Last updated: March 2, 2026
What is the Current Status of NDC 00527-1369?
NDC 00527-1369 corresponds to Aflibercept injection, marketed under the brand name Eylea. It is an anti-VEGF agent primarily used to treat wet age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
Market Size and Demand
Patient Population
- Wet AMD affects approximately 11 million Americans, with an aging population driving ongoing demand.
- Diabetic retinopathy, with DME as a complication, affects over 7 million U.S. adults with diabetes.
- Retinal vein occlusion impacts about 1 million Americans.
Market Penetration
- Eylea holds a dominant position among anti-VEGF therapies, competing with Avastin (off-label), Lucentis, and newer agents.
- Approximately 75% of prescriptions for wet AMD are for Eylea, with a growing share in DME and RVO indications.
Revenue Data
- In 2022, Eylea generated approximately $7.2 billion in global sales, with the U.S. accounting for the majority.
Competitive Landscape
| Drug |
Manufacturer |
Indication(s) |
Market Share (2022) |
Price Per Dose (USD) |
Dosing Frequency |
| Eylea (Aflibercept) |
Regeneron |
AMD, DME, RVO |
65% |
$2,000 per injection |
Every 4-8 weeks |
| Lucentis |
Genentech |
AMD, DME, RVO |
20% |
$2,300 per injection |
Monthly to bi-monthly |
| Avastin (Off-label) |
Roche |
AMD, DME, RVO (off-label use) |
10% |
$50-$100 per injection |
Varies as used off-label |
Note: Prices vary based on payer contracts and distribution channels.
Price Projections
Short-Term Outlook (Next 2 Years)
- Current prices for Eylea are stable at approximately $2,000 per injection.
- No significant upcoming patent expirations or biosimilar entries expected until 2025.
- Anticipated pricing stabilization or slight decrease (~5%) with increased biosimilar competition after patent expiry.
Long-Term Outlook (3-5 Years)
- Entry of biosimilars projected between 2024 and 2026.
- Biosimilars, potentially priced at 20-40% below Eylea, could drive prices downward.
- Price erosion estimates around 15-25% for Eylea post-biosimilar launch.
Impact of Biosimilars
| Year |
Predicted Biosimilar Launch |
Expected Price Reduction |
Key Players |
| 2024 |
Pending FDA approval |
20-30% |
Coherus Biosciences, Samsung Bioepis |
| 2025 |
Market entry |
30-40% |
Multiple biosimilar contenders |
Note: Regulatory pathways, patent litigation, and market acceptance influence timing.
Regulatory and Policy Factors
- Patent protection extends until at least 2024 in the U.S.
- The Biologics Price Competition and Innovation Act (BPCIA) facilitates biosimilar entries, potentially impacting prices.
- Payer policies increasingly favor biosimilars to reduce drug costs.
Key Market Dynamics
- Growing prevalence of target indications sustains demand.
- Physician familiarity favors Eylea, complicating biosimilar uptake.
- Insurance coverage and formularies influence actual patient out-of-pocket costs.
Key Takeaways
- NDC 00527-1369, Eylea, remains a market leader with stable pricing.
- Biosimilar competition is imminent in 2024-2026, creating potential price declines.
- Demand driven by aging populations and rising diabetic retinopathy prevalence supports continued revenue.
- Price projections indicate a 15-25% reduction over the next 3-5 years post-biosimilar entry.
- Market share may shift as biosimilars gain acceptance and prescribing patterns evolve.
FAQs
Q1: When are biosimilars for Eylea expected to enter the U.S. market?
A1: Pending FDA approvals, biosimilars are anticipated between 2024 and 2026.
Q2: How will biosimilar entry affect Eylea’s price?
A2: Biosimilars could reduce Eylea’s price by 20-40% over 1-2 years after market entry.
Q3: What factors influence the adoption of biosimilars among ophthalmologists?
A3: Physician comfort, patent litigations, and formulary policies significantly impact biosimilar adoption.
Q4: Are there any regulatory hurdles delaying biosimilar approval?
A4: Biosimilar approval depends on FDA evaluation of similarity, safety, and efficacy; delays can occur due to evidence requirements or litigation.
Q5: What is the current market share of Eylea in the U.S.?
A5: Approximately 75% of prescriptions for wet AMD and a sizable portion for DME and RVO.
Sources
[1] EvaluatePharma. (2022). Global and US drug sales data.
[2] FDA. (2022). Biosimilar approval timeline.
[3] IQVIA. (2022). U.S. prescription data and market share.
[4] Regeneron Pharmaceuticals. (2022). Eylea prescribing information.
[5] Centers for Disease Control and Prevention. (2022). Diabetes and age-related macular degeneration statistics.
