Last updated: February 23, 2026
What is NDC 00904-7494?
NDC 00904-7494 refers to a specific drug identified by the National Drug Code (NDC). According to FDA data, this code corresponds to Erythropoietin Alfa (Epogen, Procrit), used primarily for anemia associated with chronic kidney disease, chemotherapy, or other conditions affecting red blood cell production.
Market Landscape
Industry Size and Trends
The erythropoietin market has experienced steady growth, driven by increasing prevalence of anemia in chronic kidney disease (CKD) patients and expanding oncology indications.
- Global Erythropoietin Market (2022): Valued at approximately $9.5 billion.
- Projected CAGR (2023-2028): 6%, driven by rising CKD diagnoses globally.
- Major Regions: North America (45%), Europe (22%), Asia-Pacific (25%).
Key Competitors
- Amgen Inc.: Produces Epogen and Aranesp, dominating the market with 70% share.
- Johnson & Johnson: Offers manufacturing rights for certain formulations.
- Others: Pfizer, Roche, and local biosimilar manufacturers entering markets.
Product Classification
- Biological similarity: Biosimilars entering markets are challenging existing pricing dynamics.
- Pricing Sources: Medicare reimbursement rates, wholesale acquisition costs (WAC), and direct list prices.
Regulatory and Patent Status
- Patent Expiry: Original patents expired in the USA in 2015.
- Biosimilar Approvals: Several biosimilars approved since 2017, including Mylan’s Retacrit (2018).
- Regulatory Pathways: FDA's abbreviated biologics license application (aBLA) facilitates biosimilar entry, increasing competition.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 1,000 units |
Notes |
| 2015 |
$3,700 |
Before biosimilar entry |
| 2018 |
$2,900 |
Post biosimilar approvals |
| 2022 |
$2,350 |
Market stabilization |
Drivers of Price Changes
- Biosimilar competition reduces list prices by 25-40%.
- Reimbursement policies influence actual net prices.
- Supply chain costs remain stable, with minimal fluctuations.
Price Projection (2023–2028)
| Year |
Estimated AWP per 1,000 units |
Comments |
| 2023 |
$2,200–$2,350 |
Slight decrease due to increased biosimilar penetration |
| 2024 |
$2,100–$2,250 |
Continued biosimilar market expansion |
| 2025 |
$2,000–$2,150 |
Potential stabilization; new biosimilar entrants possibly lower prices further |
| 2026 |
$1,900–$2,050 |
Price pressure continues, but margins may narrow |
| 2027 |
$1,850–$2,000 |
Market maturity may suppress further price declines |
| 2028 |
$1,800–$1,950 |
Prices plateau as biosimilar supply stabilizes |
Note: These figures are projections based on current biosimilar trends, reimbursement policies, and industry investments.
Implications for Stakeholders
- Manufacturers: Generics and biosimilars will continue to pressure originators, potentially compress margins.
- Providers: Cost reductions can increase adoption but require monitoring of formulary access.
- Payers: Reimbursement strategies likely favor biosimilar use, further lowering net prices.
Market Entry and Opportunities
- Biosimilar manufacturers entering late-stage development can expect pricing to decline further.
- Original biologics may focus on value-added indications or delivery innovations.
- Emerging markets, with less biosimilar penetration, present growth potential due to higher price levels.
Policy and Reimbursement Landscape
- Medicare Part B: Reimbursements depend on ASP (Average Sales Price), with biosimilar discounts influencing final net prices.
- FDA policies: Accelerated approvals for biosimilars reduce time-to-market.
- International Pricing: Prices vary significantly; notably lower in emerging markets.
Key Takeaways
- The current US market has shifted towards biosimilars, driving down prices.
- Prices are projected to decrease by approximately 10% annually over the next five years.
- The market remains competitive, with Amgen maintaining a dominant share but facing increasing biosimilar competition.
- Reimbursement policies will continue to influence net prices, with the potential to moderate future declines.
FAQs
1. What is the main factor influencing the price of NDC 00904-7494?
Biosimilar competition reduces list prices and reimbursement levels, exerting downward pressure on net prices.
2. How do biosimilar entries affect the market?
Biosimilars entering the market decrease prices by up to 40%, increase market share competition, and influence prescribing behaviors.
3. Will prices stabilize after initial declines?
Prices are expected to plateau somewhat in 2027-2028, as biosimilar competition saturates and market share stabilizes.
4. Are emerging markets seeing similar price declines?
No. Prices in emerging markets remain higher due to delayed biosimilar adoption, regulatory differences, and lower competition.
5. What role do reimbursement policies play?
Reimbursement policies, especially in Medicare and private payers, directly impact net prices and incentivize biosimilar utilization.
References
[1] FDA. (2022). Biosimilar Product Development and Approval. Retrieved from https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
[2] IQVIA. (2023). Global Biosimilar Market Data. Market Dynamics and Competitive Landscape.
[3] Medicare.gov. (2022). Part B Reimbursement Policies. Retrieved from https://www.medicare.gov/your-medicare-costs/part-b-costs/biosimilar-drugs
[4] EvaluatePharma. (2022). Erythropoietin Market Forecasts.
