Last updated: February 27, 2026
What is NDC 45802-0846?
NDC 45802-0846 covers Aflibercept Injection, marketed as Eylea. It is a VEGF inhibitor indicated for treating various ocular conditions, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion.
Market Overview
Current Market Size
- Estimated global market value of anti-VEGF therapies in ophthalmology was approximately $8.2 billion in 2022 (IQVIA).
- Eylea accounts for roughly 50% of this market in the U.S., with sales exceeding $3 billion annually.
Competitive Landscape
- Primary competitors include Ranibizumab (Lucentis) and Bevacizumab (Avastin).
- Eylea's patent exclusivity in the U.S. is set to expire in 2023, with biosimilar competition expected thereafter.
Patent and Regulatory Status
- Cleared by the FDA for multiple indications.
- Patent protections extended through formulation and manufacturing patents until at least 2023.
- Biosimilar approval anticipated from 2024, potentially reducing market share.
Price Dynamics
Current Pricing
- Average wholesale price (AWP): Approximately $1,850 per dose for Eylea.
- The typical injection regimen involves administering two injections per month initially, then quarterly.
Pricing Trends
- The drug has experienced price stabilization over the last five years, despite increasing competition.
- Biosimilar entry is projected to reduce the wholesale price by 30-50% within the first year of market entrance.
Reimbursement Factors
- Medicare reimbursement rate for Eylea is around $1,600 per injection.
- Patient out-of-pocket costs depend on insurance coverage but typically range from $50 to $150 per injection due to co-pay and assistance programs.
Price Projections
| Year |
Estimated Wholesale Price per Dose |
Market Share (Pre-Biosimilar) |
Market Share (Post-Biosimilar) |
Revenue Impact |
| 2023 |
$1,850 |
100% |
70% |
Stable at ~$3 billion |
| 2024 |
$1,850 |
70% |
20% |
Decline begins, ~$2 billion |
| 2025 |
$1,100-$1,300 (biosimilars) |
50% |
30% |
Sharp decline, ~$1.5 billion |
| 2026+ |
$1,000 or lower |
30-40% |
50-60% |
Market consolidation, revenue stabilizes at ~$1 billion |
Pricing reductions assume biosimilar uptake increasing over 2 years. Actual prices depend on negotiations, formulary placements, and regional policies.
Future Market Drivers
- Patent expiration in 2023 opens biosimilar market entry.
- Emerging therapies such as novel biologics targeting neo-angiogenesis could reshape the landscape.
- Pricing pressures from payers and government agencies may reduce reimbursement rates.
Regulatory and Policy Factors
- The FDA has approved biosimilar versions as of 2023, with uptake varying by payor and region.
- The U.S. government’s push for biosimilar adoption aims at reducing healthcare expenditure.
- Patent litigation or extensions could delay biosimilar availability.
Key Takeaways
- NDC 45802-0846 (Eylea) is a leading ophthalmic biologic with a significant market share in wet AMD, DME, and RVO.
- The current price is around $1,850 per dose, generating multi-billion-dollar revenues.
- Patent expiry in 2023 and biosimilar approvals are expected to cause substantial price and market share declines from 2024 onward.
- Price reductions could reach 30-50% upon biosimilar entry, impacting revenue streams.
- Market dynamics will depend on biosimilar adoption, regulatory policies, and potential development of alternative treatments.
FAQs
Q1: When will biosimilars for Eylea enter the U.S. market?
A1: Biosimilar approvals were granted in 2023, with market entry expected in 2024 or shortly thereafter.
Q2: How will biosimilar competition impact Eylea’s market share?
A2: Biosimilars are projected to capture 30-50% of the market within two years, leading to significant price reductions.
Q3: What are the major alternative therapies in development?
A3: Novel biologics and gene therapies targeting ocular neovascularization are in clinical trials, but none are currently near regulatory approval.
Q4: How might pricing trends evolve beyond 2025?
A4: Prices are likely to stabilize around $1,000 or lower due to biosimilar competition and cost containment pressures.
Q5: What is the impact of current policies on the biosimilar market?
A5: Policy efforts support biosimilar adoption to reduce healthcare costs, potentially accelerating biosimilar uptake and price declines.
References
- IQVIA. (2023). Global ophthalmic drug sales.
- U.S. Food and Drug Administration. (2023). Biosimilar approvals and labeling.
- Medicare.gov. (2023). Part B drug reimbursement rates.
- EvaluatePharma. (2022). Biologic and biosimilar market outlook.
- FDA. (2023). Eylea (aflibercept) prescribing information.
