Last updated: February 20, 2026
What is NDC 00245-1071?
NDC 00245-1071 identifies a specific drug product registered with the Food and Drug Administration (FDA) under the National Drug Code (NDC) system. Based on available data, this NDC corresponds to Aflibercept Injection, 4 mg/mL (trade name: Eylea), used primarily for treating neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal conditions.
Market Size and Dynamics
Global and U.S. Market
The global ophthalmic drugs market was valued at approximately $10.3 billion in 2022, with a compound annual growth rate (CAGR) of 4.7% projected from 2023 to 2028 (Market Research Future, 2023). The U.S. ophthalmic therapeutics segment accounts for roughly 45% of this market.
Market Share and Competition
- Eylea holds the dominant position in the anti-VEGF therapy space for retinal diseases, with an estimated 75% market share in the U.S. (IQVIA, 2023).
- Major competitors include Lucentis (ranibizumab) and Beovu (brolucizumab).
- The patent for Eylea expired in 2022, opening the market for biosimilars.
Key Drivers
- Rising prevalence of retinal diseases: AMD affects over 200 million people globally.
- Aging demographic: 65+ population drives increased demand.
- Off-label uses: Expanded indications increase utilization.
Price History and Current Pricing
Wholesale Acquisition Cost (WAC)
- The typical WAC for Eylea in 2022 was about $2,100 per injection (average dose: 2 mg), with a standard treatment regimen of monthly injections for the first 3 months, then quarterly.
- Insurance rebates and discounts reduce the actual price paid by payers and patients.
Reimbursement and Pricing Trends
- Medicare reimburses approximately $2,200 per injection.
- Commercial insurers often negotiate discounts, reducing net prices by 10-20%.
Competitive Pricing Post-Patent Expiry
The entry of biosimilars is expected to impact prices significantly:
- Biosimilar versions, approved in Europe and approved or pending in the U.S., are projected to be priced 10-35% lower than branded versions initially.
- Market analysts forecast biosimilar prices ranging from $1,600 to $1,800 per injection.
Future Price Projections (2023-2028)
| Year |
Branded Eylea Price |
Biosimilar Price |
Estimated Market Share of Biosimilars |
Notes |
| 2023 |
$2,100 |
$1,800 |
10% |
Post-patent expiry, initial biosimilar launch |
| 2024 |
$2,100 |
$1,700 |
25% |
Growing biosimilar adoption |
| 2025 |
$2,100 |
$1,600 |
50% |
Significant biosimilar market penetration |
| 2026 |
$2,000 |
$1,500 |
65% |
Price competition intensifies |
| 2027 |
$1,900 |
$1,500 |
75% |
Market stabilizes with biosimilar dominance |
| 2028 |
$1,850 |
$1,400 |
80% |
Pricing adjustments stabilize |
Assumptions: Price reductions are largely due to biosimilar entry, with some brand discounting to maintain market share; volume growth supports revenue despite lower unit prices.
Regulatory and Policy Factors
- The Biosimilar User Fee Act (BsUFA) accelerates biosimilar approvals, potentially increasing market share.
- CMS and private payers promote biosimilars through formulary preferences.
- Patent litigation delays for biosimilar approval are diminishing, accelerating competitive entry.
Key Risks
- Slow biosimilar adoption due to prescriber or patient resistance.
- Price erosion driven by aggressive biosimilar pricing strategies.
- Potential supply chain disruptions impacting distribution and pricing.
Strategic Implications
- Companies holding patents may shift toward value-added services or fixed-dose combinations to maintain revenues.
- Biosimilar manufacturers seeking to penetrate the U.S. market will likely price aggressively, undercutting branded prices.
- Payers will continue to negotiate rebates and discounts, influencing the effective market price.
Summary of Price Trajectory
| Timeline |
Price Range (per injection) |
Market Share of Biosimilars |
Notes |
| 2022 |
$2,100 |
0% |
Branded dominates |
| 2023-2024 |
$2,000–$2,100 |
10–25% |
Entry of biosimilars begins |
| 2025–2026 |
$1,600–$1,800 |
50–75% |
Biosimilars gain majority market share |
Key Takeaways
- The patent expiration of Eylea in 2022 shifts pricing pressure toward biosimilars.
- Wholesale prices are expected to decline between 10-30% over the next five years, with biosimilars seizing up to 80% of the market.
- Market growth remains robust due to the aging population and increasing disease prevalence.
- Reimbursement policies favor biosimilar adoption, further reducing net prices.
FAQs
1. What factors influence the pricing of NDC 00245-1071?
Pricing depends on patent status, biosimilar competition, negotiation power of payers, and healthcare policy changes.
2. How soon will biosimilars impact the price of Eylea?
Biosimilars already entered European markets; U.S. entry is expected within 1-2 years. Significant price reductions may occur within 2-4 years.
3. What role do insurance companies play in pricing?
Insurers negotiate rebates and discounts, significantly reducing final treatment costs from list prices.
4. How does the aging population affect market size?
It increases demand for retinal disease treatments, supporting sustained revenues despite price competition.
5. What future regulatory changes could impact prices?
Enhanced biosimilar approval pathways and reimbursement policies favor biosimilar adoption, pressuring branded drug prices.
References
[1] Market Research Future. (2023). Ophthalmic Drugs Market Research Report.
[2] IQVIA. (2023). U.S. Prescription Market Data.
[3] U.S. FDA. (2022). Approved Biosimilars and Patent Expiry Dates.
[4] Centers for Medicare & Medicaid Services. (2022). National Drug Rebate and Price Data.
