Last updated: February 24, 2026
What is the drug associated with NDC 00456-1110?
NDC 00456-1110 is associated with Aflibercept (Eylea), a vascular endothelial growth factor (VEGF) inhibitor used primarily for ophthalmologic conditions such as age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). It is marketed by Regeneron Pharmaceuticals.
What is the current market landscape?
Market size
As of 2022, the global ophthalmology drug market was valued at approximately USD 13 billion. Aflibercept accounts for an estimated 35% of intravitreal injection therapy sales within this segment, valued at USD 4.55 billion in 2022. The COVID-19 pandemic caused disruptions, but the market is steady with recovery expected through 2024.
Market penetration
Eylea holds approximately 65% of the US age-related macular degeneration treatment market, with rivals such as Lucentis (ranibizumab) and Beovu (brolucizumab). Market penetration remains high due to:
- Proven efficacy
- Extended dosing intervals
- Favorable safety profile
Key competitors
| Drug |
Market share (2022) |
Dosing frequency |
Price per injection (USD) |
Approved indications |
| Aflibercept |
65% |
Every 8-12 weeks |
2,000 – 2,200 |
AMD, DME, RVO |
| Ranibizumab |
25% |
Monthly/As needed |
1,950 – 2,150 |
AMD, DME, RVO |
| Brolucizumab |
10% |
Every 12 weeks |
2,400 |
AMD |
What are the pricing trends?
2022 pricing overview
The average wholesale price (AWP) per injection ranges between USD 2,000 and USD 2,200 for Eylea. Negotiated prices under insurance plans or via hospital purchasing agreements are typically lower, with discounts of 10-20%.
Factors influencing pricing
- Patent protections until 2023-2024
- Biosimilar entry anticipated post-patent expiry
- Negotiation leverage by payers and pharmacy benefit managers
Biosimilar impact
Biosimilar versions of Eylea are under development, with a potential market entry projected within 12-18 months after patent expiration. Biosimilars often reduce prices by 20-40%, impacting Eylea's revenue.
What is the forecast for future sales and prices?
Sales projections
| Year |
Estimated global sales (USD billion) |
Key drivers |
Assumptions |
| 2023 |
5.2 |
Market stabilization, patent expiry impacts |
Moderate growth due to increased adoption and dose extensions |
| 2024 |
5.8 |
Biosimilar competition emerges |
Volume shifts toward biosimilars, price pressure increases |
| 2025 |
6.5 |
Biosimilar uptake, expanded indications |
Competitive pricing reduces Eylea’s market share |
Price projections
| Year |
Expected price per injection (USD) |
Change from previous |
Rationale |
| 2023 |
2,200 |
Stable |
Patent protections uphold pricing |
| 2024 |
1,900 |
-13.6% |
Biosimilar competition and negotiated discounts |
| 2025 |
1,700 |
-10.5% |
Increased biosimilar market share, expanded provider negotiations |
What are key legal and regulatory factors?
- Patent expiration for Eylea is projected between late 2023 and early 2024 in the U.S.
- FDA approvals for biosimilars are underway; the first biosimilar is expected to launch shortly after patent expiry.
- Payers may place formulary restrictions, influencing revenue and market share.
What are the implications for stakeholders?
- Pharmaceutical companies: Biosimilar development and market entry present competitive threats but also opportunities for licensing or partnership.
- Healthcare providers: Reimbursement policies and formularies impact prescribing patterns.
- Investors: Revenue streams will likely face downward pressure post-2024, with price erosion and volume shifts.
Key Takeaways
- NDC 00456-1110, representing Aflibercept (Eylea), dominates the intravitreal injection market for retinal diseases.
- Current price per injection is approximately USD 2,000–2,200 in the US, with discounts driven by insurance negotiations.
- Patent expiry is imminent, with biosimilar competition projected to enter the market within 12-18 months.
- Sales forecasts anticipate stabilization in 2023, followed by growth constraints due to biosimilar pricing.
- Price per injection is expected to decline by approximately 20-25% through 2025 due to biosimilar market entry.
FAQs
-
When does patent protection for Eylea expire?
Patent protections are expected to expire between late 2023 and early 2024 in the US.
-
How will biosimilars affect pricing?
Biosimilars are projected to reduce Eylea’s price by 20-40%, causing revenue declines for the originator.
-
What factors influence Eylea’s market share?
The drug’s efficacy, dosing interval, safety profile, and biosimilar competition influence market share.
-
Are there upcoming regulatory approvals for biosimilars?
Yes, multiple biosimilars are under review, with approvals likely within the next 12 months.
-
What are the risks to future revenue streams?
Patent expiry, biosimilar entry, and payer-driven price negotiations are primary risks.
References
[1] Statista. (2022). Global ophthalmology market value. https://www.statista.com
[2] IQVIA. (2022). Top-selling ophthalmology drugs. https://www.iqvia.com
[3] FDA. (2023). Biosimilar development and approval updates. https://www.fda.gov
[4] Regeneron Pharmaceuticals. (2022). Eylea prescribing information. https://www.regeneron.com
