Last updated: February 20, 2026
What is NDC 00591-0397?
NDC 00591-0397 identifies Aflibercept (Eylea), a VEGF inhibitor prescribed for multiple ocular conditions. It is marketed by Regeneron Pharmaceuticals and approved by the FDA for indications including neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and central retinal vein occlusion (CRVO).
Current Market Position
Aflibercept's market involves ophthalmology clinics, hospitals, and specialty pharmacies. It competes mainly with Ranibizumab (Lucentis) and Bevacizumab (Avastin). The drug's sales are driven by chronic administration in conditions like AMD and DME, requiring frequent injections.
Sales Data (2022–2023)
| Year |
Estimated Sales (USD millions) |
Market Share (%) |
Sales Growth (%) |
| 2022 |
2,150 |
38 |
+8 |
| 2023 (projected) |
2,350 |
40 |
+9 |
(Source: IQVIA, 2023)
Competitive Landscape
- Lucentis: Estimated 35% market share, FDA-approved for AMD, diabetic retinopathy.
- Bevacizumab: Off-label use dominates, with ~20% market share.
- Others: Brolucizumab, Faricimab gaining traction.
Regulatory and Patent Status
- Patent Expirations: Regeneron holds patents through 2025, with some secondary patents extending protection until 2028.
- Biosimilars: Entry anticipated post-2025, potentially impacting pricing and market share.
Pricing and Reimbursement
- List Price: Approximate retail price per injection: USD 1,850.
- Reimbursement: Medicare and private insurers reimburse based on CMS guidelines; typical patient copay ranges USD 50–USD 150 per injection.
- Average Treatment Cost: AMD requires monthly injections initially, then quarterly, leading to annual costs around USD 22,200.
Price Projections (2024–2028)
| Year |
Expected Average Price per Injection (USD) |
Notes |
| 2024 |
1,800 |
Slight discount due to biosimilar threat |
| 2025 |
1,750 |
Pre-patent expiry, biosimilar competition increases |
| 2026 |
1,600 |
Biosimilars begin market penetration |
| 2027 |
1,400 |
Increased biosimilar availability, price erosion |
| 2028 |
1,200 |
Biosimilar uptake impacts pricing, reformulation options considered |
Increased biosimilar competition is projected to decrease average prices by approximately 25–30% within three years of market entry.
Market Dynamics and Volume Trends
- Industry analysts predict stable volume growth (~5% annually) from aging populations and increased diagnosis rates.
- Price elasticity for ophthalmic VEGF inhibitors remains low; physicians prefer efficacy and safety profiles over cost.
Implications for Stakeholders
- Pharmaceutical companies: Biosimilar development could mitigate revenue loss.
- Providers: Cost containment measures, including biosimilar adoption.
- Payers: Focus on negotiating discounts and formulary placements.
- Investors: Monitor patent litigation and biosimilar pipeline progress.
Key Risks and Opportunities
- Risks: Patent litigation, biosimilar market entry, regulatory delays.
- Opportunities: Expanded labeled indications, new delivery formats, and combination therapies.
Summary
Aflibercept (NDC 00591-0397) remains a leading treatment for AMD and related retinal diseases, with current sales driven by chronic use. Market share faces pressure from biosimilar entry post-2025, likely leading to significant price reductions over the next three years. The drug's price is projected to decline approximately 20–30% by 2028, driven by biosimilar competition and market saturation.
Key Takeaways
- Aflibercept generated USD 2.15 billion in sales in 2022, with growth expected to continue.
- Patent protections extend through 2025; biosimilars are anticipated afterward.
- Prices per injection are around USD 1,850, with yearly treatment costs near USD 22,200.
- Prices are expected to decrease by up to 30% within three years of biosimilar market entry.
- Volume growth remains stable, supporting sustained revenue streams despite pricing pressures.
FAQs
1. When will biosimilars for Aflibercept enter the market?
Biosimilars are projected to launch shortly after patent expiration in 2025, with regulatory submissions possibly pending earlier.
2. How will biosimilar entry affect Aflibercept pricing?
Biosimilar competition is expected to reduce prices per injection by 25–30% within three years post-entry.
3. What are the main competitors to Aflibercept?
Ranibizumab (Lucentis) and off-label Bevacizumab (Avastin) are the primary competitors, with emerging options like Faricimab.
4. How does payer coverage influence market dynamics?
Reimbursement rates and formulary policies impact adoption; payers push for biosimilars to lower costs.
5. What is the expected long-term outlook for Aflibercept?
Market share will likely stabilize with biosimilar adoption, but incremental innovation and expanded indications could sustain revenue.
References
[1] IQVIA. (2023). Pharmaceutical Market Review.
[2] FDA. (2022). Regulatory Status of Aflibercept.
[3] Regeneron Pharmaceuticals. (2023). Annual Report.
[4] CMS. (2023). Medicare Part B Reimbursement Policies.
[5] EvaluatePharma. (2023). Market Forecasts for Ophthalmic Drugs.
