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 September 2025), 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.

“This patent issuance is an important milestone that strengthens the intellectual property supporting REZENOPY^™ and reinforces the value of our exclusive commercialization rights,” commented Narasimhan Mani, 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.”

“REZENOPY^™ addresses a critical public health need with a differentiated, high dosage formulation designed to combat today’s more potent opioids,” stated Shankar Hariharan, 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.”

Simon Scholte, Vice President & General Manager for the Lexington Site at Kindeva, commented, “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.”

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.

About Kindeva

At Kindeva, we manufacture more tomorrows for patients worldwide. With best-in-class facilities and comprehensive CDMO services, we offer more than manufacturing—we deliver strategic value. Our global network of 10 manufacturing and R&D sites offer exceptional integrated knowledge and capabilities, including Annex 1-compliant state-of-the-art aseptic fill finish capacity and next-generation sustainable inhalation propellant technology. By combining expertise in injectable, pulmonary, nasal and dermal drug delivery, we help meet the demands of today and deliver the possibilities of tomorrow. Find out more at https://www.kindevadd.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

FAQ

What patent did SCIENTURE (SCNX) receive for REZENOPY and when is it effective?

SCIENTURE announced U.S. Patent No. 12,514,854 B2 covering REZENOPY, effective Jan 6, 2026.

How long does the new REZENOPY patent for SCNX protect the product?

The issued patent expires on Feb 5, 2041, providing long-term IP protection if listed in the Orange Book.

Does SCIENTURE (SCNX) have U.S. commercialization rights for REZENOPY?

Yes; SCIENTURE holds exclusive U.S. commercialization rights under a March 2025 definitive agreement with Summit.

When did REZENOPY receive FDA approval and what distinguishes it?

REZENOPY received FDA approval on Apr 19, 2024 and is the highest-dosage FDA-approved naloxone HCl nasal spray.

How large is the U.S. naloxone market relevant to SCNX's REZENOPY?

IQVIA reported approximately $154 million in annual U.S. naloxone sales and 9.3 million units (MAT Sep 2025).

What are key commercialization risks for SCNX with REZENOPY?

Key risks include NDA ownership contingent on commercial obligations and reliance on Summit for manufacturing and supply.