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Last Updated: March 26, 2026

EDECRIN Drug Patent Profile


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Which patents cover Edecrin, and what generic alternatives are available?

Edecrin is a drug marketed by Bausch and is included in two NDAs.

The generic ingredient in EDECRIN is ethacrynic acid. There are thirteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ethacrynic acid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Edecrin

A generic version of EDECRIN was approved as ethacrynic acid by ADAPTIS on June 30th, 2016.

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Summary for EDECRIN
Drug patent expirations by year for EDECRIN
Drug Prices for EDECRIN

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Recent Clinical Trials for EDECRIN

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SponsorPhase
Eugene Lee, MDPhase 1
University of Kansas Medical CenterPhase 1

See all EDECRIN clinical trials

Pharmacology for EDECRIN
Drug ClassLoop Diuretic
Physiological EffectIncreased Diuresis at Loop of Henle

US Patents and Regulatory Information for EDECRIN

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bausch EDECRIN ethacrynic acid TABLET;ORAL 016092-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bausch EDECRIN ethacrynic acid TABLET;ORAL 016092-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Edecrin (Ethadrin)

Last updated: March 1, 2026

What Is the Current Market Position of Edecrin?

Edecrin, with the generic name ethacrynic acid, is a diuretic primarily prescribed for cases of edema associated with congestive heart failure, hepatic, or renal disease. It is a loop diuretic that is less commonly used today compared to agents like furosemide or bumetanide, due to its side effect profile and availability of alternative therapies.

  • Market share: Edecrin occupies a niche segment primarily in specialized or resistant cases. It accounts for less than 1% of the global diuretic market, which is valued at approximately USD 10 billion as of 2022.[1]
  • Regulatory status: Approved in multiple jurisdictions, including the US, EU, and Japan, but no recent updates suggest significant changes in its regulatory standing.
  • Sales volume: Market data indicates declining prescription volumes over the last decade, reflecting its reduced prominence in clinical guidelines.

What Are the Key Drivers Influencing Its Market Dynamics?

Clinical Guidelines and Prescribing Trends

  • The shift towards more potent or better-tolerated diuretics like loop diuretics (furosemide, bumetanide) and thiazides has reduced reliance on ethacrynic acid.
  • Edecrin's use is limited to specific cases of allergy or resistance to other diuretics, constraining its overall market growth.

Patent and Generic Status

  • Ethacrynic acid is off patent globally, existing as a generic medication for over 30 years.
  • High generic penetration reduces prices and margins, limiting financial incentives for pharmaceutical companies.

Competitive Landscape

  • Major competitors: Furosemide (Lasix), bumetanide, torsemide.
  • These alternatives offer similar efficacy with fewer side effects, particularly less ototoxicity associated with ethacrynic acid.

Regulatory Environment

  • Regulatory agencies have not introduced new restrictions or mandates for Edecrin.
  • Maintenance of approval relies largely on existing clinical data, which is limited compared to newer agents.

Patent Expirations and Market Saturation

  • Patent expiration dates: Ethacrynic acid's first patents expired in the late 1980s.
  • Market saturation persists, with little scope for expansion without formulation or indication modifications.

What Are the Financial Projections for Edecrin?

Revenue Trends

  • Global sales are estimated at USD 20-30 million annually, mostly from North America and Europe.[2]
  • Sales have declined at a compound annual growth rate (CAGR) of approximately 3% over the past decade.

Future Revenue Outlook

  • Projections suggest continued decline, driven by:

    • Aging population with increasing kidney and cardiovascular diseases.
    • Marginal improvements in alternative diuretics.
    • Limited new indications or formulations.
  • Market analysts predict that unless new clinical evidence emerges to reposition Edecrin, annual revenues could drop below USD 15 million by 2030.

Cost and Profitability

  • Manufacturing costs are low due to the generic status.
  • Margins are slim, estimated to be below 10%, primarily due to pricing pressures.

What Are the Opportunities and Risks?

Opportunities

  • Developing extended-release or combination formulations to improve compliance or efficacy.
  • Expanding indications to certain rare conditions, subject to clinical trials.
  • Strategic marketing targeting niche physician groups for resistant cases.

Risks

  • Regulatory shifts favoring newer, better-tolerated agents.
  • Pricing pressures from generic competition.
  • Declining prescription rates due to evolving clinical practices.

Summary Table

Parameter Value/Status
Market size USD 10 billion (diuretic market, 2022)
Edecrin market share Less than 1% (~USD 20-30 million annually)
CAGR (past decade) -3%
Patent status Off-patent since late 1980s
Regulatory approvals Approved globally; no recent updates
Major competitors Furosemide, bumetanide
Revenue forecast (2030) Below USD 15 million

Key Takeaways

  • Edecrin's position is stable but declining within the global diuretic market.
  • Limited growth prospects stem from clinical practice shifts, generic competition, and lack of new indications.
  • Potential exists for niche applications or formulation innovations, but market forces favor newer agents.
  • Revenue projections indicate continued attrition, with substantial reductions expected by 2030.
  • Cost structure favors low margins, making Edecrin less attractive for large-scale investment.

FAQs

Q1: What factors have contributed to the decline in Edecrin’s market share?
Clinical preference for other loop diuretics with better safety profiles and broader indications has reduced Edecrin’s prescribing.

Q2: Are there any recent efforts to reposition Edecrin in the market?
No prominent initiatives are publicly reported; focus remains on its niche or resistant-use cases.

Q3: How do the side effect profiles impact market dynamics?
Edecrin's association with ototoxicity limits its use, especially as safer alternatives are available.

Q4: Can reformulations boost Edecrin sales?
Potential exists, but regulatory and clinical validation hurdles may impede development.

Q5: What is the potential for Edecrin in developing countries?
Limited due to existing generics' affordability and competition from other low-cost diuretics.


References

[1] MarketWatch. (2022). Diuretic Market Size, Share & Trends Analysis.
[2] IQVIA. (2022). Global Sales Data for Diuretics.

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