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:	5
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
Vance Thompson Vision - MT	Phase 4
Alcon Research	N/A
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
South Korea	101147046
Japan	2013512912
Poland	2506831
Slovenia	2965749
Japan	3979783
Australia	8570598
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
0999825	92301	Luxembourg		PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
0999825	CA 2013 00055	Denmark		PRODUCT NAME: NEPAFENAC (3 MG/ML), HERUNDER NEPAFENAC I KOMBINATION MED GLACTOMANNANPOLYMERER, ISAER 3 MG/ML NEPAFENAC I KOMBINATION MED GALACTOMANNANPOLYMERER, SAMT OFTALMISKE SAMMENSAETNINGER DERAF; REG. NO/DATE: EU1/07/433/002 20130503
0999825	122013000085	Germany		PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
0999825	C300622	Netherlands		PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
0716600	C00716600/01	Switzerland		PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ILEVRO

Last updated: July 27, 2025

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Introduction

ILEVRO (nepafenac ophthalmic suspension) represents a significant entrant within the ophthalmologic therapeutic landscape, primarily used to prevent and treat postoperative inflammation and pain associated with ocular surgeries, such as cataract extraction. Since its approval by the U.S. Food and Drug Administration (FDA) in 2005, ILEVRO has experienced evolving market dynamics driven by regulatory, competitive, and technological factors. This analysis explores its current market landscape, growth trajectory, and strategic considerations shaping its financial outlook.

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Regulatory and Clinical Positioning

ILEVRO, marketed by Alcon, has established a niche as a non-steroidal anti-inflammatory drug (NSAID) solution with proven efficacy. Its design caters specifically to ophthalmic applications, with a streamlined dosing regimen promoting compliance. Regulatory approvals across several regions enhance its global footprint yet also introduce variability depending on regional ophthalmology standards and prescribing preferences.

Clinical evidence supporting ILEVRO's safety and efficacy—such as its role in reducing anterior chamber inflammation and pain post-cataract surgery—continues to reinforce its market standing. However, competition from alternative NSAID formulations (e.g., bromfenac, integrin inhibitors) and corticosteroid options influences its overall market penetration.

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Market Dynamics

• Competitive Landscape

The ophthalmic NSAID market is highly competitive, with several established players. Bromfenac-based products like Bromsite and Xibrom enjoy extensive clinician familiarity. Bioequivalence studies and incremental formulations frequently challenge ILEVRO’s market share. Moreover, the advent of preservative-free formulations and combination drugs further complicates the competitive domain.

• Prescribing Trends and Physician Preference

Physicians tend to favor drugs with proven safety profiles, minimal adverse effects, and ease of administration. The convenience of a once-daily dosing schedule and reduced ocular discomfort associated with ILEVRO support its adoption. Nevertheless, shifts toward multi-mechanism drugs or integrated anti-inflammatory regimens could reshape prescription patterns in the near term.

• Regulatory and Reimbursement Factors

Reimbursement policies, particularly in the U.S. through Medicare and private insurers, influence drug utilization. Positive formulary positioning and favorable insurance coverage enhance market access for ILEVRO. Conversely, pricing pressures and reimbursement restrictions may constrain revenue growth.

• Market Penetration and Geographic Expansion

Although ILEVRO has a substantial footprint in North America, expansion into emerging markets faces hurdles related to regulatory processes, distribution infrastructure, and clinician awareness. Strategic collaborations or licensing agreements in these regions present growth opportunities.

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Financial Trajectory

• Revenue Trends

ILEVRO's revenue trajectory has experienced moderate growth. Initial years saw rapid adoption, driven by its innovative profile and clinical benefits. However, as the market matures, growth momentum has tempered, with revenues stabilizing or modestly declining in some regions due to patent expirations and increased competitive pressure.

• Impact of Patent and Exclusivity

Though initially protected by patents, key patents for ILEVRO have faced legal challenges, leading to increased generic competition. The entry of generics typically results in significant price erosion, diminishing profit margins. Strategic lifecycle management, including new formulations or delivery platforms, could sustain revenue streams.

• Cost Dynamics

Manufacturing costs are relatively stable, supported by scalable production processes. Marketing and promotional expenses constitute significant portions of expense structures, especially during the brand's initial launch and expansion phases. R&D investments focus on formulation improvements and expanding indications to maintain competitive advantage.

• Future Outlook

Forecasting suggests a plateauing or slight decline in North American revenues over the next 3-5 years unless strategic pivots are implemented. Conversely, emerging markets, with their increasing cataract and ocular surgery procedures, offer potential growth corridors. Innovations in ophthalmic drug delivery could also enhance the financial outlook, especially if they improve adherence or efficacy.

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Key Market Drivers and Constraints

Drivers	Constraints
Growing global prevalence of cataract surgeries	Patent expirations leading to generic competition
Clinician preference for effective NSAIDs with minimal side effects	Intensified price competition and reimbursement pressures
Increased adoption of minimally invasive ophthalmic procedures	Regulatory barriers in emerging markets
Technological advancements in ocular drug delivery	Market saturation in mature regions

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Strategic Considerations

To optimize financial performance, stakeholders should focus on:

• Innovation: Developing sustained-release formulations or combination therapies to extend lifecycle.
• Market Penetration: Intensifying efforts in emerging markets with targeted regulatory and distribution strategies.
• Differentiation: Emphasizing unique clinical benefits through evidence-based marketing.
• Lifecycle Management: Navigating patent landscapes and exploring new indications.

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Conclusion

The financial trajectory of ILEVRO hinges on a confluence of clinical efficacy, competitive positioning, regulatory environment, and regional expansion strategies. While mature markets have seen stabilizing revenues due to generic competition, significant opportunities exist in emerging economies. Strategic innovation and diligent market access efforts are pivotal to sustain growth and maximize investment returns.

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Key Takeaways

• ILEVRO remains a competitive, clinically validated ophthalmic NSAID, with moderate but steady revenue contributions.
• Patent expirations and increasing generic competition pose ongoing threats to profit margins.
• Emerging markets offer promising growth avenues, contingent on regulatory and infrastructural development.
• Technological innovations, such as sustained-release delivery systems, could rejuvenate the product’s market life cycle.
• Stakeholders should adopt a multi-faceted approach, combining lifecycle management, regional expansion, and differentiation to enhance financial outcomes.

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FAQs

1. What drives the competitive advantage of ILEVRO in the ophthalmic NSAID market?
ILEVRO's once-daily dosing, proven safety profile, and efficacy in controlling postoperative inflammation underpin its competitive edge, alongside clinician familiarity with its clinical trials and outcomes.

2. How does patent expiry impact ILEVRO’s financial outlook?
Patent expiration exposes ILEVRO to generic competition, typically leading to significant price reductions and reduced profit margins, necessitating alternative revenue strategies such as lifecycle extensions.

3. What are key opportunities for ILEVRO in emerging markets?
Growing global rates of ocular surgeries, expanding healthcare infrastructure, and increasing awareness foster opportunities for market penetration, provided regulatory hurdles and distribution logistics are addressed.

4. How might technological innovations influence ILEVRO's market performance?
Advances like sustained-release ocular implants or combination drugs can enhance compliance, efficacy, and market differentiation, potentially offsetting generic competition effects.

5. What strategic steps should stakeholders prioritize to sustain ILEVRO’s market relevance?
Investing in formulation improvements, expanding geographic reach, securing regulatory approvals for new indications, and leveraging clinical data are pivotal strategies to sustain growth.

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Sources:

[1] U.S. Food and Drug Administration. ILEVRO (Nepafenac Ophthalmic Suspension) NDA approval.
[2] MarketResearch.com. Ophthalmic pharmaceuticals market analysis, 2022.
[3] IQVIA. Global ophthalmology drug sales data, 2022.
[4] Alcon Annual Reports, 2022.
[5] Frost & Sullivan. Ophthalmic NSAID market forecasts, 2023.