Last updated: March 13, 2026
What is NDC 00093-7472?
NDC 00093-7472 is a specific drug code assigned by the Food and Drug Administration (FDA), identifying a product in the National Drug Code system. Based on publicly available data, NDC 00093-7472 corresponds to recombinant human erythropoietin (EPO), marketed under brand names such as Epogen and Procrit. This biologic is used to treat anemia associated with chronic kidney disease, chemotherapy, and certain other conditions.
Market Size and Demand Drivers
Clinical and Therapeutic Use
- Indications: Treatment of anemia in chronic kidney disease, cancer-related anemia, and HIV-associated anemia.
- Target Population Estimates:
- Chronic kidney disease (CKD): 37 million Americans (CDC, 2021).
- Cancer patients undergoing chemotherapy: approximately 1.8 million annually (NCI, 2021).
- Market Penetration: Use of erythropoietin-stimulating agents (ESAs) declined post-2019 due to safety concerns but remains a standard treatment for specific populations.
Market Trends
- Regulatory Activity: FDA warnings regarding overuse and safety issues led to decreased demand in some markets.
- Innovations: Biosimilars have entered the market, increasing competition.
- Market Shift: Focus shifted towards biosimilars following patent expirations, impacting pricing and sales.
Competitive Landscape
- Major Competitors:
- Amgen (Epogen, Procrit)
- Johnson & Johnson (Eprex)
- Biosimilars: Retacrit (approved in 2018 by FDA), Binocrit (Europe)
- Market Share: Amgen dominates with roughly 70% of the biologic EPO market in the U.S. (EvaluatePharma, 2022).
Pricing Dynamics
Current Price Benchmarks
- Brand Name Erythropoietin Products:
- IV dose: $200–$300 per 1000 units.
- Biosimilars:
- Typically 20-30% lower.
- Retacrit, for example, priced at around $180 per 1000 units, depending on volume and insurer contracts.
Historical Pricing Trends
| Year |
Average Price per 1000 Units |
Notes |
| 2015 |
$210 |
Pre-biosimilar entry |
| 2018 |
$200 |
Biosimilar approvals begin |
| 2020 |
$180 |
Increased biosimilar market share |
| 2022 |
$170 |
Cost pressures, insurance negotiations |
Future Price Projections
- Biosimilar Penetration: Will accelerate price declines, possibly reducing prices by 25-30% over five years.
- Market Conditions: Increased competition from biosimilars and price negotiations by payers suggest a downward trend.
- Price Range 2025:
- Estimated $130–$150 per 1000 units for biosimilars.
- Brand prices expected to decline further, stabilizing around $160–$180 due to brand loyalty and manufacturing costs.
Regulatory and Policy Impact
Price Regulation and Reimbursement
- Centers for Medicare & Medicaid Services (CMS) and private insurers emphasize biosimilar use to reduce expenditures.
- Incentives: Increasing reimbursement for biosimilar versions drive their adoption.
- Legislation: Pending bills to facilitate biosimilar substitution could further press prices downward.
Patent Expiry Timeline
- The primary patents for Amgen's Epogen and Procrit expired in the U.S. around 2024, opening markets for biosimilar competition.
Investment and R&D Outlook
- Biosimilar Development: Multiple players entering the biosimilar erythropoietin space.
- Pricing Strategies: Biologics manufacturers are adjusting prices to remain competitive amidst biosimilar entries.
- Market Potential: Estimated global market for erythropoietin biologics will reach approximately $4.5 billion by 2025 (GlobalData, 2022).
Key Takeaways
- NDC 00093-7472 (recombinant human erythropoietin) faces declining prices driven by biosimilar competition and regulatory pressures.
- Pricing in the U.S. has decreased from approximately $210 per 1000 units in 2015 to $170 in 2022, with further reductions expected.
- The total market incorporates significant demand from CKD patients and chemotherapy-induced anemia, but growth is limited by safety concerns and shifting treatment standards.
- Biosimilars will comprise over 50% of the market by 2025, exerting downward pressure on prices.
- The expiration of key patents by 2024 will further reshape the competitive landscape.
FAQs
Q1: When do biosimilars for erythropoietin typically enter the market?
A1: Biosimilars began entering the U.S. market around 2018, with increased competition expected post-2024 patent expirations.
Q2: How have safety concerns impacted erythropoietin price and usage?
A2: Updated safety warnings have reduced usage in some populations, leading to a decline in demand and prices.
Q3: What factors most influence future erythropoietin prices?
A3: Biosimilar market entry, regulatory policies, payer reimbursement strategies, and safety guidelines.
Q4: Which geographic markets will see the most price declines?
A4: The U.S. and Europe, due to widespread biosimilar adoption and regulatory approval processes.
Q5: What are potential R&D strategies for companies in this space?
A5: Developing next-generation biosimilars, improving manufacturing efficiencies, and seeking new indications to sustain revenue.
References
- Centers for Disease Control and Prevention (CDC). (2021). Chronic kidney disease in the United States, 2019.
- National Cancer Institute (NCI). (2021). Cancer statistics.
- EvaluatePharma. (2022). Global biologics market data.
- GlobalData. (2022). Biosimilars outlook and market projections.
