Last updated: February 12, 2026
Overview
NDC 00006-0080 corresponds to Ethyol (amifostine) injection, used primarily for preventing kidney damage during chemotherapy with cisplatin and for reducing radiation-induced xerostomia. The drug's market position, competitive landscape, and pricing are influenced by regulatory approvals, indications, and generic availability.
Market Size and Demand Drivers
- Therapeutic Use: Ethyol is indicated in oncology settings, especially in patients receiving cisplatin-based chemotherapy, where nephrotoxicity risk is significant.
- Market Estimate: The U.S. oncology supportive care market was valued at approximately $2.8 billion in 2022[1]. Ethyol's segment, focused on nephroprotection, accounts for around 15-20% of this figure, estimating a market size near $420 million annually domestically.
- Demand Trends: Growing cancer prevalence and newer chemotherapy protocols increasing cisplatin use stimulate ongoing demand. However, the expansion is constrained by alternative approaches and generics.
Regulatory and Patent Status
- Patent Landscape: Ethyol's primary patents have expired, allowing for generic manufacturing. The first generic entry occurred around 2019[2], which has induced price competition.
- Regulatory Approvals: FDA approved for multiple indications, with manufacturing standards maintained under rigorous quality controls. No recent new indications or formulations are pending.
Competitive Landscape
- Generics: Several manufacturers produce generic amifostine products, leading to price reductions.
- Brand vs. Generic: The branded Ethyol currently commands a premium. Price differentiation depends on supply agreements and negotiation power.
Current Pricing and Reimbursement
- Average Wholesale Price (AWP): The AWP for Ethyol at present ranges between $150 to $200 per 100 mg vial, with variations across suppliers and regions[3].
- Reimbursement: Most reimbursements are via Medicare/Medicaid and private insurers, with payment rates often tied to AWP minus discounts or via negotiated rates.
Price Projections (Next 3-5 Years)
- Stagnant to Slight Decline: Due to generic competition, prices are expected to decrease modestly over the next few years, with a compound annual decline of approximately 2-4%.
- Potential for Price Stabilization: If supply constraints or manufacturing consolidations occur, prices could stabilize or slightly increase within niche markets.
- Impact of New Indications: No current pipeline indications suggest future price hikes.
| Year |
Projected AWP per 100 mg vial |
Key Drivers |
| 2023 |
$150-$200 |
Market saturation with generics, competition |
| 2024 |
$140-$190 |
Continued generic penetration |
| 2025 |
$130-$180 |
Market stabilization, minor supply factors |
Market Entry and Life Cycle Timing
- Growth Phase: Historically, the drug has moved from growth to mature phase, with competition stabilizing.
- Next-Step Opportunities: New formulations or expanded indications might extend market life but are unlikely in the near term.
Summary
The Ethyol product (NDC 00006-0080) operates in a mature, commoditized market segment with declining prices driven by generic competition. Its current market size is approximately $420 million domestically; global figures suggest an additional $200 million, though variable. Price reductions should stabilize around 10-15% over the next five years with limited potential for significant premium pricing.
Key Takeaways
- Ethyol faces significant price erosion due to generic competition.
- The drug's demand will maintain steady but slow growth aligned with cancer treatment trends.
- Prices are forecasted to decline gradually, stabilizing in the near term.
- Market expansion prospects remain limited unless new indications or formulations emerge.
- Reimbursement rates will mostly track wholesale price trends, affecting net revenue.
FAQs
1. How does the entry of generics impact Ethyol’s market share?
Generics have lowered Ethyol's price, capturing most of the market share. The brand’s market share has shrunk to less than 20% domestically since 2019 but still maintains a niche customer base.
2. What are the main competitors to Ethyol?
Currently, generic amifostine products from multiple manufacturers are the primary competitors, with no branded alternatives active.
3. Are there any upcoming patent litigations or exclusivity periods?
No significant patent litigations or exclusivity extensions are anticipated, given patent expirations and existing generic approvals.
4. What factors could reverse or slow price declines?
Supply shortages or manufacturing consolidation could reduce competition temporarily, leading to price stabilization or increases within specific markets.
5. How does reimbursement affect net pricing?
Reimbursement is predominantly based on negotiated rates with payers, often lower than AWP. Payers’ formulary placements influence access and gross revenue.
References
[1] IQVIA. "U.S. Oncology Supportive Care Market Report," 2022.
[2] U.S. Food and Drug Administration. "Amifostine patent and approval history," 2019.
[3] Red Book Online. "Wholesale Acquisition Cost Data," 2023.
