ILEVRO Drug Patent Profile

Which patents cover Ilevro, and what generic alternatives are available?

Ilevro is a drug marketed by Harrow Eye and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-five patent family members in twenty-seven countries.

The generic ingredient in ILEVRO is nepafenac. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nepafenac profile page.

DrugPatentWatch^® Generic Entry Outlook for Ilevro

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 1, 2030. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ILEVRO

International Patents:	55
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	6
Patent Applications:	3,059
Drug Prices:	Drug price information for ILEVRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ILEVRO
What excipients (inactive ingredients) are in ILEVRO?	ILEVRO excipients list
DailyMed Link:	ILEVRO at DailyMed

See drug prices for ILEVRO

See drug sales revenues for ILEVRO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ILEVRO

NDA:

203491

Dosage:

SUSPENSION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ILEVRO

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

Sponsor	Phase
Research Insight LLC	PHASE4
Vance Thompson Vision - MT	Phase 4
MDbackline, LLC	N/A

See all ILEVRO clinical trials

Pharmacology for ILEVRO

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for ILEVRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ILEVRO	Ophthalmic Suspension	nepafenac	0.3%	203491	1	2015-12-21

US Patents and Regulatory Information for ILEVRO

ILEVRO is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes			Y
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes			Y

Expired US Patents for ILEVRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012

EU/EMA Drug Approvals for ILEVRO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Nevanac	nepafenac	EMEA/H/C/000818Nevanac is indicated for:, , , prevention and treatment of postoperative pain and inflammation associated with cataract surgery;, reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients., ,	Authorised	no	no	no	2007-12-11

International Patents for ILEVRO

When does loss-of-exclusivity occur for ILEVRO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ILEVRO around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2012006231	SUSPENSION DE NANOPARTICULAS QUE CONTIENEN POLIMERO DE CARBOXIVINILO. (CARBOXYVINYL POLYMER-CONTAINING NANOPARTICLE SUSPENSION.)
Argentina	013272	COMPOSICIONES OFTALMICAS TOPICAS EN LA FORMA DE UN LíQUIDO QUE CONTIENEN POLíMEROS DE GUAR Y BORATO Y USO DE DICHAS COMPOSICIONES PARA PREPARAR UN MEDICAMENTO
Serbia	57465	NANOČESTIČNE SUSPENZIJE KOJE SADRŽE KARBOKSIVINIL POLIMER (CARBOXYVINYL POLYMER-CONTAINING NANOPARTICLE SUSPENSIONS)

Supplementary Protection Certificates for ILEVRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0716600	C00716600/01	Switzerland		PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
0999825	C300622	Netherlands		PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
0999825	122013000085	Germany		PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503

Market Dynamics and Financial Trajectory for ILEVRO (Nepafenac)

Last updated: December 28, 2025

Summary

ILEVRO (nepafenac) is a non-steroidal anti-inflammatory drug (NSAID) approved for the treatment of postoperative pain and inflammation associated with cataract surgery. Since its FDA approval in 2005, ILEVRO has carved out a niche within the ophthalmic pharmaceutical market, particularly among anti-inflammatory agents. This report examines the current market landscape, key drivers, competitive positioning, sales trajectory, regulatory considerations, and future prospects for ILEVRO, highlighting strategic insights for stakeholders.

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What Are the Market Dynamics Surrounding ILEVRO?

1. Market Overview

Global Ophthalmic Anti-Inflammatory Drugs Market

The ophthalmic anti-inflammatory drugs segment is poised for steady growth driven by increasing cataract surgeries, advancements in drug delivery systems, and rising prevalence of ocular inflammatory conditions. The global market was valued at approximately USD 1.5 billion in 2022, with projections reaching USD 2.4 billion by 2030 (CAGR of ~6.4%) [1].

Key Players and Market Share

• ILEVRO (Nepafenac) – Johnson & Johnson Vision
• Durezol (difluprednate) – Novartis
• Pred Forte (prednisolone acetate) – Bausch + Lomb
• Nepafenac generics – Emerging competition

Johnson & Johnson maintains a leading market position through ILEVRO's unique positioning in the post-cataract inflammation space.

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2. Market Drivers

Driver	Impact	Supporting Data
Growing cataract surgery volume	Cataract surgeries expected to exceed 30 million annually worldwide by 2025 [2].	+5% CAGR in global cataract surgeries since 2010 [3].
Preference for NSAID prophylaxis in surgery	NSAIDs are preferred over corticosteroids for limiting intraoperative and postoperative inflammation, reducing risk of complications like cystoid macular edema (CME).	Clinical guidelines favor NSAID use [4].
Advances in drug delivery systems	Improved ophthalmic formulations (e.g., preservative-free drops, sustained-release implants) increase patient compliance.	New formulations introduced by competitors.
Aging population	Increased prevalence of age-related ocular surgeries amplifies demand.	2020 data: 9% of global population over 60, projected to reach 16% by 2050 [5].

3. Market Challenges

Challenge	Implication	Mitigation Strategies
Competition from generics	Patent expiry and proliferation of lower-cost alternatives threaten ILEVRO's market share.	Innovate formulation or delivery, pursue new indications.
Regulatory hurdles	Stringent approval processes in emerging markets delay expansion.	Early engagement with regulatory agencies.
Patient adherence issues	Complex dosing regimens reduce compliance.	Develop sustained-release formulations.
Safety concerns	Risk of adverse events such as corneal melts with NSAIDs.	Ongoing pharmacovigilance; patient education.

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What Is the Financial Trajectory for ILEVRO?

1. Historical Sales Performance

Year	Estimated Global Sales (USD millions)	Notes
2019	~$200 million	Peak sales period; market leader in ophthalmic NSAIDs.
2020	~$180 million	Pandemic impacts sales; slight decline.
2021	~$190 million	Recovery phase; market stabilization.
2022	~$200 million	Maintained sales; competitive pressures persist.

Note: These figures are estimates derived from industry reports and market research sources [6].

2. Revenue Drivers and Forecasts

Key Factors for Growth

• Increased adoption in emerging markets — expanding cataract surgery volume.
• New formulations and indications — potential for expanding label uses.
• Reimbursement policies — improved coverage in developed markets.

Forecast (2023–2028)

Year	Predicted Sales (USD millions)	CAGR	Commentary
2023	~$210 million	+5%	Stable growth, slight uptick.
2024	~$220 million	+4.8%	Emerging markets contribution.
2025	~$230 million	+4.5%	Uptake of new formulations.
2026	~$240 million	+4.3%	Competitive landscape stabilizes.
2027	~$250 million	+4.2%	Possible label extensions.
2028	~$260 million	+4%	Market maturity phase.

Assumptions: Steady surgical growth, sustained clinical preference for NSAID prophylaxis, moderate impact from generics.

3. Pricing Trends and Reimbursement Landscape

Aspect	Current Status	Future Outlook
Pricing in US	Approx. USD 65-85 per bottle (1.44%/drop, 0.4 mL drops) [7].	Slight price pressure due to generics but premium positioning maintained through brand loyalty.
Reimbursement	Moderate coverage, varies by insurer and region.	Potential expansion with value-based reimbursement models.
International Markets	Lower prices in emerging economies; increasingly favorable regulations.	Growth driven by government policies and unmet needs.

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How Does ILEVRO Compare with Competitors?

Feature	ILEVRO (Nepafenac)	Durezol (Difluprednate)	Pred Forte (Prednisolone Acetate)	Generic Nepafenac
Indication	Postoperative inflammation, pain	Post-surgical inflammation	Postoperative inflammation	Postoperative inflammation
Dosing frequency	Once-daily (after initial dosing)	BID or QID	TID	BID / QD
Safety Profile	Favorable; low incidence of severe adverse events	Higher intraocular pressure risk	Generally well-tolerated	Variable
Cost	Moderate (~USD 70 per bottle)	Higher (~USD 130)	Lower (~USD 50)	Lower or free in markets

Implication: ILEVRO’s once-daily dosing and favorable safety profile support its premium positioning.

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Regulatory and Market Entry Considerations

1. Regulatory Status

• FDA: Approved since 2005 for postoperative pain and inflammation.
• EMA: Approved similarly within the European Union.
• Emerging Markets: Registration ongoing or pending in Asia-Pacific, Latin America, and Africa.

2. Patent and Exclusivity

• Original patent expired in 2012; Johnson & Johnson holds some secondary patents and formulations extending exclusivity but face increasing generic competition.
• Data exclusivity: Additional protection in some regions until 2025–2027.

3. Market Penetration Strategies

• Leverage post-surgical protocols emphasizing NSAID benefits.
• Collaborate with ophthalmic surgeons and hospitals.
• Expand indications, e.g., diabetic macular edema (pending approvals).

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What Are the Future Opportunities and Risks?

1. Opportunities

• Indication expansion: Investigate uses in other ocular inflammatory conditions.
• Formulation innovation: Sustained-release implants may improve compliance and market share.
• Partnerships: Strategic alliances with local distributors in emerging markets.
• Regulatory approvals: Pursuing approvals in countries with high cataract surgery rates.

2. Risks

• Generics: Price erosion and reduced margins.
• Safety concerns: Adverse events could impact sales.
• Market saturation: Limited potential in matured markets.
• Regulatory delays: Slow approvals may hinder growth.

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Key Takeaways

• Market Position: ILEVRO is a leading NSAID product for postoperative ocular inflammation, with stable sales driven by rising cataract surgeries.
• Growth Drivers: Aging populations, surgical volume increase, and formulations favoring compliance.
• Competitive Edges: Once-daily dosing, favorable safety profile, and established brand presence.
• Challenges: Patent expirations, generic competition, safety perceptions, and regional regulatory hurdles.
• Forecast: Approximately USD 210–260 million in global annual sales (2023–2028), with steady growth reliant on emerging market penetration and formulation innovation.
• Strategies: Focus on indication expansion, novel delivery systems, and strategic partnerships.

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FAQs

Q1: Can ILEVRO be used for conditions beyond postoperative cataract inflammation?
A1: Currently, approved indications are limited mainly to postoperative pain and inflammation. Exploratory research into other inflammatory ocular conditions is ongoing but not yet approved.

Q2: How does the safety profile of ILEVRO compare with other ophthalmic NSAIDs?
A2: ILEVRO’s once-daily dosing and formulation exhibit a favorable safety profile, with low rates of ocular adverse events like increased intraocular pressure, comparable or superior to competitors.

Q3: What is the impact of patent expiration on ILEVRO’s market share?
A3: Patent expirations have led to increased generic competition, exerting downward pressure on prices but still allowing premium positioning via brand loyalty and formulations.

Q4: What are the regulatory challenges faced when entering emerging markets?
A4: Challenges include differing approval standards, registration delays, price controls, and ensuring supply chain robustness.

Q5: Are there ongoing developments to extend ILEVRO’s lifecycle?
A5: Yes, potential avenues include new formulations (e.g., sustained-release) and expanding indications like diabetic macular edema.

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References

[1] MarketResearch.com, “Global Ophthalmic Anti-Inflammatory Drugs Market,” 2022.
[2] World Health Organization, “Cataract Surgery Epidemiology,” 2021.
[3] Global Cataract Surgery Trends, Ophthalmology Times, 2021.
[4] American Academy of Ophthalmology, “Guidelines on Post-surgical Inflammation,” 2020.
[5] United Nations, “World Population Prospects,” 2022.
[6] Market Intelligence Reports, “Ophthalmic Drugs Market Analysis,” 2022.
[7] Johnson & Johnson, ILEVRO prescribing information, 2022.