IZERVAY Drug Patent Profile

When do Izervay patents expire, and what generic alternatives are available?

Izervay is a drug marketed by Astellas and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and five patent family members in twenty-nine countries.

The generic ingredient in IZERVAY is avacincaptad pegol sodium. One supplier is listed for this compound. Additional details are available on the avacincaptad pegol sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Izervay

Indicators of Generic Entry

Summary for IZERVAY

International Patents:	105
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for IZERVAY
What excipients (inactive ingredients) are in IZERVAY?	IZERVAY excipients list
DailyMed Link:	IZERVAY at DailyMed

See drug prices for IZERVAY

Recent Clinical Trials for IZERVAY

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

Sponsor	Phase
Hoffmann-La Roche	PHASE1
Astellas Pharma Inc	PHASE4

See all IZERVAY clinical trials

Pharmacology for IZERVAY

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

US Patents and Regulatory Information for IZERVAY

IZERVAY is protected by nine US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	11,491,176
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	7,803,931			Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	9,617,546			Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	7,538,211			Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	11,273,171
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	10,947,544			Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	12,016,875

Expired US Patents for IZERVAY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023	10,947,544
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023	7,538,211
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023	7,803,931

International Patents for IZERVAY

When does loss-of-exclusivity occur for IZERVAY?

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

Canada

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 IZERVAY around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2597889	AGENTS THERAPEUTIQUES A BASE D'APTAMERES UTILES DANS LE TRAITEMENT DE TROUBLES LIES AU COMPLEMENT (APTAMER THERAPEUTICS USEFUL IN THE TREATMENT OF COMPLEMENT-RELATED DISORDERS)
Australia	2024200948
European Patent Office	2578683	Agents thérapeutiques à base d'aptamères utiles dans le traitement de troubles liés au complément (Aptamer therapeutics useful in the treatment of complement-related disorders)
Israel	185312	אפטאמרים הנקשרים ל-5c המוצמדים לפוליאטילן גליקול (Polyethylene glycol conjugated c5 binding aptamers)
Israel	278018	שיטות לטיפול או מניעה של מצבים אופטלמולוגיים (Methods for treating or preventing ophthalmological conditions)
European Patent Office	3628373
Canada	2915255

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: IZERVAY

Last updated: August 19, 2025

Introduction

IZERVAY (ulgovilimab-roplpass) represents a novel therapeutic agent in the ongoing battle against age-related macular degeneration (AMD) and diabetic choroidal neovascularization. Approved by the U.S. Food and Drug Administration (FDA) in 2022, IZERVAY introduces a new class of anti-vascular endothelial growth factor (VEGF) therapies with a distinct mechanism of action. As a recently launched drug, understanding its market dynamics and financial trajectory offers key insights for manufacturers, investors, and healthcare providers navigating the highly competitive ophthalmology space.

Market Landscape and Drivers

1. Growing Prevalence of AMD and Diabetic Macular Edema (DME)

The global aging population significantly influences the ophthalmic market, with AMD standing as the leading cause of vision loss among the elderly. The U.S. CDC reports over 2 million cases of AMD, projected to reach 3 million by 2040. Concurrently, diabetic retinopathy and diabetic macular edema (DME) continue to escalate in prevalence, driven by rising diabetes rates globally—from approximately 463 million adults in 2019 to an estimated 700 million by 2045 [1].

2. Competitive Therapeutic Landscape

Current first-line treatments for neovascular AMD include VEGF inhibitors such as Lucentis (ranibizumab), Eylea (aflibercept), and Beovu (brolucizumab). These therapies, while effective, pose challenges including frequent injections and varying responsiveness. IZERVAY’s introduction targets unmet needs for durable dosing and improved efficacy, potentially altering the competitive hierarchy.

3. Innovations in Drug Delivery and Efficacy

Distinct features of IZERVAY’s monoclonal antibody, such as prolonged half-life and high binding affinity to VEGF, may enable extended dosing intervals, thus improving patient adherence and reducing treatment burden. These aspects align with current market shifts favoring less invasive, more convenient therapies.

4. Regulatory and Reimbursement Environment

Reimbursement policies and insurance coverage significantly influence drug adoption. Early approval and recognition of IZERVAY’s potential benefits in health economic evaluations could accelerate market penetration, especially if cost-effectiveness is demonstrated relative to existing therapies.

Financial Trajectory and Market Penetration

1. Launch Phase and Revenue Projections

As a newly launched asset, IZERVAY’s initial revenue generation remains modest but promising. Analyst estimates project US sales reaching approximately $120-150 million within the first 12-18 months post-launch, contingent on prescribing trends and physician acceptance [2]. Growth is expected to accelerate as the drug gains market share and expands into international markets.

2. Pricing Strategies and Market Share

Pricing will play a critical role in revenue trajectory. Given current anti-VEGF therapies average $2,000-$3,000 per injection, IZERVAY’s pricing strategy will balance profit margins and market competitiveness. Demonstrating superior efficacy or allowing longer dosing intervals would justify premium pricing, positively impacting margins.

3. Competitive Barriers and Market Share Dynamics

Barriers include clinician familiarity with existing therapies, patent protections, and clinical trial data. As real-world evidence accumulates, demonstrating advantages of IZERVAY, market share is expected to increase, particularly among patients requiring more flexible dosing schedules.

4. Pricing and Reimbursement Challenges

Reimbursement considerations, especially with national health agencies emphasizing cost-effectiveness, could influence adoption rates. Successful navigation of health insurance formularies and inclusion in treatment guidelines will be instrumental for revenue growth.

5. Long-term Growth Opportunities

Given the pipeline of combination therapies and potential for expanded indications—such as diabetic retinopathy or other retinal vascular conditions—IZERVAY’s financial trajectory could extend beyond AMD, offering diversified revenue streams.

Market Risks and Challenges

1. Patent and Market Exclusivity

Patent expiration timelines are critical for projecting long-term revenue. Current patents are protected till at least 2030, allowing for a substantial market window.

2. Competitive Advancements

Emerging treatments, including gene therapies and biosimilars, may threaten market share growth. Disruptive innovations or regulatory hurdles could also impede financial prospects.

3. Clinical and Regulatory Uncertainties

Ongoing studies assessing long-term safety, durability of effect, and comparative effectiveness will influence future prescribing patterns and, consequently, revenue.

4. Economic and Reimbursement Fluctuations

Changes in healthcare policy, pricing pressures, or shifts toward value-based care models could impact drug reimbursement and doctor prescribing behavior.

Strategic Outlook and Recommendations

To capitalize on market opportunities, stakeholders should emphasize robust post-marketing surveillance, real-world evidence collection, and strategic pricing aligned with demonstrated benefits. Building alliances for combination therapy development and exploring expanded indications can bolster long-term revenue streams.

Key Takeaways

• IZERVAY entered a lucrative ophthalmology market with high unmet needs, supported by rising AMD and DME prevalence.
• Its differentiating features, especially extended dosing intervals, position it favorably amidst existing therapies.
• Near-term revenue is modest but poised for growth as market share increases, contingent on clinical validation and reimbursement strategies.
• Long-term financial success depends on patent protection, competitive innovation, and potential expansion into related indications.
• Continuous data generation and proactive engagement with payers will be essential for sustaining growth and optimizing market penetration.

Frequently Asked Questions

Q1: How does IZERVAY differ from existing anti-VEGF therapies?

A1: IZERVAY features a monoclonal antibody designed for enhanced binding affinity and prolonged half-life, enabling potentially longer dosing intervals and reduced treatment burden compared to traditional anti-VEGF agents.

Q2: What is the current market reception of IZERVAY?

A2: As a recent launch, initial adoption is modest. However, early clinical data and physician feedback suggest positive reception, especially among patients seeking less frequent injections.

Q3: What are the primary barriers to IZERVAY’s market growth?

A3: Barriers include familiarity with established therapies, reimbursement challenges, clinical trial data requirements for long-term efficacy, and competition from biosimilars or alternative modalities.

Q4: How might future pipeline developments influence IZERVAY’s financial trajectory?

A4: Expansion into additional indications, combination therapies, and improved delivery methods could diversify revenue sources and strengthen its market position.

Q5: What steps should stakeholders take to maximize IZERVAY’s market potential?

A5: Focus on generating robust clinical evidence, engaging payers early, optimizing pricing strategies, and exploring collaborations for expanded indications will be pivotal.

References

[1] National Institutes of Health. "Age-Related Macular Degeneration." https://nei.nih.gov/health/maculardegen (Accessed January 2023).

[2] MarketWatch. "Pharmaceuticals: IZERVAY U.S. Revenue Estimates." Estimated projections, 2023.