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 March 31, 2032. 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:	2,910
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

Philippines

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
Austria	215366
Australia	2818495
Australia	689277
Canada	2167524	COMPOSITIONS ADMINISTRABLES PAR VOIE LOCALE CONTENANT DES DERIVES D'ACIDE 3-BENZOYLPHENYLACETIQUE POUR LE TRAITEMENT DE TROUBLES INFLAMMATOIRES OPHTALMIQUES (TOPICALLY ADMINISTRABLE COMPOSITIONS CONTAINING 3-BENZOYLPHENYLACETIC ACID DERIVATIVES FOR TREATMENT OF OPHTHALMIC INFLAMMATORY DISORDERS)
China	1088992
China	1129397

Supplementary Protection Certificates for ILEVRO

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

Last updated: July 25, 2026

ILEVRO (nepafenac ophthalmic) Market Dynamics and Financial Trajectory (Revenue, Exclusivity, Competition)

ILEVRO (nepafenac ophthalmic suspension 0.3%) is a U.S.-listed prescription ophthalmic for ocular pain and inflammation associated with cataract surgery and for reducing the risk of ocular inflammation after surgery. Financial performance is driven by (1) cataract procedure volume, (2) penetration of perioperative NSAID regimens, (3) pricing and channel mix in U.S. specialty and mail, and (4) the rate at which generic and authorized equivalents replace branded supply. In the post-patent phase, ILEVRO’s market dynamics typically shift toward price competition and distribution consolidation in the ophthalmic category.

What is the market size and demand driver for ILEVRO (nepafenac 0.3%)?

Core indication and clinical demand linkage. ILEVRO’s commercial ceiling correlates with cataract surgery incidence and the ophthalmology prescribing pattern for perioperative anti-inflammatory therapy. The spend pool is not “nepafenac” alone; it is the cataract perioperative eye-drop bundle that often includes NSAIDs, steroids, and antibiotics (with variable sequencing and combination use).

Demand sensitivity profile.

• Procedure volume: More cataract surgeries generally lift NSAID utilization.
• Surgeon protocol preference: Some surgeons standardize an NSAID brand and dosing schedule.
• Formulary access: Managed care and hospital formularies can shift utilization quickly when lower-cost generics enter.
• Switching barriers: For topical ophthalmics, switching friction is usually low once equivalent products are available.

Market structure.

• Ophthalmology is brand-liquid but generic-fragmented. Brands can maintain share through co-pay support, patient/clinician awareness, and dispenser relationships, but generic entry typically compresses ASPs.
• Channel mix matters. ILEVRO’s revenue path is affected by buy-and-bill norms versus retail fulfillment and whether hospital outpatient pharmacy contracts negotiate rapidly after launch of authorized or first-wave generics.

How is ILEVRO priced and what is the impact on revenue trajectory?

Pricing pressure post-generic entry. For branded ophthalmic products, U.S. net sales often follow a common pattern after sustained generic availability:

1. Branded list price holds longer than net price.
2. Net revenue per unit declines as wholesalers and retailers rebalance to lower-cost SKUs.
3. Volume can fall sharply because substitutions happen at the dispensing stage.

What determines net revenue retention.

• Number and timing of generic competitors (including ANDA “early filers” and authorized generics if any).
• Therapeutic equivalence approvals and substitution rules (state-level substitution, pharmacy policy).
• Patient assistance and payer restrictions (commercial insurance and Medicare Part D plan edits).
• Contracting with pharmacy benefit managers and large accounts.

When does ILEVRO lose exclusivity and what are the generic launch risks?

Key exclusivity concept for ophthalmics: ILEVRO’s ability to block generic entry depends on patent coverage and, separately, any regulatory exclusivities tied to the original NDA. As patents expire or are invalidated, ANDA applicants can enter, and branded share declines as generic availability expands.

Generic entry risk is driven by two pathways:

• Patent-expiration timing: If the Orange Book patent estate expires, generics can launch at expiration absent a stay.
• Paragraph IV litigation: If an ANDA challenges a listed patent, launch timing can be delayed by litigation and any resulting settlement or court-ordered stay.

Because this analysis requires precise Orange Book listings, ANDA/P-IV status, and specific expiration/180-day exclusivity dates tied to ILEVRO, publication-specific patent and litigation timelines must be sourced from authoritative U.S. Orange Book and FDA patent-litigation records. This dataset is not provided in the prompt, so a complete, accurate launch timetable cannot be produced.

What is the Orange Book status of ILEVRO (nepafenac 0.3%)?

Orange Book status drives freedom-to-operate for generics. The Orange Book listing typically includes:

• Product exclusivity expiration (regulatory data exclusivity, if any).
• Patent term for composition, formulation, and method-of-use.
• Listing codes that map to patent claims and the basis for exclusivity.

A complete Orange Book table requires the exact Orange Book entry for ILEVRO (including patent numbers, expiration dates, and claim types/codes). The prompt does not include those listings, so an Orange Book status breakdown cannot be stated accurately.

How many patents protect ILEVRO and which companies hold them?

Patent estate scope matters in ophthalmics. For topical ophthalmic NSAIDs, patent coverage often includes:

• Drug substance/enantiomer or polymorph (where applicable).
• Formulation and concentration.
• Particle size or suspension stability parameters.
• Dosing regimen and method-of-treatment or method-of-use.

A quantified “how many patents” assessment requires enumerating ILEVRO Orange Book patents and their assignees, plus expiration dates. Without the Orange Book patent list in the prompt, a defensible count and holder mapping cannot be provided.

What patent litigation affects ILEVRO (Paragraph IV, settlements, stays)?

Paragraph IV is the main U.S. payer-to-brand inflection event. Branded ophthalmics are commonly targeted with ANDA challenges that lead to:

• 30-month stays (if litigation is initiated within statutory time windows),
• subsequent court rulings on validity or non-infringement,
• settlement agreements that define launch timing or market allocation.

A litigation and settlement timeline requires access to Orange Book “patent dispute” records (FDA’s ANDA litigation database) and court dockets. Those specifics are not included in the prompt, so a precise litigation impact assessment cannot be completed.

Which generics or authorized equivalents compete with ILEVRO?

Competition is usually multi-SKU after first-wave launches. In ophthalmic NSAIDs, competitive substitution tends to expand in waves:

• First ANDA launches at the earliest lawful date.
• Follow-on ANDAs enter once formulation stability and bioequivalence are proven.
• Retail and mail-order stocking shifts to lowest net-cost SKUs.

A “who competes” list requires specific FDA-approved products and labels for nepafenac ophthalmic suspension 0.3% (including manufacturer, ANDA number, and launch sequencing). The prompt does not include that roster, so an accurate competitor map cannot be produced.

How does ILEVRO compare with other topical NSAID ophthalmics (ketorolac, bromfenac, diclofenac)?

Substitution logic is protocol-driven and price-sensitive.

• Many ophthalmology practices select one NSAID class for routine perioperative care.
• Differences in dosing schedules and device formats influence switching.
• Once a lower-cost nepafenac equivalent exists, budget pressure pushes substitution, but clinicians may keep preferred regimens when protocol constraints exist.

A meaningful financial comparison needs current U.S. sales or at least market-share and net pricing data for class rivals, plus current exclusivity status for each rival drug’s patent estate. The prompt does not provide those data, so a quantitative comparison cannot be stated.

What formulation and device-related IP barriers exist for nepafenac ophthalmic suspensions?

Where formulation patents can matter. In ophthalmic suspensions, IP and regulatory barriers often concentrate on:

• suspension stability over shelf life,
• particle size distribution and sedimentation rate,
• viscosity modifiers and surfactant systems,
• preservative system constraints (or compatibility with multi-dose use).

Regulatory barriers are usually lower than IP barriers after expiration. Generics can often match the active and concentration, but if formulation stability or excipient systems fall within protected claims, they may be delayed by infringement allegations or design-around requirements.

A precise “which formulation patents” mapping again requires the Orange Book patent list and claim texts or at minimum patent titles/claim scopes. Without that dataset, formulation IP barriers cannot be itemized.

What is the FDA regulatory trajectory for ILEVRO (NDA status, labeling, switching)?

Regulatory milestones that matter commercially:

• label indications and dosing instructions that drive clinician adoption,
• changes to safety warnings or contraindications affecting persistence,
• approval of generic equivalents and any label substitutions.

A complete regulatory trajectory requires NDA/label revision history and approval records for generic nepafenac 0.3% products. The prompt does not include those source details, so the FDA narrative cannot be made complete and accurate.

How do payer dynamics and reimbursement affect ILEVRO net sales?

Net sales are payer- and contract-driven.

• PBM formularies can move a branded ophthalmic off preferred tiers once generics are available.
• Plan exclusions and step edits reduce brand persistence.
• Medicare Part D manages cost with tiered co-pays.
• Institutional contracting in cataract surgery centers can swing procurement to lowest-cost equivalent SKUs.

Financial trajectory is usually strongest pre-generic entry and after each contracting renegotiation cycle post-entry.

What is the expected revenue path for ILEVRO over the next 3–5 years?

A forward-looking revenue trajectory requires:

• current U.S. net sales run-rate,
• current generic penetration and price indices,
• patent expiration schedule and litigation outcomes,
• competitive newcomer timing.

Those elements are not included in the prompt, and a forecast without them would not be accurate.

Key takeaways

• ILEVRO demand tracks cataract surgery volume and perioperative ophthalmology NSAID prescribing.
• Brand financial performance is most sensitive to pricing compression and generic substitution once patent barriers fall away.
• Exact Orange Book status, patent counts, expiration dates, and Paragraph IV litigation timing are required to map the real revenue inflection points.
• Competitive dynamics in topical ophthalmics are rapid after generic availability, with net revenue usually declining faster than list price.

FAQs

1. How does generic substitution typically change ILEVRO net sales after ANDA launch?
2. What dosing schedule differences between nepafenac 0.3% and ketorolac or bromfenac can affect switching rates?
3. Do ophthalmic NSAID products face multi-payer formularies that materially drive brand persistence?
4. How do settlement agreements in FDA Paragraph IV cases influence launch timing for nepafenac 0.3%?
5. What types of formulation stability claims most often slow generic ophthalmic suspensions?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. U.S. Food and Drug Administration. ANDA Patent Dispute Information. (Accessed 2026).
3. U.S. Food and Drug Administration. Drug Labels and FDA approval package information for ILEVRO and related nepafenac ophthalmic products. (Accessed 2026).

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