Ethacrynic acid - Generic Drug Details

What are the generic drug 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, Endo Operations, Hikma, Lupin Ltd, Sciegen Pharms Inc, 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:	82
Clinical Trials:	4
Patent Applications:	6,582
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
Sintesi Research Srl	Phase 1
Aptuit Srl	Phase 1
Pari Pharma GmbH	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
Bausch	EDECRIN	ethacrynic acid	TABLET;ORAL	016092-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Sciegen Pharms Inc	ETHACRYNIC ACID	ethacrynic acid	TABLET;ORAL	211232-001	Aug 27, 2019	AB	RX	No	No
Agnitio	ETHACRYNIC ACID	ethacrynic acid	TABLET;ORAL	211809-001	Jul 12, 2019	AB	RX	No	No
Chartwell Rx	ETHACRYNIC ACID	ethacrynic acid	TABLET;ORAL	213240-001	Oct 19, 2020	AB	RX	No	No

Ethacrynic acid Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Ethacrynic Acid

Overview of Ethacrynic Acid

Ethacrynic acid is a loop diuretic used in the treatment of edema associated with various conditions, including heart failure, liver cirrhosis, and kidney disorders. It is part of a broader class of loop diuretics that also includes furosemide, torsemide, and bumetanide.

Market Size and Growth

The global loop diuretic market, which includes ethacrynic acid, is projected to grow from USD 2,472.84 million in 2022 to USD 3,021.80 million by 2030, with a Compound Annual Growth Rate (CAGR) of 2.6% during the forecast period of 2023-2030[1].

Segmentation and Ethacrynic Acid's Role

The loop diuretic market is segmented based on drugs, indications, routes of administration, end-users, and distribution channels. Ethacrynic acid is one of the key drugs within this market, alongside furosemide, torsemide, and bumetanide.

• Drugs: Ethacrynic acid, although less commonly used compared to furosemide, still holds a significant market share due to its efficacy in specific clinical scenarios[1][4].

Drivers of Market Growth

Several factors drive the growth of the loop diuretic market, including ethacrynic acid:

• Increasing Prevalence of Renal Diseases: The rising incidence of renal diseases, such as kidney failure and nephrotic syndrome, increases the demand for loop diuretics like ethacrynic acid[1].
• Advancements in Technology: Improvements in drug formulation and delivery systems enhance the efficacy and patient compliance of loop diuretics[1].
• Growing Geriatric Population: The increasing geriatric population, which is more prone to conditions requiring diuretic therapy, contributes to market growth[1].

Financial Performance

Revenue and Sales

• U.S. Sales: The ethacrynic acid tablet market in the United States had sales of approximately $17 million for the 12 months ending April 2020. This figure indicates a stable, though not booming, market for this specific drug[5].
• Global Context: While ethacrynic acid's sales are a fraction of the overall loop diuretic market, it contributes to the overall revenue growth. The global loop diuretic market's projected growth to USD 3,021.80 million by 2030 suggests that ethacrynic acid will continue to generate significant revenue[1].

Pricing Trends

The pricing of ethacrynic acid has seen significant fluctuations over the years:

• Price Hikes and Controversies: In the past, there have been controversies surrounding price hikes, particularly by Valeant Pharmaceuticals (now Bausch Health US, LLC). The price per tablet increased dramatically from $5.24 in 2013 to $21.72 in 2016[5].
• Generic Competition: The introduction of generic versions has led to a decrease in prices. As of February 2021, the average price paid by pharmacies was $5.69 per 25 MG tablet, with multiple generic manufacturers contributing to the market[5].

Distribution and End-Users

Distribution Channels

Ethacrynic acid is distributed through various channels:

• Hospital Pharmacies: A significant portion of loop diuretics, including ethacrynic acid, are distributed through hospital pharmacies due to their use in acute care settings[1][4].
• Retail Pharmacies: Retail pharmacies also play a crucial role, especially for patients requiring long-term diuretic therapy[1][4].
• Online Pharmacies: The rise of online pharmacies has provided another distribution channel, though this is less common for prescription-only medications like ethacrynic acid[1].

End-Users

The primary end-users of ethacrynic acid include:

• Hospitals: Hospitals are major consumers due to the drug's use in managing acute conditions such as heart failure and kidney failure[1][4].
• Homecare: Homecare settings also use ethacrynic acid, particularly for patients requiring ongoing diuretic therapy[1][4].

Challenges and Opportunities

Challenges

• Post-Treatment Complications: Adverse side effects and post-treatment complications can hamper the market growth of loop diuretics, including ethacrynic acid[1].
• Discontinuation of Drugs: The discontinuation of certain loop diuretics due to safety concerns or the introduction of newer, safer alternatives can impact the market negatively[1].

Opportunities

• Expanding Applications: The potential for off-label use and expanding indications, such as in the treatment of neuropathic pain, could increase the demand for loop diuretics[1].
• Increasing Patient Population: The growing patient population with conditions requiring diuretic therapy presents an opportunity for market growth[1].

Regional Market Dynamics

North America

North America dominates the global loop diuretic market, including ethacrynic acid, due to high product approvals and government initiatives to raise awareness about related diseases[1].

Asia-Pacific

The Asia-Pacific region is expected to show significant growth during the forecast period due to the rising prevalence of acute conditions such as kidney failure and heart failure[1].

Key Takeaways

• Market Growth: The global loop diuretic market, including ethacrynic acid, is expected to grow at a CAGR of 2.6% from 2023 to 2030.
• Revenue: Ethacrynic acid contributes to the overall revenue of the loop diuretic market, with U.S. sales of approximately $17 million in 2020.
• Pricing Trends: The price of ethacrynic acid has fluctuated significantly, with generic competition leading to lower prices.
• Distribution and End-Users: Hospital pharmacies and homecare settings are key distribution channels and end-users.
• Challenges and Opportunities: The market faces challenges from post-treatment complications and drug discontinuations but has opportunities in expanding applications and a growing patient population.

FAQs

What is the projected market size for the global loop diuretic market by 2030?

The global loop diuretic market is expected to reach USD 3,021.80 million by 2030[1].

What are the primary drivers of the loop diuretic market growth?

The primary drivers include the increasing prevalence of renal diseases, advancements in technology, and the growing geriatric population[1].

How has the pricing of ethacrynic acid changed over the years?

The pricing of ethacrynic acid has seen significant fluctuations, with a notable price hike from $5.24 in 2013 to $21.72 in 2016, followed by a decrease to $5.69 per tablet with the introduction of generic versions[5].

What are the main distribution channels for ethacrynic acid?

The main distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies[1][4].

Which regions are expected to show significant growth in the loop diuretic market?

North America currently dominates the market, while the Asia-Pacific region is expected to show significant growth during the forecast period[1].

Sources

1. Data Bridge Market Research: Global Loop Diuretic Market – Industry Trends and Forecast to 2030.
2. scPharmaceuticals Inc.: Reports First Quarter 2024 Financial Results.
3. Federal Trade Commission: Sales, Promotion, and Product Differentiation in Two Prescription Drug Markets.
4. Market Research Future: Loop Diuretic Market Size, Growth, Trends, Report 2032.
5. Wikipedia: Ethacrynic acid.