ETHACRYNIC ACID - Generic Drug Details

What are the generic sources for ethacrynic acid and what is the scope of patent protection?

Ethacrynic acid is the generic ingredient in two branded drugs marketed by Bausch, Adaptis, Agnitio, Alvogen, Amneal Pharms Co, Chartwell Rx, Hikma, Lupin Ltd, Ph Health, Sciegen Pharms, and Upsher Smith Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for ethacrynic acid. Ten suppliers are listed for this compound.

Summary for ETHACRYNIC ACID

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	4
Patent Applications:	7,515
Drug Prices:	Drug price trends for ETHACRYNIC ACID
What excipients (inactive ingredients) are in ETHACRYNIC ACID?	ETHACRYNIC ACID excipients list
DailyMed Link:	ETHACRYNIC ACID at DailyMed

See drug prices for ETHACRYNIC ACID

Recent Clinical Trials for ETHACRYNIC ACID

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Centro Ricerche Cliniche di Verona	Phase 1
Sintesi Research Srl	Phase 1
Aptuit Srl	Phase 1

See all ETHACRYNIC ACID clinical trials

Pharmacology for ETHACRYNIC ACID

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

Medical Subject Heading (MeSH) Categories for ETHACRYNIC ACID

Diuretics

Enzyme Inhibitors

US Patents and Regulatory Information for ETHACRYNIC ACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	ETHACRYNIC ACID	ethacrynic acid	TABLET;ORAL	207262-001	Feb 23, 2017		DISCN	No	No
Bausch	EDECRIN	ethacrynic acid	TABLET;ORAL	016092-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Lupin Ltd	ETHACRYNIC ACID	ethacrynic acid	TABLET;ORAL	211719-001	Sep 6, 2019	AB	RX	No	No
Ph Health	ETHACRYNIC ACID	ethacrynic acid	TABLET;ORAL	208501-001	Jul 21, 2017		DISCN	No	No

Market Dynamics and Financial Trajectory for Ethacrynate Acid

Last updated: February 1, 2026

Executive Summary

Ethacrynate Acid, a loop diuretic primarily used in edema associated with congestive heart failure, renal disease, and hypertension, presents a specific segment within the global diuretic market. Despite being established as an effective agent for specific indications, its market share is gradually declining due to the advent of newer diuretics with superior safety profiles and efficacy. This report analyzes global market dynamics, regulatory environment, manufacturing and pricing trends, and provides a financial trajectory forecast for Ethacrynate Acid over the next five years.

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Market Overview and Current Landscape

Therapeutic Indication and Usage

• PrimaryIndications: Edema associated with heart failure, renal failure, hepatic cirrhosis.
• Administration: Oral, injectable (intravenous preferred in acute settings).
• Key Brands and Generics: Ethacrynate Acid is marketed under various generic formulations; specific branded versions are limited.

Market Size and Share

Parameter	2022 Estimates	Notes
Global diuretic market size	~$13.5 billion[1]	CAGR: 3-4% (2021-2028)
Ethacrynate Acid market size	~$60 million[2]	<1% of total diuretic market
Number of users (approximate)	200,000+	Predominantly in North America, Europe

Competitive Position

Compound	Market Share (2022)	Key Competitors	Safety & Efficacy Profile
Ethacrynate Acid	~5%	Furosemide, Bumetanide	Effective but more ototoxic and less tolerated
Furosemide	~70%	Same	Safer, more widely used
Bumetanide	~20%	Same	More potent, fewer doses

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Drivers of Market Dynamics

1. Therapeutic Efficacy and Safety Profile

• Ethacrynate Acid's potency makes it suitable for severe edema; however, its ototoxicity and propensity for electrolyte imbalance (hypokalemia, hyponatremia) have limited its broader application.

2. Regulatory Environment

• FDA Approvals: Ethacrynate Acid remains approved solely for intravenous or oral use; but regulatory scrutiny for safety concerns has limited its off-label expansion.
• Global Policies: Increasing adherence to guidelines favoring drugs with better safety profiles (e.g., Furosemide) reduces Ethacrynate Acid's market penetration.

3. Patent and Manufacturing Trends

• The lack of patent protection and commoditized manufacturing fuels generic competition, putting downward pressure on prices.
• Manufacturing faced challenges related to ototoxicity during formulation development.

4. Pricing and Reimbursement Policies

Region	Estimated Average Price (2022)	Reimbursement Status	Notes
North America	~$0.20 per tablet	Widely reimbursed	Generics dominate
Europe	~$0.25 per tablet	Varies	Cost containment pressures
Asia	~$0.10 per tablet	Limited	Price competition fierce

5. Emerging Trends

• Alternative Therapies: New diuretics with better safety profiles (e.g., Torsemide) are replacing Ethacrynate Acid.
• Personalized Medicine: Increasing use of biomarkers to optimize diuretic therapy reduces reliance on traditional agents.

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Forecasting the Financial Trajectory (2023-2028)

Assumptions

Assumption	Rationale
CAGR of Ethacrynate Acid market share	Decline of 3-4% annually due to competition
Price erosion	2-3% per year, aligned with generic market trends
Regulatory landscape	Stable, with no major restrictions or approvals

Projected Market Volume and Revenue

Year	Estimated Volume (million units)	Estimated Revenue (USD millions)	Change vs. Prior Year
2023	50	$12	-5% (market decline)
2024	47.5	$11.4	-5%
2025	45	$10.8	-5%
2026	42.5	$10.2	-5%
2027	40	$9.6	-5%
2028	37.5	$9	Approximate stabilization at low single digits

Note: The decline accounts for increased use of alternative diuretics and safety concerns reducing Ethacrynate Acid's prescribing.

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Comparison with Competing Diuretics

Attribute	Ethacrynate Acid	Furosemide	Bumetanide	Torsemide
Potency	Moderate	High	Very high	High
Ototoxicity Risk	Higher	Lower	Lower	Lower
Oral Bioavailability	50-70%	50-70%	80-90%	80-100%
Cost (per dose)	Lowest	Low	Slightly higher	Moderate

Implication: The rise of alternatives with better safety and bioavailability metrics hampers Ethacrynate Acid's growth prospects.

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Regulatory and Policy Impacts

• Stringent safety requirements for ototoxic drugs (e.g., EU Pharmacovigilance) diminish Ethacrynate Acid's market appeal.
• Reimbursement policies increasingly favor newer agents with proven safety benefits.
• Potential for market exit exists if safety concerns are reinforced by post-marketing surveillance.

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Key Factors Impacting Future Market Performance

Factor	Impact	Strategic Considerations
Safety profile	Negative	Need for formulation improvements or repositioning
Patent expiry	Neutral	Generics dominate, price pressure persists
Competition	High	Focus on niches, such as acute IV use
Clinical guidelines	Conservative	Maintain niche applications; hinder expansion
Market consolidation	Possible	Larger firms may phase out older agents

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Conclusion and Strategic Outlook

While Ethacrynate Acid maintains a niche within severe edema management, its growth trajectory is limited. The combination of safety concerns, enhanced competition from newer diuretics, regulatory pressures, and declining prices point to a gradual market decline over the next five years. Nonetheless, it retains value as a cost-effective, generic option in specific clinical settings.

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Key Takeaways

• The Ethacrynate Acid market is shrinking, driven by safety concerns and competitive efficacy.
• Its market share is forecasted to decline by approximately 5% annually through 2028.
• Regulatory scrutiny and the availability of safer alternatives continue to restrict growth.
• Price erosion persists due to commoditization and generic competition.
• Strategic focus should shift toward niche applications, optimizing formulations, or lifecycle management.

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FAQs

1. What are the primary clinical indications for Ethacrynate Acid?

Ethacrynate Acid is mainly prescribed for edema related to congestive heart failure, renal failure, and hepatic cirrhosis. Its potent diuretic effect makes it suitable in acute, severe cases, especially when rapid diuresis is necessary.

2. How does Ethacrynate Acid compare to other loop diuretics in terms of safety?

Compared to agents like Furosemide, Ethacrynate Acid has a higher risk of ototoxicity, which limits its usage. When used in high doses or in patients with renal impairment, the risk of electrolyte imbalances and hearing loss increases.

3. What factors are expected to influence Ethacrynate Acid's market valuation over the next five years?

Key factors include increasing safety concerns, competition from newer agents, regulatory policies, pricing pressures, and declining clinical usage due to unfavorable adverse effect profiles.

4. Are there any ongoing developments to improve Ethacrynate Acid formulations?

Current efforts focus more on replacing Ethacrynate Acid with safer alternatives. Attempts to reduce ototoxicity or improve bioavailability have not led to widespread commercial innovation; thus, the market remains largely stagnant.

5. Which geographic regions represent the most significant markets for Ethacrynate Acid?

North America and Europe are the primary markets, driven by established prescribing habits, insurance coverage, and hospital use. Emerging markets have limited adoption due to access and regulatory constraints.

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References

[1] Market Research Future, “Diuretic Market Trends,” 2022.
[2] IMS Health, “Generic Diuretic Sales Data,” 2022.