Scienture Secures Third Patent for ARBLI Losartan Oral Suspension, Extending Market Exclusivity Through 2041
核心洞察
Scienture Holdings (搜索) received its third USPTO (搜索) patent for ARBLI (搜索) (losartan potassium) oral suspension, providing intellectual property protection through October 7, 2041.
ARBLI (搜索) represents the first and only FDA-approved ready-to-use liquid formulation of losartan, targeting the $241 million U.S. losartan market with approximately 72 million annual prescriptions.
The proprietary oral suspension addresses unmet needs for pediatric, geriatric, and other patients with swallowing difficulties, eliminating the variability associated with pharmacy compounding.
Scienture Holdings (搜索) Inc. (NASDAQ: SCNX) announced that the United States Patent and Trademark Office has granted its third patent covering ARBLI (搜索) (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 provides intellectual property protection through October 7, 2041.
Strengthening Intellectual Property Portfolio
"This third patent further strengthens our intellectual property portfolio around ARBLI (搜索) and reinforces the long-term value of this differentiated asset," commented Narasimhan Mani, President and co-CEO of Scienture. The patent grant extends market exclusivity for the company's proprietary formulation, positioning ARBLI as a protected therapeutic option in the competitive hypertension (搜索) treatment landscape.
ARBLI (搜索) addresses a significant market opportunity within the U.S. losartan market, which totals approximately $241 million annually with around 72 million prescriptions. The ready-to-dispense formulation eliminates the need for compounding and provides flexible dosing options for patients with oral adherence challenges.
Addressing Unmet Medical Needs
The oral suspension formulation specifically targets pediatric, geriatric, and other patient populations with difficulty swallowing tablets. By eliminating the variability and inconvenience associated with pharmacy compounding, ARBLI (搜索) delivers a consistent, convenient, and scalable solution for healthcare providers.
ARBLI (搜索) is FDA-approved for multiple indications, including treatment of hypertension (搜索) in patients greater than six years old, reducing the risk of stroke (搜索) in patients with hypertension and left ventricular hypertrophy (搜索), and treating diabetic nephropathy (搜索) in certain patients with type 2 diabetes (搜索). The formulation 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 when stored at room temperature.
Commercial Progress and Market Position
Since its commercial launch, Scienture has made meaningful progress in advancing ARBLI (搜索) 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 (搜索), 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."
Clinical Significance and Safety Profile
As an angiotensin II receptor (搜索) blocker (ARB), ARBLI (搜索) provides the same therapeutic benefits as tablet formulations of losartan while addressing compliance challenges in specific patient populations. The most common adverse reactions include dizziness, upper respiratory infection, nasal congestion, and back pain, with an incidence of 2% or greater compared to placebo.
The formulation addresses critical safety considerations, including contraindications during pregnancy and specific warnings for patients with diabetes or renal impairment when used with aliskiren. The product has not been studied in patients with severe hepatic impairment.
Hypertension (搜索) affects nearly half of adults in the United States, or 119.9 million people according to the CDC, representing a substantial patient population that could benefit from improved treatment options. The condition is defined as systolic blood pressure of 140 mmHg or higher and diastolic blood pressure of 90 mmHg or higher, and serves as a risk factor for stroke (搜索) and heart disease.