SCIENTURE announces FDA Orange Book Patent Listing for ArbliTM, (losartanpotassium) Oral Suspension, 10mg/mL.

Associated Press

19-05-2025

TAMPA, FL, May 19, 2025 (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 developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce that the U.S. Food and Drug Administration (FDA) has listed U.S. Patent Nos. 11890273 (the '273 patent) and 12156869 (the '869 patent), each with an expiration date of October 2041, in its Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for Arbli™, (losartan potassium) Oral Suspension, 10mg/mL, approved under New Drug Application (NDA# N218772).
The '869 patent and the '273 patent, both titled, 'Losartan Liquid Formulations and Methods of Use,' cover stable, liquid pharmaceutical compositions of Losartan and methods of treating patients in need of Losartan by administration of the novel formulations described. The listing reinforces Scienture's intellectual property position and may serve as a basis for statutory exclusivity and market protection under the Hatch-Waxman Act.
Arbli™ is meant for the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes. Arbli™ is the first and only FDA approved ready-to-use oral liquid losartan in the U.S. market.
Arbli™ is a novel proprietary formulation of losartan, a proven therapy for treating hypertension, which provides a tailored approach to patients that require or prefer an oral liquid option of losartan. Appropriate dosing is now easier, safe and effective, while providing the assurance of quality as an FDA-approved product. Arbli™ provides a safe and convenient option to patients requiring a liquid formulation and addresses the intrinsic risks associated with potential inconsistencies in the process of crushing tablets to extemporaneously compound losartan prescriptions.
Losartan is classified as an angiotensin receptor blocker (ARB) for treating hypertension and is one of the highest prescribed molecules for this indication. Current products in the market containing losartan are available only as oral solids, which can be further compounded to a liquid formulation. Arbli™ is the first 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. IQVIA data (March 2025) indicates a total annual sales of approximately $276 million and a prescription volume of 69 million (TRx) for losartan in the US market.
'This Orange Book listing marks a major regulatory milestone for our company and reaffirms our commitment to bringing safe, effective, and high-quality treatments to patients.' said Shankar Hariharan, Ph.D., President of Scienture, LLC. 'It's a testament to the rigor of our development program and the dedication of our team.'
'The listing of patents for Arbli™ in the Orange Book strengthens our IP position and enhances our commercial pathway in the U.S. market,' remarked Narasimhan Mani, Ph.D., MBA President of Scienture, LLC..' It validates our science, our team, and our belief in patient-first innovation. It is a key step forward in our mission to bring accessible, high-impact therapies to those who need them most.'
About Arbli™
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 18 months from the date of manufacture when stored at room temperature, based on the data submitted in the NDA. Once the 24-months stability data is submitted to the FDA, the shelf-life of the product is expected to be extended to 24-months at room temperature.
INDICATION
Arbli™ is an angiotensin II receptor blocker (ARB) indicated for:
IMPORTANT SAFETY INFORMATION
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'), is the parent company of its wholly owned subsidiary, Scienture, LLC 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, LLC are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit and www.scientureholdings.com.
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SCIENTURE HOLDINGS, INC.
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Tampa, Florida 33634
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