SOAANZ Drug Patent Profile

When do Soaanz patents expire, and when can generic versions of Soaanz launch?

Soaanz is a drug marketed by Sarfe Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in SOAANZ is torsemide. There are sixteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the torsemide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Soaanz

A generic version of SOAANZ was approved as torsemide by STRIDES PHARMA on May 27^th, 2003.

Summary for SOAANZ

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
Patent Applications:	4,694
Drug Prices:	Drug price information for SOAANZ
What excipients (inactive ingredients) are in SOAANZ?	SOAANZ excipients list
DailyMed Link:	SOAANZ at DailyMed

See drug prices for SOAANZ

Pharmacology for SOAANZ

Drug Class	Loop Diuretic
Physiological Effect	Increased Diuresis at Loop of Henle

US Patents and Regulatory Information for SOAANZ

SOAANZ is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sarfe Pharms	SOAANZ	torsemide	TABLET;ORAL	213218-001	Jun 14, 2021		DISCN	Yes	No	10,154,963		Y
Sarfe Pharms	SOAANZ	torsemide	TABLET;ORAL	213218-003	Nov 17, 2021		RX	Yes	No
Sarfe Pharms	SOAANZ	torsemide	TABLET;ORAL	213218-002	Jun 14, 2021		DISCN	Yes	No	10,154,963		Y

International Patents for SOAANZ

See the table below for patents covering SOAANZ around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3065718	FORMULATIONS À LIBÉRATION CONTRÔLÉE COMPRENANT DU TORSÉMIDE (CONTROLLED-RELEASE FORMULATIONS COMPRISING TORSEMIDE)
World Intellectual Property Organization (WIPO)	2015050570

SOAANZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SOAANZ

Introduction to SOAANZ

SOAANZ, developed by Sarfez Pharmaceuticals Inc., is a new formulation of the loop diuretic torsemide, recently approved by the FDA for the treatment of edema associated with heart failure or renal disease in adults. This article delves into the market dynamics and financial trajectory of SOAANZ, examining its position within the broader diuretics market.

Market Context: Diuretics Global Market

The global diuretics market has been experiencing steady growth, driven by several key factors. The market size is projected to increase from $0.71 billion in 2023 to $0.75 billion in 2024, with a compound annual growth rate (CAGR) of 4.8%. By 2028, the market is expected to reach $0.88 billion, growing at a CAGR of 4.2%[1][4].

Driving Factors for Market Growth

Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases such as hypertension, heart failure, and renal disorders is a significant driver for the diuretics market. For instance, the Centers for Disease Control and Prevention reported that around 37 million people, or 15% of US adults, were afflicted by chronic kidney diseases in 2021[4].

Aging Population and Lifestyle Changes

An aging population and lifestyle changes, including the consumption of unhealthy, mineral-rich foods, contribute to the rise in kidney disorders and subsequently drive the demand for diuretic drugs[4].

Pharmaceutical Innovation and Clinical Guidelines

Continuous advancements in pharmaceutical innovation and the impact of clinical guidelines also play crucial roles in the market's growth. The adoption of personalized medicine and innovative drug development approaches are notable trends in the forecast period[1][4].

SOAANZ: A New Formulation of Torsemide

FDA Approval and Clinical Significance

SOAANZ was approved by the FDA based on the established safety and efficacy of the original torsemide formulation and a pharmacokinetic/pharmacodynamic study in healthy volunteers. This new formulation is designed to provide a gradual and sustained diuresis, potentially lowering the risk of excessive urination and hypokalemia[2].

Pharmacokinetics and Dosage

The pharmacokinetic profile of SOAANZ shows a lower peak serum concentration and a longer time to peak concentration compared to standard torsemide. The initial dosage of SOAANZ is 20 mg orally once daily, with the dose to be doubled until desired diuresis is achieved[2].

Market Position and Competition

Pricing and Cost

SOAANZ is significantly more expensive than the generic version of torsemide. A supply of 30 SOAANZ 20-mg tablets costs around $285, compared to $6.90 for generic torsemide. This pricing difference raises questions about the clinical advantage of SOAANZ over the original formulation[2][5].

Marketing and Distribution

Sarfez Pharmaceuticals Inc. has entered into a consulting agreement with Novo Integrated Sciences Inc. and Clinical Consultants International LLC to leverage their extensive network of hospitals, physicians, and independent pharmacies for the marketing and distribution of SOAANZ. This strategic partnership aims to enhance the reach and adoption of SOAANZ in the market[1][4].

Financial Trajectory

Revenue Projections

Given the overall growth of the diuretics market, SOAANZ is expected to contribute to the increasing revenues. However, its high price point may limit its market share compared to generic alternatives. The revenue generated by SOAANZ will depend on its adoption rate and the ability of Sarfez Pharmaceuticals to effectively market and distribute the drug[1][4].

Challenges and Opportunities

One of the significant challenges for SOAANZ is the competition from generic torsemide, which is substantially cheaper. However, the integration of telehealth and remote monitoring, as well as the use of digital health solutions, could provide opportunities for SOAANZ to differentiate itself and improve patient outcomes[1][4].

Impact of Drug Shortages

Price Erosion and Market Dynamics

Drug shortages, particularly affecting off-patent drugs with low prices, can impact the market dynamics. Price erosion, often driven by tenders and other market dynamics rather than competition between manufacturers, can threaten the sustainability and competitiveness of the pharmaceutical market. While SOAANZ is not an off-patent drug, understanding these broader market dynamics is crucial for long-term strategy[3].

Key Takeaways

• Market Growth: The diuretics market is expected to grow steadily, driven by the prevalence of chronic diseases, an aging population, and pharmaceutical innovation.
• SOAANZ Position: SOAANZ, a new formulation of torsemide, offers a gradual and sustained diuresis but is significantly more expensive than generic torsemide.
• Pricing and Competition: The high price of SOAANZ may limit its market share, despite its potential clinical advantages.
• Marketing and Distribution: Strategic partnerships are crucial for the effective marketing and distribution of SOAANZ.
• Financial Trajectory: SOAANZ's revenue will depend on its adoption rate and the ability to differentiate itself in a competitive market.

FAQs

What is SOAANZ and how is it different from generic torsemide?

SOAANZ is a new formulation of the loop diuretic torsemide, approved by the FDA for the treatment of edema associated with heart failure or renal disease. It is designed to provide a gradual and sustained diuresis, potentially reducing the risk of excessive urination and hypokalemia, but it is significantly more expensive than generic torsemide[2].

What are the key drivers of the diuretics market growth?

The key drivers include the increasing prevalence of chronic diseases such as hypertension and heart failure, an aging population, lifestyle changes, pharmaceutical innovation, and clinical guidelines[1][4].

How does the pricing of SOAANZ compare to generic torsemide?

A supply of 30 SOAANZ 20-mg tablets costs around $285, compared to $6.90 for generic torsemide. This significant price difference raises questions about the clinical advantage of SOAANZ over the original formulation[2][5].

What are the challenges faced by SOAANZ in the market?

SOAANZ faces competition from generic torsemide due to its high price point. Additionally, it must differentiate itself through effective marketing and distribution strategies to gain market share[1][4].

How does SOAANZ fit into the broader trend of personalized medicine and digital health solutions?

SOAANZ can benefit from the integration of telehealth and remote monitoring, as well as the use of digital health solutions, to improve patient outcomes and differentiate itself in the market[1][4].

What is the impact of drug shortages on the diuretics market?

Drug shortages, particularly affecting off-patent drugs, can lead to price erosion and threaten the sustainability and competitiveness of the pharmaceutical market. While SOAANZ is not directly affected, understanding these dynamics is important for long-term market strategy[3].

Sources

1. The Business Research Company: Diuretics Global Market Report 2024.
2. The Medical Letter: A New Torsemide Formulation (Soaanz) for Edema.
3. Office of Health Economics: The Dynamics of Drug Shortages.
4. Research and Markets: Diuretics Global Market Report 2024.
5. Drugs.com: Soaanz Prices, Coupons, Copay Cards & Patient Assistance.