OMIDRIA Drug Patent Profile

When do Omidria patents expire, and when can generic versions of Omidria launch?

Omidria is a drug marketed by Rayner Surgical and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in thirty-eight countries.

The generic ingredient in OMIDRIA is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Omidria

A generic version of OMIDRIA was approved as ketorolac tromethamine; phenylephrine hydrochloride by LUPIN LTD on July 1^st, 2019.

Summary for OMIDRIA

International Patents:	59
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	31
Drug Prices:	Drug price information for OMIDRIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMIDRIA
What excipients (inactive ingredients) are in OMIDRIA?	OMIDRIA excipients list
DailyMed Link:	OMIDRIA at DailyMed

See drug prices for OMIDRIA

Recent Clinical Trials for OMIDRIA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Inder Paul Singh, M.D.	PHASE1
The Eye Associates	PHASE1
Luigi Rondas	Phase 3

See all OMIDRIA clinical trials

Pharmacology for OMIDRIA

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug alpha-1 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for OMIDRIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OMIDRIA	Injection	ketorolac tromethamine; phenylephrine hydrochloride	1%/0.3%	205388	1	2015-05-29

US Patents and Regulatory Information for OMIDRIA

OMIDRIA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes			Y
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes					Y
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014	AT	RX	Yes	Yes					Y

Expired US Patents for OMIDRIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388-001	May 30, 2014

International Patents for OMIDRIA

See the table below for patents covering OMIDRIA around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2397574
Serbia	62188	STABILNI MIDRIJATSKI I ANTI-INFLAMATORNI RASTVORI BEZ KONZERVANSA ZA UBRIZGAVANJE (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION)
Eurasian Patent Organization	033811	СТАБИЛЬНЫЕ БЕСКОНСЕРВАНТНЫЕ МИДРИАТИЧЕСКИЕ И ПРОТИВОВОСПАЛИТЕЛЬНЫЕ РАСТВОРЫ ДЛЯ ИНЪЕКЦИЙ (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION)

Supplementary Protection Certificates for OMIDRIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	1590074-9	Sweden		PRODUCT NAME: EN KOMBINATION INNEFATTANDE FENYLEFRIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV OCH KETOROLAK ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/15/1018 20150730
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	C20150054 00179	Estonia		PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015

Market Dynamics and Financial Trajectory for OMIDRIA

Last updated: December 30, 2025

Executive Summary

OMIDRIA (phenylephrine and ketorolac ophthalmic solution) is a combination drug approved by the FDA in 2015 for intraocular use during cataract surgery and intraocular lens (IOL) replacement. As an innovative product in ophthalmic anesthesia, OMIDRIA addresses both analgesic and mydriatic needs, positioning it within a lucrative ophthalmic market. This analysis evaluates the current market dynamics, competitive landscape, factor drivers influencing its adoption, and financial projections based on historical data, market trends, and strategic initiatives.

Introduction

The ophthalmic pharmaceutical market is projected to reach USD 22.8 billion by 2027, with a compound annual growth rate (CAGR) of approximately 4–6% (2022–2027)[1]. OMIDRIA, as a niche but expanding product, leverages increasing cataract procedures, advancements in surgical techniques, and rising prevalence of age-related ocular conditions. This report provides an in-depth analysis of OMIDRIA's market trajectory, key factors influencing its growth, potential challenges, and future revenue outlook.

---

What Are the Key Market Drivers for OMIDRIA?

1. Surge in Cataract Procedures

Global and US Trends
Cataract surgeries are among the most common surgical procedures worldwide. The American Academy of Ophthalmology reports over 3 million surgeries annually in the US alone, with this number expected to grow by 4–5% annually due to demographic shifts and enhanced surgical indications[2].

Impact on OMIDRIA
Increased surgeries directly boost demand for intraoperative mydriatics and analgesics—core applications of OMIDRIA. The drug's ability to maintain pupil dilation and reduce intraoperative pain enhances surgical outcomes, favoring its adoption.

2. Advancements in Surgical Techniques

Minimally Invasive Procedures
The adoption of micro-incisional and phacoemulsification techniques demands optimized pharmacology to improve surgical efficiency.

OMIDRIA's Role
Its dual action improves surgical convenience—reducing intraoperative miosis and pain—driving its preferred use among surgeons.

3. Regulatory and Reimbursement Landscape

FDA Approval and Payer Support
Post-approval, CMS and private payers have started reimbursing OMIDRIA under outpatient procedures, increasing accessibility[3].

Incentives for Adoption
Its status as a specifically approved drug provides confidence to providers and insurers, facilitating wider utilization.

4. Market Penetration and Physician Acceptance

Physician Adoption Rates
According to published sales data, OMIDRIA adoption has grown steadily, with an approximate 40% penetration among US cataract surgeons by 2022[4].

Educational Initiatives
Clinician outreach and clinical guidelines promote usage, further accelerating sales.

---

How Does Competitive Landscape Shape OMIDRIA’s Market?

Competitor	Product Name	Indication	Market Share (2022)	Differentiators
Bausch + Lomb	Mydriacyl (phenylephrine)	Mydriasis	60%	Widely used, off-label in surgeries
Alcon	Phenylephrine hydrochloride	Mydriasis	20%	Generic availability
Omeros Corporation	OMIDRIA	Mydriasis & analgesia	20%	Dual action, FDA-approved

Key Competitors

• Off-label phenylephrine formulations dominate due to lower costs.
• Generic phenylephrine solutions are sold at lower prices but lack FDA approval for intraoperative use.

Market Position of OMIDRIA

• Differentiates as the only FDA-approved drug combining phenylephrine and ketorolac.
• Maintains premium pricing (USD 100–150 per vial), supported by clinical preference.

---

Financial Trajectory Analysis

Revenue Growth Drivers

Factors	Impact	Remarks
Procedure Volume	+	Expected CAGR of 4–5% in US cataract surgeries
Market Penetration	+	Estimated increase from 40% to 60% by 2027
Pricing Strategy	+	Premium pricing maintained due to clinical benefits
Reimbursement Policies	+	Likely to expand, especially with CMS support

Historical Financial Performance (2018–2022)

Year	Estimated Sales (USD millions)	Notes
2018	50	Launch phase, modest adoption
2019	150	Accelerated uptake, initial reimbursement
2020	250	COVID-19 pandemic disrupted surgeries but rebounded
2021	350	Increased acceptance and physician education
2022	400	Saturation approaching, slow growth

Projected Revenue (2023–2027)

Assuming steady growth driven by procedure volume and expanding adoption, forecasted revenues are:

Year	Estimated Sales (USD millions)	CAGR	Assumptions
2023	440	10%	Continuation of growth trend
2024	484	10%	New markets in Europe & Asia
2025	533	10%	Increased reimbursement support
2026	586	10%	Broader clinician acceptance
2027	645	10%	Market saturation approaches

---

Future Trends and Innovation Opportunities

Expansion into Global Markets

• Regulatory approvals pending in Europe and Asia—potential to double the market size.
• Local manufacturing partnerships may reduce costs and facilitate adoption.

Product Lifecycle Management

• Development of smaller vial sizes and multi-use formulations to optimize cost efficiency.
• Integration with other intraocular drugs for comprehensive surgical management.

Digital and Data Analytics

• Use of real-world evidence to demonstrate cost-effectiveness may influence payer policies.
• Digital marketing strategies targeted at ophthalmic surgeons.

---

Potential Challenges and Risks

Risk	Details	Mitigation Strategies
Regulatory Delays	New markets require approval processes	Early engagement, localized data collection
Competitive Pricing	Generics threaten premium positioning	Demonstrate clinical superiority, differential reimbursement
Reimbursement Cuts	Policy shifts can impact profitability	Engage with policymakers; diversify markets
Clinical Adoption Lag	Skepticism toward new drugs	Strong clinical evidence, education campaigns

---

Key Comparisons: OMIDRIA vs. Alternatives

Attribute	OMIDRIA	Phenylephrine (off-label)	Other Mydriatics
FDA Approval	Yes	No	No
Dual Action (Myadriasis + Analgesia)	Yes	No	No
Cost per Vial	USD 125–150	USD 10–20 (off-label)	Similar or higher
Reimbursement Support	Yes	No	Limited
Clinical Evidence	Robust	Variable	Limited

---

Conclusion: Strategic Outlook for OMIDRIA

OMIDRIA stands positioned as a premium intraoperative ophthalmic drug with stable growth prospects, driven by rising cataract surgery volumes, technological advances, and favorable reimbursement policies. Its unique dual-action profile and FDA approval provide distinct competitive advantages. However, ongoing market penetration, expanding global access, and innovation are critical to sustain and augment its financial trajectory.

---

Key Takeaways

• Market Expansion: Increasing cataract surgeries and global approvals offer substantial growth opportunities.
• Market Penetration: Penetration levels, currently around 40–50%, are expected to rise, enhancing revenue.
• Pricing & Reimbursement: Premium pricing supported by clinical benefits and payer reimbursement sustains profitability.
• Competition: Off-label phenylephrine and generics dominate, but OMIDRIA’s approval and dual-action differentiate it.
• Risks & Mitigation: Regulatory, pricing, and adoption risks necessitate strategic focus on evidence generation and global expansion.

---

FAQs

1. What factors most influence OMIDRIA’s market growth?
The growth hinges on increasing cataract procedure volumes, physician adoption driven by clinical benefits, reimbursement policies, and expansion into international markets.

2. How does OMIDRIA compare cost-wise to off-label phenylephrine solutions?
OMIDRIA’s vial costs are significantly higher (USD 125–150) but are justified by FDA approval, dual-action efficacy, and reimbursement opportunities, whereas off-label phenylephrine solutions cost USD 10–20 per dose.

3. What are the main barriers to OMIDRIA’s wider adoption?
Limited physician awareness, resistance to switching from off-label medications, reimbursement challenges, and pricing concerns.

4. Are there upcoming innovations or regulatory approvals that could affect OMIDRIA’s market?
Yes, approvals in Europe and Asia, and formulation enhancements could further expand its market.

5. How important is reimbursement support for OMIDRIA’s financial success?
Crucial. Reimbursement policies directly impact the drug’s accessibility and thus sales volume, making policy engagement a key strategic priority.

---

References

[1] MarketWatch. “Ophthalmic Drugs Market Size, Share & Trends Analysis Report, 2022–2027.” 2022.
[2] American Academy of Ophthalmology. “Cataract Surgery Statistics.” 2022.
[3] CMS. “OPPS Final Rule & Reimbursement Policies.” 2021.
[4] IQVIA. “Ophthalmic Drug Market Data.” 2022.

---

Disclaimer: All projections and data points are estimates based on available market data and trends, subject to change with new market developments.