Avacincaptad pegol sodium - Generic Drug Details

What are the generic 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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Avacincaptad pegol sodium has one hundred and three patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for avacincaptad pegol sodium

International Patents:	103
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	avacincaptad pegol sodium at DailyMed

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	10,947,544			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	7,803,931			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	7,803,931
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023	7,538,211

International Patents for avacincaptad pegol sodium

Country	Patent Number	Title	Estimated Expiration
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)
World Intellectual Property Organization (WIPO)	2005079363
South Korea	20150095956	APTAMER THERAPEUTICS USEFUL IN THE TREATMENT OF COMPLEMENT-RELATED DISORDERS
Philippines	12015502773	METHODS FOR TREATING OR PREVENTING OPTHALMOLOGICAL CONDITIONS

Market Dynamics and Financial Trajectory for Avacincaptad Pegol Sodium

Last updated: July 27, 2025

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Introduction

Avacincaptad pegol sodium (ACP-702), marketed as Zilucoplan, represents a promising therapeutic agent primarily developed for ocular indications, specifically age-related macular degeneration (AMD). As a compact, complement-inhibiting peptide, its clinical development hinged on addressing unmet needs in retinal degenerative diseases. Analyzing the market dynamics and financial trajectory of avacincaptad pegol sodium involves understanding its therapeutic potential, competitive landscape, regulatory progress, and commercial viability.

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Pharmacological Profile and Clinical Development

Avacincaptad pegol sodium functions as a complement component 5 (C5) inhibitor, designed to mitigate inflammation-mediated retinal damage. AMD, particularly the geographic atrophy (GA) subtype, exhibits limited treatment options, significantly contributing to visual impairment. The drug demonstrated promising results in Phase III trials, showing a statistically significant reduction in lesion growth and stabilization of vision loss [1].

Successful completion of pivotal trials catalyzed regulatory reviews, with the potential for accelerated approval pathways in key markets such as the US and Europe. Notably, the drug’s targeted mechanism aligns with the growing paradigm shift toward personalized, pathway-specific ophthalmic treatments.

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Market Landscape and Demand Drivers

Unmet Clinical Needs

Age-related macular degeneration, especially GA, affects an estimated 5 million Americans and is projected to double by 2040. Currently, no FDA-approved, widely accessible treatments exist for GA, establishing a substantial unmet demand. The current off-label use of intravitreal injections of anti-VEGF agents primarily benefits neovascular AMD, leaving GA patients underserved—a significant market gap.

Competitive Environment

While complement inhibition as a therapeutic strategy is relatively novel in AMD, drug developers are actively exploring alternative agents targeting complement pathways—such as apellis pharmaceuticals’ APL-2 (Pegcetacoplan). The competitive landscape remains dynamic, with several companies racing to develop and commercialize effective treatments.

Potential competition may also stem from emerging gene therapies and regenerative approaches. However, the long-term safety, dosing convenience, and cost profiles of avacincaptad pegol sodium are likely to influence market share.

Regulatory and Reimbursement Trends

Regulatory agencies like the FDA are increasingly receptive to expedited review pathways, especially for therapies addressing high-bidelity, unmet needs. The potential for Priority Review or Breakthrough Designation can shorten approval timelines, accelerating revenue realization.

Reimbursement landscapes hinge on demonstrated clinical efficacy, safety, and cost-effectiveness. Payers may favor treatments that stabilize or improve vision, reducing long-term healthcare costs related to vision impairment.

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Financial Trajectory and Commercialization Strategy

Revenue Projections

The initial commercial opportunity for avacincaptad pegol sodium hinges on the prevalence of GA and patient access rates. Assuming FDA approval, early adoption is likely to be led by specialist ophthalmology centers.

Analysts estimate that the global AMD treatment market could reach USD 15 billion by 2028, with GA-specific treatments capturing a significant segment (~USD 3–5 billion) given the current treatment gap [2].

Pricing strategies will substantially influence revenue streams. Considering the high cost of intravitreal injections, positioning avacincaptad pegol sodium as an effective, safe, and possibly less frequent dosing regimen could justify premium pricing and foster higher adoption rates.

Cost Considerations and Profit Margins

Development costs, including R&D, clinical trials, and regulatory filings, typically span USD 300–500 million for innovative ophthalmics [3]. Post-approval, manufacturing costs—particularly for peptide-based drugs—are moderate but require stringent quality controls.

Profitability will depend on patient acceptance, reimbursement levels, and competition intensity. A well-managed commercialization approach with strategic partnerships could enhance revenue prospects.

Market Penetration and Growth

Early-stage market penetration strategies should prioritize geographically strategic launches in North America and Europe, leveraging existing relationships with ophthalmologists. The focus must be on securing formulary approvals, clinician education, and patient convenience.

As data accumulates, expanding indications (e.g., other complement-mediated retinal disorders) can extend the drug’s market lifetime, similar to the trajectory of other complement inhibitors.

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Regulatory and Market Risks

Potential hurdles include regulatory delays, unforeseen adverse effects, or lack of significant real-world efficacy data affecting payer confidence. Moreover, intense competition from alternative therapeutics or technological solutions could impact market share.

The high cost of clinical development and market entry expenses necessitate strategies for effective investor confidence and funding continuity.

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Conclusion

Avacincaptad pegol sodium represents a compelling candidate in the ophthalmic pharmaceutical market, driven by a significant unmet need in GA. Its success hinges on regulatory approvals, clinical efficacy, safety, pricing, and reimbursement strategies. The drug’s financial trajectory will likely follow a path of rapid initial growth upon market entry, tempered by competitive and regulatory challenges. Strategic partnerships, lifecycle management, and a focused commercialization plan are critical to unlocking its full market potential.

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Key Takeaways

• Addressing an unmet need: Avacincaptad pegol sodium targets GA, a condition lacking approved treatments, positioning it favorably in the ophthalmic market.
• Market growth potential: With an expanding patient population and high healthcare costs associated with vision loss, the product can capture a substantial market share.
• Regulatory pathways: Priority review and accelerated approval options can fast-track commercialization, boosting early revenue streams.
• Competitive landscape: The emergence of other complement inhibitors and innovative treatment modalities requires vigilant market strategy and differentiation.
• Revenue and profitability prospects: Based on pricing, reimbursement, and adoption rates, the drug has the potential for multi-billion-dollar sales within a few years post-launch.

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FAQs

1. What is the primary indication for avacincaptad pegol sodium?
It is primarily developed for geograpic atrophy (GA), an advanced form of age-related macular degeneration that leads to irreversible vision loss.

2. How does avacincaptad pegol sodium differentiate itself from existing AMD treatments?
Unlike anti-VEGF therapies that target neovascular AMD, avacincaptad pegol sodium inhibits the complement pathway, addressing the inflammatory component of GA, which currently lacks approved treatments.

3. What are the key regulatory milestones expected for this drug?
Regulatory agencies are evaluating clinical trial data for potential approval pathways such as standard and accelerated reviews, with approval timelines influenced by the robustness of clinical efficacy and safety data.

4. How significant is the market opportunity for avacincaptad pegol sodium?
The market for GA treatments could reach USD 3–5 billion globally, driven by the high unmet clinical need and aging populations.

5. What risks could impact the financial success of avacincaptad pegol sodium?
Potential risks include regulatory delays, safety concerns, limited real-world efficacy, aggressive competition, and reimbursement challenges.

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References

1. Clinical Trial Data for Avacincaptad Pegol Sodium
2. Market Research Future. "Age-related Macular Degeneration Treatment Market." 2022.
3. EvaluatePharma. "R&D Investment & Cost Analysis." 2021.