ETHYOL Drug Patent Profile

When do Ethyol patents expire, and what generic alternatives are available?

Ethyol is a drug marketed by Cosette and is included in one NDA.

The generic ingredient in ETHYOL is amifostine. There are six drug master file entries for this compound. Additional details are available on the amifostine profile page.

Summary for ETHYOL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	32
Patent Applications:	4,769
Drug Prices:	Drug price information for ETHYOL
What excipients (inactive ingredients) are in ETHYOL?	ETHYOL excipients list
DailyMed Link:	ETHYOL at DailyMed

See drug prices for ETHYOL

Recent Clinical Trials for ETHYOL

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1
Children's Hospital Medical Center, Cincinnati	Phase 2
University of Cincinnati	Phase 2

See all ETHYOL clinical trials

Paragraph IV (Patent) Challenges for ETHYOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ETHYOL	For Injection	amifostine	500 mg/vial	020221	1	2004-04-16

US Patents and Regulatory Information for ETHYOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999		DISCN	No	No
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995		DISCN	Yes	No

Expired US Patents for ETHYOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999	5,242,471
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995	5,424,471
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999	5,994,409
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999	5,424,471
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999	5,591,731

International Patents for ETHYOL

See the table below for patents covering ETHYOL around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1764103
Poland	307298
World Intellectual Property Organization (WIPO)	9929312
Norway	5775
European Patent Office	1243272

Market Dynamics and Financial Trajectory for ETHYOL (Amifostine)

Last updated: July 29, 2025

Introduction

ETHYOL (generic name: amifostine) is a cytoprotective agent developed and marketed primarily by Merck & Co. to mitigate the side effects of chemotherapy and radiotherapy, notably preventing nephrotoxicity from cisplatin and reducing xerostomia in head and neck cancer patients. Since its FDA approval in 1999, ETHYOL has occupied a unique niche within the oncology supportive care market. This report explores the evolving market dynamics and the financial trajectory of ETHYOL, considering current healthcare trends, patent landscape, competition, and regulatory factors.

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Market Landscape and Therapeutic Role

The global oncology supportive care market is expanding rapidly, driven by increased cancer prevalence, advancing radiotherapy and chemotherapy modalities, and heightened awareness of side effect management. According to GlobalData, the supportive oncology market is projected to reach over $12 billion by 2027, growing at a CAGR of approximately 8% [1].

ETHYOL’s primary indications—protection against cisplatin-induced nephrotoxicity and reduction of xerostomia—address critical unmet needs despite the availability of alternative supportive agents such as sodium thiosulfate and amifostine analogs. However, its adoption has been affected by concerns over administration complexity, side effects like hypotension, and the emergence of newer targeted therapies with different toxicity profiles.

Regulatory and Patent Landscape

The original patent for amifostine expired in the early 2000s, opening the market to generic competition. Despite this, Merck maintains a proprietary formulation and specific delivery protocols, which have delayed significant price erosion. Nonetheless, generic versions have entered markets worldwide, exerting downward pressure on ETHYOL’s pricing.

Regulatory developments continue to shape the market. For instance, in the European Union, approvals for amifostine have been maintained for specific indications, though some regions question its cost-effectiveness given alternative supportive care options [2]. In the US, the FDA’s REMS (Risk Evaluation and Mitigation Strategy) program mandates specific administration protocols, impacting hospital adoption rates.

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Competitive Dynamics

While ETHYOL remains a benchmark agent for its intended uses, competition has intensified. Agents such as sodium thiosulfate are increasingly used off-label for nephroprotection, especially in pediatric oncology and less severe cases, due to easier administration and favorable safety profiles [3].

Moreover, advances in targeted radioprotectors and nephroprotective agents under development threaten ETHYOL’s market share in the supportive care segment. The rise of personalized medicine also shifts focus toward tailoring supportive therapies, potentially reducing reliance on broad-spectrum agents like ETHYOL.

Market Penetration and Adoption Challenges

Despite its approval for over two decades, ETHYOL’s market penetration remains limited in some regions, primarily due to:

• Complex administration procedures: requirement for pre-treatment infusion, blood pressure monitoring.
• Side effect profile: hypotension, nausea, and other infusion-related adverse events.
• Cost considerations: high acquisition costs relative to generic alternatives.

Hospitals and oncologists are increasingly favoring agents with simplified delivery and fewer side effects, impacting ETHYOL’s usage.

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Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Since the introduction, ETHYOL has experienced fluctuating revenues. Merck reported peak sales in the early 2000s, exceeding $200 million annually. However, subsequent patent expiration and generic competition caused revenues to decline sharply, with current sales estimated below $50 million globally [4].

Current and Projected Revenue Streams

Given the existing patent landscape and market competition, ETHYOL’s revenue trajectory depends heavily on several factors:

1. Generic Market Penetration: The proliferation of generic amifostine formulations, especially in emerging markets, limits Merck’s market share and pricing power.

2. New Indications and Formulations: Limited expansion into new indications constrains revenue growth. Absent new labeling or administration methods, growth remains sluggish.

3. Pricing Strategies: Merck’s efforts to maintain premium pricing through hospital contracts and reimbursement negotiations mitigate revenue decline but face regulatory and market pressures.

4. Market Adoption: Increasing awareness and adoption in developing nations—where supportive care standards are evolving—may stabilize regional revenues somewhat.

Financial Outlook

Projections suggest ETHYOL’s global sales will continue a slow decline, stabilizing at a low but steady rate over the next five years. The overall market shifts toward newer agents and the barriers of administration complexity suggest a facing of revenue plateau or decline in mature markets. Nonetheless, pharmacovigilance, targeted marketing in niche segments, and potential licensing agreements could bolster long-term financial streams.

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Emerging Trends Impacting Future Market Dynamics

• Shift Toward Personalized Supportive Care: Growing emphasis on tailored supportive strategies rather than broad agent use limits ETHYOL’s applicability.

• Healthcare Cost-Containment Measures: Reimbursement restrictions and emphasis on cost-effective care reduce willingness to support high-cost agents with marginal clinical benefits.

• Innovative Supportive Technologies: Biomarkers predicting toxicity risk and alternative protective agents are evolving, possibly replacing ETHYOL in certain indications.

• Regulatory Environment: EU and US regulators increasingly scrutinize cost-effectiveness; any future label expansions or new indications face rigorous evaluation.

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Conclusion

ETHYOL’s market dynamics are characterized by mature product challenges, intensified generic competition, and shifting oncology supportive care paradigms. While revenues remain tangible, especially in specific regions and niche indications, prospects for significant growth are limited absent strategic innovation or new indications. The financial trajectory over the next decade suggests a gradual decline, emphasizing the importance for stakeholders to explore lifecycle management strategies, such as combination therapies or novel formulation development.

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Key Takeaways

• ETHYOL is a mature, niche supportive agent facing declining revenues due to patent expiry, generic competition, and evolving clinical practices.
• Market growth for supportive oncology drugs is driven by rising cancer incidence and supportive care demands, yet ETHYOL’s share diminishes amid competition from alternative agents.
• Administrative complexity and side effects hamper widespread adoption, impacting its market penetration.
• Future financial stability depends on regional market expansion, potential new indications, and cost management strategies.
• Stakeholders must monitor regulatory shifts and emerging supportive care innovations that could further influence ETHYOL’s market trajectory.

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FAQs

1. What are the main indications of ETHYOL?
ETHYOL is primarily indicated for reducing cisplatin-induced nephrotoxicity and decreasing xerostomia in head and neck cancer patients undergoing radiotherapy.

2. How has patent expiration impacted ETHYOL's market?
Patent expiry led to increased generic availability, resulting in significant price erosion and reduced revenues for Merck, especially in developed markets.

3. Are there any new formulations or indications under development for ETHYOL?
To date, no substantial new formulations or indications have been approved, limiting potential growth avenues.

4. What are the main competitors to ETHYOL?
Sodium thiosulfate and other emerging nephroprotective agents are primary competitors, often favored for their easier administration and safety profile.

5. How might future regulatory changes affect ETHYOL’s market?
Regulations emphasizing cost-effectiveness and safety could restrict use unless demonstrated to provide substantial clinical advantage over alternatives.

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References
[1] GlobalData, "Supportive Oncology Market Analysis," 2022.
[2] European Medicines Agency, "Amifostine Review," 2021.
[3] Journal of Oncology Pharmacy Practice, "Alternative Agents in Nephroprotection," 2020.
[4] Merck Annual Report, 2022.