ETHACRYNATE SODIUM - Generic Drug Details

What are the generic sources for ethacrynate sodium and what is the scope of freedom to operate?

Ethacrynate sodium is the generic ingredient in two branded drugs marketed by Bausch, Mylan Institutional, Ph Health, 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. Two 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:	2
Raw Ingredient (Bulk) Api Vendors:	16
Patent Applications:	880
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
Bausch	EDECRIN	ethacrynate sodium	INJECTABLE;INJECTION	016093-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Sterimax	ETHACRYNATE SODIUM	ethacrynate sodium	INJECTABLE;INJECTION	208663-001	Jun 9, 2020	AP	RX	No	No
Zydus Pharms	ETHACRYNATE SODIUM	ethacrynate sodium	INJECTABLE;INJECTION	207758-001	Nov 17, 2017	AP	RX	No	No
Mylan Institutional	ETHACRYNATE SODIUM	ethacrynate sodium	INJECTABLE;INJECTION	204634-001	Aug 23, 2016		DISCN	No	No
Ph Health	ETHACRYNATE SODIUM	ethacrynate sodium	INJECTABLE;INJECTION	205473-001	Jul 29, 2015	AP	RX	No	No

Market Dynamics and Financial Trajectory for Ethacrynate Sodium

Last updated: January 26, 2026

Summary

Ethacrynate sodium, a potent loop diuretic primarily used for edema associated with heart failure, liver disease, and renal conditions, has a niche but steady market presence. Its market dynamics are shaped by evolving clinical practices, regulatory frameworks, and competition from newer agents. Currently, the global pharmaceutical landscape for ethacrynate sodium remains relatively stable, with incremental growth driven by regional healthcare needs and formulary preferences. Financial trajectories predict modest but consistent revenue streams, influenced predominantly by patent status, manufacturing costs, and healthcare policies.

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What Are the Key Market Drivers for Ethacrynate Sodium?

Factor	Impact	Details
Clinical Efficacy and Safety	Positive	Recognized for effective diuretic action, especially in cases resistant to other agents.
Institutional Formularies	Steady demand	Widely adopted in hospitals, clinics, and dialysis centers.
Regulatory Approvals	Limited new approvals	Existing approvals maintained; minimal new indications.
Healthcare Infrastructure	Growing markets in low-to-middle income countries	Expansion of healthcare capacity increases demand.
Competitive Landscape	Moderate competition	Competition from drugs like furosemide, bumetanide, and torsemide.

How Do Regulatory Policies Influence Market Dynamics?

Aspect	Effect	Details
Patent Status	Market exclusivity limited post expiration	No current patents restrict generic manufacturing; market largely commoditized.
Regulatory Approvals	Stability in supply chain	Generally registered for essential uses; regulatory hurdles minimal in key markets.
Pricing Regulations	Varies regionally	Price controls in certain countries influence profitability and access.
Reimbursement Policies	Affects utilization	Reimbursement rates for hospital-administered drugs impact volumes.

What Is the Current Competitive Landscape?

Major Players	Market Share (Estimate)	Notes
Generic Manufacturers	70-85%	Dominates due to patent expiry; low barriers to entry.
Brand Name (if any)	15-30%	Limited; primarily in specific institutional formulary settings.

Competitors	Key Alternatives	Differences
Furosemide (Lasix)	Most commonly used loop diuretic	More widely available; often more cost-effective.
Bumetanide	Similar efficacy to ethacrynate sodium	Higher potency; favored in some cases.
Torsemide	Longer half-life, improved compliance	Used increasingly but less prevalent.

What Are the Revenue Projections and Financial Trajectory?

Parameter	Current Estimate / Trend	Implications
Global Market Size (2022)	~$50-70 million	Based on regional sales data and hospital formulary inclusion.
Growth Rate (CAGR, 2023-2028)	2-3%	Steady growth driven by hospital demand and regional healthcare expansion.
Major Revenue Contributors	North America, Europe, parts of Asia	Market size largest in developed nations with established hospital systems.
Price Trends	Slight decline or stabilization post-generic entry	Competition and patent expiry suppress premium pricing.

Key Factors Affecting Revenue	Description
Patent Expiry	No current patents; generic competition caps pricing.
Manufacturing Costs	Moderate; economies of scale possible with increased volume.
Regulatory Environment	Stable; some markets face price controls.
Market Penetration	Limited newer indications restrict growth beyond current use cases.

How Does Ethacrynate Sodium Fit Into Broader Diuretic Market Trends?

Trend	Impact on Ethacrynate Sodium Market
Shift Toward Newer Loop Diuretics	Slight decline due to preference for more potent, longer-acting agents.
Generic Drug Penetration	Increased commoditization reduces profitability, stabilizes market size.
Emergence of Combination therapies	Minimal impact; alternative combination treatments less relevant for ethacrynate sodium.
Growing Global Healthcare Access	Expands market in underserved regions, maintaining demand.

What Are the Challenges Facing Ethacrynate Sodium Market?

Challenge	Description
Limited Innovation	Few new indications or formulations; innovation constrained by existing approvals.
Market Competition	Price competition from generics and alternative diuretics reduces margins.
Regional Disparities	Limited access in low-income regions; regulatory and supply chain issues.
Prescriber Preference	Preference for other diuretics with better side effect profiles or pharmacokinetics.

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Comparative Table: Ethacrynate Sodium Versus Key Diuretics

Parameter	Ethacrynate Sodium	Furosemide	Bumetanide	Torsemide
Potency	Moderate	High	High	High
Duration of Action	Short	Short	Short	Longer
Administration Route	IV/IM	Oral/IV	Oral/IV	Oral/IV
Indications	Edema, resistant cases	Edema, hypertension	Edema, hypertension	Edema, hypertension, chronic heart failure
Cost Factors	Low and stable	Very low	Low	Slightly higher
Market Share	Niche	Dominant in hospitals	Limited	Increasing in some regions

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Key Takeaways

• Ethacrynate sodium sustains a niche role as an effective loop diuretic, especially for resistant cases.
• The global market remains stable, with modest growth projections (~2-3% CAGR) driven by regional healthcare development.
• Patent expiration and generic competition significantly influence pricing and profitability.
• Market dynamics favor low-cost generics, with competition mainly from other existing diuretics.
• The increasing adoption of newer agents with better pharmacokinetic profiles may marginally impact future demand.

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FAQs

1. What factors influence the price of ethacrynate sodium?
Pricing is influenced by generic competition, manufacturing costs, regional price regulations, and hospital purchasing policies. Patent expiry leads to lower prices.

2. Are there new indications or formulations in development for ethacrynate sodium?
Currently, no significant new indications or formulations are under active development, limiting innovation-driven growth.

3. How does regional healthcare infrastructure affect its market?
Developing healthcare systems in low- and middle-income countries increase demand, though regulatory and supply challenges may limit uptake.

4. What alternative drugs are most competitive with ethacrynate sodium?
Furosemide is the most prevalent alternative, with bumetanide and torsemide also competing, especially in specific clinical scenarios.

5. How might regulatory frameworks impact future market dynamics?
Stringent regulations, pricing controls, and reimbursement policies may suppress profitability but ensure ongoing supply stability.

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References

[1] Market research reports, 2022.
[2] FDA and EMA drug approval databases.
[3] Global healthcare expenditure data, WHO.
[4] Industry publications and pricing analyses, 2022-2023.