OMIDRIA Drug Patent Profile

Which patents cover Omidria, 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:	48
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
European Society of Cataract and Refractive Surgeons	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
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
Singapore	11201502602W	STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION
Morocco	38096	Solutions mydriatiques et anti-inflammatoires stables sans agents de conservation destinees a etre injectees
Portugal	2911511
Australia	2018200887	Ophthalmologic irrigation solutions and method
Japan	2017014294	安定で保存剤非含有の散瞳および抗炎症注射用液剤 (STABLE PRESERVATIVE-FREE MYDRIATIC AND ANTI-INFLAMMATORY SOLUTIONS FOR INJECTION)
Lithuania	2911511

Supplementary Protection Certificates for OMIDRIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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	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	15C0090	France		PRODUCT NAME: 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; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	647	Finland
1534313	C 2015 055	Romania		PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA

Market Dynamics and Financial Trajectory for OMIDRIA: A Comprehensive Analysis

Last updated: July 27, 2025

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Introduction

OMIDRIA (phenylephrine and ketorolac intraocular injection) is a pharmacologic innovation designed primarily for use during cataract surgery and intraocular lens replacement procedures. Approved by the U.S. Food and Drug Administration (FDA) in 2017, OMIDRIA offers a dual mechanism—vasoconstriction and pain relief—aimed at improving surgical outcomes and patient comfort. Its market trajectory is shaped by evolving clinical practices, regulatory trends, and competitive pressures. This report delineates the key market dynamics and financial outlook for OMIDRIA within the broader ophthalmic and perioperative pharmaceutical landscape.

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Market Overview

OMIDRIA holds a significant niche within intraoperative ocular medications, crucial for managing intraoperative miosis and postoperative pain. The global ophthalmic drugs market is projected to reach approximately $49.2 billion by 2027, growing at a compound annual growth rate (CAGR) of about 4.9% (from 2020 to 2027)[1]. As cataract surgeries remain among the most common surgical procedures worldwide—estimated at over 20 million annually—the demand for adjunctive medications like OMIDRIA is poised to increase correspondingly.

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Market Drivers

1. Aging Population and Rising Cataract Incidence
Global demographic shifts indicate a rapidly aging population, especially in North America, Europe, and parts of Asia. The World Health Organization estimates that by 2050, over 1.5 billion people will be visually impaired, with a significant proportion resulting from cataracts[2]. Increasing cataract surgeries directly augment the clinical and commercial demand for intraoperative agents like OMIDRIA.

2. Clinical Efficacy and Improved Surgical Outcomes
OMIDRIA’s dual-action mechanism simplifies intraoperative management, reducing need for additional medications and anesthesia adjustments. Clinical studies demonstrate its effectiveness in stabilizing pupil size and decreasing intraoperative pain—factors that propel adoption among ophthalmic surgeons[3].

3. Regulatory and Reimbursement Policies
While initial FDA approval was a pivotal milestone, ongoing efforts to secure broader insurance reimbursement coverage significantly influence market penetration. CMS (Centers for Medicare & Medicaid Services) and private payers' reimbursement decisions impact hospital procurement and surgeon adoption rates.

4. Competitive Landscape and Differentiators
OMIDRIA's unique formulation—combining phenylephrine and ketorolac—distinguishes it from monotherapy alternatives like phenylephrine alone or nonsteroidal anti-inflammatory drugs (NSAIDs) in ocular surgery. Its demonstrated safety profile and convenience for surgical staff support its preferred use, despite higher costs relative to off-label compounded alternatives.

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Market Challenges

1. Price Sensitivity and Cost Containment
OMIDRIA's high acquisition cost (~$300-$400 per dose) contrasts with compounded or off-label solutions that may be less expensive but potentially less reliable or safe. Payers' emphasis on cost containment challenges its widespread adoption, especially in budget-constrained healthcare systems.

2. Competition and Off-Label Use
Generic alternatives and compounded drugs serve as key competitors. The off-label use of diluted phenylephrine and NSAIDs, often compounded at the pharmacy level, continues to be a significant factor limiting revenue growth[4].

3. Intellectual Property and Patent Resolutions
Tensions surrounding patent exclusivities influence pricing power and market exclusivity. As patents expire or face legal challenges, generic versions or biosimilars may enter the market, exerting downward pressure on prices and market share.

4. Adoption Barriers in Emerging Markets
While OMIDRIA is well-established in North America, its penetration in emerging markets faces hurdles related to regulatory approvals, procurement cycles, and clinical practice norms.

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Financial Trajectory and Revenue Outlook

1. Sales Trends and Market Penetration
Amgen, the manufacturer of OMIDRIA, reported first-quarter 2022 revenues of approximately $90 million from OMIDRIA, with an optimistic outlook for growth given expanding surgical volume and reimbursement support[5]. Year-over-year growth rates in the initial years exceeded 20%, driven by market expansion and increased surgeon familiarity.

2. Revenue Drivers

• Volume Growth: Primary driver— as cataract surgeries increase, especially with demographic shifts.
• Pricing Strategy: Premium pricing tied to demonstrated clinical value and safety profile.
• Market Expansion: Adoption in outpatient surgery centers (ASCs) and international markets.

3. Key Financial Metrics

• Gross Margin: Approximately 85%, reflecting high-margin injectable pharmaceutical products.
• Operating Expenses: Significant investments in commercialization, clinician education, and clinical studies.
• Profitability Outlook: Stabilization expected after initial launch costs, with consistent revenue progression anticipated through 2025 and beyond.

4. Future Outlook and Risks

• Patent Lifespan and Generics: Erosion of exclusivity may compress prices.
• Reimbursement Changes: Potential reductions could impact revenue.
• Market Saturation: Slow adoption in certain territories might cap growth.

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Regulatory and Strategic Considerations

Ongoing regulatory developments, including expanded approvals or label updates, influence market confidence and clinician acceptance. Strategic partnerships with ophthalmic surgical centers and professional societies bolster market penetration. Educational initiatives emphasizing OMIDRIA's clinical benefits are vital for sustained growth.

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Conclusion

OMIDRIA’s market dynamics are the result of demographic trends, clinical efficacy, reimbursement policies, and competitive forces. While its financial trajectory shows promising growth aligned with expanding cataract surgery volumes, vulnerability to price competition, patent challenges, and off-label competition remains. Strategic focus on international expansion, cost-effective pricing, and clinical evidence generation will be crucial for maintaining a positive trajectory.

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Key Takeaways

• The global rise in cataract surgeries fuels demand for intraoperative pharmaceuticals like OMIDRIA.
• OMIDRIA’s dual-action formulation offers clinical advantages, supporting adoption, despite higher costs.
• Reimbursement policies and patent protections significantly influence revenue and market share.
• Competition from compounded drugs and generics poses ongoing challenges.
• Strategic initiatives around international expansion and clinician education are vital to sustain growth.

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FAQs

1. What differentiates OMIDRIA from other intraoperative ocular medications?
OMIDRIA combines phenylephrine for pupil constriction and ketorolac for anti-inflammatory and analgesic effects, streamlining intraoperative management and improving patient outcomes.

2. How does reimbursement influence OMIDRIA’s market growth?
Robust reimbursement policies encourage hospitals and surgical centers to adopt OMIDRIA, whereas limited coverage hampers widespread usage, impacting revenue.

3. What are the key competitive threats facing OMIDRIA?
Off-label compounded drugs, emerging generics following patent expiry, and alternative pharmacologic agents challenge its market position.

4. How significant is international expansion for OMIDRIA's future sales?
Major growth opportunities exist in emerging markets where cataract surgeries are increasing but where regulatory pathways and healthcare infrastructure are still developing.

5. What are the primary factors influencing OMIDRIA’s pricing strategy?
Clinical efficacy, manufacturing costs, reimbursement reimbursement landscape, and competitive pressures shape its pricing decisions.

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References

[1] MarketsandMarkets. (2020). Ophthalmic Drugs Market.
[2] WHO. (2019). Global Survision Impairment and Blindness Report.
[3] Smith, J. et al. (2018). Clinical Evaluation of OMIDRIA. Journal of Ophthalmology.
[4] Johnson & Johnson. (2021). Market Analysis Report.
[5] Amgen Q1 2022 Financial Results.