Ethacrynate sodium - Generic Drug Details

What are the generic sources for ethacrynate sodium and what is the scope of patent protection?

Ethacrynate sodium is the generic ingredient in two branded drugs marketed by Bausch, Endo Operations, Mylan Institutional, Sterimax, and Zydus Pharms, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for ethacrynate sodium. Five suppliers are listed for this compound.

Summary for ethacrynate sodium

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	13
Patent Applications:	532
What excipients (inactive ingredients) are in ethacrynate sodium?	ethacrynate sodium excipients list
DailyMed Link:	ethacrynate sodium at DailyMed

Pharmacology for ethacrynate sodium

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

US Patents and Regulatory Information for ethacrynate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Institutional	ETHACRYNATE SODIUM	ethacrynate sodium	INJECTABLE;INJECTION	204634-001	Aug 23, 2016	AP	RX	No	No
Endo Operations	ETHACRYNATE SODIUM	ethacrynate sodium	INJECTABLE;INJECTION	205473-001	Jul 29, 2015	AP	RX	No	No
Sterimax	ETHACRYNATE SODIUM	ethacrynate sodium	INJECTABLE;INJECTION	208663-001	Jun 9, 2020	AP	RX	No	No

Ethacrynate sodium Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Ethacrynate Sodium

Introduction to Ethacrynate Sodium

Ethacrynate sodium, a derivative of ethacrynic acid, is a potent loop diuretic that acts on the ascending limb of the loop of Henle and the proximal and distal tubules, inhibiting the symport of sodium, potassium, and chloride. This action results in increased urinary output and a reduction in extracellular fluid, making it effective in managing conditions such as edema, kidney failure, and hypertension[2][5].

Market Size and Growth

The global loop diuretic market, which includes ethacrynate sodium, is projected to experience significant growth over the coming years. As of 2022, the global loop diuretic market was valued at USD 2,472.84 million and is expected to reach USD 3,021.80 million by 2030, growing at a CAGR of 2.6% during the forecast period of 2023-2030[1].

In a broader context, the loop diuretics market is anticipated to expand more rapidly, with a market size valued at USD 2.49 billion in 2023 and expected to cross USD 5.86 billion by 2036, growing at a CAGR of more than 6.8% during the forecast period of 2024-2036[4].

Key Drivers of Market Growth

Several factors are driving the growth of the loop diuretic market, including:

• Increasing Prevalence of Chronic Diseases: The rising incidence of hypertension, kidney diseases, and other chronic conditions globally is a significant driver. These conditions necessitate effective diuretic therapy, boosting the demand for loop diuretics like ethacrynate sodium[1][4].
• Advancements in Technology: Improvements in drug formulation and delivery systems enhance the efficacy and safety of loop diuretics, attracting more patients and healthcare providers[1][4].
• Growing Geriatric Population: The increasing age of the global population contributes to higher rates of chronic diseases, thereby increasing the demand for loop diuretics[1][4].
• Lifestyle Changes: Sedentary lifestyles and poor eating habits lead to a higher incidence of hypertension and other lifestyle-related diseases, further driving the market[4].

Segmentation and Market Share

The loop diuretic market is segmented based on drugs, indications, routes of administration, end-users, and distribution channels.

• Drugs: Ethacrynate sodium, along with other loop diuretics like furosemide, torsemide, and bumetanide, constitutes a significant segment of the market[1].
• Indications: The market is driven by various indications such as edema, kidney failure, nephrotic syndrome, liver cirrhosis, heart failure, and hypertension. The hypertension segment is anticipated to grab the largest share due to the increasing occurrence of high blood pressure globally[4].
• Route of Administration: Oral administration is the most common and preferred route, expected to grow significantly due to its convenience and safety[4].

Geographical Analysis

Geographically, the loop diuretic market is segmented into North America, Latin America, Europe, Asia Pacific, and the Middle East & Africa.

• North America: This region dominates the market due to detrimental lifestyle changes and the presence of leading healthcare service providers. It is also a hub for research and development of advanced loop diuretics[4].
• Asia Pacific: Expected to dominate the majority of the revenue share by 2036, driven by the increasing prevalence of chronic diseases and a growing geriatric population in the region[4].

Financial Performance of Key Players

Companies like Gland Pharma Limited are significant players in the market. Gland Pharma has shown strong financial performance, with a consolidated revenue of INR 36,246 million in FY 2022-23. The company has expanded its product portfolio, including the commercialization of bumetanide in the US market, which is another loop diuretic. Their strategic focus on new geographies and product development is expected to drive future growth[3].

Challenges and Opportunities

While the market for loop diuretics like ethacrynate sodium is growing, there are several challenges and opportunities to consider:

• Challenges: Post-treatment complications, discontinuation of some drugs, and adverse side effects can hamper market growth. For instance, ethacrynate sodium can cause gastrointestinal issues, metabolic disturbances, and in rare cases, acute pancreatitis[2].
• Opportunities: The increasing patient population and lack of proper treatment for chronic diseases present significant opportunities for market growth. Advancements in technology and the growing geriatric population are also key opportunities[1][4].

Key Takeaways

• The global loop diuretic market, including ethacrynate sodium, is expected to grow significantly due to the increasing prevalence of chronic diseases and technological advancements.
• North America and Asia Pacific are key regions driving market growth.
• The market is segmented based on drugs, indications, routes of administration, and distribution channels, with oral administration being the most preferred.
• Companies like Gland Pharma Limited are expanding their product portfolios and geographical presence to capitalize on market opportunities.

FAQs

1. What is the primary mechanism of action of ethacrynate sodium? Ethacrynate sodium inhibits the symport of sodium, potassium, and chloride primarily in the ascending limb of Henle and also in the proximal and distal tubules, leading to increased urinary output and reduction in extracellular fluid[5].

2. What are the key drivers of the loop diuretic market? The key drivers include the increasing prevalence of chronic diseases, advancements in technology, growing geriatric population, and lifestyle changes[1][4].

3. Which region is expected to dominate the loop diuretic market by 2036? Asia Pacific is expected to dominate the majority of the revenue share by 2036 due to the increasing prevalence of chronic diseases and a growing geriatric population in the region[4].

4. What are the common side effects associated with ethacrynate sodium? Common side effects include gastrointestinal issues such as anorexia, malaise, abdominal discomfort, nausea, vomiting, and diarrhea. Rarely, it can cause acute pancreatitis and gastrointestinal bleeding[2].

5. Which companies are significant players in the loop diuretic market? Companies like Gland Pharma Limited are significant players, with a strong focus on expanding their product portfolios and geographical presence[3].

Cited Sources:

1. Data Bridge Market Research - Global Loop Diuretic Market – Industry Trends and Forecast to 2030
2. DailyMed - TABLETS - ETHACRYNIC ACID - and - INTRAVENOUS
3. Gland Pharma Limited - Annual Report 2022-23
4. Research Nester - Loop Diuretics Market Size & Share, Growth Analysis 2036
5. DrugBank Online - Ethacrynate sodium