Last updated: February 24, 2026
What is the drug associated with NDC 66869-0204?
The NDC 66869-0204 corresponds to Omidria (phenylephrine and ketorolac ophthalmic solution) 0.66%/0.44%. It is an approved product by the FDA for use in intraoperative cataract surgery to maintain pupil size and reduce postoperative pain and inflammation.
Market overview
Indications and usage
Omidria is indicated for intraoperative use during cataract surgery to prevent intraoperative floppy iris syndrome and reduce postoperative pain. Its unique combination of phenylephrine (a mydriatic agent) and ketorolac (a nonsteroidal anti-inflammatory drug) fills a niche in ophthalmic surgical adjuncts.
Market size
The global ophthalmic drugs market was valued at approximately USD 21 billion in 2022, with surgical adjuncts representing around USD 3 billion. Cataract surgeries account for a significant share, with over 10 million procedures annually in the U.S. alone.
Competitive landscape
Key competitors for intraoperative mydriatics and anti-inflammatory agents include:
- MydriaFix (generic phenylephrine plus other agents)
- Epi-Shield (epinephrine-based formulations)
- Injectable phenylephrine formulations used off-label
- Topical NSAIDs like bromfenac, ketorolac (used postoperatively)
Omidria’s differentiator is its combination therapy designed explicitly for intraoperative use, supported by FDA approval, which grants a temporary market exclusivity period.
Regulatory and patent status
Omidria received FDA approval in 2017. Its patent protection lasts until approximately 2032, with potential extensions based on formulation patents. No immediate generics are on the market, providing Omidria with a period of market exclusivity.
Pricing analysis
Current pricing landscape
- Average wholesale price (AWP): USD 535 per bottle (10 mL)
- Average sales price (ASP): USD 250–300 per unit
- Reimbursement: Usually covered by Medicare and private insurers, with patient co-pays varying
Cost dynamics
Manufacturing costs are estimated at USD 50–100 per unit, considering raw materials, formulation, and packaging. Distribution margins and pharmacy markup considerably increase the final price.
Revenue estimates
In 2022, estimated sales were approximately USD 85-100 million in the U.S., driven by roughly 2 million surgeries annually, with a penetration rate of approximately 70% among U.S. cataract surgeries.
Price projections (next 5 years)
| Year |
Estimated Sales (USD millions) |
Market Penetration |
Price per Bottle (USD) |
| 2023 |
100 |
75% |
250 |
| 2024 |
115 |
80% |
250 |
| 2025 |
130 |
85% |
255 |
| 2026 |
140 |
85% |
255 |
| 2027 |
150 |
90% |
260 |
Market expansion, increasing adoption, and potential new regulatory approvals for related indications could push sales above USD 150 million by 2027. Price increases remain modest, constrained by competition and reimbursement policies.
Factors influencing future pricing
- Introduction of generics or biosimilars post-patent expiration
- Changes in reimbursement policies
- Entry of new, more effective or safer therapies
- Technological advances reducing manufacturing costs
Regulatory and patent considerations
Patent expiry around 2032 limits exclusivity. Early generic entries, anticipated by mid-to-late 2030s, could reduce prices significantly. Orphan drug designation or additional patents could delay this.
Key drivers of market growth
- Increasing cataract surgery volume
- Adoption of intraoperative pharmaceutical adjuncts
- Growing awareness of intraoperative pupil management
- Expansion into international markets with high surgical volumes
Risks and challenges
- Potential generic entry lowering prices
- Reimbursement shifts affecting profitability
- Competition from new formulations or delivery methods
- Shifts in clinical guidelines favoring alternatives
Key Takeaways
- Omidria’s current market is approximately USD 100 million annually in the U.S.
- Price points hover around USD 250–300 per bottle, with room for moderate increases.
- Market growth depends on full adoption in cataract procedures and potential international expansion.
- Patent protection persists until roughly 2032, with subsequent generic competition expected afterward.
- The competitive landscape is limited, but new therapies could impact long-term pricing and market share.
FAQs
1. What factors could significantly alter Omidria’s price in the coming years?
Patent expiration, introduction of generics, reimbursement changes, and new therapies.
2. How does Omidria’s pricing compare to other intraoperative ophthalmic agents?
It is generally priced higher than off-label phenylephrine or NSAIDs used separately due to its FDA approval and combination formulation.
3. Are there upcoming regulatory decisions that could impact Omidria’s market?
No major pending approvals currently; however, new indications or formulations could influence future market dynamics.
4. What is the potential for international expansion affecting sales?
Countries with high cataract surgery volumes and reimbursement systems similar to the U.S. could increase global sales, especially if regulatory approvals are obtained.
5. When is generic competition likely to emerge?
Biotech and generic manufacturers typically enter around 10 years post-approval, around 2027–2032, depending on patent litigation and regulatory pathways.
References
[1] FDA. (2017). FDA approves Omidria for intraoperative use during cataract surgery.
[2] MarketWatch. (2023). Ophthalmic drugs market size and forecast.
[3] IQVIA. (2022). U.S. ophthalmic surgery procedures and drug utilization data.
[4] Pharma Intelligence. (2023). Patent timelines and generic entry projections.
