Last updated: February 24, 2026
What is NDC 46122-0529?
NDC 46122-0529 identifies a drug within the National Drug Code system. Based on publicly available databases, NDC 46122-0529 refers to Aflibercept Injection, 4 Milligrams (mg). Aflibercept is marketed under the brand name Eylea, primarily used for treating retinal diseases such as age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal vascular conditions.
Market Overview
Market Scope
The global retinal drug market is driven by the increasing prevalence of diabetic retinopathy, AMD, and other retinal vascular disorders. The injection form of aflibercept is a preferred treatment due to its efficacy in inhibiting vascular endothelial growth factor (VEGF).
Market Size
- The global anti-VEGF drugs market was valued at approximately USD 8 billion in 2022.
- The retinal injection segment accounts for over 60% of this market.
- The U.S. market represents roughly 45% of global sales.
Key Competitors
- Ranibizumab (Lucentis): Competes directly; approved for similar indications.
- Bevacizumab (Avastin): Off-label use; lower price point, widely used.
- Faricimab: New entrant with potential to disrupt existing market shares.
Distribution Channels
- Hospital outpatient clinics: 70%
- Specialty ophthalmology clinics: 20%
- Retail pharmacies: 10%
Regulatory Status
- Approved by FDA since September 2011 for exudative AMD.
- Expanded indications include diabetic macular edema and other retinal vascular conditions.
Price Trends and Projections
Current Pricing
- Wholesale Acquisition Cost (WAC): USD 1,950 per 4 mg vial (as of Q1 2023).
- Average selling price (ASP): USD 2,100–2,300 per vial, depending on negotiated discounts.
- Reimbursement varies: Medicare Part B reimburses approximately USD 2,200 per injection.
Pricing Dynamics
- The price has remained relatively stable since 2018, with minor fluctuations.
- Offers for biosimilars could pressure prices downward, expected once biosimilar entry is imminent.
Future Price Trends
- Biosimilar Competition: Approval and market entry projected within 2–3 years.
- Price Reduction Estimates: Biosimilars could reduce prices by 20–40%.
- Innovation and superior delivery methods may limit further reductions; prices may stabilize around USD 1,500–1,800 per vial post-biosimilar penetration.
- Price adjustments will also depend on payor negotiations, healthcare policies, and manufacturing costs.
Pricing Projection Table (Next 3 Years)
| Year |
Price Range (USD per vial) |
Influencing Factors |
| 2023 |
2,100 – 2,300 |
Current market conditions, no biosimilar entries |
| 2024 |
1,900 – 2,200 |
Biosimilar approval, early adoption |
| 2025 |
1,500 – 1,800 |
Market saturation with biosimilar options |
Market Entry Opportunities and Risks
Opportunities
- Growing demand in emerging markets.
- Pediatric and off-label uses expanding.
- Development of sustained-release formulations could increase dosing intervals and revenue.
Risks
- Biosimilar market entry leading to volume-driven price drops.
- Regulatory delays affecting new formulations.
- Reimbursement cuts in healthcare systems.
Key Takeaways
- NDC 46122-0529 (aflibercept 4 mg) maintains a high retail and wholesale price due to its efficacy and limited competition.
- The impending biosimilar approval is the primary factor influencing future price declines.
- The market is mature with steady demand, but pricing is susceptible to regulatory, competitive, and healthcare policy changes.
- Price stabilization estimates post-biosimilar entry suggest a reduction of approximately 20–40% from current levels.
FAQs
Q1: When is the biosimilar for aflibercept expected to launch?
A1: Regulatory approval is projected within 2–3 years, depending on manufacturers’ submissions and FDA review timelines.
Q2: How does aflibercept compare price-wise to its competitors?
A2: Aflibercept’s ASP of around USD 2,200 per vial exceeds ranibizumab (USD 2,000) and far exceeds off-label bevacizumab (USD 50–100), reflecting differences in efficacy, patent protection, and manufacturing costs.
Q3: What factors could prevent price reductions?
A3: Limited biosimilar supply, patent extensions, or regulatory hurdles could inhibit price declines.
Q4: Are there regional differences in pricing?
A4: Yes; prices tend to be higher in the U.S. due to reimbursement rates, whereas emerging markets see lower prices.
Q5: How might innovations affect market share and pricing?
A5: Advances such as longer-acting formulations could preserve market share and allow premium pricing.
References
- IQVIA. (2023). U.S. Prescription Drug Market Data.
- FDA. (2022). Approval history for aflibercept.
- EvaluatePharma. (2022). Global Oncology and Ophthalmology Markets.
- CMS. (2023). Medicare Part B Drug Reimbursements.
- Biosimilar Development Reports. (2022). Biosimilar Entry and Impact.
[1] EvaluatePharma. (2022). Global Oncology and Ophthalmology Markets.
