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 sixty-three 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 on July 1^st, 2019.

Summary for OMIDRIA

International Patents:	63
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	32
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	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

International Patents for OMIDRIA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2003261304	OPHTHALMOLOGIC IRRIGATION SOLUTIONS AND METHOD
Australia	2009248461	Ophthalmologic irrigation solutions and method
Australia	2013202330	Ophthalmologic irrigation solutions and method
Australia	2016201834	Ophthalmologic irrigation solutions and method
Australia	2018200887	Ophthalmologic irrigation solutions and method
Canada	2493581	SOLUTIONS ET PROCEDE D'IRRIGATION OPHTALMOLOGIQUE (OPHTHALMOLOGIC IRRIGATION SOLUTIONS AND METHOD)

Supplementary Protection Certificates for OMIDRIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	CA 2015 00072	Denmark		PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. 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	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	C20150054 00179	Estonia		PRODUCT NAME: FENUEUELEFRIIN/KETOROLAK;REG NO/DATE: EU/1/15/1018 30.07.2015
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728

Omidria Market Dynamics and Financial Trajectory (Revenue, Pricing, and Exclusivity Risks)

Last updated: July 21, 2026

Omidria (phenylephrine and ketorolac injection) remains a niche ophthalmic perioperative product with revenue driven by cataract-surgery volumes, adoption by surgical centers, and contracting dynamics for ambulatory surgery and hospital outpatient departments. Financial trajectory is shaped by patent and regulatory status for the original formulation, substitution risk from generics or licensed alternatives (primarily within perioperative cataract settings), and channel reimbursement pressure.

What is Omidria’s sales trajectory and who drives demand?

Omidria is used in cataract surgery to reduce postoperative pain and improve intraoperative visualization by combining phenylephrine (pupil dilation) with ketorolac (NSAID analgesia). Demand is concentrated in settings that consistently perform high cataract volumes: hospital outpatient and ambulatory surgery centers (ASCs).

Demand drivers

• Cataract procedure volumes and growth in the eligible elderly population.
• Surgeon and facility adoption behavior (protocol-driven use after early adoption).
• Formulary and contracting terms in ophthalmic drug procurement.
• Per-case reimbursement economics in the Medicare outpatient and commercial channels.

Primary commercial channel behavior

• Omidria is purchased in bulk by facilities that standardize perioperative cataract order sets.
• Adoption depends on whether facilities treat perioperative analgesia and visualization as a bundle and whether they lock in preferred products through group purchasing organization (GPO) relationships and pharmacy benefit managers (PBMs) for institutional accounts.

Featured snippet answer

• Omidria’s sales trajectory tracks US cataract surgery throughput and institutional adoption, with margin and growth constrained by reimbursement and price pressure typical of perioperative ophthalmic injectables.

How do market dynamics affect Omidria pricing and net revenue?

Net revenue is influenced by:

• List price vs. net price: institutional discounts, rebates, and contracting in outpatient settings.
• Mix: shift toward higher-volume ASCs or higher-acuity hospitals with different contracting structures.
• Payer economics: reimbursement rates for outpatient surgical drugs and bundled billing practices that reduce the economic incremental benefit of add-on therapies.

Key pricing pressure mechanisms

• Procurement benchmarking across competing intraoperative and postoperative pain-control strategies.
• Budget impact scrutiny at hospital system level for perioperative drug formularies.
• Risk of substitution if alternative products are viewed as therapeutically equivalent in outcomes or workflow.

What is Omidria’s competitive landscape in perioperative cataract surgery?

Omidria’s competitive set is not purely “another drug with the same indication.” It is perioperative alternatives that target:

• postoperative pain/inflammation (NSAID-based options),
• intraoperative pupil dilation and visualization support (alpha-agonist approaches),
• and combined strategies used by surgeons.

Competitive pressure points

• Competing NSAID protocols delivered as drops or intracameral/other perioperative formulations.
• Alpha-agonist dilation approaches as monotherapies or protocol components.
• Institutional preference for fewer SKUs and simplified workflows.

Featured snippet answer

• Omidria competes as a procedural, standardized cataract-surgery adjunct, so adoption risk comes from protocol substitution and contracting rather than only from direct molecule-level generics.

How do exclusivity and patent expiry timelines affect Omidria’s financial outlook?

Omidria is a branded combination product with a formulation-specific and/or method-of-use IP footprint. Financial valuation and forward planning depend on:

• whether generic entry is feasible immediately after market exclusivity ends,
• whether patents cover the specific combination, the perioperative administration method, or key performance properties,
• and whether Orange Book-listed patents create a barrier to Paragraph IV filings.

Exclusivity risk assessment framework (for Omidria)

• Identify whether the bottleneck is formulation patents (composition of matter/combination) or method-of-use/administration patents.
• Determine whether any protected claims would be infringed by typical generic labeling and instructions for use.
• Track whether litigation or settlements impose delayed launch.

Featured snippet answer

• Omidria’s revenue durability depends on patent barriers against combination-use in cataract surgery and any settlement-driven launch delays following exclusivity.

What is the Orange Book status of Omidria and which patents protect it?

Omidria’s patent protection posture is defined by FDA Orange Book listings for:

• active ingredient(s),
• dosage form,
• and listed patents tied to approval.

How to read the patent estate for a combination product

• Combination products often face layered protection:
  • formulation/composition coverage for the active combination,
  • method-of-use coverage for perioperative administration,
  • and sometimes manufacturing or device-administration workflow claims.

Impact to market

• The Orange Book drives generic entry strategy and litigation posture. If key patents are narrowly tied to the combination and administration, generic challengers must either engineer around or certify non-infringement/invalidity for those claims.

What generic entry risks exist for Omidria?

Generic entry risk has two components: legal feasibility and commercial feasibility.

Legal feasibility

• Paragraph IV challenges test Orange Book patents.
• If Omidria’s estate includes strong combination or administration claims, challengers face injunction risk and delayed launch.

Commercial feasibility

• Even if approval is granted, uptake depends on:
  • surgeon comfort with alternative preparation,
  • facility protocol changes,
  • and whether the generic meets workflow requirements and stability specs for perioperative use.

Featured snippet answer

• Omidria generic risk is primarily an IP and labeling barrier question. Adoption risk is secondary but can be large because facilities often treat perioperative order sets as standardized bundles.

What patent litigation affects Omidria and how do settlements change launch timing?

For branded perioperative injectables, litigation outcomes typically determine:

• launch delays,
• design-around labeling boundaries,
• and whether a generic can enter without “at-risk” commercial sales.

Settlement mechanics that matter for revenue

• Automatic or court-enforced stay provisions can postpone final generics even after regulatory approvals.
• Settlement terms can include:
  • agreed effective dates for launch,
  • marketing restrictions to avoid label-triggered infringement,
  • cross-licenses or covenants not to sue.

Featured snippet answer

• Any Omidria settlement that delays launch directly affects near-term revenue exposure by controlling the earliest date a discounted generic can gain share.

How strong is the patent estate for Omidria compared with other perioperative ophthalmics?

A branded niche injectable’s patent strength is judged by:

• number of active Orange Book-listed patents at time of analysis,
• claim breadth (combination vs. narrow administration),
• and history of Paragraph IV filings and litigation outcomes.

Comparison set

• Use the patent estate strength of adjacent perioperative ophthalmic products:
  • products targeting postoperative inflammation and pain,
  • intracameral or perioperative delivery NSAIDs,
  • and intraoperative visualization/pupil-related agents.

Commercial interpretation

• A thick, combination-protecting estate generally delays full generic substitution.
• A thin estate or early design-around claims typically accelerates share loss and net price erosion.

What biosimilar risk exists for Omidria?

Omidria is a small-molecule drug combination, not a biologic. Biosimilar pathways do not apply.

Featured snippet answer

• Biosimilar risk is not applicable to Omidria because it is not a biologic product.

How does Omidria’s reimbursement and contracting environment shape margins?

Institutional margin outcomes depend on net price and case volume. Key determinants include:

• Outpatient reimbursement constraints that cap incremental add-on economics.
• Contracting structures:
  • multi-tier discounts tied to quarterly purchase volumes,
  • GPO pricing tiers,
  • and system-level formulary negotiations.

Revenue quality indicators

• Stability of purchase volume per facility (retention).
• Ability to defend net price through contracting cycles.
• Mix shift toward higher-volume cataract programs.

How do formulation and administration patents affect generic design-around?

For combination perioperative products, design-around strategies often focus on:

• changing concentration ratios,
• altering delivery method or administration timing,
• and labeling instruction modifications that avoid method-of-use triggers.

Practical barrier

• If patents cover administration during specific intraoperative steps, generics can face:
  • label carve-outs,
  • enforcement risk if off-label practice mirrors the patented method,
  • and reduced adoption if the generic’s label is less operational.

What timeline governs exclusivity and potential launch in US markets?

Financial forecasting requires a timeline that separates:

• regulatory exclusivity (if any) that blocks certain applications,
• patent expiration that blocks infringement,
• and litigation or settlement effects that delay actual launch.

Forecast logic

• If patents expire later than any exclusivity window, the earliest launch is constrained by the patent estate and any Paragraph IV litigation stay.
• If exclusivity ends first but patents remain, generics can still be held at bay pending resolution.

What role does FDA pathway status play in Omidria competition?

For branded injectables, competition hinges on:

• Whether a generic can file as an ANDA based on reference listed drug (RLD) and satisfy bioequivalence requirements,
• Whether the Orange Book patent list triggers patent certification and litigation.

Featured snippet answer

• FDA regulatory status determines whether challengers can attempt entry. Orange Book patent listings determine whether they can enter without infringement exposure.

---

Key Takeaways

• Omidria’s revenue is driven by institutional adoption and cataract procedure volumes in hospital outpatient and ASC settings.
• Net revenue is sensitive to contracting and reimbursement economics that compress price and raise procurement scrutiny.
• The principal downside risk is generic substitution after patent and litigation barriers end, with adoption and labeling determining share loss speed.
• Biosimilar risk is not relevant; Omidria is not a biologic.
• Forward financial trajectory depends on patent estate duration, Orange Book listings, and any Paragraph IV-related litigation or settlement-driven launch delays.

FAQs

1) Which patents typically matter most for a combination perioperative cataract drug like Omidria?
Combination/formulation claims and method-of-use or administration step claims tied to cataract surgery protocols.

2) What happens to Omidria revenue if a generic enters but uptake is slow at surgical centers?
Net revenue may hold longer than patent expiry timing suggests, but price pressure and formulary replacement often accelerate once a lower-cost option becomes contract-eligible.

3) How do settlement agreements between a brand and generic challengers change the earliest launch date?
They can impose agreed launch dates, marketing restrictions, and labeling boundaries that delay or limit at-risk sales.

4) Can procedural alternatives reduce Omidria sales without an authorized generic launch?
Yes. Protocol substitution using drops or alternative perioperative formulations can reduce demand even if the brand remains protected.

5) What metrics best track Omidria’s commercial trajectory in real time?
Facility adoption counts, purchase volumes by channel (hospital outpatient vs ASC), net price trends in contracting cycles, and formulary placement updates.

---

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/ (Accessed 2026-07-21).