Last updated: March 1, 2026
What is the drug with NDC 00904-6564?
The National Drug Code (NDC) 00904-6564 corresponds to Aflibercept Injection, marketed as Eylea. It is a monoclonal antibody designed for intravitreal injection to treat various eye conditions, primarily age-related macular degeneration (AMD), diabetic retinopathy, and macular edema.
Market Size and Demand Drivers
Current Market Scope
- The global ophthalmic drugs market was valued at approximately USD 12.9 billion in 2022, with anti-VEGF agents representing a significant share.
- The anti-VEGF segment grew at a compound annual growth rate (CAGR) of 8.2% from 2018 to 2022.
- Eylea holds a dominant market share in the U.S. and global anti-VEGF therapies, with approximately 60% of prescriptions among anti-VEGF agents in 2022.
Key Clinical Indications
- Age-related macular degeneration (wet AMD)
- Diabetic macular edema (DME)
- Hemorrhagic diabetic retinopathy
- Central retinal vein occlusion (CRVO)
Market Dynamics
- An aging population increases prevalence of AMD, DME, and other retinal diseases.
- Increasing screening and diagnosis rates in developed and emerging markets drive demand.
- Competitive landscape includes off-label use of other anti-VEGF drugs, notably ranibizumab (Lucentis) and off-patent bevacizumab.
Competitive Positioning
| Product |
Market Share (2022) |
Pricing (per dosage) |
Approval Year |
Indications |
| Eylea (Aflibercept) |
~60% |
USD 1,850 |
2011 |
AMD, DME, RVO |
| Lucentis |
~25% |
USD 2,000 |
2006 |
AMD, DME, retinal vein occlusion |
| Bevacizumab |
Variable |
USD 50–80 |
2004 (off-label) |
Off-label, lower-cost alternative |
Note: Eylea's price in the U.S. averages USD 1,850 per injection, which may vary based on supplier, insurance, and regional policies.
Price Projections and Trends
Historical Pricing Trends
- Introduced in 2011 at approximately USD 1,850 per injection.
- Price adjustments over the past decade have been minimal relative to inflation, with some discounts or discounts via insurance and pharmacy benefit managers (PBMs).
- The average wholesale acquisition cost (AWAC) has remained stable, with minor fluctuations.
Near-term Price Outlook (Next 3-5 Years)
- Pricing Stability: Market forces and patent protections support price stability.
- Potential Price Reductions: Driven by biosimilar developments and increased biosimilar approval pathways.
- Cost Negotiations: Value-based negotiations by healthcare providers and payers could exert downward pressure.
Impact of Biosimilars and Generics
- No biosimilar has yet secured FDA approval for aflibercept as of 2023.
- Entry of biosimilars would pressure prices downward by 20–40% within 2 years of market entry.
- Pricing elasticity is limited due to the critical nature of the therapy and the patent exclusivity period.
Regulatory and Policy Considerations
- The U.S. FDA approved Eylea in 2011; patent protection extends until 2027.
- The Biden administration's focus on drug price transparency may influence future negotiations but has yet to materially affect aflibercept prices.
- International markets show variable pricing, often lower than U.S. levels, due to regulatory and reimbursement differences.
Revenue Projections
| Year |
Estimated U.S. Sales (USD billion) |
Growth Rate |
Key Assumptions |
| 2022 |
3.1 |
N/A |
Market penetration, treatment volume |
| 2023 |
3.3 |
6.5% |
Steady demand, minimal price change |
| 2025 |
3.7 |
5.5% annually |
Increased treatment rates, no biosimilar entry |
| 2027 |
4.0 |
4.8% annually |
Patent expiration approaching, biosimilar threat |
Market Risks and Opportunities
Risks
- Biosimilar approval and entry.
- Changes in healthcare policy or reimbursement.
- Price erosion due to competitive pressures.
Opportunities
- Expanding indications, including new retinal and ocular conditions.
- Geographic expansion in emerging markets.
- Development of longer-acting formulations reducing treatment frequency.
Key Takeaways
- Eylea (aflibercept) dominates the anti-VEGF segment for retinal diseases, with stable pricing and high market penetration.
- The drug’s price in the U.S. remains around USD 1,850 per injection, with limited short-term declines expected.
- Biosimilar entry remains the primary long-term risk but has not yet materialized.
- Revenue growth will be driven by increasing disease prevalence and treatment adherence rather than significant price increases.
FAQs
What factors could lead to a reduction in Eylea's price?
Biosimilar competition, regulatory pressures, and negotiations by payers.
How does Eylea's price compare internationally?
It varies; generally lower outside the U.S. due to regulatory and market dynamics.
When might biosimilars for aflibercept enter the market?
Potentially by 2027, aligned with patent expiry and regulatory approval pathways.
How do treatment costs impact healthcare budgets?
High per-injection costs challenge reimbursement systems, influencing formulary decisions and patient access.
What are the best alternatives if Eylea prices decline?
Bevacizumab offers a significantly lower-cost off-label alternative, and new therapies could disrupt the market.
References
- MarketWatch. (2023). Global ophthalmic drugs market size. Retrieved from https://www.marketwatch.com/
- IQVIA. (2022). U.S. prescription data on anti-VEGF therapies.
- U.S. Food and Drug Administration (FDA). (2011). Approval letter for Eylea (aflibercept).
- EvaluatePharma. (2022). 2022 Drug Sales Data.
- Agency for Healthcare Research and Quality (AHRQ). (2022). Healthcare cost analysis report.
[1] Smith, J., & Lee, T. (2022). “Market dynamics in ophthalmology industry,” Journal of Drug Economics, 29(4), 211–225.
