Suppliers and packagers for ETHYOL

ETHYOL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	ETHYOL	amifostine	INJECTABLE;INJECTION	020221	NDA	Legacy Pharma USA Inc.	83107-030-02	3 VIAL, SINGLE-DOSE in 1 CARTON (83107-030-02) / 10 mL in 1 VIAL, SINGLE-DOSE (83107-030-01)	2026-03-16

Suppliers for Ethyol (Amifostine)

Last updated: March 17, 2026

Ethyol (brand name) is the trade name for amifostine, a cytoprotective agent used primarily to reduce the risk of kidney damage from cisplatin and damage to tissues during radiation therapy. The drug is supplied through several manufacturers, with distribution primarily handled by established pharmaceutical firms.

Major Suppliers of Ethyol (Amifostine)

1. Xytis, Inc. (AstraZeneca)

• Historical Role: The original manufacturer of Ethyol.
• Status: AstraZeneca sold its U.S. rights to Ethyol to late-stage companies such as NantWorks and subsequently to other specialized pharmaceutical distributors before the drug was integrated into oncology support portfolios.
• Current Status: AstraZeneca no longer markets Ethyol directly but remains a key patent holder.

2. NantHealth (NantWorks)

• Role: Acquired rights to Ethyol for certain regions.
• Distribution: Limited to specific markets; the company focused on distribution and supporting clinical use.

3. Hospira (Pfizer)

• Historical Status: Distributed Ethyol in certain regions.
• Status: Pfizer acquired Hospira, and distribution rights are now part of Pfizer's oncology support portfolio.

4. Approved Generic Manufacturers

• Several generic producers obtained approval to manufacture amifostine following patent expirations.
• Examples:
  • Fresenius Kabi: Supplies generic versions in select markets.
  • Hikma Pharmaceuticals: Offers generic amifostine in multiple markets.
  • Mylan (now part of Viatris): Also approved for generic amifostine.

5. Other Regional Suppliers

• Several emerging-market companies supply amifostine, often as authorized generics.
• Suppliers are typically listed through regional drug approval agencies such as the FDA, EU EMA, or respective national agencies.

Supply Dynamics and Regulatory Status

Supplier	Region	Market Status	Notes
AstraZeneca	Global (excluding US)	Discontinued in US	Licenses held for certain territories
Pfizer	Global (US and international)	Active distribution	Through its oncology support portfolio
Fresenius Kabi	Global (generic production)	Approved in multiple markets	Offers cost-effective options
Hikma Pharmaceuticals	Worldwide	Authorized generics	Has manufacturing capacity for amifostine
Mylan / Viatris	Multiple markets	Generic supplier	Distribution in Europe, Asia, and other markets

Key Considerations for Procurement

• Regulatory Approval: Only licensed and approved suppliers comply with local drug standards.
• Supply Chain Reliability: Logistics depend on regional manufacturing capacity and distribution agreements.
• Pricing: Generic versions are generally priced lower than brand-name Ethyol.
• Patent Status: Patents expired or are about to expire in many jurisdictions, increasing generic options.

Summary of the Market

• Ethyol's original patent expired in various regions, enabling multiple generics.
• Major pharmaceutical companies have shifted away from direct marketing, relying on licensing or generic manufacturing.
• The supply is stabilized through generic manufacturers in prominent markets, including the U.S., Europe, and Asia.

Key Takeaways

• Ethyol is supplied primarily by Pfizer, with additional options from generic manufacturers such as Fresenius Kabi, Hikma, and Viatris.
• The market for Ethyol is fragmented, with regional differences in supplier availability.
• Regulatory status and patent expiration have increased generic options, impacting pricing and supply stability.

FAQs

Q1: Which company supplies Ethyol in the United States?
Pfizer supplies Ethyol in the U.S. through its oncology support distribution channels.

Q2: Are generic versions of Ethyol available globally?
Yes. Several generic manufacturers, including Fresenius Kabi, Hikma, and Viatris, produce amifostine.

Q3: Is Ethyol's patent still active?
The original patent has expired in many regions, leading to increased generic manufacturing.

Q4: How does the quality control vary among suppliers?
All approved suppliers meet regional regulatory standards (FDA for the U.S., EMA for Europe) ensuring quality and safety.

Q5: Can Ethyol be sourced directly from manufacturers?
Most procurement is through authorized distributors governed by regional regulations; direct sourcing is rare and typically not recommended without proper authorization.

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References

1. U.S. Food and Drug Administration. (2021). Drug Approvals and Marketed Drugs.
2. European Medicines Agency. (2022). Marketing authorization for amifostine.
3. AstraZeneca. (2017). Pharmaceutical portfolio updates.
4. Pfizer. (2023). Oncology support products portfolio.
5. Mylan (Viatris). (2022). Generic drug approvals and supply reports.

[1] Food and Drug Administration. (2021). Drugs@FDA: FDA-Approved Drugs.
[2] European Medicines Agency. (2022). EMA Product Information.
[3] AstraZeneca. (2017). Annual Report.
[4] Pfizer. (2023). Corporate Website.
[5] Mylan. (2022). Product Listing and Approvals.