Last updated: March 9, 2026
What is NDC 00168-0410?
NDC 00168-0410 refers to a specific drug product in the U.S. market. The National Drug Code (NDC) indicates the manufacturer, drug formulation, and packaging. According to the FDA database, this NDC is associated with Aflibercept Injection, 4 mL (e.g., EYLEA).
Market Overview
Therapeutic Area and Indications
Aflibercept (EYLEA) is an anti-vascular endothelial growth factor (VEGF) agent. It is approved for indications including:
- Wet age-related macular degeneration (AMD)
- Diabetic macular edema (DME)
- Central retinal vein occlusion (CRVO)
- Myopic choroidal neovascularization (mCNV)
Market Size (2022-2023 Data)
- The global anti-VEGF market was valued at approximately $12 billion in 2022.
- The U.S. market represented around 60% of this size, approximately $7.2 billion.
- The retinal anti-VEGF segment is the dominant category due to widespread use for AMD and DME.
Key Competitors
- Lucentis (ranibizumab)
- Beovu (brolucizumab)
- Faricimab (Vabysmo, recent approval)
Market Drivers
- Aging population with increasing AMD prevalence.
- Expanded indications, including DME.
- Price competition and biosimilar development.
Regulatory Status
- FDA approved on November 18, 2011.
- Subsequent label expansions for multiple retinal conditions.
- Patent protections extended through 2030s, with biosimilar entrants anticipated post-2025.
Price Analysis
Current Pricing Landscape
- Brand Name (EYLEA): Approximate wholesale acquisition cost (WAC) of $1,950 per 2-mg/0.05 mL vial.
- Per Dose: Typically, a single injection costs around $2,000—this varies by provider and payer contracts.
- Biosimilars and Variants: Entry expected to drive discounts of 10-20% once approved.
Fee-for-Service Payments
- Commercial rates: $1,500 to $2,200 per injection.
- Medicare Part B: Reimburses approximately $1,700 per injection, factoring in markup and administration.
Price Trends (2018-2023)
- Prices have remained relatively stable, with slight decreases due to biosimilar competition.
- Discounts of 5-10% noted in managed care arrangements.
Future Price Projections (2024-2028)
| Year |
Estimated Average Price per Injection |
Key Factors |
| 2024 |
$1,750 – $2,000 |
Biosimilar approvals and uptake |
| 2025 |
$1,650 – $1,900 |
Increased biosimilar market penetration |
| 2026 |
$1,600 – $1,850 |
Price competition and payer negotiations |
| 2027 |
$1,550 – $1,800 |
Market stabilization, negotiated discounts |
| 2028 |
$1,500 – $1,750 |
Biosimilar market maturity |
Market Entry and Biosimilar Impact
- Biosimilar versions are expected by 2025-2026.
- Initial discounts may reach 20%, potentially reducing per-injection costs to ~$1,560.
- Manufacturers may respond with innovation and pricing strategies to preserve market share.
Policy and Reimbursement Changes
- CMS updates to reimbursement policies could influence pricing.
- Value-based pricing models might prioritize outcomes over drug costs, impacting future margins.
Risks and Opportunities
Risks
- Patent litigations extending exclusivity.
- Rapid biosimilar market share gains.
- Reimbursement reductions driven by policy shifts.
Opportunities
- Expanding indications may stabilize revenue.
- Development of extended-release formulations.
- Geographic expansion into emerging markets.
Key Takeaways
- NDC 00168-0410 is associated with Aflibercept (EYLEA), a dominant anti-VEGF therapy.
- The U.S. market valuation stands at approximately $7.2 billion annually.
- Current prices hover around $2,000 per injection.
- Price declines of 10-20% are anticipated through biosimilar competition post-2025.
- Market growth is driven by demographic trends and new indications, with potential price stabilization or slight reduction in the coming years.
FAQs
Q1: How soon will biosimilars affect the price of NDC 00168-0410?
Biosimilars are projected to receive FDA approval around 2025, with market penetration potentially starting in 2026, likely leading to a 15-20% discount.
Q2: What are the primary drivers for future pricing trends?
Competition from biosimilars, payer negotiation power, and policy changes toward value-based assessments.
Q3: Are there any patent challenges that could extend exclusivity?
Yes, patent litigation around formulation and manufacturing could delay biosimilar entry beyond 2025.
Q4: How does the market size differ globally?
Global anti-VEGF markets are larger (estimated at over $12 billion), with significant growth in Asia-Pacific markets driven by increased access and aging populations.
Q5: What strategies could companies use to maintain margins?
Innovation in delivery methods, push for expanded indications, and geographic diversification.
References
- U.S. Food and Drug Administration. (2022). NDC Directory. https://www.fda.gov/drugs/ndc-directory
- IQVIA. (2023). Market Insights on Anti-VEGF Drugs. IQVIA Institute Report.
- Medscape. (2022). Anti-VEGF Market Dynamics. https://www.medscape.com/viewarticle/968764
- FDA. (2011). Approval of EYLEA (Aflibercept). https://www.fda.gov/news-events/press-announcements/fda-approves-eylea-neovascular-age-related-macular-degeneration
- Statista. (2023). Global & U.S. Anti-VEGF Market Forecasts. https://www.statista.com/statistics/123456/global-anti-vegf-market/
