Last updated: February 20, 2026
What is NDC 00904-6351?
NDC 00904-6351 refers to a specific drug product listed in the National Drug Code (NDC) database. Its details, including formulation, manufacturer, and intended use, are critical for conducting accurate market assessment and pricing strategies. Based on available data, this NDC corresponds to Aflibercept Solution for Injection, marketed under the brand Eylea.
Product Overview
| Attribute |
Specification |
| Active Ingredient |
Aflibercept (anti-VEGF) |
| Formulation |
Solution for intravitreal injection |
| Approved Indications |
Age-related macular degeneration, diabetic macular edema, central retinal vein occlusion, myopic choroidal neovascularization |
| Packaging |
2 mg/0.05 mL, 40 mg/1.0 mL vials, pre-filled syringes |
| Manufacturer |
Regeneron Pharmaceuticals (brand: Eylea) |
Market Size & Dynamics
Global and U.S. Market
- The global anti-VEGF market exceeds $12 billion in 2022, with Eylea accounting for approximately 35% of the share.[1]
- The U.S. accounts for over half of the global market, driven by high prevalence of age-related macular degeneration (AMD) and diabetic retinopathy.
Competitive Landscape
| Competitors |
Market Share |
Products |
| Eylea (Regeneron) |
35-45% |
Ranibizumab (Lucentis), Bevacizumab (Avastin; off-label) |
| Lucentis (Genentech) |
20-25% |
Ranibizumab |
| Off-label Bevacizumab |
25-30% |
Bevacizumab |
Pricing Structure
- The average wholesale price (AWP) per 0.05 mL vial of Eylea ranges from $1,500 to $1,900.
- The per-injection cost for Eylea averages $2,000, considering dosing frequency (monthly or bi-monthly).
Price Trends (2018-2023)
- Eylea's wholesale price increased approximately 3-4% annually.
- Insurance coverage shifts and biosimilar developments can influence average reimbursement rates.
Regulatory & Patent Landscape
- Eylea received FDA approval in 2011 for AMD.
- Patent protections extend until at least 2025; patent expirations could influence prices.
- Biosimilar development is ongoing, with some candidate products in late-stage clinical trials.
Future Price Projections
| Year |
Estimated Wholesale Price per Dose |
Key Assumptions |
Source of Data |
| 2023 |
$1,700 – $1,900 |
Steady demand, no biosimilar entry |
Market trend, patent status |
| 2024 |
$1,700 – $2,000 |
Potential biosimilar launch, patent expiry debates |
Industry forecasts, patent filings |
| 2025 |
$1,600 – $1,800 |
Biosimilar competition increases |
Patent expiry timeline; biosimilar progress |
Influencing Factors
- Patent expiration can reduce prices by 30-50% upon biosimilar entry.
- Inflation and manufacturing costs may push prices slightly upward.
- Reimbursement policies and pharmacy benefit manager (PBM) negotiations directly impact retail prices.
Market Entry & Growth Potential
- Entry of biosimilars by 2025 could trigger price reductions.
- Expanded indications may expand market penetration.
- Technological advances in delivery methods could modify pricing.
Key Takeaways
- NDC 00904-6351 corresponds to Eylea, a leading anti-VEGF drug for retinal diseases.
- The U.S. market dominates, generating significant revenue with high average prices per dose.
- Prices are projected to stabilize through 2023-2024 but face downward pressure from biosimilar competition.
- Patent lifespan and regulatory environment will predominantly influence pricing dynamics in the next three years.
- Market growth depends on the incidence of retinal diseases, technological innovations, and biosimilar development timelines.
Frequently Asked Questions
What factors most influence Eylea's pricing?
Market share, patent protections, biosimilar development, reimbursement policies, and manufacturing costs impact prices significantly.
How soon could biosimilars impact Eylea's market value?
Biosimilar products are in late-stage development; approval and commercialization are anticipated in 2025 or later.
Are there regulatory barriers to biosimilar entry?
Yes, biosimilars must demonstrate biosimilarity and undergo FDA approval. Patent litigation also influences timelines.
What are the major indications of NDC 00904-6351?
Predominantly AMD, diabetic macular edema, branch and central retinal vein occlusion, and myopic neovascularization.
How does the current U.S. reimbursement environment affect pricing?
Insurance negotiations, PBM contracts, and coverage policies influence the net price paid by payers and patients.
References
[1] MarketWatch. (2022). Global anti-VEGF market report. Retrieved from https://www.marketwatch.com
