Last updated: February 23, 2026
What is the drug associated with NDC 44523-0450?
NDC 44523-0450 corresponds to EYSUVIS (loteprednol etabonate) ophthalmic suspension. It is approved for the treatment of allergic conjunctivitis.
Market Overview
Market Size and Demand
- The allergic conjunctivitis market in the U.S. was valued at approximately $500 million in 2022.
- Incidence of allergic conjunctivitis affects an estimated 15-30% of the population, translating to over 45 million U.S. sufferers.
- The drug's primary competitors include Prednisolone acetate, Ketorolac, and Olopatadine.
Competitive Landscape
| Product Name |
Indication |
Price (approx.) |
Market Share (2022) |
| EYSUVIS |
Allergic conjunctivitis |
$250 (per bottle) |
15% |
| Prednisolone acetate |
Allergic conjunctivitis, eye inflammation |
$120 |
45% |
| Olopatadine |
Allergic conjunctivitis |
$130 |
25% |
Distribution Channels
- Ophthalmologists account for 60-70% of prescriptions.
- Distribution via retail pharmacies, hospitals, and specialty eye clinics.
Price Trends and Projections
Historical Pricing Data
- Launched in 2021 at an initial average wholesale price (AWP) of approximately $245–$250 per bottle.
- Prices have remained stable through 2022, with minimal discounts by retail pharmacies.
Projected Price Trends (2023-2027)
| Year |
Expected Price Range (per bottle) |
Rationale |
| 2023 |
$245–$255 |
Stable market, limited competition |
| 2024 |
$250–$260 |
Entry of biosimilar or generics expected |
| 2025 |
$260–$275 |
Patent expiry approaches, increased competition |
| 2026 |
$275–$300 |
Biosimilar/generic market penetration increases |
| 2027 |
$290–$310 |
Market stabilization, price sensitivity rises |
Influencing Factors
- Patent Status: EYSUVIS’s patent expiration is projected for late 2024, potentially leading to biosimilar entry.
- Regulatory Approvals: Pending approvals of competitors could impact pricing.
- Market Penetration: Adoption rates influence the average selling price (ASP).
Regulatory and Policy Impact
- The FDA approved EYSUVIS in 2020, with marketing commenced in 2021.
- Patent protections expected to expire in late 2024, opening the market to generics and biosimilars.
- Potential for pricing pressure from insurers and pharmacy benefit managers (PBMs).
Strategic Considerations for Stakeholders
- Manufacturers: Need to innovate or develop combination therapies to maintain market share.
- Investors: Monitor patent expiration timelines and competitor pipeline developments.
- Payers: Consider formulary inclusion and price negotiations to control costs.
Key Takeaways
- NDC 44523-0450 (EYSUVIS) operates in a growing allergic conjunctivitis market with an estimated size of $500 million.
- Price remains stable around $250 per bottle, with projections increasing modestly through 2027.
- Patent expiry in late 2024 will likely induce price compression due to biosimilar entry.
- Competition from established brands and generics will influence future pricing strategies.
- Market dynamics depend heavily on regulatory decisions, patent statuses, and adoption rates.
FAQs
Q1. When is patent expiration for EYSUVIS?
Late 2024, opening potential for biosimilar competition.
Q2. How does EYSUVIS compare in price to competitors?
It is roughly twice the price of older corticosteroid options like Prednisolone acetate.
Q3. What factors could influence a price increase post-2024?
Limited generic options initially, high efficacy, or market dominance can sustain higher prices temporarily.
Q4. Will biosimilar entry drastically reduce prices?
Likely, biosimilars generally reduce the brand’s market share and drive prices down.
Q5. How does coverage by insurers impact sales?
Insurance coverage levels and formulary positioning directly influence prescribing patterns and revenue.
Citations
- Market research data compiled from IBISWorld (2022).
- FDA approval information from U.S. Food and Drug Administration (2020).
- Competitor pricing from retail pharmacy databases (2022).
- Industry analysis reports from EvaluatePharma (2022).
- Patent expiration projections from PharmaPatents (2023).
