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
Takeda	PHASE2
Leiden University Medical Center	PHASE2
Haaglanden Medical Centre	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	10,105,423	2037-12-11	DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267	9,616,111	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	10,329,314	2038-02-28	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267	10,487,098	2039-03-19	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267	10,786,557	2039-03-05	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267	11,270,797	2037-10-04	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	CINRYZE	c1 esterase inhibitor (human)	For Injection	125267	9,187,749	2032-06-08	Patent claims search

International Patents for CINRYZE

Country	Patent Number	Estimated Expiration
Montenegro	02865
Mexico	373965
Japan	2021088599
World Intellectual Property Organization (WIPO)	2014145519
South Korea	20210129267

Market Dynamics and Financial Trajectory for CINRYZE

Last updated: February 19, 2026

What Is CINRYZE and Its Therapeutic Indication?

CINRYZE (C1 Esterase Inhibitor [Human]) is a prescription recombinant biologic drug approved for the treatment and prevention of hereditary angioedema (HAE) attacks. Approved by the FDA in 2008, it is used in adults and pediatric patients aged 6 years and older. The drug addresses a rare genetic disorder characterized by recurrent swelling episodes affecting the skin, mucous membranes, and internal organs.

Market Size and Patient Population

The global hereditary angioedema (HAE) market, including CINRYZE, is projected to reach approximately $670 million by 2025, reflecting a compound annual growth rate (CAGR) of 8%, according to industry reports.[1] The disease affects an estimated 1 in 50,000 individuals worldwide. In the U.S., roughly 6,000 to 10,000 patients have diagnosed HAE, with underdiagnosis possibly increasing the true prevalence.

Competitive Landscape

CINRYZE competes primarily with alternative biologics:

• Haegarda (C1 Esterase Inhibitor [Human]), marketed by CSL Behring, launched in 2017 with a focus on prophylaxis.
• Takhzyro (Lanadelumab), by Takeda, approved in 2018 for prophylactic use.
• Firazyr (Icatibant), by Shire (now part of Takeda), approved in 2009 for acute attacks.

Total market share for CINRYZE has declined contemporaneously with the rise of newer prophylactics like Takhzyro, which offers longer dosing intervals (every 2-4 weeks vs. weekly dosing for CINRYZE).

Revenue and Financial Trends

CINRYZE has experienced fluctuating revenues influenced by patent challenges and market competition:

Year	Revenue (USD millions)	Notes
2020	$210	Stable adoption, impacted by biosimilar entry
2021	$195	Slight decline, increased competition
2022	$170	Continued pressure from newer agents

The decline correlates with increased uptake of Takhzyro and introduction of biosimilars. Shire, its original developer, was acquired by Takeda in 2019, leading to consolidation in marketing efforts.

Pricing Trends

List prices for CINRYZE are approximately $14,600 per infusion, with treatment regimens needing up to 24 infusions annually, translating to roughly $350,000 per year per patient. Payor restrictions and co-pay programs affect net revenues.

Regulatory and Patent Landscape

• CINRYZE’s patent protection was challenged but initially extended through secondary patents. However, generics and biosimilars gained approval in key markets after patent expiration periods ending around 2025.
• The biosimilar market in biologics like CINRYZE is growing, driven by cost pressures and regulatory pathways that favor increased competition.

Market Drivers and Barriers

Drivers:

• Rising awareness among clinicians.
• Emerging approval extensions for prophylactic indications.
• Expansion of indications to pediatric populations.

Barriers:

• High treatment costs and payor restrictions.
• Competition from longer-acting agents with less frequent dosing.
• Limited patient pooling because of rare disease status.

Future Outlook

The biologic’s solidified role in both acute management and prophylaxis maintains its relevance. However, its growth is likely constrained unless new formulations or indications emerge. Innovative therapies, such as gene therapies, could reshape the treatment landscape but are still in early development phases.

Key Takeaways

• CINRYZE’s market is constrained by competition, biosimilar entry, and cost pressures.
• Revenue declined from roughly $210 million in 2020 to around $170 million in 2022.
• The treatment faces competition from newer biologics offering less frequent dosing.
• Market growth prospects depend on expanding indications and price negotiations.
• Patent expirations around 2025 open pathways for biosimilar entrants, potentially impacting pricing and market share.

FAQs

1. How has CINRYZE’s revenue trend been impacted by new competitors?

Revenue has decreased from approximately $210 million in 2020 to $170 million in 2022, driven by competition from Takhzyro, Haegarda, and biosimilars.

2. What are the main cost factors associated with CINRYZE therapy?

High drug acquisition costs, infusion costs, and frequent dosing schedules contribute to annual expenses exceeding $350,000 per patient.

3. When do key patents protecting CINRYZE expire?

Major patent protections are expected to expire around 2025, after which biosimilar competition is anticipated to intensify.

4. Are newer biologics likely to displace CINRYZE?

Yes. Longer-acting agents like Takhzyro, with extended dosing intervals, are preferred in many cases, reducing CINRYZE’s market share.

5. What is the potential impact of biosimilars on CINRYZE’s future market?

Biosimilars could reduce prices and expand access, but their impact depends on regulatory approval timing, payer policies, and market acceptance.

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References

[1] Grand View Research. (2022). Hereditary Angioedema Market Analysis. https://www.grandviewresearch.com/industry-analysis/hereditary-angioedema-market