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IZERVAY Drug Patent Profile

Which patents cover Izervay, 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 two patent family members in twenty-seven 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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 14, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for IZERVAY

International Patents:	102
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for IZERVAY

NDA:

217225

Dosage:

SOLUTION;INTRAVITREAL

^*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.

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.

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
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes				Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes				Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes				Y

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:

Australia

Brazil

Canada

China

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
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)
Australia	2024200948	Methods for treating or preventing ophthalmological conditions
Canada	3124030	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)
Spain	2429442

IZERVAY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for IZERVAY

Introduction to IZERVAY

IZERVAY, developed by Astellas and originally from Iveric Bio, is a significant player in the treatment of geographic atrophy (GA), an advanced form of age-related macular degeneration. The drug has garnered attention for its efficacy and the competitive landscape it operates in.

Clinical Efficacy and Safety

IZERVAY has demonstrated promising results in clinical trials. The 2-year GATHER2 study presented at the American Academy of Ophthalmology 2023 Annual Meeting showed that the drug, administered monthly or every other month, significantly reduced the mean rate of GA lesion growth. Specifically, monthly dosing resulted in a 14% reduction, while dosing every other month after initial monthly dosing led to a 19% reduction in lesion growth[1].

However, IZERVAY fell short of a prespecified objective related to reducing vision loss, which will be further explored in sensitivity analyses[1][4].

In terms of safety, the drug has shown a favorable profile with no cases of ischemic neuropathy or retinal vasculitis reported in the GATHER2 analysis. This is particularly noteworthy given the safety concerns surrounding its competitor, Apellis' Syfovre, which has been associated with occlusive retinal vasculitis[1][4].

Market Competition

The market for GA treatments is highly competitive, with IZERVAY facing off against Apellis' Syfovre. The competition is intense, with each drug having its own set of advantages and challenges.

• Syfovre's Safety Concerns: Syfovre has faced significant setbacks due to reports of occlusive retinal vasculitis, which has impacted its market performance. Despite recent data showing no events of retinal vasculitis in over 24,000 injections, the initial safety incidents hampered its first-mover advantage[1][4].
• IZERVAY's Advantage: The absence of retinal vasculitis cases in IZERVAY's safety profile has given it a slight edge in the market. Additionally, the drug's receipt of a J-code in April 2024 has facilitated insurance billing and reimbursement, further enhancing its market position[2][4].

Financial Performance and Projections

Astellas' acquisition of Iveric Bio for $5.9 billion was driven by the potential of IZERVAY as a revenue-generating pillar. Here are some key financial insights:

• Early Sales: As of the third quarter of 2023, Astellas reported around $8 million in early sales from IZERVAY. This is a modest start, but the company is optimistic about the drug's long-term potential[1].
• Market Valuation: The competition from IZERVAY has impacted Apellis' stock performance, with Wells Fargo reducing the price target for Apellis from $57 to $48 due to increased competition. However, Apellis still maintains a robust revenue growth trajectory, with a 394.93% increase in sales over the last twelve months[2].
• Market Growth: The global age-related macular degeneration (AMD) drugs market, which includes GA treatments, is forecasted to grow from $10.46 billion in 2024 to $17.37 billion by 2029, driven by a CAGR of 10.7%. This growth is supported by increasing prevalence of AMD, research and development, and improvements in reimbursement policies[3].

Regulatory Updates

• FDA Approval: IZERVAY received FDA approval based on study results demonstrating its efficacy for up to 12 months. Recently, the FDA accepted a supplemental New Drug Application (sNDA) to include positive 2-year data in the US Prescribing Information for IZERVAY, with a target action date set for November 19, 2024[1][4].

Financial Implications for Astellas

The acquisition of Iveric Bio and the subsequent performance of IZERVAY are crucial for Astellas' financial strategy, particularly as the company faces the loss of exclusivity for its star cancer drug Xtandi. IZERVAY is positioned as a key revenue-generating pillar to help mitigate this loss[1].

Market Outlook

The market dynamics for IZERVAY are influenced by several factors:

• Competition: The ongoing competition with Syfovre will continue to shape the market. However, IZERVAY's safety profile and recent regulatory approvals position it favorably.
• Regulatory Environment: The acceptance of the sNDA and the potential inclusion of 2-year data in the prescribing information will further solidify IZERVAY's market position.
• Market Growth: The expanding AMD drugs market provides a fertile ground for IZERVAY to grow, driven by increasing demand and improving reimbursement policies.

Key Takeaways

• Clinical Efficacy: IZERVAY has shown significant reductions in GA lesion growth and a favorable safety profile.
• Market Competition: The drug faces competition from Syfovre, but its safety advantages and recent regulatory approvals give it an edge.
• Financial Performance: Early sales are modest, but the drug is expected to be a key revenue generator for Astellas.
• Regulatory Updates: Recent FDA approvals and the acceptance of the sNDA are positive indicators for the drug's market trajectory.
• Market Growth: The AMD drugs market is expected to grow significantly, providing a strong foundation for IZERVAY's future performance.

FAQs

1. What is IZERVAY used for?

   • IZERVAY is used for the treatment of geographic atrophy (GA), an advanced form of age-related macular degeneration.

2. How does IZERVAY compare to Syfovre in terms of safety?

   • IZERVAY has a more favorable safety profile compared to Syfovre, with no reported cases of retinal vasculitis, whereas Syfovre has been associated with this condition.

3. What are the financial implications of IZERVAY for Astellas?

   • IZERVAY is expected to be a key revenue-generating pillar for Astellas, helping to mitigate the loss of exclusivity for its star cancer drug Xtandi.

4. What is the current market size and growth forecast for AMD drugs?

   • The global AMD drugs market is forecasted to grow from $10.46 billion in 2024 to $17.37 billion by 2029, driven by a CAGR of 10.7%.

5. What regulatory milestones has IZERVAY recently achieved?

   • IZERVAY received FDA approval and recently had its sNDA accepted to include positive 2-year data in the US Prescribing Information, with a target action date set for November 19, 2024.

Sources

1. https://www.fiercepharma.com/pharma/astellas-izervay-given-monthly-or-every-other-month-prevails-2-year-study
2. https://www.investing.com/news/company-news/wells-fargo-lowers-apellis-stock-pt-on-competition-concerns-from-izervay-93CH-3454122
3. https://www.marketsandmarkets.com/Market-Reports/age-related-macular-degeneration-market-37446234.html
4. https://www.delveinsight.com/blog/opportunities-in-dry-amd-treatment
5. https://www.astellas.com/en/news/29576