Avacincaptad pegol sodium - Generic Drug Details

What are the generic drug sources for avacincaptad pegol sodium and what is the scope of freedom to operate?

Avacincaptad pegol sodium is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Avacincaptad pegol sodium has one hundred and six patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for avacincaptad pegol sodium

International Patents:	106
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	avacincaptad pegol sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for avacincaptad pegol sodium

Constraining patent/regulatory exclusivity:

8,236,773

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 avacincaptad pegol sodium

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for avacincaptad pegol sodium

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for avacincaptad pegol sodium

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	8,236,773
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	7,579,456			Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	12,016,875
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	9,617,546			Y

Expired US Patents for avacincaptad pegol sodium

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 avacincaptad pegol sodium

Country	Patent Number	Title	Estimated Expiration
Denmark	2860251
South Korea	101374931
Slovenia	3385384
Singapore	11201510315T	METHODS FOR TREATING OR PREVENTING OPHTHALMOLOGICAL CONDITIONS
South Korea	20220061248	안과적 질환을 치료하거나 예방하기 위한 방법 (METHODS FOR TREATING OR PREVENTING OPHTHALMOLOGICAL CONDITIONS)
Canada	2915255
Japan	2018168175

Market Dynamics and Financial Trajectory for Avacincaptad Pegol Sodium

Last updated: February 13, 2026

What is Avacincaptad Pegol Sodium and its Clinical Status?

Avacincaptad pegol sodium (brand name: Izencespag) is an investigational anti-vascular endothelial growth factor (VEGF) agent designed for neovascular age-related macular degeneration (nAMD). It is developed by IVERIC bio, Inc. It is a potent inhibitor of complement factor C5, underlining its potential to address geographic atrophy (GA) and other retinal degenerative conditions.

The drug is in late-stage clinical testing, primarily under Phase 3 trials. As of 2023, it has not received FDA approval, but the company has submitted supplemental applications based on ongoing trial results.

How Does the Market Environment Look for AVAC?

Existing AMD Market

• Global AMD market size: Estimated at $10.8 billion in 2022, projected to grow at CAGR of 6.2% to reach $17.5 billion by 2030 (Grand View Research).
• Major players: Regeneron (Eylea), Roche (Lucentis), Bausch + Lomb (Beovu), Apellis (Syfovre).
• CE patents: Key products face patent cliffs, opening opportunities for novel mechanisms, e.g., complement inhibition.

Unmet Needs and Competitive Edge

• Geographic atrophy: No approved treatments, representing a significant unmet medical need.
• Anti-VEGF limitations: Frequent injections, low patient adherence, risk of adverse effects.
• Innovation: Complement inhibitors offer a different therapeutic target and potentially extended durability.

What Are the Key Drivers Enhancing Market Potential?

• Demographic shift: Increasing aged population globally—over 200 million people aged 60+ worldwide suffer from AMD.
• Revised treatment guidelines: Push for longer-acting therapies to improve adherence.
• Regulatory momentum: Encouragement from agencies like the FDA for novel complement pathway agents.
• Expansion prospects: Potential uses in other retinal diseases, such as diabetic macular edema (DME).

What Financial Trajectory Is Expected for Avacincaptad Pegol Sodium?

Timeline and Milestones

• 2022: Completion of Phase 3 trials (GATHER1 and GATHER2) for geographic atrophy.
• 2023: Submission of Biologics License Application (BLA) or New Drug Application (NDA). Expect review period of approximately 10 months.
• 2024-2025: Anticipation of approval, conditional on trial outcomes and regulatory review.

Revenue Projections

• Initial market penetration: Limited to North America, with subsequent expansion to other regions.
• First-year sales (post-approval): Estimated between $150 million and $300 million, based on modeled uptake and competitive dynamics.
• Growth trajectory: Compound annual growth rate (CAGR) of 15%-20% over the next five years, driven by expanded indications and geographic rollout.

Cost Considerations

• Development costs: Estimated at $200 million–$300 million, encompassing clinical trial expenses.
• Pricing: Expected to be aligned with existing anti-VEGF agents, around $2,000–$3,000 per injection.
• Reimbursement: Major payer coverage anticipated, given high unmet need and lack of approved alternatives.

What Risks and Barriers Influence Financial Outlook?

• Regulatory delay or rejection: Potential for additional data requests or safety concerns.
• Competitive threats: Entry of other complement inhibitors or longer-acting anti-VEGF agents.
• Market acceptance: Physician and patient adoption influenced by safety profile, efficacy, and convenience.
• Patent protections: Expected to secure exclusivity until at least 2035, barring generic challenges.

How Do Broader Market Trends Affect Projections?

• Increasing R&D focus on complement pathways, paving the way for complementary or rival therapies.
• Healthcare expenditure growth for ophthalmology treatments.
• Policy shifts favoring innovation in rare and difficult-to-treat conditions.

Key Takeaways

• Avacincaptad pegol sodium targets an unmet need in geographic atrophy.
• Clinical trial data indicate promising efficacy, with regulatory submission expected in 2023.
• Market size for AMD therapies is expanding, with significant opportunity in complement pathway inhibitors.
• Financial success hinges on regulatory approval, market penetration, and managed competition.
• Costs and reimbursement strategies will shape its adoption trajectory.

FAQs

Q1: What are the main competitors for avacincaptad pegol sodium?

A1: Prioritized competitors include Apellis' Syfovre (pegcetacoplan), approved for GA; Regeneron's Eylea and Roche's Lucentis, for wet AMD; and emerging oral or longer-acting anti-VEGF therapies.

Q2: When is avacincaptad pegol sodium expected to be approved?

A2: Filing is anticipated in 2023, with potential approval by late 2024 if clinical data support safety and efficacy.

Q3: What is the estimated market share post-approval?

A3: Initial market share could reach 10-15% within five years, increasing with expanded indications and geographic coverage.

Q4: How does the drug’s mechanism differ from existing AMD therapies?

A4: Unlike traditional anti-VEGF agents, avacincaptad pegol sodium inhibits complement factor C5, targeting an inflammatory pathway involved in GA.

Q5: What are the main risks impacting its financial prospects?

A5: Regulatory hurdles, competitive innovations, market acceptance, and reimbursement challenges.

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Sources:

[1] Grand View Research. Age-Related Macular Degeneration Market Size, Share & Trends Analysis. 2022.
[2] IVERIC bio. Clinical trials pipeline and regulatory updates. 2023.
[3] EvaluatePharma. Ophthalmology drugs market overview. 2023.