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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-four patent family members in twenty-six countries.

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

DrugPatentWatch^® Generic Entry Outlook for Ilevro

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:	94
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	5
Patent Applications:	2,384
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

Recent Clinical Trials for ILEVRO

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

Sponsor	Phase
Vance Thompson Vision - MT	Phase 4
MDbackline, LLC	N/A
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 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
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	7,947,295		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/000818 Nevanac 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

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2506831	SUSPENSION DE NANOPARTICULES CONTENANT UN POLYMÈRE DE TYPE CARBOXYVINYLE (CARBOXYVINYL POLYMER-CONTAINING NANOPARTICLE SUSPENSIONS)
European Patent Office	3028692	COMPOSITIONS OPHTHALMIQUES CONTENANT UNE ASSOCIATION SYNERGIQUE DE DEUX POLYMERES (OPHTHALMIC COMPOSITIONS CONTAINING A SYNERGISTIC COMBINATION OF TWO POLYMERS)
Canada	2839849	COMPOSITIONS OPHTALMOLOGIQUES CONTENANT UNE ASSOCIATION SYNERGIQUE DE DEUX POLYMERES (OPHTHALMIC COMPOSITIONS CONTAINING A SYNERGISTIC COMBINATION OF TWO POLYMERS)
Denmark	2116227
Japan	2007197461	OPHTHALMIC COMPOSITION CONTAINING GALACTOMANNAN POLYMER AND BORATE

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	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
0999825	122013000085	Germany		PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503

ILEVRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ILEVRO

Introduction to ILEVRO

ILEVRO, a topical non-steroidal anti-inflammatory drug (NSAID), is used to treat pain and inflammation following cataract surgery. It is one of the key ophthalmic products acquired by Harrow, a leading U.S. eyecare pharmaceutical company, from Novartis.

Market Size and Growth of Ophthalmic Drugs

The U.S. ophthalmic drugs market, within which ILEVRO operates, is experiencing significant growth. As of 2023, the market size was estimated at approximately USD 16.11 billion and is projected to reach USD 33.51 billion by 2033, growing at a CAGR of 7.6% from 2024 to 2033[1][4].

Segment Analysis

The branded drugs segment, which includes ILEVRO, accounted for the largest share in the U.S. ophthalmic drugs market in 2023. This segment is driven by the growing prevalence of eye disorders and the increasing demand for innovative treatments and therapies[1][4].

Acquisition and Financial Implications

Harrow entered into a binding agreement with Novartis to acquire the exclusive U.S. commercial rights to ILEVRO, along with other ophthalmic products such as NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE. This transaction involved a one-time payment of $130 million at closing, with an additional $45 million payable in a milestone payment upon the commercial availability of TRIESENCE[3][5].

Revenue and Profit Projections

Following the acquisition, Harrow began receiving net profit payments for the acquired products during an estimated 6-month NDA transfer period. After this period, Harrow assumed control over all U.S. market activities for these products, including manufacturing and distribution. This strategic move is expected to enhance Harrow's revenue and profitability in the ophthalmic drugs market[3][5].

Market Demand and Indications

Market research indicates an increasing demand for the indications treated by ILEVRO and other acquired products. This demand is driven by the rising prevalence of eye disorders, such as cataracts and post-surgical inflammation, which are common among the aging population. The U.S. population's aging trend is a significant factor contributing to the growth in the incidences of these conditions[3].

Competitive Landscape

The U.S. ophthalmic drugs market is highly competitive, with several key players including Harrow, Regeneron Pharmaceuticals, and Astellas Pharma. The anti-VEGF agents segment, for instance, held a dominant revenue share of 32.8% in 2023, highlighting the competitive nature of the market. However, the acquisition of ILEVRO and other products positions Harrow strongly within this competitive landscape[1][4].

Regulatory Approvals and Coding

Regulatory approvals and unique coding systems play a crucial role in the market dynamics. For example, Iveric Bio's IZERVAY received a permanent and unique Healthcare Common Procedure Coding System (HCPS) J-code from the U.S. Centers for Medicare and Medicaid Services (CMS), which supports the market growth by facilitating reimbursement and adoption of these therapies[1][4].

Financial Performance of Harrow

Harrow's financial performance has been positively impacted by the acquisition of ophthalmic products, including ILEVRO. In 2022, Harrow reported full-year revenues of $88.6 million, a 22% increase over the full-year 2021 revenues of $72.5 million. The company's adjusted EBITDA also showed significant improvement, reflecting the strategic benefits of focusing solely on ophthalmology assets[2].

Technological Advancements and Collaborations

Technological advancements and strategic collaborations are key drivers of growth in the ophthalmic drugs market. For instance, FDA approvals such as the one received by Regeneron Pharmaceuticals for EYLEA HD (aflibercept) for treating wet AMD and diabetic retinopathy, and the launch of new formulations by Harrow, contribute to the market's expansion[1][2].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as regulatory hurdles and the need for continuous innovation. However, these challenges also present opportunities for companies like Harrow to invest in research and development, leading to the creation of new and innovative treatments.

Key Takeaways

• Market Growth: The U.S. ophthalmic drugs market is projected to grow significantly, driven by the increasing prevalence of eye disorders.
• Acquisition Impact: Harrow's acquisition of ILEVRO and other ophthalmic products from Novartis is expected to enhance its revenue and market position.
• Regulatory Support: Unique coding systems and FDA approvals are crucial for the adoption and reimbursement of ophthalmic therapies.
• Competitive Landscape: The market is highly competitive, with several key players investing in research and development.
• Financial Performance: Harrow's financial performance has improved following the acquisition and focus on ophthalmology assets.

Frequently Asked Questions (FAQs)

Q: What is ILEVRO used for? A: ILEVRO is used to treat pain and inflammation following cataract surgery.

Q: Who acquired the U.S. rights to ILEVRO? A: Harrow acquired the exclusive U.S. commercial rights to ILEVRO from Novartis.

Q: What is the projected growth rate of the U.S. ophthalmic drugs market? A: The U.S. ophthalmic drugs market is projected to grow at a CAGR of 7.6% from 2024 to 2033.

Q: What other products did Harrow acquire along with ILEVRO? A: Harrow acquired NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE along with ILEVRO.

Q: How has Harrow's financial performance been impacted by the acquisition? A: Harrow's financial performance has improved, with a 22% increase in revenues from 2021 to 2022, following the acquisition and focus on ophthalmology assets.

Cited Sources:

1. Nova One Advisor: US Ophthalmic Drugs Market Size and Growth.
2. Harrow: Fourth Quarter and Year-End 2022 Financial Results.
3. Harrow: Agreement to Acquire Exclusive U.S. Rights to ILEVRO®, NEVANAC®, VIGAMOX®, MAXIDEX®, and TRIESENCE®.
4. Grand View Research: U.S. Ophthalmic Drugs Market Size | Industry Report, 2030.
5. BioSpace: Harrow Closes Acquisition of U.S. Rights to ILEVRO®, NEVANAC®, VIGAMOX®, MAXIDEX®, and TRIESENCE®.