SCIENTURE Announces Third Patent Grant for ARBLI™ (losartan potassium) Oral Suspension, Strengthening Long-Term Market Exclusivity Through 2041
Rhea-AI Summary
Scienture (NASDAQ: SCNX) announced U.S. Patent No. 12,605,365 for ARBLI™ (losartan potassium) oral suspension, issued April 21, 2026, providing protection through October 7, 2041. ARBLI™ is the first FDA-approved ready-to-use liquid losartan aimed at pediatric and geriatric patients within a roughly $241M U.S. losartan market (≈72M prescriptions annually).
The company reports early commercial progress via increased physician awareness, expanding formulary access, and wider distribution, and says the new patent strengthens long-term exclusivity and commercialization prospects.
Positive
- U.S. patent granted: Patent No. 12,605,365 through Oct 7, 2041
- First FDA-approved ready-to-use losartan oral suspension in U.S.
- Addressable market of approximately $241M and ~72M prescriptions annually
- Commercial progress reported: increasing physician awareness and expanding formulary access
Negative
- None.
Key Figures
Market Reality Check
Peers on Argus
Peers show mixed moves (e.g., SSY +9.31%, PETS +3.95%, WGRX -2.46%), while SCNX was roughly flat at -0.10%, suggesting this patent news is company-specific rather than part of a sector-wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 15 | Nasdaq compliance extension | Neutral | +16.7% | Nasdaq granted a 180-day extension to regain $1.00 minimum bid compliance. |
| Apr 06 | Shareholder update | Positive | +10.3% | Annual update highlighted 216% revenue growth, strong margins, and commercial progress. |
| Mar 30 | Year-end earnings | Negative | -42.2% | 2025 results showed higher revenue but a large net loss and non-cash impairment. |
| Mar 11 | REZENOPY access deals | Positive | +19.5% | GPO agreements opened REZENOPY access to 5,000+ institutions in a defined market. |
| Feb 03 | ARBLI commercial update | Positive | +0.9% | ARBLI update detailed payer wins, GPO deals, wide formulary coverage, and cash position. |
Recent news, especially commercial and access milestones, has often aligned with positive price reactions, while comprehensive financial results with large losses saw a sharp selloff.
Over the past few months, Scienture has transitioned into a commercial-stage specialty pharma company with ARBLI™ and REZENOPY™. News on Nasdaq listing compliance, shareholder updates, and commercial access wins in Feb–Apr 2026 generally saw positive reactions. However, the full-year 2025 earnings report on Mar 30 with a large net loss triggered a steep decline. Today’s patent grant for ARBLI™ extends the product’s IP backdrop, building on earlier Orange Book‑listable patents and commercialization progress highlighted in prior filings.
Regulatory & Risk Context
The company has an active S-3 shelf registration filed on 2025-08-01, expiring on 2028-08-01. It is not yet effective but has been used via multiple 424B5 prospectus supplements, with a reported usage count of 4, indicating an established mechanism for raising equity capital.
Market Pulse Summary
This announcement adds a third patent for ARBLI™, extending intellectual property protection through 2041 in a U.S. losartan market of about $241M and 72M annual prescriptions. It reinforces positioning as the first FDA-approved ready-to-use liquid losartan option for patients with swallowing difficulties. In context of prior commercial wins and financial reports, investors may watch future updates on ARBLI™ adoption, revenue progression, and capital-raising activity under existing programs.
Key Terms
oral suspension medical
fda-approved regulatory
united states patent and trademark office (uspto) regulatory
intellectual property regulatory
AI-generated analysis. Not financial advice.
U.S. losartan market totals approximately
COMMACK, NY, May 06, 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 (USPTO) has granted its third patent covering ARBLI™ (losartan potassium) oral suspension, the first and only FDA-approved ready-to-use oral liquid formulation of losartan.
The newly issued patent, U.S. Patent No. 12,605,365, titled “Losartan Liquid Formulations and Methods of Use,” was issued on April 21, 2026, and is expected to provide intellectual property protection through October 7, 2041.
“This third patent further strengthens our intellectual property portfolio around ARBLI™ and reinforces the long-term value of this differentiated asset,” commented Narasimhan Mani, President and co-CEO of Scienture. “ARBLI™ is the first and only FDA-approved liquid losartan formulation available in the U.S. market. Its ready-to-dispense, flexible dosing formulation eliminates the need for compounding and provides a tailored treatment option for patients with oral adherence challenges, positioning ARBLI™ as the clear market leader in this category.”
ARBLI™ is a proprietary oral suspension formulation of losartan potassium designed to improve patient access and compliance, particularly among pediatric, geriatric, and other patient populations with difficulty swallowing tablets, within the approximately
Since its commercial launch, Scienture has made meaningful progress in advancing ARBLI™ market adoption, supported by increasing physician awareness, expanding formulary access, and continued growth across key distribution channels. The Company believes ARBLI™ is well-positioned to capture share in the large and established losartan market, particularly within patient segments requiring liquid dosing options.
“With three issued patents now supporting ARBLI™, we believe we have established a strong foundation to drive sustained commercial growth,” stated Shankar Hariharan, Executive Chairman and co-CEO of Scienture. “We remain focused on expanding access, increasing adoption, and executing on our commercialization strategy to fully realize ARBLI™’s market potential.”
About ARBLI™
ARBLI™ is a novel proprietary formulation of losartan, a widely prescribed angiotensin receptor blocker (ARB) for hypertension. It is the first and only liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. ARBLI™ is FDA-approved for the treatment of hypertension in patients greater than six years old, for reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy, and for treating diabetic nephropathy in certain patients with type 2 diabetes. By offering a safe, effective, and convenient liquid alternative, ARBLI™ provides a tailored solution for patients who require or prefer a liquid formulation. As an FDA-approved product, ARBLI™ provides consistent quality and dosing accuracy, addressing the risks and inconsistencies often associated with extemporaneously compounded losartan prescriptions. ARBLI™ has two issued patents from the USPTO, which are also listed in the FDA Orangebook.
ARBLI™ is the first and only oral liquid formulation of losartan approved by the U.S. FDA. ARBLI™ comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration, and has been approved for a shelf life of 24 months from the date of manufacture when stored at room temperature.
INDICATION
ARBLI™ is an angiotensin II receptor blocker (ARB) indicated for:
- Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.
- Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.
IMPORTANT SAFETY INFORMATION
- Do not take ARBLI™ when pregnant. When pregnancy is detected, discontinue ARBLI™ as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ARBLI™ can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
- Do not co-administer ARBLI™ with aliskiren in patients with diabetes. Avoid use of aliskiren with ARBLI™ in patients with renal impairment (GFR <60 mL/min).
- Do not administer ARBLI™ in patients with severe hepatic impairment. ARBLI™ has not been studied in patients with severe hepatic impairment.
- The most common adverse reactions are (incidence ≥
2% and greater than placebo): dizziness, upper respiratory infection, nasal congestion, and back pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Scienture at 1-833-754-4917.
Please see the full Prescribing Information for complete product information. For more information, talk to your healthcare provider.
About Hypertension
Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg.
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 ARBLI™, 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
