Last updated: March 9, 2026
What is NDC 31722-0092?
NDC 31722-0092 is a biologic drug, identified as Eylea (aflibercept) for injection. It is approved for indications including age-related macular degeneration (AMD), diabetic retinopathy, and other retinal diseases.
Market Overview
Product Details
- Therapeutic Class: Anti-VEGF agent
- Formulation: 2 mg/0.05 mL single-use vial or pre-filled syringe
- USP: Approved in 2011 by the FDA
- Manufacturers: Regeneron Pharmaceuticals, Bayer Healthcare (distribution partner)
Market Size
- Estimated US market size in 2022: $1.6 billion (IQVIA)
- Growing at an annual rate of approximately 6% due to expanding indications and increasing prevalence of AMD and diabetic retinopathy.
Competitive Landscape
- Main competitors include Lucentis (ranibizumab), Avastin (off-label use), and newer agents like Beovu (brolucizumab).
- Market share (Q2 2023): Eylea holds approximately 60%, Lucentis 25%, Beovu 10%, others 5%.
Key Drivers
- Aging population
- Rising rates of diabetes
- Increasing awareness and diagnosis of retinal diseases
- Off-label use of Avastin sustains high overall anti-VEGF market volume
Regulatory and Policy Factors
- Patent expiration: Original patent expiring in 2024; biosimilar entry expected thereafter.
- Reimbursement status: Widely covered by Medicare and private insurers; biosimilar pathway advancements may influence pricing.
Price Projections
Current Pricing
- Average wholesale price (AWP): Approximately $2,100 per injection.
- Average selling price (ASP): Estimated around $1,950.
- Patient co-pay: Varies but often $0–$25 due to insurance coverage.
Short-Term Outlook (Next 3 Years)
- No significant price change expected before patent expiry.
- Slight price decreases driven by negotiations and formulary adjustments.
| Year |
Projected AWP per Injection |
Key Notes |
| 2023 |
$2,100 |
Stable, no major policy shifts |
| 2024 |
$2,050 (pre-patent expiry) |
Slight reduction, patent ending |
| 2025 |
$1,950–$2,100 |
Potential biosimilar entry influences price negotiations |
Post-Patent Entry (2024 and beyond)
- Biosimilars expected to enter the US market at 20-30% discount initially compared to Eylea.
- Final biosimilar prices might stabilize around $1,450–$1,600 per injection.
- Price erosion for Eylea could reach 10-15% over 2–3 years post-biosimilar launch.
Long-Term Projections (Next 5-7 Years)
- Biosimilar competitive pressure will reduce Eylea's price by an estimated 20–35%.
- New formulations or combination therapies could introduce further price variability.
- Total market volume growth will sustain revenue levels despite price reduction.
Market Share Predictions
- Eylea's market share may decline to 45–50% within 3 years after biosimilar entry.
- Remaining market share will shift towards biosimilars, with branded drugs maintaining premium pricing in certain indications.
- The volume of injections could grow at an annual rate of 4–6%, partly offsetting price declines.
Regulatory & Policy Impact
- Future policies promoting biosimilar use could accelerate price erosion.
- Incentives for biosimilar adoption in Medicare could further challenge Eylea pricing.
- Patent litigation and exclusivity extensions might temporarily hinder biosimilar market penetration.
Key Takeaways
- NDC 31722-0092 (Eylea) is a dominant anti-VEGF therapy with a significant market share.
- The US market for Eylea is approximately $1.6 billion and growing.
- Price is roughly $2,100 per dose, with expected slight decreases before patent expiry.
- Biosimilar entry in 2024 is likely to reduce prices by 20–35%, impacting revenue.
- Market share will decline as biosimilars gain acceptance, but volume growth may stabilize revenue.
FAQs
1. What factors will most influence Eylea’s future pricing?
Patent expiration, biosimilar market entry, reimbursement policies, and negotiations with payers.
2. How does biosimilar pricing compare to branded Eylea?
Initially 20-30% lower; long-term discounts may reach 35% or more.
3. What is the expected timeline for biosimilar entry?
Entry projected after patent expiry, expected around late 2024.
4. Which rivals pose the greatest competitive threat?
Lucentis and Beovu, especially if biosimilars gain market share.
5. How might pricing vary in international markets?
Pricing often lower outside the US due to different regulatory and market dynamics.
References
[1] IQVIA. (2022). Pharmaceutical Market Estimates.
[2] FDA. (2011). Eylea (aflibercept) injection approval documentation.
[3] EvaluatePharma. (2023). Biologics Price Trends.
[4] Centers for Medicare & Medicaid Services. (2023). Reimbursement policies.
[5] BioPharm International. (2023). Biosimilar Entry and Pricing Strategies.
