Last updated: February 23, 2026
What is NDC 69452-0288?
NDC 69452-0288 corresponds to Omidria (phenylephrine and ketorolac injection). It is indicated for use during cataract surgery to maintain pupil size and reduce postoperative pain.
Current Market Landscape
Regulatory Status
- FDA Approval: Approved in December 2015.
- Patent Status: Patent protection was granted, with exclusivity through at least 2023, though specific patent expirations vary.
Commercial Data
- Market Size (2022): Estimated at approximately $110 million in the United States.
- Sales Trends: Steady growth observed since FDA approval, driven by increased cataract surgeries.
Competitive Environment
- Major Competitors: Alternatives like phenylephrine alone, ketorolac via off-label use, or compounded formulations.
- Differentiation: Omidria uniquely combines phenylephrine and ketorolac, providing both pupil dilation and pain reduction in one product.
Distribution Channels
- Primarily sold through hospital and outpatient surgical centers.
- Reimbursement codes (e.g., CPT codes) facilitate adoption.
Price & Pricing Trends
Current Pricing
- Per vial (single-use, 0.3 mL): Approximate wholesale price at $370 to $420.
- Average Selling Price (ASP): Around $430, considering variability based on volume discounts and provider negotiation.
Pricing Comparison
| Product |
Price per Unit |
Indication |
Notes |
| Omidria |
$370 - $420 |
Cataract surgery, intraoperative use |
Includes phenylephrine and ketorolac |
| Phenylephrine (off-label) |
$25 - $50 |
Dilator, not approved for intraocular use |
Re-purposed from other indications |
| Ketorolac injection (off-label) |
$50 - $80 |
Pain management |
Not combined with phenylephrine |
Price Trends (2020–2023)
- Slight upward pressure driven by increased surgical volume.
- Price stability observed due to limited direct competition.
- Future potential for price adjustments linked to patent expiry and market entry of generics.
Patent and Regulatory Outlook
- Patent Expiry: Likely around 2023–2024, depending on patent lifecycle and legal challenges.
- Implication: Entry of biosimilars or generics would impact pricing, potentially reducing prices by 20–40% over 1–3 years.
Market Entry and Development Strategies
- Expansion Opportunities: Outside of ophthalmology, potential off-label uses for ocular or perioperative indications.
- Pricing Strategy: As patents expire, utilize tiered pricing models to maintain market share.
Revenue Projections
| Year |
Estimated Sales in US ($ millions) |
Assumptions |
| 2023 |
$125 |
Continued growth, patent expiration approaches |
| 2024 |
$100 |
Patent expiry, competition increases |
| 2025 |
$80 |
Entry of biosimilars allows price competition |
| 2026 |
$60 |
Market stabilization, off-label use growth limited |
Risks & Opportunities
- Risks: Patent expiration, generic competition, reimbursement policy shifts, and regulatory hurdles.
- Opportunities: Broader intraoperative pain management applications, international expansion, and biosimilar development.
Key Takeaways
- Omidria maintains a stable market share with a premium priced product.
- Price is driven by limited competition and high clinical value.
- Patent expiry is predicted to precipitate price reductions.
- Market growth hinges on increased cataract surgery volume and adoption rates.
- Entry of generics could significantly reduce revenue projections post-2023.
FAQs
1. When will patent protection for Omidria expire?
Patent protections are expected to expire around 2023–2024, opening the market to generics.
2. How does Omidria's price compare to competing products?
It is priced significantly higher per vial (~$400) than off-label phenylephrine or ketorolac, which cost <$80.
3. What factors influence future price reductions?
Market entry of biosimilars or generics, increased competition, and patent expiry.
4. Are there regional or international markets for Omidria?
Yes, approvals in select countries exist, but the US remains the primary revenue driver.
5. What are potential growth avenues beyond ophthalmology?
Off-label intraoperative uses and international expansion present growth potential.
References
[1] U.S. Food and Drug Administration. (2015). Omidria (phenylephrine and ketorolac) injection approval.
[2] IQVIA. (2022). Ophthalmic drug market analysis.
[3] EvaluatePharma. (2022). Global ophthalmic drug sales overview.
