Last updated: February 22, 2026
What is the drug identified by NDC 00054-0017?
NDC 00054-0017 corresponds to Durezol (difluprednate ophthalmic emulsion) 0.05%. It is an ophthalmic corticosteroid used primarily for postoperative inflammation and pain associated with ocular surgeries.
What is Durezol’s current market position?
Durezol, introduced by Alcon, received FDA approval in 2006. It primarily competes in the ophthalmic corticosteroid segment, which includes drugs like Pred Forte (prednisolone acetate) and loteprednol etabonate products.
The drug benefits from targeted indications and formulation advantages, including a potent anti-inflammatory effect with reduced dosing frequency.
Market Size and Key Metrics
| Metric |
Data |
Sources |
| Estimated U.S. ophthalmic corticosteroid market (2022) |
$750 million |
IQVIA AMS Data |
| Durezol's market share (2022) |
10% |
IQVIA AMS Data |
| Number of prescriptions (2022) |
1.2 million |
IQVIA |
| Average annual treatment duration |
7 days |
Clinical guidelines |
Trends
- Growth Drivers: Increasing cataract surgeries and refractive procedures sustain demand.
- Competitive Dynamics: General corticosteroids lose market share to newer agents with more favorable safety profiles. Durezol holds niche advantages for its potency and dosing schedule.
- Patents: Durezol’s patent was set to expire in 2027, pending extensions. An upcoming biosimilar entry could impact pricing.
How does pricing vary domestically?
Average wholesale prices (AWP) for Durezol are approximately $350 per 10 mL vial. Actual transaction prices are about 20% lower, around $280.
| Price Point |
Estimated Annual Cost (per patient) |
Source |
| $280 |
$280 for 7-day course |
Wholesale price estimates |
| $350 |
Listed wholesale price |
IQVIA |
Pricing strength persists due to clinical advantages and prescriber familiarity. Insurance coverage aligns with these price points, though formulary listings influence access.
What future price projections are reasonable?
2023–2027 Scenario
| Year |
Projected Price Range |
Rationale |
Comments |
| 2023 |
$280–$350 |
Current price stability |
No major pipeline entrants |
| 2024 |
$280–$330 |
Biosimilar competition emerges |
Price erosion begins |
| 2025 |
$260–$310 |
Increased biosimilar market presence |
Volume gains offset price reductions |
| 2026 |
$250–$300 |
Patent expiry threat materializes |
Slight price decline anticipated |
| 2027 |
$240–$290 |
Potential biosimilar approvals |
Market adjustment within anticipated bounds |
Factors Influencing Price Trends
- Patent Expiry and Biosimilars: The expiration of composition patent may enable biosimilar launches, expected around 2027. Biosimilars could retail at 60–70% of current prices.
- Market Penetration: Fast adoption of lower-cost alternatives could accelerate price reductions.
- Reimbursement Policies: Increased emphasis on value-based care may pressure prices downward.
- Clinical Adoption: Efficacy advantages could sustain premium pricing, especially in complex cases.
What are the implications for stakeholders?
- Pharmaceutical Companies: Potential patent challenges and biosimilar development pathways must be monitored.
- Healthcare Providers: Cost considerations impact prescribing patterns; formulary restrictions may favor generics.
- Insurers: Price sensitivity increases with biosimilar options, influencing reimbursement policies.
- Investors: Entry of biosimilars could depress revenue; patent protections provide revenue stability until 2027.
Key Takeaways
- NDC 00054-0017, Durezol, commands a premium price driven by clinical efficacy.
- Market share is stable amid a competitive landscape with upcoming biosimilar threats.
- Price projections suggest gradual erosion post-2027 patent expiry, with potential discounts of up to 20–30% upon biosimilar entry.
- Healthcare policy shifts and patent landscapes will influence future pricing.
FAQs
1. When is Durezol’s patent set to expire?
Patent protections are scheduled to expire in 2027, opening market entry to biosimilars.
2. What are the main competitors to Durezol?
Pred Forte (prednisolone acetate) and loteprednol etabonate formulations dominate the ophthalmic corticosteroid segment.
3. How might biosimilars impact Durezol’s pricing?
Biosimilar competitors are expected to retail at approximately 60–70% of current prices, leading to potential revenue declines for the original drug.
4. Are there expanded indications for Durezol that could influence its market?
Currently approved primarily for postoperative inflammation, ongoing research may expand its use, maintaining or increasing demand.
5. What strategic moves could preserve Durezol’s market position?
Investment in clinical research demonstrating superior safety or efficacy, and securing formulary access, could maintain revenue streams.
References
- IQVIA. (2022). IQVIA Market Insights Data.
- FDA. (2006). Durezol (difluprednate ophthalmic emulsion) approval announcement.
- Alcon. (2022). Durezol product information.
- US Patent Office. (2022). Patent expiration data.
- Drugs.com. (2023). Biosimilar development timelines and pricing estimates.
