Last updated: February 15, 2026
What is the current market status and price projection for NDC 00115-1750?
NDC 00115-1750 refers to Ozurdex (dexamethasone intravitreal implant 0.7 mg), used primarily for treating macular edema following branch or central retinal vein occlusion, diabetic macular edema, and non-infectious uveitis.
Market Overview
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Market Size & Demand:
The global ophthalmology drug market, including intravitreal implants, was valued at approximately $9.3 billion in 2022. The demand for corticosteroid implants like Ozurdex has grown due to the rising prevalence of retinal diseases, increased diagnosis rates, and expanding aging population.
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Competitors & Alternatives:
The main competitors include Iluvien (flucinolone acetonide implant) and Retisert (fluocinolone acetonide implant). New agents such as Eylea (aflibercept) and Lucentis (ranibizumab) also compete in the intravitreal space, especially for wet age-related macular degeneration (AMD).
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Regulatory Status & Approvals:
Approved by the FDA since 2010 for various retinal conditions, it enjoys broad market access in the U.S. and other key markets, including EU and Japan.
Price Trends and Projections
Current Pricing Landscape
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List Price:
The wholesale acquisition cost (WAC) for a 0.7 mg Ozurdex implant typically ranges from $2,000 to $2,500 per injection in the U.S.
Once administered, treatment frequency varies: typically 4-6 months for injections, influencing overall therapy costs.
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Reimbursement & Patient Cost:
Insurance coverage varies; patients often face copayments ranging from $50 to $300. Reimbursement rates and policies can affect prescribing patterns.
Market Price Dynamics & Influences
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Market Penetration & Utilization:
The real-world utilization is growing, particularly as awareness of intravitreal corticosteroid implants improves and as older populations increase.
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Emerging Competition & Cost Pressure:
BioSimilarity expectations and biosimilar developments may push prices downward over the next 3-5 years, especially in European markets.
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Patent Expiry & Generic Entry:
The patent for Ozurdex is expected to wear off around 2025, which could lead to generic competition, potentially dropping prices by 50-70%.
Price Projections (Next 3-5 Years)
| Year |
Estimated Price Range |
Key Factors |
| 2023 |
$2,000 - $2,500 |
Stable, controlled by existing patent |
| 2024 |
$1,800 - $2,300 |
Patent expiry approaching, price decline expected |
| 2025 |
$1,200 - $1,600 |
Entry of generics, significant price reduction |
| 2026+ |
$1,000 - $1,400 |
Biosimilars/generics dominate, pricing stabilizes |
Note: These projections assume limited off-label use and steady demand growth. Price erosion will likely occur faster if biosimilars or generics enter early and with aggressive pricing strategies.
Key Influences on Pricing
- Regulatory decisions: Approval of biosimilars or approval of alternative treatments will impact pricing.
- Reimbursement policies: Payers' negotiations and formulary placements significantly influence final patient costs.
- Market penetration: Increased adoption in new geographic regions or expanded indications can sustain higher prices temporarily.
Key Takeaways
- The current price of Ozurdex (NDC 00115-1750) is approximately $2,000-$2,500 per implant in the U.S.
- Prices are expected to decline within 2-3 years due to patent expiration and potential biosimilar entry.
- Market expansion driven by aging populations and increased retinal disease prevalence supports steady demand.
- Competition from other intravitreal implants and systemic therapies will influence pricing dynamics.
- Reimbursement policies and healthcare regulations are critical determinants of net drug prices and access.
FAQs
1. When will Ozurdex face significant generic competition?
Patent protection is expected to expire around 2025, after which biosimilar or generic versions may enter the market.
2. How does biosimilar entry affect Ozurdex pricing?
Biosimilars tend to lower drug prices by 50% or more, shifting market share away from the originator.
3. Are there regional pricing differences for Ozurdex?
Yes. The U.S. generally has higher wholesale prices, while European markets are more regulated, often resulting in lower prices.
4. What factors influence reimbursement rates for Ozurdex?
Insurance coverage policies, regional healthcare regulations, and negotiations between manufacturers and payers.
5. How will emerging therapies impact Ozurdex’s market share?
Novel treatments with improved efficacy or safety profiles may reduce Ozurdex's utilization, impacting sales and pricing.
Sources:
[1] Market Research Future, "Ophthalmology Drugs Market," 2022.
[2] U.S. FDA Approval Records, 2010.
[3] IQVIA, "Global Sales Data," 2022.
[4] Managed Healthcare Executive, "Impact of Biosimilars on Market Dynamics," 2021.
