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 sixty-two 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:	62
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
The Eye Associates	PHASE1
Inder Paul Singh, M.D.	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	Solution	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
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
Croatia	P20210980
South Africa	201502684	STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION
Eurasian Patent Organization	201590807	СТАБИЛЬНЫЕ БЕСКОНСЕРВАНТНЫЕ МИДРИАТИЧЕСКИЕ И ПРОТИВОВОСПАЛИТЕЛЬНЫЕ РАСТВОРЫ ДЛЯ ИНЪЕКЦИЙ
South Korea	102496463
Japan	2016196511

Supplementary Protection Certificates for OMIDRIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	C20150054 00179	Estonia		PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015
1534313	264 5031-2015	Slovakia		PRODUCT NAME: FENYLEFRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/KETOROLAK VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	92923	Luxembourg		PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730

Market Dynamics and Financial Trajectory for OMIDRIA

Last updated: February 20, 2026

OMIDRIA (phenylephrine and ketorolac intraocular solution) is an FDA-approved drug indicated for use during cataract surgery to prevent intraoperative miosis and postoperative pain. Its market position hinges on surgical volume, competitive landscape, pricing, and reimbursement policies.

Market Overview

• The global cataract surgery market exceeded 10 million procedures annually, with a compound annual growth rate (CAGR) of approximately 4% through 2027 (Fortune Business Insights, 2022).
• OMIDRIA's primary target accounts for corporate revenues derived from intraoperative pharmaceutical sales during cataract procedures.

Market Drivers

• Surgical volume growth: Aging populations in North America and Europe increase demand for cataract procedures.
• Regulatory clearance: FDA approval in 2017 facilitated hospital adoption.
• Enhanced surgical outcomes: Evidence shows OMIDRIA reduces the need for intraoperative iris dilators, lowering associated risks and costs.
• Reimbursement policies: CMS and private insurers reimburse for OMIDRIA, with reimbursement rates influencing usage.

Market Challenges

• Pricing pressure: The wholesale acquisition cost (WAC) hovers between $150 and $170 per bottle.
• Competition: Generic alternatives and off-label opioids (e.g., ketorolac from compounding pharmacies) may erode market share.
• Provider adoption: One-time adoption costs, physician preference, and hospital formulary decisions delay uptake.

Revenue Generation and Financial Forecast

Revenue Components

Revenue Source	Value / Notes
Drug sales to hospitals	Major revenue source; driven by procedure volume
Reimbursement rates	Approximately $300 per dose with coverage by Medicare, Medicaid, and private insurers
Market share	Estimated 35%-50% within its segment; fluctuates with competition
Pricing strategy	Premium pricing justified by clinical benefits; susceptible to pressure
Sales trend	Market growth driven by increasing cataract surgeries; sales growth estimated at 4-6% annually pre-pandemic. Pandemic-related slowdown caused temporary declines.

Financial Outlook (2023-2027)

Year	Estimated Cataract Procedures	Estimated OMIDRIA Units Sold	Revenue ($ millions)	Notes
2023	11 million	8 million	120-150	Post-pandemic recovery continues; usage expanding
2024	11.4 million	9 million	135-165	Adoption accelerates with expanded hospital contracts
2025	11.8 million	10 million	150-180	Competitive pressures influence pricing; volume growth stabilizes
2026	12 million	11 million	165-200	Market maturation; adoption plateauing in mature regions
2027	12.2 million	11.5 million	170-210	Steady growth, potential market share gains from new entrants

Key Financial Metrics

• Gross profit margin: Estimated at 55%-60%, influenced by manufacturing costs and discounting strategies.
• Operating expenses: R&D and sales & marketing account for approximately 20%-25% of revenues.
• Profitability: Expected EBITDA margins of 30%-40% depending on market penetration and pricing pressures.

Competitive Landscape

• Generic phenylephrine and ketorolac formulations: Price-sensitive, less regulated, but requires compounding pharmacies, posing a threat.
• Other pharmaceutical agents: Some surgeons prefer off-label use of plain ketorolac, complicating market share gains.
• Potential entrants: Companies developing alternative formulations or delivery systems could disrupt the current market.

Regulatory and Policy Impacts

• Reimbursement policies: Any changes by CMS or private payers affecting sale prices could influence profitability.
• FDA updates: New safety or efficacy data could lead to formulary restrictions or expanded indications.
• Market access: Distribution agreements with hospital systems influence geographic and hospital-type penetration.

Summary

OMIDRIA's financial trajectory is shaped by ongoing procedural growth in cataract surgery, competitive pressures from generics and off-label use, and reimbursement policies. While current revenues are stable with growth potential, future performance depends on market share expansion and pricing strategies.

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Key Takeaways

• OMIDRIA benefits from growing cataract surgery volume and reimbursement support, with revenues projected to increase modestly through 2027.
• Competitive risks include generic formulations and off-label use, which could pressure pricing and market share.
• Market growth averages 4% annually, driven by aging populations, but pandemic effects caused transient declines.
• Profitability depends on managing manufacturing costs, reimbursement rates, and gaining prescription volume.
• Regulatory or policy changes could significantly influence future revenues.

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FAQs

1. How does OMIDRIA compare to off-label ketorolac use?
Off-label ketorolac from compounding pharmacies is less regulated and cheaper but lacks FDA approval, standardization, and safety assurance associated with OMIDRIA.

2. What factors could alter OMIDRIA's reimbursement rates?
Policy reforms by CMS, changes in hospital procurement policies, or emerging cost-effectiveness data could impact reimbursement levels.

3. Who are OMIDRIA's main competitors?
Generic phenylephrine and ketorolac formulations from compounding pharmacies; alternative proprietary drugs with similar indications.

4. How does COVID-19 impact OMIDRIA sales?
Pandemic-related reductions in elective surgeries temporarily slowed sales; recovery aligns with surgery volume rebound.

5. What is the potential for new indications or formulations?
Limited pipeline activity exists; future growth relies on expanded hospital contracts and potential new delivery methods rather than new indications.

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Sources

[1] Fortune Business Insights. (2022). Cataract Surgery Market Size, Share & Industry Analysis.
[2] FDA. (2017). OMIDRIA (phenylephrine and ketorolac ophthalmic solution).
[3] IQVIA. (2022). Ophthalmic pharmaceuticals market report.