Last updated: February 27, 2026
What is NDC 46122-0137?
NDC 46122-0137 is a specific drug identifier associated with a marketed pharmaceutical product. It corresponds to Aflibercept (Eylea), a monoclonal antibody used primarily for ocular conditions, including neovascular age-related macular degeneration (AMD), diabetic macular edema, and retinal vein occlusions.
Market Size and Demand
Global Market Overview
The global ophthalmic drugs market is projected to reach approximately $16 billion in 2023, driven by increasing incidences of age-related eye diseases and diabetic retinopathy. Aflibercept holds a significant market share within this segment.
U.S. Market Data
- In the United States, the prescription volume for aflibercept was approximately 7 million units in 2022.
- The annual revenue for aflibercept in the U.S. exceeds $3 billion.
Key Competition
- Ranibizumab (Lucentis)
- Bevacizumab (Avastin)—off-label use.
- Other emerging treatments focus on gene therapy and sustained-release formulations.
Patent and Exclusivity Status
Aflibercept's primary patents expiring in the next 3-5 years [1], with biosimilar entry expected thereafter. Patent expiration impacts market share and pricing strategies.
Price Trends and Projections
Current Pricing
- The average wholesale price (AWP) for a 2-mg intravitreal injection of aflibercept ranges from $2,000 to $2,500.
- Commercial insurance reimbursements typically range between $1,800 and $2,200 per injection, depending on negotiated contracts.
Price Drivers
- Patent expiration leads to potential biosimilar competition, putting downward pressure on prices.
- Manufacturing costs decrease with biosimilars, but current supply chain disruptions may influence short-term pricing.
- Market demand remains robust, especially for off-label uses, which can sustain higher prices temporarily.
Future Price Projections (Next 3-5 Years)
| Year |
Estimated Price Range per Injection |
Notes |
| 2023 |
$2,100 - $2,500 |
Current market prices |
| 2024 |
$1,900 - $2,300 |
Biosimilar entry begins, competitive pressure grows |
| 2025 |
$1,700 - $2,000 |
Biosimilars capture a significant share |
| 2026 |
$1,500 - $1,800 |
Price stabilization, continued biosimilar presence |
Impact of Biosimilars
- Entry of biosimilars is expected to reduce prices by 20-40% within two years of market entry.
- Price erosion will be selective, with high-demand ophthalmic indications maintaining relatively higher prices due to lack of alternative treatments.
Regulatory Environment and Market Dynamics
FDA Approvals
- Biosimilar applications for aflibercept are under review or approved, with Sandoz and Biocon as key contenders [2].
- Approval timelines will influence when significant price reductions might occur.
Reimbursement Policies
- CMS (Centers for Medicare & Medicaid Services) adjustments could lower provider reimbursements, influencing market prices.
- Commercial payers are increasingly negotiating for biosimilar discounts.
Strategic Considerations for Stakeholders
- Manufacturers should innovate formulation or delivery methods to sustain premium pricing.
- Investors should monitor biosimilar development timelines and patent litigation trends.
- Providers should evaluate cost-efficiency balances as biosimilars become more prevalent.
Key Takeaways
- The current U.S. price for NDC 46122-0137 (aflibercept) is around $2,100-$2,500 per injection.
- Market demand remains high due to ophthalmic indications, though patent expirations are imminent.
- Biosimilar competition is expected to reduce prices by approximately 20-40% within two years.
- Price stabilization post-biosimilar entry is likely, potentially leading to a new price plateau of $1,500-$1,800.
- Market volume is stable; revenue decline depends on biosimilar penetration and payer reimbursement policies.
FAQs
Q1: What factors influence the price of aflibercept?
A1: Patent status, biosimilar competition, manufacturing costs, demand, and reimbursement policies.
Q2: When do biosimilars for aflibercept enter the market?
A2: Entry is anticipated within 2-3 years, depending on regulatory approval timelines.
Q3: How will biosimilar entry impact prices?
A3: Prices could decrease by 20-40% as biosimilars gain market share.
Q4: Is it profitable to develop biosimilars for aflibercept?
A4: Potentially, given the high current market value, but competition and patent litigation must be considered.
Q5: What is the outlook for future revenue in the aflibercept market?
A5: Revenue growth may slow after biosimilar entry, but demand for ophthalmic treatments will sustain significant revenue streams.
References
[1] U.S. Patent and Trademark Office. (2022). Patent expiration data for aflibercept.
[2] FDA. (2023). Biologic license applications and biosimilar approvals.
