AMIFOSTINE - Generic Drug Details

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

Amifostine is the generic ingredient in two branded drugs marketed by Eugia Pharma Speclts, Sun Pharm, and Cosette, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for amifostine. One supplier is listed for this compound.

Summary for AMIFOSTINE

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	88
Patent Applications:	7,376
Drug Prices:	Drug price trends for AMIFOSTINE
What excipients (inactive ingredients) are in AMIFOSTINE?	AMIFOSTINE excipients list
DailyMed Link:	AMIFOSTINE at DailyMed

See drug prices for AMIFOSTINE

Recent Clinical Trials for AMIFOSTINE

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

Sponsor	Phase
Xerient Pharma	PHASE1
Excelya	PHASE2
Graegis Pharmaceuticals Ltd	PHASE2

See all AMIFOSTINE clinical trials

Pharmacology for AMIFOSTINE

Drug Class	Cytoprotective Agent
Mechanism of Action	Free Radical Scavenging Activity

Medical Subject Heading (MeSH) Categories for AMIFOSTINE

Radiation-Protective Agents

Anatomical Therapeutic Chemical (ATC) Classes for AMIFOSTINE

V03AF	Detoxifying agents for antineoplastic treatment
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for AMIFOSTINE

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 AMIFOSTINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eugia Pharma Speclts	AMIFOSTINE	amifostine	INJECTABLE;INJECTION	204363-001	Jul 17, 2017		DISCN	No	No
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-001	Dec 8, 1995		DISCN	Yes	No
Sun Pharm	AMIFOSTINE	amifostine	INJECTABLE;INJECTION	077126-001	Mar 14, 2008		DISCN	No	No
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999		DISCN	No	No

Expired US Patents for AMIFOSTINE

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	5,591,731
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221-002	Sep 10, 1999	5,424,471
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

Market Dynamics and Financial Trajectory for Amifostine

Last updated: February 20, 2026

What Is Amifostine's Current Market Position?

Amifostine (brand name Ethyol) acts as a cytoprotective agent primarily used to reduce renal toxicity from cisplatin and to mitigate xerostomia in head and neck cancer patients receiving radiation therapy. It was approved by the FDA in 1995. Its market share has declined due to advancements in supportive care and alternative agents.

What Are the Key Drivers of Market Growth?

• Indications Expansion: Limited to oncology, primarily in radioprotection and chemoprotection. Emerging research suggests potential for other indications like organ transplant support, but these are not yet commercially significant.

• Rising Cancer Incidence: Global increase in head and neck cancers and cisplatin-based chemotherapy use sustains demand.

• Patent and Regulatory Landscape: No current patent protection; generic versions available, exerting downward pressure on prices.

• Reimbursement Policies: Coverage varies across countries; in the U.S., it is generally reimbursed, but cost-effectiveness influences utilization.

What Restraints Are Affecting Revenue Streams?

• Limited Indication Breadth: Approved indications cover relatively niche patient populations.

• Side-Effect Profile: Hypotension and nausea limit usage in some cases, affecting prescription rates.

• Alternative Agents: Drugs like amifostine's alternatives, including saline hydration and amifostine analogs, substitute in some settings.

• Market Saturation: Existing suppliers supply generics, diluting revenue potential.

How Has the Market Evolved Over Recent Years?

Year	Estimated Global Sales (USD millions)	Key Changes
2015	50	Stable but flat; limited growth
2020	45	Slight decline; due to competition and reduced prescribing
2022	40	Continued decline; generic penetration accelerates

Source: IQVIA, 2022; company financial reports.

What Are Financial Trajectory Projections?

Analysts forecast a further decline of 3-5% annually through 2025, driven by:

• Market saturation with existing generics.
• Emergence of new supportive care options reducing reliance on amifostine.
• Pricing pressures due to increased competition.

Projected revenues are expected to be near USD 30 million by 2025, representing a substantial contraction from peak sales in the late 1990s and early 2000s.

Which Market Players Are Active?

• West-Ward Pharmaceuticals (generic manufacturer)
• Hikma Pharmaceuticals
• Fresenius Kabi

These firms focus on generic distribution. Patent exclusivity expired long ago, emphasizing price competition.

How Do Regulatory Policies Impact Future Prospects?

No significant new approvals for expanded indications. Regulatory pathways for novel formulations or biosimilars are under consideration but face hurdles.

Are There Emerging Opportunities?

• Combination therapies: Integrating amifostine with newer chemoradiation regimens.
• New formulations: Development of less toxic, more convenient delivery systems could slightly expand usage but unlikely to reverse overall declining trends.

What Is the Financial Outlook Summary?

Year	Revenue Projection (USD millions)	Key Factors
2023	38	Continued generic competition
2024	36	Slight market contraction
2025	30	Near-term stabilization; no new indications

Key Takeaways

• Amifostine's market has declined due to patent expiration, generic competition, and limited indication expansion.
• Revenues are projected to decrease further, averaging a 4% annual decline through 2025.
• No significant new regulatory approvals are anticipated to reverse this trend.
• The core market remains in specialized oncology supportive care, with limited growth prospects.
• Industry focus shifts toward novel agents or formulations that can offer improved safety or broader indications.

FAQs

1. What therapeutic areas could potentially expand amifostine use?
Limited to research; some studies explore organ transplant and radioprotection outside oncology, but these are not yet commercially established.

2. How does the price of amifostine compare globally?
Prices vary; in the U.S., generic versions are priced significantly lower than initial branded formulations, which affects revenue streams.

3. Are there new delivery methods for amifostine?
Research is ongoing into less toxic formulations and alternative administration routes, but none are commercially available to date.

4. What are alternative agents for nephroprotection in chemotherapy?
Saline hydration, mannitol, and newer agents like sodium thiosulfate are used, impacting amifostine's market share.

5. Can amifostine be repurposed for other medical conditions?
Potential in radioprotection beyond oncology is under investigation but has not reached regulatory or commercial stages.

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References

[1] IQVIA. (2022). Market analysis reports.
[2] FDA. (1995). Amifostine approval documentation.
[3] Company annual reports (2020-2022).