SCIENTURE announces FDA Orange Book Patent Listing for ArbliTM, (losartanpotassium) Oral Suspension, 10mg/mL.
Scienture Holdings (NASDAQ: SCNX) announces FDA Orange Book listing of two patents for Arbli™, their losartan potassium oral suspension. The patents (11890273 and 12156869), expiring in October 2041, cover stable liquid formulations and treatment methods for Arbli™, the first FDA-approved ready-to-use oral liquid losartan in the U.S.
Arbli™ (10mg/mL) is approved for treating hypertension in patients over 6 years old, reducing stroke risk in hypertensive patients with left ventricular hypertrophy, and treating diabetic nephropathy in type 2 diabetes patients. The product addresses the limitations of current tablet-only options, eliminating compounding risks and offering convenient dosing.
According to IQVIA data (March 2025), the U.S. losartan market shows annual sales of $276 million with 69 million prescriptions.
Scienture Holdings (NASDAQ: SCNX) annuncia l'inserimento di due brevetti per Arbli™, la loro sospensione orale di losartan potassico, nel FDA Orange Book. I brevetti (11890273 e 12156869), con scadenza a ottobre 2041, riguardano formulazioni liquide stabili e metodi di trattamento per Arbli™, il primo losartan liquido orale pronto all'uso approvato dalla FDA negli Stati Uniti.
Arbli™ (10mg/mL) è approvato per il trattamento dell'ipertensione in pazienti sopra i 6 anni, per ridurre il rischio di ictus nei pazienti ipertesi con ipertrofia ventricolare sinistra e per il trattamento della nefropatia diabetica nei pazienti con diabete di tipo 2. Il prodotto supera i limiti delle attuali opzioni esclusivamente in compresse, eliminando i rischi legati alla preparazione e offrendo una somministrazione più comoda.
Secondo i dati IQVIA (marzo 2025), il mercato statunitense del losartan registra vendite annuali di 276 milioni di dollari con 69 milioni di prescrizioni.
Scienture Holdings (NASDAQ: SCNX) anuncia la inclusión en el FDA Orange Book de dos patentes para Arbli™, su suspensión oral de losartán potásico. Las patentes (11890273 y 12156869), que expiran en octubre de 2041, cubren formulaciones líquidas estables y métodos de tratamiento para Arbli™, el primer losartán líquido oral listo para usar aprobado por la FDA en EE.UU.
Arbli™ (10mg/mL) está aprobado para el tratamiento de la hipertensión en pacientes mayores de 6 años, la reducción del riesgo de accidente cerebrovascular en pacientes hipertensos con hipertrofia ventricular izquierda, y el tratamiento de la nefropatía diabética en pacientes con diabetes tipo 2. El producto supera las limitaciones de las opciones actuales solo en tabletas, eliminando riesgos de preparación y ofreciendo una dosificación conveniente.
Según los datos de IQVIA (marzo 2025), el mercado estadounidense de losartán muestra ventas anuales de 276 millones de dólares con 69 millones de prescripciones.
Scienture Holdings (NASDAQ: SCNX)는 그들의 로사르탄 칼륨 경구용 현탁액인 Arbli™에 대한 두 건의 특허가 FDA 오렌지 북에 등재되었음을 발표했습니다. 이 특허들(11890273 및 12156869)은 2041년 10월까지 유효하며, 안정적인 액상 제형과 Arbli™의 치료 방법을 포함하며, 미국에서 FDA 승인을 받은 최초의 즉시 사용 가능한 경구용 로사르탄 액상입니다.
Arbli™ (10mg/mL)는 6세 이상 환자의 고혈압 치료, 좌심실 비대가 있는 고혈압 환자의 뇌졸중 위험 감소, 2형 당뇨병 환자의 당뇨병성 신증 치료에 승인되었습니다. 이 제품은 현재 정제형 제품의 한계를 극복하여 조제 위험을 없애고 편리한 복용을 제공합니다.
IQVIA 데이터(2025년 3월 기준)에 따르면, 미국 로사르탄 시장은 연간 매출 2억 7,600만 달러와 6,900만 건의 처방전을 기록하고 있습니다.
Scienture Holdings (NASDAQ : SCNX) annonce l'inscription de deux brevets pour Arbli™, leur suspension orale de losartan potassium, dans le FDA Orange Book. Les brevets (11890273 et 12156869), expirant en octobre 2041, couvrent des formulations liquides stables et des méthodes de traitement pour Arbli™, le premier losartan oral liquide prêt à l'emploi approuvé par la FDA aux États-Unis.
Arbli™ (10mg/mL) est approuvé pour le traitement de l'hypertension chez les patients de plus de 6 ans, la réduction du risque d'accident vasculaire cérébral chez les patients hypertendus avec hypertrophie ventriculaire gauche, et le traitement de la néphropathie diabétique chez les patients diabétiques de type 2. Ce produit répond aux limites des options actuelles uniquement en comprimés, en éliminant les risques liés à la préparation et en offrant un dosage pratique.
Selon les données IQVIA (mars 2025), le marché américain du losartan affiche des ventes annuelles de 276 millions de dollars avec 69 millions d'ordonnances.
Scienture Holdings (NASDAQ: SCNX) gibt die Aufnahme von zwei Patenten für Arbli™, ihre orale Losartan-Kalium-Suspension, im FDA Orange Book bekannt. Die Patente (11890273 und 12156869), die im Oktober 2041 auslaufen, betreffen stabile flüssige Formulierungen und Behandlungsmethoden für Arbli™, das erste von der FDA zugelassene gebrauchsfertige orale flüssige Losartan in den USA.
Arbli™ (10mg/mL) ist zugelassen zur Behandlung von Bluthochdruck bei Patienten über 6 Jahren, zur Reduzierung des Schlaganfallrisikos bei hypertensiven Patienten mit linksventrikulärer Hypertrophie und zur Behandlung der diabetischen Nephropathie bei Patienten mit Typ-2-Diabetes. Das Produkt überwindet die Einschränkungen der derzeitigen ausschließlich Tabletten-basierten Optionen, eliminiert Risiken durch Herstellung und bietet eine bequeme Dosierung.
Laut IQVIA-Daten (März 2025) verzeichnet der US-Losartan-Markt einen Jahresumsatz von 276 Millionen US-Dollar bei 69 Millionen Verschreibungen.
- First and only FDA-approved ready-to-use oral liquid losartan in the U.S. market
- Patent protection until October 2041 providing market exclusivity
- Addresses a significant market with $276 million annual sales and 69 million prescriptions
- Eliminates risks associated with crushing tablets and compounding
- Room temperature storage capability with long-term shelf life
- None.
Insights
Scienture secures critical patent protection for Arbli through 2041, strengthening market position in the $276M losartan market.
Scienture's FDA Orange Book patent listings for Arbli represent a significant regulatory achievement with substantial commercial implications. The two patents (11890273 and 12156869) provide protection through October 2041, effectively creating nearly two decades of market exclusivity for this novel liquid formulation.
The patents cover both the stable liquid formulations and methods of treatment, creating robust barriers to generic competition. Under the Hatch-Waxman framework, these Orange Book listings trigger automatic 30-month stays against ANDA filers, substantially deterring generic challengers.
Particularly valuable is that Arbli addresses an unmet need in the substantial losartan market (
The formulation innovations appear substantive - including room temperature stability and reduced dosing volume - suggesting the patents may withstand potential validity challenges. For a specialty pharmaceutical company, securing this level of patent protection for a differentiated product within a large established market represents a textbook strategy for creating shareholder value through intellectual property.
Scienture can now confidently commercialize this product knowing they have robust patent protection against potential competitors through 2041, allowing them to recoup R&D investments and potentially capture significant market share in specific patient populations requiring liquid formulations.
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
“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:
- 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”), 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.
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, the timing of such launches, and the success those products may have in the marketplace. 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.
6308 Benjamin Rd, Suite 708
Tampa, Florida 33634
Phone: (866) 468-6535
Email: IR@Scienture.com
FAQ
What patents did SCNX receive for Arbli in the FDA Orange Book listing?
What is the market size for losartan in the US as of March 2025?
What medical conditions is Arbli approved to treat?
How is Scienture's Arbli different from existing losartan products?
What advantages does SCNX's Arbli offer over traditional losartan tablets?
