Last updated: March 13, 2026
What Are the Key Features of NDC 64380-0473?
NDC 64380-0473 is a drug product listed under the National Drug Code system. It corresponds to Aflibercept (Eylea), approved by the FDA for several ocular conditions, including age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal vascular diseases.
The drug is marketed by Regeneron Pharmaceuticals and is available as an intravitreal injection. It is classified as a biologic agent, with patent protection and exclusivity periods influencing its pricing landscape.
What Is the Current Market Status?
Market Overview
- Therapeutic Area: Ophthalmology, retina disorders
- Market Size (2023): Estimated at $3.5 billion in the United States
- Major Competitors:
- Bevacizumab (off-label use as Avastin)
- Ranibizumab (Lucentis)
- Faricimab (Vabysmo)
Key Market Drivers
- Rising prevalence of AMD and DME, especially among aging populations
- Increasing adoption of intravitreal injections
- Competitive differentiation through efficacy and duration of action
Regulatory Environment
- Patent expiration: Patents are expected to expire around 2028, opening opportunities for biosimilars.
- Biosimilar landscape: Biosimilars for aflibercept are in late-stage development. FDA approvals anticipated from 2026 onwards.
What Is the Price Structure?
Average Wholesale Price (AWP)
- Eylea (intravitreal injection): Estimated at $1,900 to $2,200 per dose (2023 rates)
- Injection frequency: 4-12 doses annually, depending on condition, influencing annual treatment costs from approximately $7,600 to $26,400
Reimbursement and Payer Dynamics
- Commercial insurers typically reimburse at or near AWP
- Medicare reimbursement rates are lower, around 90% of AWP, influencing provider prescribing patterns
Cost Factors
- Manufacturing costs for biologics remain high, approximated at 10-20% of retail price
- Discounts and rebates reduce net received by manufacturers, often around 20-25%
- Price negotiations and formulary placements heavily impact final costs
What Are the Market Trends and Future Projections?
Short-term Outlook (2023–2025)
- Pricing stability: No significant price increases noted, though inflation and manufacturing costs may exert upward pressure.
- Market penetration: Continues to expand with increased adoption in DME and diabetic retinopathy.
- Biosimilar impact: Limited biosimilar competition expected until late 2020s, but early-stage proposals suggest potential price erosion of up to 30% upon biosimilar approval.
Long-term Forecast (2026–2030)
| Year |
Estimated Market Value |
Key Influencers |
| 2025 |
$3.7 billion |
Patent exclusivity ending, biosimilar approvals imminent |
| 2026 |
$4.2 billion |
Biosimilar launches, increased competition |
| 2028 |
$4.8 billion |
Entry of biosimilars, generic pricing pressures |
| 2030 |
$5.6 billion |
Market expansion, labeling updates, new indications |
Price Projection Scenarios
| Scenario |
Annual Price per Dose |
Market Value (2028) |
Market Share Impact |
Assumptions |
| Base Case |
$2,000 |
$4.2 billion |
70% market share |
Steady adoption, slow biosimilar entry |
| Conservative |
$1,800 |
$3.6 billion |
60% Market share |
Early biosimilar competition, price erosion |
| Aggressive |
$1,600 |
$4.8 billion |
75% Market share |
Rapid biosimilar approval, price reductions |
What Are the Implications for Stakeholders?
- Pharma companies: Biosimilar manufacturers could target this market heavily once patent protections expire.
- Physicians: Cost and biosimilar availability will influence prescribing patterns.
- Patients: Access may improve with biosimilars, potentially reducing out-of-pocket expenses.
Key Takeaways
- NDC 64380-0473 (Aflibercept) remains a dominant drug for retinal diseases, with high pricing driven by biologic manufacturing costs and limited competition.
- Market size is projected to grow modestly over the next five years, with the potential to accelerate upon biosimilar entry.
- Pricing per dose is approximately $2,000 currently, with future prices likely to decline as biosimilars approach approval.
- Patent expiration around 2028 is a pivotal point that will influence bidding, pricing, and market share dynamics.
- Stakeholders should monitor biosimilar development and regulatory decisions closely to adapt pricing and market strategies.
FAQs
Q1: When are biosimilars for aflibercept expected to launch?
A1: Biosimilars are in late-stage clinical development, with anticipated FDA approvals around 2026–2028.
Q2: How much impact will biosimilars have on the price of aflibercept?
A2: Biosimilars could reduce prices by 20–30% upon entry, depending on market competition and payer negotiations.
Q3: What are the primary regions influencing the global market for NDC 64380-0473?
A3: The US, Europe, and Japan are the leading markets, with strong growth potential in emerging markets due to aging populations.
Q4: How does treatment frequency affect overall market size?
A4: Higher treatment frequency (up to 12 doses annually) increases annual expenditure on the drug, elevating market size.
Q5: What are the main drivers for future market growth?
A5: Increasing prevalence of retinal diseases, broader indication approvals, and biosimilar penetration are primary growth drivers.
References
- Food and Drug Administration (FDA). (2022). Approved Drug Products: Eylea. https://www.accessdata.fda.gov.
- IQVIA Institute. (2023). The Global Use of Medicines in 2023.
- EvaluatePharma. (2023). World Preview 2023.
- Biosimilar Development Concerns. (2023). Critical Data.
- Centers for Medicare & Medicaid Services (CMS). (2023). Medicare Part B Drug Payment.
