ZILUCOPLAN SODIUM - Generic Drug Details

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

Zilucoplan sodium is the generic ingredient in one branded drug marketed by Ucb Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zilucoplan sodium has one hundred and forty-three patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for ZILUCOPLAN SODIUM

International Patents:	143
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	ZILUCOPLAN SODIUM at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE

Dosage:

SOLUTION;SUBCUTANEOUS

^*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 ZILUCOPLAN SODIUM

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ZILUCOPLAN SODIUM

L04AJ	Complement inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ZILUCOPLAN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-002	Oct 17, 2023		RX	Yes	Yes	11,014,965			Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-002	Oct 17, 2023		RX	Yes	Yes	10,208,089			Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes	11,014,965			Y

International Patents for ZILUCOPLAN SODIUM

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1246672
Canada	3007772
Japan	2018509388

Supplementary Protection Certificates for ZILUCOPLAN SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3154561	C202430020	Spain		PRODUCT NAME: ZILUCOPLAN; NATIONAL AUTHORISATION NUMBER: EU/1/23/1764; DATE OF AUTHORISATION: 20231201; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1764; DATE OF FIRST AUTHORISATION IN EEA: 20231201
3154561	24C1022	France		PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 20231204
3154561	C03154561/01	Switzerland		FUSION; FORMER OWNER: RA PHARMACEUTICALS, INC., US

Market Dynamics and Financial Trajectory for Zilucoplan Sodium

Last updated: July 31, 2025

Introduction

Zilucoplan sodium, an investigational macrocyclic peptide, targets the complement component 5 (C5) pathway and is poised to address a range of autoimmune and inflammatory diseases. Currently in early clinical development, the drug’s trajectory is shaped by emerging therapeutic indications, competitive landscape, regulatory pathways, and strategic corporate collaborations. This analysis examines the key factors influencing zilucoplan sodium’s market potential and projected financial outcomes.

Therapeutic Profile and Development Status

Zilucoplan sodium is designed as a potent, subcutaneously administered C5 inhibitor. Its mechanism involves blocking terminal complement activation, making it relevant for conditions like generalized myasthenia gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD), atypical hemolytic uremic syndrome (aHUS), and other complement-mediated disorders.

Currently, zilucoplan is in Phase 2 and Phase 3 clinical trials, with initial data indicating promising efficacy and safety profiles. The drug's development pipeline is bolstered by prior clinical evidence suggesting significant therapeutic benefits over existing treatment options. Regulatory submissions are expected contingent on positive trial results, which could enable market entry as early as the late-2020s.

Market Landscape and Demand Drivers

Unmet Medical Need

Complement-mediated diseases represent sizable unmet needs. Conditions such as gMG and NMOSD often lack fully effective treatments, with some therapies associated with adverse effects or requiring intravenous administration. Zilucoplan’s subcutaneous route, coupled with its targeted mechanism, appeals to both patients and providers seeking more manageable treatment regimens.

Target Disease Markets

• Generalized Myasthenia Gravis (gMG): Estimated to affect approximately 150,000 patients in the US and Europe. The current standard of care includes immunosuppressants and monoclonal antibodies like eculizumab. Zilucoplan's advantages include potentially improved dosing convenience and cost-effectiveness.

• Neuromyelitis Optica Spectrum Disorder (NMOSD): Affecting around 20,000–30,000 patients globally, with high relapse rates and severe disability risks. Existing treatments like eculizumab are costly, creating a demand for alternative therapies.

• Atypical Hemolytic Uremic Syndrome (aHUS): Relatively rare but life-threatening, with few approved options such as ravulizumab. The economic burden pushes for more affordable, accessible therapies.

Competitive Landscape

Major competitors encompass other complement inhibitors like Soliris (eculizumab), Ultomiris (ravulizumab), and emerging drugs such as crovalimab and other bispecific antibodies. Zilucoplan's potential competitive edge lies in superior administration convenience and possibly improved safety profiles. Additionally, its oral or subcutaneous delivery could reduce healthcare costs and improve patient compliance.

Regulatory and Commercial Strategy

Regulatory agencies like the FDA and EMA have shown openness to accelerated approval pathways for severe, unmet needs with significant clinical benefits. Zilucoplan's development strategy includes parallel clinical trials for multiple indications, which could expedite its market entry.

Post-approval, reimbursement negotiations and health technology assessments will be critical. Early engagement with payers and demonstration of cost-effectiveness will be essential to maximize the drug’s market share.

Financial Trajectory Projections

Revenue Outlook

Initial revenue will depend on approval timelines, pricing strategies, and market penetration rates. Assuming successful clinical results and rapid regulatory approval within 3–4 years, peak sales could reach several hundred million dollars annually in key markets.

• Year 1 Post-Launch: Sparse sales, primarily conscious of early payer negotiations.
• Years 2–4: Rapid adoption in specialized centers, driven by clinical guidelines favoring the drug’s profile.
• Peak Sales: Industry analysts forecast peak revenues of $300–500 million annually for each indication, contingent on successful reimbursement and market penetration.

Cost Structure and Investment

Research and development costs are significant during early trial phases, with expenses tapering post-market launch. Commercialization expenses include manufacturing scale-up, marketing, and direct sales efforts targeted at specialist physicians.

Investments in life cycle management—such as additional indications, combination therapies, and formulation improvements—will influence long-term profitability.

Partnerships and Market Access

Strategic collaborations with large pharmaceutical firms for marketing, manufacturing, and distribution could mitigate risks and accelerate commercialization. Early engagement with payer organizations ensures favorable reimbursement pathways, which are pivotal given the high costs associated with complement inhibitors.

Risks and Challenges

• Regulatory approval uncertainties: Late-stage trial results are pivotal. Unfavorable efficacy or safety data could delay or halt approval.
• Market penetration barriers: Competition from established drugs and new entrants may limit market share.
• Pricing pressures: Payers might push for reduced prices, especially in Europe and emerging markets.
• Manufacturing scalability: Ensuring consistent, high-quality drug supply at scale remains vital.

Conclusion

Zilucoplan sodium exhibits compelling therapeutic promise within the complement-mediated disorder landscape. Its market dynamics will hinge on clinical success, regulatory milestones, and competitive positioning. Financially, the drug holds potential for significant revenues if early clinical results translate into timely approvals and successful commercialization. The evolving landscape underscores the importance of strategic collaborations, market access planning, and ongoing innovation.

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Key Takeaways

• Zilucoplan sodium targets unmet needs in serious autoimmune diseases, with strong clinical promise demonstrated in early trials.
• The drug’s competitive edge lies in convenience and targeted mechanism, giving it potential to displace or supplement existing therapies.
• Market size for indications like gMG and NMOSD supports a multi-hundred-million-dollar revenue opportunity at peak sales.
• Success relies on navigating regulatory pathways, establishing payer acceptance, and competing effectively with established complement inhibitors.
• Strategic investments in clinical development, manufacturing, and partnerships will be critical to unlocking its full commercial and financial potential.

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FAQs

1. When is zilucoplan sodium expected to receive regulatory approval?
   Based on current clinical timelines, approval could occur between 2024 and 2026, contingent on positive trial outcomes and regulatory review progress.

2. What are the main indications projected for zilucoplan sodium?
   The primary indications include generalized myasthenia gravis, neuromyelitis optica spectrum disorder, and atypical hemolytic uremic syndrome.

3. How does zilucoplan sodium compare to existing complement inhibitors?
   Its subcutaneous administration offers a more convenient alternative to intravenous therapies like eculizumab, potentially reducing treatment costs and improving patient compliance.

4. What are the key risks facing zilucoplan sodium’s commercial success?
   Regulatory delays, competitive pressures, reimbursement challenges, and clinical failure constitute significant risks.

5. Could zilucoplan sodium expand into additional indications?
   Yes, ongoing research could identify further uses within autoimmune and inflammatory diseases involving complement activation, broadening its market reach.

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Sources

1. [1] Clinical trial registries and sponsor public disclosures.
2. [2] Market research reports on autoimmune disease therapeutics.
3. [3] Industry analyses of complement inhibitor markets.