Last updated: February 14, 2026
What is NDC 00597-0041?
NDC 00597-0041 refers to a generic or brand-specific drug product registered under the National Drug Code (NDC) system. Based on available data, this code corresponds to Aflibercept Injection, marketed as Eylea by Regeneron Pharmaceuticals. Eylea is an anti-VEGF medication approved for multiple ocular conditions, including neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and proliferative diabetic retinopathy (PDR).
Market Overview
Indications and Revenue Drivers
- AMD accounts for approximately 90% of Eylea’s U.S. revenue.
- DME and PDR constitute smaller segments but contribute to total sales.
- The global ophthalmic anti-VEGF market was valued at ~$9.2 billion in 2022, with Eylea holding approximately 50% of the U.S. market share, maintaining its position as a leading treatment option.
- Key competitors include Ranibizumab (Lucentis) by Genentech and Bevacizumab (off-label as Avastin).
Competitive Position
- Eylea's advantages include longer dosing intervals, which reduce treatment burden.
- Patent expirations elsewhere, notably in Europe, have intensified off-label bevacizumab use, pressuring Eylea as a premium-priced drug.
Regulatory Environment
- Patents for Eylea in the U.S. expired in 2023.
- Generic formulations are expected from biosimilar manufacturers, significantly impacting market share and pricing.
Current Pricing Dynamics
| Price Component |
Approximate Price (per dose) |
Notes |
| Original Brand (Eylea) |
$2,000–$2,300 |
Per-injection cost in the U.S. as of Q1 2023 |
| Biosimilar (expected) |
$1,200–$1,600 |
Projected initial pricing based on biosimilar launches |
| Off-label Bevacizumab |
$50–$150 per injection |
Used off-label, significantly cheaper, but not FDA-approved |
Pricing Trends
- Post-patent expiry, Eylea pricing has stabilized but faced pressure from generics.
- Biosimilars are expected to enter the market within 12–24 months, leading to potential price reductions of 20–40% initially.
- Payers increasingly favor lower-cost alternatives, affecting reimbursement rates.
Market Penetration and Adoption Forecast
| Year |
Estimated Market Share |
Key Factors |
| 2023 |
50% |
Leading treatment but under patent expiration threat |
| 2024–2025 |
40–45% |
Biosimilar entrants expand, branded Eylea declines slightly |
| 2026–2027 |
35–40% |
Biosimilar dominance, branded Eylea's market share decreases |
Demand is expected to decline marginally in the face of biosimilar competition, especially among payers and institutions prioritizing lower costs.
Price Projections
| Year |
Average Price per Dose |
Factors Influencing Price |
| 2023 |
$2,200 |
No biosimilars widely available yet |
| 2024 |
$1,600–$1,800 |
Biosimilars introduced, market competition heightens |
| 2025 |
$1,200–$1,500 |
Biosimilar market share expands, further cost pressures |
These projections assume continued patent loss effects and successful biosimilar market entry.
Implications for Stakeholders
- Manufacturers: Opportunity in biosimilar development, with potential for substantial market share expansion if pricing strategies are aggressive.
- Investors: Likely decline in brand-name revenue over 2–3 years; increased valuation for biosimilar firms.
- Payers: Push toward biosimilars to control costs, affecting reimbursement policies.
- Providers: Shift toward cost-effective therapies, potentially reducing use of original biologics.
Conclusion
The market for NDC 00597-0041 (Eylea) faces significant change driven by patent expiry and biosimilar competition. Price projections suggest a decline in per-dose pricing over the next three years, with notable declines starting in 2024. Manufacturers able to capitalize on biosimilar entry and optimize supply chains could mitigate revenue loss.
Key Takeaways
- NDC 00597-0041 corresponds to Eylea, a leading anti-VEGF for ocular indications.
- The global ophthalmic anti-VEGF market exceeded $9 billion in 2022; Eylea maintains significant share.
- Patent expiration in 2023 paves the way for biosimilar entry, prompting a price decline.
- Price per dose is expected to decrease 20–40% by 2025, influenced by biosimilar competition.
- Market share for the original biologic will diminish as biosimilars gain acceptance and reimbursement policies favor lower-cost options.
FAQs
1. When will biosimilars for Eylea be available in the U.S.?
Biosimilar development has been completed, with regulatory submissions underway. Market entry is anticipated within 12–24 months, subject to FDA approval and market dynamics.
2. How does biosimilar pricing compare to the original Eylea?
Biosimilars are expected to cost 20–40% less initially, with prices ranging from approximately $1,200 to $1,600 per dose, compared to $2,000–$2,300 for Eylea.
3. What impact will biosimilars have on Eylea’s market share?
Biosimilars are projected to capture 30–50% of the market by 2025, reducing Eylea’s share from around 50% (current) to below 40%.
4. Are there regulatory hurdles for biosimilar approval of Eylea?
Yes. Biosimilar approval in the U.S. requires demonstrating high similarity to the reference product and similar efficacy and safety profiles, which has been achieved by several biosimilar candidates.
5. What are the main drivers for future price reductions?
Market entry of biosimilars, payer preference for lower-cost options, patent expirations, and increased competition among biologics.
References
- Market research reports on ophthalmic anti-VEGF therapies.
- FDA approvals and patent data for Eylea and biosimilars.
- Industry publications and pricing surveys for biologic drugs.
- Company disclosures from Regeneron and biosimilar competitors.
