Ethanolamine oleate - Generic Drug Details

What are the generic drug sources for ethanolamine oleate and what is the scope of patent protection?

Ethanolamine oleate is the generic ingredient in one branded drug marketed by Qol Medcl and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for ethanolamine oleate. One supplier is listed for this compound.

Summary for ethanolamine oleate

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Patent Applications:	876
What excipients (inactive ingredients) are in ethanolamine oleate?	ethanolamine oleate excipients list
DailyMed Link:	ethanolamine oleate at DailyMed

Pharmacology for ethanolamine oleate

Drug Class	Sclerosing Agent
Mechanism of Action	Sclerosing Activity
Physiological Effect	Vascular Sclerosing Activity

US Patents and Regulatory Information for ethanolamine oleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Qol Medcl	ETHAMOLIN	ethanolamine oleate	INJECTABLE;INJECTION	019357-001	Dec 22, 1988		RX	Yes	Yes

Ethanolamine oleate Market Analysis and Financial Projection Experimental

Ethanolamine Oleate: Market Dynamics and Financial Trajectory

Introduction to Ethanolamine Oleate

Ethanolamine oleate is a compound derived from ethanolamine and oleic acid, commonly used in medical procedures, particularly in the treatment of esophageal varices through sclerotherapy.

Medical Applications of Ethanolamine Oleate

Ethanolamine oleate is primarily used as a sclerosant in the treatment of esophageal varices, a condition often associated with liver cirrhosis. It works by inducing thrombosis and subsequent fibrosis of the varices, thereby preventing bleeding.

Efficacy and Safety

A study comparing ethanolamine oleate with absolute alcohol as a variceal sclerosant found that while ethanolamine oleate is effective, absolute alcohol may be a more efficient and cost-effective alternative. The study showed that sclerotherapy with absolute alcohol eradicated esophageal varices significantly earlier and required fewer injection courses compared to ethanolamine oleate[2].

Market Dynamics

Demand and Growth

The demand for ethanolamine oleate is influenced by several factors, including the prevalence of liver diseases and the need for effective treatments for esophageal varices. However, the market for ethanolamine oleate is relatively niche compared to the broader ethanolamines market.

Competitive Landscape

The competitive landscape for ethanolamine oleate is characterized by the presence of alternative sclerosants, such as absolute alcohol, which have shown comparable or superior efficacy in some studies. This competition can impact the market share and growth of ethanolamine oleate[2].

Regulatory Environment

The use of ethanolamine oleate in medical procedures is subject to stringent regulatory oversight. Regulatory approvals and compliance with safety standards are crucial for the continued use and market growth of this compound.

Financial Trajectory

Market Size and Revenue

While specific financial data for ethanolamine oleate alone is not readily available, it is part of the larger ethanolamines market. The global ethanolamines market was valued at USD 3.52 billion in 2023 and is expected to grow at a CAGR of 3.07% from 2024 to 2030, reaching nearly USD 4.35 billion[5].

Cost Considerations

Ethanolamine oleate is significantly more expensive than absolute alcohol, with a total cost per patient of around $60 compared to $0.50 for alcohol. This cost difference can be a significant factor in the financial trajectory of ethanolamine oleate, especially in healthcare systems where cost-effectiveness is a major consideration[2].

Regional Analysis

Global Market

The global ethanolamines market, which includes ethanolamine oleate, is led by the Asia-Pacific region, driven by countries like China and India. However, the specific demand for ethanolamine oleate may vary by region based on healthcare practices and the prevalence of liver diseases[5].

North America and Europe

In North America and Europe, the market for ethanolamine oleate may be more stable due to established healthcare practices. However, these regions are also subject to stringent regulatory environments, which can impact market dynamics[5].

Challenges and Opportunities

Challenges

• Rising Costs: The high cost of ethanolamine oleate compared to alternative sclerosants is a significant challenge.
• Regulatory Scrutiny: Strict regulatory requirements can limit market growth.
• Alternative Treatments: The availability of more efficient and cost-effective alternatives, such as absolute alcohol, poses a competitive threat[2].

Opportunities

• Increasing Prevalence of Liver Diseases: The growing prevalence of liver diseases could increase demand for effective treatments like ethanolamine oleate.
• Innovations in Healthcare: Advances in medical procedures and the development of new applications could expand the market for ethanolamine oleate.

Key Takeaways

• Ethanolamine oleate is used primarily in the treatment of esophageal varices through sclerotherapy.
• The compound faces competition from alternative sclerosants like absolute alcohol.
• The financial trajectory is influenced by its high cost and regulatory environment.
• The global ethanolamines market, which includes ethanolamine oleate, is expected to grow at a CAGR of 3.07% from 2024 to 2030.
• Regional demand varies, with the Asia-Pacific region leading the global market.

FAQs

What is ethanolamine oleate used for?

Ethanolamine oleate is used as a sclerosant in the treatment of esophageal varices, a condition often associated with liver cirrhosis.

How does ethanolamine oleate compare to absolute alcohol in sclerotherapy?

Ethanolamine oleate is less efficient and more expensive than absolute alcohol in sclerotherapy, requiring more injection courses and resulting in longer treatment times[2].

What are the main challenges facing the market for ethanolamine oleate?

The main challenges include high costs, stringent regulatory requirements, and the availability of more efficient and cost-effective alternative treatments.

Which regions are leading the market for ethanolamine oleate?

The Asia-Pacific region, particularly China and India, is leading the global market for ethanolamines, including ethanolamine oleate[5].

What is the expected growth rate of the global ethanolamines market?

The global ethanolamines market is expected to grow at a CAGR of 3.07% from 2024 to 2030[5].

Sources

1. Mordor Intelligence: Ethanolamines Market - Prices, Growth & Industry Analysis
2. PubMed: Ethanolamine oleate versus absolute alcohol as a variceal sclerosant
3. Stellar Market Research: US Ethanolamine Market: Industry Analysis and Forecast (2024-2030)
4. Frontiers in Molecular Biosciences: (Not directly relevant to the topic)
5. Maximize Market Research: Ethanolamines Market- Industry Analysis and Forecast (2024-2030)