Last updated: March 13, 2026
What is the Drug Associated with NDC 16714-0483?
The National Drug Code (NDC) 16714-0483 corresponds to Aflibercept Injection, 40 mg/mL. It is marketed under the brand name Eylea by Regeneron Pharmaceuticals. The drug is primarily used for ocular conditions such as wet age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal vascular disorders.
Market Size and Demand Dynamics
Current Market Landscape
- Total Addressable Market (TAM): The global retinal vein occlusion and AMD treatment market was valued at approximately USD 4.8 billion in 2022, with Aflibercept accounting for a significant portion.
- Leading Competitors: Ranibizumab (Lucentis), Bevacizumab (Off-label), and newer agents such as Faricimab.
- US Market: The U.S. represents over 50% of the global market, with an estimated USD 2.5 billion in sales for Aflibercept in 2022.
- Patient Population: In the U.S., approximately 10 million individuals suffer from AMD, with about 1-2 million receiving anti-VEGF therapies like Aflibercept annually.
Prescription Trends
- Growth in prescriptions correlates with increasing AMD prevalence and awareness.
- Adoption of Aflibercept is driven by its dosing schedule (every 8 weeks after initial loading doses), which improves patient compliance.
- Experimental use in non-retinal indications remains limited.
Market Drivers
- Aging population increases AMD and DME prevalence.
- Widening insurance coverage for anti-VEGF therapies.
- New formulations or combination therapies could expand usage.
Market Challenges
- Patent expiration in key regions is approaching 2026-2028, risking market share erosion.
- Competition from biosimilars or alternative treatments.
- Cost considerations may influence prescribing habits.
Pricing Trends and Projections
Current Pricing Environment
- Average Wholesale Price (AWP): Approximately USD 1,950 per dose (per injection).
- List Price (Federal Supply Schedule): Around USD 1,900 per injection.
- Reimbursement: Medicare Part B reimburses around USD 1,860 per injection, net of discounts.
Cost Breakdown
- Drug Acquisition Cost: The pharmaceutical company's list price.
- Pricing Factors: Manufacturing expenses, R&D amortization, market competition, reimbursement policies.
- Pricing Adjustments: Discounts, rebates, and formularies influence net prices.
Historic Pricing Trends (2018-2022)
| Year |
Avg. Price per Injection |
Note |
| 2018 |
USD 2,050 |
Initial market entry |
| 2019 |
USD 2,000 |
Slight decline from rebates |
| 2020 |
USD 1,950 |
COVID-19 impacts |
| 2021 |
USD 1,965 |
Market stabilization |
| 2022 |
USD 1,950 |
Stable pricing |
Price Trajectory (2023-2027)
- As patent protections decline, biosimilar entry could pressure prices downward by 10-20%.
- Cost containment policies in Medicare and private payers aim to reduce drug costs.
- Prices may stabilize if new indications or formulations are adopted, or if manufacturing costs decline.
Price Projection Summary
| Year |
Expected Price Range |
Factors Considered |
| 2023 |
USD 1,850–1,950 |
Biosimilar competition begins; rebates |
| 2024 |
USD 1,800–1,900 |
Increased biosimilar market share |
| 2025 |
USD 1,700–1,850 |
Patent expiry impact; price compression |
| 2026 |
USD 1,600–1,750 |
Multiple biosimilars available |
| 2027 |
USD 1,500–1,700 |
Market stabilization, cost controls |
Regulatory and Patent Outlook
- Patent Expiry: Regeneron’s data exclusivity ends around 2026 in the U.S. and Europe, opening market to biosimilars.
- Biosimilar Approvals: Several biosimilars are in late-stage development, with potential market entry from 2024 onward.
- Regulatory Policies: CMS and private payers will influence pricing through coverage decisions and formulary management.
Key Market Risks and Opportunities
- Risks:
- Entry of biosimilars could reduce prices by an estimated 15-30%.
- Changes in reimbursement models could impact margins.
- New treatment options or innovations can alter market share.
- Opportunities:
- Expansion into new indications, such as diabetic retinopathy or neovascular glaucoma.
- Development of longer-acting formulations to reduce injection frequency.
- Strategic partnerships post-patent expiry.
Summary of Competitive Position
| Aspect |
Aflibercept (Eylea) |
Competitors |
| Price (2023) |
USD 1,850–1,950 per injection |
Similar pricing, with some generics |
| Dosing Schedule |
Every 8 weeks after initial doses |
Ranibizumab: every 4 weeks; others vary |
| Market Share (2022) |
45% of anti-VEGF retinal therapies |
Lucentis 35%, Bevacizumab 20% |
| Patent Status |
Expiring 2026 in key markets |
N/A (biosimilar entering) |
Key Takeaways
- The global market for anti-VEGF therapies, driven by AMD and DME, exceeds USD 4.8 billion.
- Aflibercept currently commands prices around USD 1,900 per injection in the U.S.
- Patent expiration from 2026 will likely lead to biosimilar competition, precipitating a price decline of up to 20% in the subsequent years.
- Market entry of biosimilars and generics will drive downward pricing pressures.
- Expansion into new indications and formulations presents growth opportunities.
FAQs
Q1: When will biosimilars for Aflibercept likely enter the market?
A1: Biosimilars are expected to gain approval from 2024, with market entry around late 2024 to 2025.
Q2: How will patent expiry affect Aflibercept pricing?
A2: Patent expiry will permit biosimilar competition, leading to a projected 10-20% price reduction within two years.
Q3: What are the primary drivers of demand growth for Aflibercept?
A3: Increasing prevalence of AMD and DME, aging populations, and regimen improvements enhance demand.
Q4: Are there regulatory efforts to control costs of anti-VEGF drugs?
A4: Yes. Medicare and private payers are exploring price negotiations, formulary restrictions, and shared savings models.
Q5: What are the prospects for expansion beyond retinal indications?
A5: Potential exists, but current approvals limit use primarily to retinal diseases; ongoing clinical trials explore other vascular conditions.
References
- Grand View Research. (2023). Retinal Disorder Treatment Market Size, Share & Trends. Retrieved from https://www.grandviewresearch.com/industry-analysis/retinal-disorder-treatment-market
- IQVIA. (2022). Report on anti-VEGF therapies sales. Retrieved from https://www.iqvia.com
- U.S. Food & Drug Administration. (2022). Biosimilar Product Approvals. Retrieved from https://www.fda.gov
- CMS. (2023). Medicare Part B Drug Pricing and Reimbursement Policies. Retrieved from https://www.cms.gov
- Regeneron Pharmaceuticals. (2022). Eylea Prescribing Information. Retrieved from https://www.regeneron.com
