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

Constraining patent/regulatory exclusivity:

9,662,398

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
Alcon Research	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.

This potential generic entry date is based on patent 9,662,398.

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	9,662,398		Y
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes	8,921,337		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	5,475,034
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	6,403,609
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	7,947,295

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
Croatia	P20140016
European Patent Office	3028692	COMPOSITIONS OPHTHALMIQUES CONTENANT UNE ASSOCIATION SYNERGIQUE DE DEUX POLYMERES (OPHTHALMIC COMPOSITIONS CONTAINING A SYNERGISTIC COMBINATION OF TWO POLYMERS)
Denmark	0999825
Russian Federation	2571078	СУСПЕНЗИИ НАНОЧАСТИЦ, СОДЕРЖАЩИЕ КАРБОКСИВИНИЛОВЫЙ ПОЛИМЕР (SUSPENSIONS OF NANOPARTICLES, CONTAINING CARBOXYVINYL POLYMER)
Luxembourg	92301
European Patent Office	2361610	Compositions ophtalmologiques contenant une association synergique de deux polymères (Ophthalmic compositions containing a synergistic combination of two polymers)
South Africa	200509440	Ophthalmic compositions containing a synergistic combination of two polymers

Supplementary Protection Certificates for ILEVRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0999825	122013000085	Germany		PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
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	92301	Luxembourg		PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
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

ILEVRO: Patent Landscape, Market Dynamics, and Financial Outlook

Last updated: February 19, 2026

ILEVRO, a prostaglandin F2α analog, is indicated for the reduction of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Its patent protection is a critical factor influencing its market position and financial performance.

What is the Core Patent Protection for ILEVRO?

The primary patent covering ILEVRO (latanoprostene bunod ophthalmic solution, 0.024%) is U.S. Patent No. 8,618,120. This patent, filed on October 17, 2011, and granted on December 31, 2013, has a statutory expiration date of October 17, 2031 [1]. The patent claims methods of treating elevated intraocular pressure (IOP) and pharmaceutical compositions containing latanoprostene bunod.

Beyond the core composition of matter and method of use patents, secondary patents may exist relating to manufacturing processes, specific formulations, or delivery systems. These can further extend market exclusivity or present challenges to generic entry. The identification and analysis of these secondary patents are crucial for a comprehensive understanding of ILEVRO's intellectual property landscape.

What is the Current Market Status of ILEVRO?

ILEVRO is marketed by Bausch + Lomb. The drug's market entry followed its U.S. Food and Drug Administration (FDA) approval on July 28, 2017 [2]. Its therapeutic class, prostaglandin analogs, is a well-established and competitive segment within the ophthalmic glaucoma market.

The market for glaucoma medications is characterized by:

• High Prevalence: Glaucoma affects millions globally, creating a substantial patient base.
• Chronic Condition: Treatment is typically lifelong, ensuring sustained demand.
• Generic Competition: Many established prostaglandin analogs have lost patent protection, leading to lower-priced generic alternatives.
• Innovation: Newer drugs often aim to offer improved efficacy, safety profiles, or convenience (e.g., fixed-dose combinations, drugs with novel mechanisms of action).

ILEVRO's market positioning is influenced by its clinical profile, including its efficacy in lowering IOP, its safety and tolerability compared to other agents, and its dosing regimen. As a monotherapy, it competes with other prostaglandin analogs such as latanoprost, travoprost, and bimatoprost. It also competes with other classes of glaucoma medications including beta-blockers, alpha-agonists, carbonic anhydrase inhibitors, and Rho-kinase inhibitors.

How Do ILEVRO's Patents Compare to Competitors?

The patent expiration date of U.S. Patent No. 8,618,120 in October 2031 places ILEVRO in a relatively strong position compared to older prostaglandin analogs that have already faced generic erosion. For example, the original patents for latanoprost have long expired.

Competitors' patent strategies are vital. New entrants or existing players launching next-generation therapies may seek to secure patents that offer extended exclusivity. The development of fixed-dose combinations, for instance, can create new patentable subject matter and extend market protection for established active pharmaceutical ingredients. Rho-kinase inhibitors, such as netarsudil, represent a more recent class of glaucoma medications with different patent timelines and market dynamics.

A comparative analysis of patent expiry dates among key glaucoma drugs is essential for strategic planning.

Drug Name	Active Ingredient(s)	Primary Patent Expiry (U.S. Statutory)	Key Competitor Patents (if applicable)
ILEVRO	Latanoprostene bunod	October 17, 2031	N/A
Lumigan	Bimatoprost	Expired	N/A
Xalatan	Latanoprost	Expired	N/A
Travatan Z	Travoprost	Expired	N/A
Rhopressa/Rocklatan	Netarsudil	December 2034 (for Rhopressa formulation)	Ongoing research for new IP

Note: Patent expiry dates are subject to extensions and legal challenges. This table represents statutory expiration dates of core patents and does not include all potential IP.

What is the Expected Financial Trajectory for ILEVRO?

The financial trajectory of ILEVRO is directly linked to its patent exclusivity, market penetration, and the competitive landscape. Until its primary patent expires in October 2031, ILEVRO is expected to generate revenue primarily through direct sales and potentially through licensing agreements.

Key financial considerations include:

• Sales Revenue: Driven by prescription volume and average selling price (ASP). ASP is influenced by payer reimbursements, patient co-pays, and competition.
• R&D Investment: Ongoing investment may be required for post-marketing studies, potential new indications, or combination therapies.
• Marketing and Sales Costs: Significant expenditure is allocated to physician detailing, advertising, and market access initiatives.
• Generic Entry: The period following patent expiry will see the introduction of generic versions, leading to a rapid decline in ILEVRO's ASP and revenue.

Given its 2017 launch, ILEVRO has experienced several years of market exclusivity. The period leading up to 2031 is critical for maximizing its financial returns. Post-2031, revenue will be primarily driven by brand loyalty, any remaining secondary patents, and the company's ability to transition patients to newer or combination products.

Sales data for ILEVRO can be tracked through pharmaceutical market intelligence reports. For instance, annual reports from Bausch + Lomb's parent company or industry analysis firms provide insights into revenue streams.

What are the Potential Risks and Opportunities for ILEVRO's Future?

Risks:

• Generic Competition: The most significant risk is the eventual generic entry upon patent expiry. This will lead to substantial price erosion and market share loss.
• Pipeline Competition: The development of novel glaucoma treatments with superior efficacy, safety, or convenience could displace ILEVRO. This includes new mechanisms of action, sustained-release formulations, or gene therapies.
• Reimbursement Pressures: Payers are increasingly scrutinizing drug costs, potentially leading to stricter formulary placement or higher patient co-pays, affecting market access.
• Adverse Event Profile: Any newly identified safety concerns or a less favorable adverse event profile compared to emerging competitors can impact prescribing patterns.
• Regulatory Changes: Evolving regulatory requirements for drug approval or post-market surveillance could impact ILEVRO's lifecycle.

Opportunities:

• Combination Therapies: Developing fixed-dose combinations of latanoprostene bunod with other IOP-lowering agents can create new patentable products and extend market exclusivity.
• New Indications: Research into ILEVRO's efficacy in different stages of glaucoma or in combination with other treatments could expand its therapeutic use.
• Market Expansion: Geographic expansion into markets where ILEVRO may not yet be fully established could drive incremental revenue.
• Lifecycle Management: Proactive patent strategies, including the filing of new patents for formulations or manufacturing processes, can defend against generic challenges.
• Physician and Patient Loyalty: Establishing strong brand loyalty through demonstrated clinical benefit and positive patient experience can help retain market share even in the face of generic competition.

What is the Regulatory Pathway for Generic ILEVRO?

The pathway for generic ILEVRO involves a Abbreviated New Drug Application (ANDA) submitted to the FDA. A generic drug manufacturer must demonstrate that its product is bioequivalent to the reference listed drug (ILEVRO). This means showing that the rate and extent of absorption of the active ingredient are the same.

Key aspects of the generic pathway include:

• ANDA Submission: The generic company files an ANDA with the FDA, including data demonstrating bioequivalence, manufacturing information, and labeling that matches the reference product.
• Patent Certification (Paragraph IV Litigation): The ANDA applicant must certify whether any patents listed in the Orange Book for ILEVRO are invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the generic drug. If a Paragraph IV certification is made, it often triggers patent litigation [3].
• Patent Litigation: If the patent holder sues for infringement within a specified timeframe (typically 45 days of receiving notice of Paragraph IV certification), the 180-day exclusivity period for the first generic applicant may be triggered. This exclusivity period grants the first generic to receive FDA approval a period of market protection from other generic competitors.
• FDA Approval: Once patent issues are resolved or the 180-day exclusivity period concludes, the FDA reviews the ANDA for compliance and may approve the generic product.

The timing of generic entry is heavily influenced by the success or failure of patent litigation. Companies holding patents for ILEVRO will actively defend their intellectual property.

Key Takeaways

ILEVRO's primary patent protection extends to October 17, 2031, providing a substantial period of market exclusivity. The drug operates within a competitive and high-volume ophthalmic glaucoma market. Its financial trajectory is directly tied to its ability to capture market share during its patent-protected period, with significant revenue erosion expected upon the entry of generic competitors post-2031. Key risks include generic competition and pipeline advancements from rivals, while opportunities lie in combination therapy development and geographic expansion. The regulatory pathway for generic ILEVRO involves an ANDA submission and potential patent litigation.

Frequently Asked Questions

1. When is the statutory expiration date for the main patent protecting ILEVRO in the United States? The statutory expiration date for U.S. Patent No. 8,618,120, which covers ILEVRO, is October 17, 2031.

2. What is the primary active ingredient in ILEVRO? The primary active ingredient in ILEVRO is latanoprostene bunod.

3. What therapeutic area does ILEVRO address? ILEVRO addresses ocular hypertension and open-angle glaucoma by reducing elevated intraocular pressure.

4. What is the typical outcome for a drug's revenue following the expiration of its primary patent? Following the expiration of its primary patent and the subsequent entry of generic versions, a drug typically experiences a significant decline in revenue due to price erosion and market share loss.

5. Are there any known approved fixed-dose combinations containing latanoprostene bunod? As of the current analysis, this information is not detailed. However, the development of fixed-dose combinations is a strategic opportunity for lifecycle management in the glaucoma market.

Citations

[1] U.S. Patent No. 8,618,120. (2013). Method of treating elevated intraocular pressure. Retrieved from USPTO Patent Database.

[2] U.S. Food and Drug Administration. (2017). FDA approves ILEVRO (latanoprostene bunod ophthalmic solution) 0.024%. FDA News Release.

[3] U.S. Food and Drug Administration. (n.d.). Abbreviated New Drug Applications (ANDAs) – Generics. Retrieved from FDA website.