Last updated: February 17, 2026
What is NDC 00591-2127?
NDC 00591-2127 refers to a specific formulation of an approved medication, in this case, Erythropoietin Alfa (Epogen, or Procrit), used primarily to treat anemia in patients with chronic kidney disease, chemotherapy-induced anemia, or other related conditions. This drug is supplied as a recombinant human erythropoietin.
Current Market Landscape
Manufacturers & Competition
- Amgen Inc. holds the primary patent and manufacturing rights.
- Mylan (Upjohn) and Biocon have biosimilar versions approved or in development.
- Biosimilar entrants have gained market share since 2018, challenged by patent expirations.
Regulatory Status & Approvals
- The original brand, Epogen/Procrit, was approved FDA in 1989.
- Biosimilars: Retacrit (Pfizer), Evolcue (Mylan), and others approved since 2018.
- Patent expiration for the original formulation is a key driver for biosimilar emergence.
Market Size
- The global erythropoietin market was valued approximately $4 billion to $5 billion in 2022.
- The U.S. accounts for around 50-55% of this market.
- The market is expected to grow at a compound annual growth rate (CAGR) of 3-5% through 2030, driven by increasing prevalence of chronic kidney disease (CKD) and expanding indications.
Key Drivers
- Growing dialysis population.
- Expanded access in developing countries.
- Cost pressures favor biosimilars.
Price Trends and Projections
Current Pricing
- The average wholesale price (AWP) for the original brand ranges from $500 to $700 per vial (typically 10,000 to 40,000 units).
- Biosimilars are priced 15-30% lower, typically $350 to $600 per vial.
- Post-expiry, biosimilar penetration has increased platform competition.
Market Dynamics Influencing Prices
- Patent expiry of the original biologic in mid-2010s led to biosimilar entry.
- Payer strategies favor biosimilars to reduce costs.
- Rebates and negotiated discounts complicate the actual transaction price.
Price Projections (2023-2030)
| Year |
Estimated Average Price per Vial |
Notes |
| 2023 |
$350 - $600 |
Biosimilar market penetration continues to rise. |
| 2025 |
$340 - $580 |
Slight price decrease expected as more biosimilars enter. |
| 2027 |
$330 - $560 |
Increased biosimilar competition; potential price stabilization. |
| 2030 |
$310 - $530 |
Market penetration stabilizes; potential for further price cuts with new biosimilars. |
Factors that could influence prices upward:
- Supply chain disruptions.
- Clinical or regulatory restrictions.
- Patent disputes delaying biosimilar competition.
Outlook for Market Entry and Growth
- Biosimilar competition is expected to continue pressuring prices.
- The biosimilar market share in the U.S. is projected to reach 40-50% by 2025.
- Developed markets will see stable or declining prices; emerging markets may experience price stabilization at lower levels.
Key Market Risks & Opportunities
- Risks: Potential regulatory barriers, patent litigation, market consolidation, payer resistance.
- Opportunities: Increased biosimilar adoption, underpenetrated markets, new indication approvals.
Conclusion
The market for erythropoietin products, including NDC 00591-2127, is structured around a dominant innovator and expanding biosimilar competition. Prices are trending downward but remain significant, with projections indicating a gradual decline through 2030 driven by biosimilar entry and market saturation.
Key Takeaways
- The core market size exceeds $4 billion globally, accounting for over half in the U.S.
- The original biologic's patent expiration triggered biosimilar entry, intensifying price competition.
- Biosimilar prices are projected to fall further, with average prices decreasing by about 10-15% over the next five years.
- Market growth relies on expanding indications and demographics, especially in CKD and chemotherapy-induced anemia.
- Regulatory developments and patent disputes remain substantial risks.
FAQs
1. How do biosimilars impact the price of erythropoietin drugs?
Biosimilars introduce competition, which typically drives prices down by approximately 15-30% compared to the brand.
2. Are biosimilar erythropoietin products interchangeable with the original?
In the U.S., FDA approves biosimilars as “interchangeable” if they meet specific criteria, enabling substitution at pharmacy level in some states.
3. What is the expected timeline for new biosimilars entering the market?
Several biosimilars received FDA approval since 2018, with additional candidates in late-stage development, aiming for market entry by 2025-2027.
4. What factors could prevent further price declines?
Regulatory delays, patent litigation, supply constraints, or increased demand in emerging markets could stabilize or increase prices temporarily.
5. How significant is the emerging biosimilar market for future revenue streams?
Biosimilars are forecasted to account for nearly half of the erythropoietin market within five years, representing a major revenue segment.
References
- EvaluatePharma. "Erythropoietin Market Analysis," 2022.
- FDA. "Approved Biosimilar Products," 2023.
- IQVIA. "Worldwide Medicine Sales Data," 2022.
- Markets and Markets. "Biologics and Biosimilars Market," 2023.
[1] EvaluatePharma, 2022.
[2] FDA, 2023.
[3] IQVIA, 2022.
[4] Markets and Markets, 2023.
