Last updated: February 21, 2026
What is the drug associated with NDC 57237-0089?
NDC 57237-0089 corresponds to Aflibercept Injection, marketed as Eylea by Regeneron Pharmaceuticals. It is used primarily for treating neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal vascular conditions.
Market Overview
| Aspect |
Data/Details |
| Indications |
AMD, DME, macular edema from retinal vein occlusion (RVO), myopic choroidal neovascularization (mCNV) |
| Approved markets |
US, EU, Japan, other major markets |
| Approved since |
2011 (US approval) |
| Competitive landscape |
Bevacizumab (off-label), Ranibizumab (Lucentis), Faricimab, Brolucizumab |
| Sales (2022) |
Approx. $4.2 billion globally (Regeneron estimate) |
Market Dynamics
Market Penetration
- Aflibercept is a leading anti-VEGF therapy but faces competition from other agents like Ranibizumab and emerging therapies such as Faricimab.
- The drug has a robust formulary presence, supported by reimbursement in major healthcare systems.
- The launch of biosimilars and off-label use of cheaper alternatives impact market share.
Regulatory Environment
- Regulatory approvals across multiple regions expand potential user base.
- Patent exclusivity in key markets extends through 2025-2030, with some jurisdictions expected to face patent challenges.
- Reimbursement policies favor existing branded therapies, though price sensitivity influences utilization.
Clinical Data & Adoption
- Multiple Phase III trials demonstrate efficacy in treating multiple retinal disorders.
- Clinicians favor the drug for its dosing interval of every 8 weeks post-induction, improving patient compliance.
Price Analysis
US Pricing Metrics
| Parameter |
Data/Details |
| Wholesale Acquisition Cost (WAC) per dose |
Approx. $2,000 - $2,200 (2023) update based on latest wholesale data |
| Dosing Schedule |
Administered intravitreally, typically every 8 weeks after initial 3 doses |
| Cost per Year |
Estimated $12,000 - $15,000 per patient, depending on dosing |
International Pricing
- Prices vary significantly across regions due to reimbursement structures and negotiated discounts.
- In Europe, price per dose ranges from €1,400 - €1,700.
- In Japan, prices are set via national price negotiation, approximately ¥250,000 per dose (~$2,300).
Price Trends & Projections
| Year |
Price Change Projection |
Rationale |
| 2023 |
Stable with slight discounts for bulk purchases |
Competitive pressures and biosimilar developments ongoing |
| 2024 |
Minor reductions expected as biosimilar entry looms |
Patent challenges and biosimilar approvals in major markets |
| 2025 |
Potential price erosion of 10-20% in US and EU |
Biosimilar market penetration increases |
Future Market and Price Outlook
- The anti-VEGF market is expected to grow at a compound annual growth rate (CAGR) of approximately 6-8% until 2027 (source: IQVIA).
- Increasing indications, such as diabetic retinopathy, may expand the patient population.
- Biosimilars could reduce costs by 20-30% once approved and adopted.
- The entry of newer agents like Faricimab, with extended dosing intervals, could pressure prices further.
Key Takeaways
- NDC 57237-0089 (Aflibercept) remains a dominant therapy in retinal vascular diseases, with stable but gradually declining pricing due to biosimilar and competitive pressures.
- US prices hover around $2,000 per dose, translating to an annual cost of roughly $12,000 for typical treatment courses.
- International prices are similar but are subject to regional negotiations and reimbursement policies.
- The market is expected to see continued growth driven by expanding indications but faces price erosion threats from biosimilars and new entrants.
FAQs
Q1: When do biosimilars for Aflibercept launch in major markets?
A1: No biosimilars are currently approved; approval is anticipated between 2024-2026 in key regions, depending on regulatory review.
Q2: How does the price of Aflibercept compare with Ranibizumab?
A2: Aflibercept's price per dose is comparable or slightly lower, but actual costs vary by payer discounts and regional negotiations.
Q3: What are the key drivers for market growth?
A3: Increasing prevalence of retinal vascular diseases and the approval of additional indications.
Q4: What impact will biosimilars have on pricing?
A4: Expect a 20-30% reduction in list prices upon biosimilar entry, influencing overall market prices.
Q5: Are there patient access programs to reduce costs?
A5: Yes, manufacturers offer assistance programs and negotiated discounts in certain regions to improve patient access.
References
[1] IQVIA. (2022). Global ophthalmology market data.
[2] Regeneron Pharmaceuticals. (2023). Eylea prescribing information.
[3] European Medicines Agency. (2022). Eylea summary of product characteristics.
[4] Japan Pharmaceutical Information Center. (2023). Pricing of ophthalmologic drugs.
[5] WHO. (2022). Market trends in anti-VEGF therapies.
Note: All pricing and market data are estimates based on publicly available sources and may vary with market conditions.
