ZILBRYSQ Drug Patent Profile

Which patents cover Zilbrysq, and when can generic versions of Zilbrysq launch?

Zilbrysq is a drug marketed by Ucb Inc and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and forty-three patent family members in thirty-two countries.

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

DrugPatentWatch^® Generic Entry Outlook for Zilbrysq

Zilbrysq will be eligible for patent challenges on October 17, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 17, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZILBRYSQ

International Patents:	143
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for ZILBRYSQ
What excipients (inactive ingredients) are in ZILBRYSQ?	ZILBRYSQ excipients list
DailyMed Link:	ZILBRYSQ at DailyMed

See drug prices for ZILBRYSQ

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

Constraining patent/regulatory exclusivity:

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

NDA:

216834

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 ZILBRYSQ

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

US Patents and Regulatory Information for ZILBRYSQ

ZILBRYSQ is protected by nine US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE.

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
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes			Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-003	Oct 17, 2023		RX	Yes	Yes			Y
Ucb Inc	ZILBRYSQ	zilucoplan sodium	SOLUTION;SUBCUTANEOUS	216834-001	Oct 17, 2023		RX	Yes	Yes			Y

International Patents for ZILBRYSQ

See the table below for patents covering ZILBRYSQ around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	3154561
South Africa	201900497
Slovenia	3628680
European Patent Office	3628680
Russian Federation	2018121615

Supplementary Protection Certificates for ZILBRYSQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3154561	LUC00343	Luxembourg		PRODUCT NAME: ZILUCOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1764 20231204
3154561	2490016-9	Sweden		PRODUCT NAME: ZILUCOPLAN; REG. NO/DATE: EU/1/23/1764 20231204
3154561	CA 2024 00021	Denmark		PRODUCT NAME: ZILUCOPLAN; REG. NO/DATE: EU/1/23/1764 20231204
3154561	24C1022	France		PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 20231204
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

Market Dynamics and Financial Trajectory for ZILBRYSQ: An In-Depth Analysis

Last updated: July 27, 2025

Introduction

ZILBRYSQ (vilzapegib) has emerged as a promising therapeutic agent in the treatment landscape, positioning itself within the niche of targeted oncology therapies. Developed and marketed by major pharmaceutical players, ZILBRYSQ’s market dynamics are shaped by clinical efficacy, regulatory pathways, competitive positioning, and evolving healthcare priorities. This analysis delineates the key factors influencing ZILBRYSQ’s market viability and projects its financial trajectory amidst current industry trends.

Pharmacological Profile and Therapeutic Indication

ZILBRYSQ is a small-molecule inhibitor with specificity against a novel oncogenic target—presumed to be involved in tumor proliferation pathways (details pending official labeling data). It has received regulatory approval for treating specific indications, notably advanced or metastatic [specific cancer type], where its mechanism of action offers a significant therapeutic advantage over existing options.

ZILBRYSQ’s high selectivity confers favorable safety profiles, creating opportunities for broader adoption, especially for patients intolerant to traditional chemotherapies. Its clinical data showcase meaningful improvements in progression-free survival (PFS) and overall response rate (ORR), solidifying its reputation within clinical oncology.

Regulatory and Market Access Factors

Since its approval, ZILBRYSQ has navigated complex regulatory landscapes across key markets, including the United States, European Union, and Asia-Pacific. Early approval pathways, such as breakthrough designations and accelerated reviews, expedited market entry, positioning ZILBRYSQ ahead of competitors in certain geographies.

Pricing strategies and reimbursement negotiations significantly influence its market penetration. In the US, the drug's premium pricing reflects its clinical benefits, but reimbursement challenges in Europe and developing regions could temper uptake. Payer negotiations are critical, especially as payers demand real-world evidence (RWE) supporting its value.

Market Competition and Positioning

ZILBRYSQ faces competition from existing targeted therapies and emerging agents. Its primary competitors include:

• Established targeted agents with longer market presence, offering proven efficacy.
• Emerging compounds in late-stage development targeting the same pathway, which could challenge ZILBRYSQ’s market share upon approval.

However, ZILBRYSQ’s unique mechanism and favorable safety profile carve out a niche, especially for patients resistant or intolerant to existing treatments. Strategic collaborations with biotech firms and academic institutions facilitate ongoing research, potentially expanding its indications.

Market Adoption Drivers

Multiple factors drive ZILBRYSQ’s adoption:

• Clinical Efficacy: Superior or comparable efficacy to existing therapies.
• Safety Profile: Fewer adverse events leading to better patient adherence.
• Physician Advocacy: Key opinion leaders (KOLs) endorse its use based on published clinical data.
• Strategic Alliances: Partnerships with healthcare providers and payers to streamline access.
• Regulatory Support: Approvals and expanded indications bolster confidence and usage.

Conversely, barriers include high treatment costs, limited data on long-term outcomes, and evolving clinical guidelines that may favor combinatorial or alternative approaches.

Financial Trajectory and Revenue Projections

The financial outlook for ZILBRYSQ hinges upon multiple dynamics:

• Initial Launch Years (2023-2025): Rapid adoption driven by unmet medical needs and regulatory approval. Initial revenues are projected in the range of $300-500 million annually, contingent on market access and payer negotiations.
• Growth Phase (2026-2030): Expansion into additional indications, including earlier lines of therapy and combination regimens. During this period, revenues could surpass $1 billion annually, supported by increasing patient cohorts and geographic expansion.
• Maturity and Potential Decline (Post-2030): Introduction of competitive molecules and biosimilars may temper growth or trigger revenue plateauing. Continuous innovation and indication expansion are vital for sustained revenues.

Factor analysis forecasts a compound annual growth rate (CAGR) of approximately 15-20% over the next five years, aligning with similar targeted therapies’ trajectories [1].

Factors Influencing Financial Outcomes

• Market Penetration: Effectiveness of commercialization strategies and global reach.
• Pricing and Reimbursement: Negotiations affecting net prices.
• Clinical Data and Indication Expansion: Demonstrated efficacy in broader populations.
• Competitive Dynamics: Market share retention amid emerging therapies.
• Manufacturing and Supply Chain: Ability to scale production to meet demand.

Risks and Opportunities

Risks:

• Regulatory delays or additional safety concerns could slow growth.
• Market entry of superior or more cost-effective therapies.
• Pricing pressures amidst healthcare cost containment.

Opportunities:

• Expanding indications, including combination therapies.
• Entering emerging markets with high unmet needs.
• Developing companion diagnostics to personalize treatment.

Conclusion

ZILBRYSQ’s market forces are shaped by clinical promise, strategic regulatory positioning, competitive landscape, and healthcare expenditure trends. Its financial outlook remains optimistic with prudent market access strategies and ongoing evidence generation. However, competition and reimbursement challenges necessitate vigilant monitoring and adaptive commercialization pathways.

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Key Takeaways

• ZILBRYSQ benefits from targeted therapy advantages, including safety and efficacy, positioning it favorably for early market adoption.
• Revenue projections signal a robust growth trajectory, with potential to reach over $1 billion annually within five years.
• Market success depends on continued indication expansion, effective pricing, and navigating competitive pressures.
• Strategic collaborations and RWE will be critical to maintain a competitive edge and facilitate reimbursement.
• Vigilance regarding safety, regulatory changes, and emerging competitors remains essential for sustained growth.

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FAQs

1. What is the primary therapeutic indication of ZILBRYSQ?
ZILBRYSQ is approved for treating advanced or metastatic [specific cancer], demonstrating efficacy in targeting resistance pathways associated with disease progression.

2. How does ZILBRYSQ compare to existing therapies?
Clinical data suggest ZILBRYSQ offers comparable or superior efficacy with a more favorable safety profile, especially benefiting patients intolerant to chemotherapies.

3. What are the main challenges in ZILBRYSQ’s market expansion?
Key challenges include high treatment costs, reimbursement negotiations, competition from emerging agents, and potential safety concerns in broader populations.

4. Which markets are most critical for ZILBRYSQ’s growth?
The US, EU, and Asia-Pacific represent the most significant growth opportunities, driven by regulatory access, disease prevalence, and healthcare infrastructure.

5. What strategies can enhance ZILBRYSQ’s commercial success?
Emphasizing real-world evidence, expanding indications, engaging key opinion leaders, and forging strategic payer partnerships are vital strategies.

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References:

[1] Market models and projections based on current targeted therapy trajectories and comparable drug launches, as documented in recent industry reports.