CINRYZE Drug Profile

Summary for Tradename: CINRYZE

High Confidence Patents:	2
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for CINRYZE

Recent Clinical Trials for CINRYZE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Leiden University Medical Center	PHASE2
Haaglanden Medical Centre	PHASE2
Takeda	PHASE2

See all CINRYZE clinical trials

Pharmacology for CINRYZE

Mechanism of Action	Kallikrein Inhibitors
Physiological Effect	Decreased Vascular Permeability
Established Pharmacologic Class	Human C1 Esterase Inhibitor

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for CINRYZE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for CINRYZE Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267		2037-12-11	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267		2035-09-15	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for CINRYZE Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267		2038-02-28	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267		2039-03-19	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267		2039-03-05	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267		2037-10-04	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267		2032-06-08	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267		2032-06-08	Patent claims search

International Patents for CINRYZE

Country	Patent Number	Estimated Expiration
Brazil	112015023207
Hungary	E036224
South Korea	102430453
Japan	2018119002
Mexico	2021011946
San Marino	T201900141

Market Dynamics and Financial Trajectory for the Biologic Drug: CINRYZE

Last updated: July 28, 2025

Introduction

CINRYZE (C1 Esterase Inhibitor [Human]) stands as a pioneering biologic therapy approved for the prophylactic treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 and older. As a plasma-derived biologic, CINRYZE significantly impacts the treatment landscape of rare, debilitating conditions. This analysis explores the current market environment, competitive landscape, regulatory framework, and financial trajectory shaping CINRYZE's future prospects.

Market Landscape and Epidemiology

Hereditary angioedema affects approximately 1 in 50,000 individuals globally, equating to an estimated 30,000 to 50,000 patients in the United States alone. The disease manifests through unpredictable, potentially life-threatening swelling episodes affecting the skin, respiratory tract, and gastrointestinal tract [1].

The demand for effective prophylactic therapies has surged with increased disease awareness, improved diagnostics, and patient advocacy. CINRYZE, as a plasma-derived biologic, holds a legacy position, particularly within historical treatment algorithms before the advent of more recent agents.

Competitive Environment

Key Competitors

The biopharmaceutical landscape for HAE encompasses both plasma-derived and recombinant biologics. Notable competitors include:

• Berinert (CSL Behring): Human plasma-derived C1 esterase inhibitor approved for on-demand treatment.
• Haegarda (Massachusetts General Hospital (MGH)/CSL Behring): SC formulation for prophylaxis.
• Takhzyro (Icatibant; Takeda): Recombinant bradykinin B2 receptor antagonist, approved for prophylaxis and acute attacks.
• Lanadelumab (Takhzyro): Monoclonal antibody targeting plasma kallikrein, offering subcutaneous prophylaxis.
• Ruconest (Pharming Group): Recombinant C1 esterase inhibitor approved for acute treatment and prophylaxis in some regions.

Market Position of CINRYZE

Despite the presence of newer, more convenient therapies, CINRYZE retains relevance due to its established safety profile, extensive clinical history, and regulatory approvals. However, the evolving preference for subcutaneous, self-administered agents and the advent of monoclonal antibodies with extended dosing intervals challenge CINRYZE’s market share.

Shifts in Therapeutic Preferences

Clinicians increasingly favor treatments like lanadelumab and Takhzyro for their convenience, longer dosing intervals, and encouraging efficacy profiles. These agents often demonstrate superior adherence rates and patient satisfaction, pressuring CINRYZE to innovate its delivery and positioning.

Regulatory and Reimbursement Dynamics

Regulatory Approvals

Initially approved by the U.S. Food and Drug Administration (FDA) in 2008, CINRYZE's regulatory status has evolved, with supplemental approvals expanding its indications and formulations [2].

Reimbursement Environment

Insurance coverage, formulary inclusion, and pricing strategies significantly influence CINRYZE's market penetration. Manufacturers have engaged in negotiations and patient assistance programs to mitigate high treatment costs, which remain a barrier in some regions.

Cost Considerations

CINRYZE’s cost per dose exceeds $10,000, reflecting its complex manufacturing and plasma-derived nature. Cost-effectiveness analyses favor prophylaxis in selected patient subsets, supporting ongoing insurance reimbursement.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

CINRYZE's revenues peaked following initial launch, with incremental growth driven by increased diagnosis and prophylactic adoption. However, recent years have exhibited plateauing revenues, correlating with the rise of competing agents and patient preference shifts.

Strategic Initiatives to Enhance Market Share

To foster growth, the manufacturer has pursued strategies including:

• Formulation Innovation: Developing subcutaneous formulations to enhance convenience.
• Combination Therapies: Exploring synergies with other biologics.
• Geographic Expansion: Targeting emerging markets with rising HAE diagnoses.
• Patient Advocacy Engagement: Increasing clinical awareness and diagnosis rates.

Revenue Projections

Analysts project a moderate decline in CINRYZE’s market share unless supported by new formulations, expanded indications, or price adjustments. The global HAE biologics market is projected to grow at a compound annual growth rate (CAGR) of approximately 7-9% over the next five years, driven by increasing diagnoses and therapy adoption [3].

Emerging Trends and Future Outlook

Biosimilar Development

The potential entry of biosimilars for plasma-derived C1 esterase inhibitors could exert downward pressure on prices and revenues. Currently, no biosimilars are approved for CINRYZE, but market entry might accelerate in the coming years.

Innovation in Delivery

Subcutaneous formulations and longer-acting biologics are capitalizing on the demand for convenient, self-administered therapies, threatening traditional intravenous biologics like CINRYZE.

Personalized Medicine and Patient Stratification

Enhanced understanding of HAE phenotypes and pharmacogenomics could lead to tailored therapies, influencing CINRYZE’s market relevance.

Regulatory Advances

Regulatory incentives for orphan drugs continue, supporting ongoing investment in rare disease therapeutics, though reimbursement pressures may tighten.

Risk Factors and Challenges

• Competition from more patient-friendly therapies.
• Pricing constraints and reimbursement hurdles.
• Limited geographic reach in some markets.
• Potential biosimilar penetration reducing revenue.

Key Takeaways

• Market Environment: CINRYZE faces a complex competitive landscape with innovative biologics gaining favor due to convenience and longer dosing intervals.
• Revenue Trajectory: While historically profitable, CINRYZE’s revenues face stagnation and potential decline unless offset by new formulations and expanded indications.
• Strategic Focus: Emphasizing formulation innovation, geographic expansion, and patient engagement is critical to sustain growth.
• Regulatory & Reimbursement: Navigating the evolving regulatory environment and reimbursement landscape remains essential.
• Future Outlook: The biologic's long-term viability depends on adaptation to market trends, such as biosimilar competition and patient preferences for subcutaneous administration.

Conclusion

CINRYZE’s financial and market prospects depend on strategic responses to rapid shifts in the HAE biologics domain. Stakeholders must prioritize innovative delivery modalities and market expansion to maintain relevance amid advancing therapies.

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FAQs

1. How does CINRYZE compare to newer biologics in treating hereditary angioedema?
CINRYZE offers a well-established profile with proven efficacy but is less convenient than newer agents like lanadelumab and Takhzyro, which provide longer dosing intervals and subcutaneous administration, leading to increased patient preference and adherence.

2. What are the main challenges facing CINRYZE's market growth?
Challenges include competition from long-acting monoclonal antibodies, preference for subcutaneous self-administration, biosimilar entry risks, high treatment costs, and reimbursement barriers.

3. Are there any recent regulatory developments for CINRYZE?
Recent updates include expanded approvals for additional formulations, dosing regimens, and indications in certain regions. No major new approvals are anticipated imminently, but ongoing clinical trials may influence future regulatory decisions.

4. How significant is the potential impact of biosimilars on CINRYZE's revenues?
Biosimilar development could lead to price erosion and reduced market share if they gain approval and acceptance, particularly in cost-sensitive healthcare settings.

5. What strategies could enhance CINRYZE’s market position moving forward?
Innovating delivery methods (e.g., subcutaneous formulations), expanding geographic reach, engaging patient advocacy groups, and demonstrating cost-effectiveness can bolster its market presence.

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Sources

[1] Bork, K., et al. (2020). "Hereditary Angioedema: A Review." The New England Journal of Medicine.
[2] FDA. (2008). "CINRYZE (C1 Esterase Inhibitor [Human]) Approval."
[3] MarketWatch. (2022). "Hereditary Angioedema Treatment Market Size and Forecast."