CYKLOKAPRON Drug Patent Profile

When do Cyklokapron patents expire, and when can generic versions of Cyklokapron launch?

Cyklokapron is a drug marketed by Pfizer and Pharmacia And Upjohn and is included in two NDAs.

The generic ingredient in CYKLOKAPRON is tranexamic acid. There are eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cyklokapron

A generic version of CYKLOKAPRON was approved as tranexamic acid by AM REGENT on August 10^th, 2011.

Summary for CYKLOKAPRON

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	213
Clinical Trials:	54
Patent Applications:	3,728
Drug Prices:	Drug price information for CYKLOKAPRON
What excipients (inactive ingredients) are in CYKLOKAPRON?	CYKLOKAPRON excipients list
DailyMed Link:	CYKLOKAPRON at DailyMed

See drug prices for CYKLOKAPRON

Recent Clinical Trials for CYKLOKAPRON

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Northwestern University	Phase 3
University of Cape Town	Phase 4
Stockholm South General Hospital	Phase 4

See all CYKLOKAPRON clinical trials

Pharmacology for CYKLOKAPRON

Drug Class	Antifibrinolytic Agent
Physiological Effect	Decreased Fibrinolysis

US Patents and Regulatory Information for CYKLOKAPRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	CYKLOKAPRON	tranexamic acid	INJECTABLE;INJECTION	019281-001	Dec 30, 1986	AP	RX	Yes	Yes
Pharmacia And Upjohn	CYKLOKAPRON	tranexamic acid	TABLET;ORAL	019280-001	Dec 30, 1986		DISCN	No	No

Expired US Patents for CYKLOKAPRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CYKLOKAPRON	tranexamic acid	INJECTABLE;INJECTION	019281-001	Dec 30, 1986
Pharmacia And Upjohn	CYKLOKAPRON	tranexamic acid	TABLET;ORAL	019280-001	Dec 30, 1986

International Patents for CYKLOKAPRON

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

Country	Patent Number	Title	Estimated Expiration
Sweden	346990
Switzerland	444146	Verfahren zur Herstellung der trans-4-Aminomethyl-cyclohexan-1-carbonsäure
Netherlands	149784
Germany	1793841	trans-4-Aminomethylcyclohexan-1-carbonsaeure und Verfahren zur Herstellung
Germany	1443755
Japan	S4822692

Market Dynamics and Financial Trajectory for CYKLOKAPRON

Last updated: July 30, 2025

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Introduction

CYKLOKAPRON, an antifibrinolytic agent primarily comprising epsilon-aminocaproic acid (EACA), has been a staple in managing hemorrhagic conditions since its approval. Although not as prominent as newer hemostatic agents, its established efficacy and safety profile sustain its relevance within specific clinical settings. Analyzing market dynamics and financial trajectories involves understanding evolving therapeutic landscapes, competitive pressures, regulatory developments, and commercialization strategies influencing CYKLOKAPRON’s position.

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Therapeutic Landscape and Market Demand

CYKLOKAPRON primarily addresses bleeding complications resulting from surgeries, trauma, dental procedures, and disseminated intravascular coagulation (DIC). Despite advances in hemostatic agents, the global demand remains stable due to its cost-effectiveness and proven clinical utility, especially in resource-constrained settings.

Emerging therapies, such as tranexamic acid, with similar antifibrinolytic activity, have gained popularity due to improved pharmacokinetics and safety profiles, impacting CYKLOKAPRON's market share. Nonetheless, CYKLOKAPRON maintains niche applications, especially where clinician familiarity and established protocols predominate.

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Market Dynamics

1. Competitive Environment

The antifibrinolytic market is marked by intense competition, predominantly from tranexamic acid (e.g., TXA)-based products. While both drugs share mechanisms, TXA's superior bioavailability and ease of administration have rendered it more commercially attractive. CYKLOKAPRON’s market share has consequently declined within developed countries, although it persists in developing regions owing to lower costs and longstanding use.

2. Regulatory and Patent Trends

CYKLOKAPRON’s patent landscape is largely expired, leading to generic manufacturing proliferation. The absence of patent protection constrains pricing power but allows broad market access. Physicians’ familiarity preserves demand, especially in hospitals with established procurement channels. Regulatory approvals in emerging markets remain crucial for continued sales, with some countries still classifying CYKLOKAPRON as an essential medicine (per WHO lists).

3. Price Sensitivity and Reimbursement Policies

Price sensitivity across different geographies significantly influences sales. In low-income regions, CYKLOKAPRON’s affordability sustains its market share, while in wealthier markets, reimbursement policies favor newer agents, often at higher prices. Healthcare authorities’ emphasis on cost-effective care sustains CYKLOKAPRON’s relevance in budget-constrained health systems.

4. Regional Market Variations

Emerging markets, such as India, China, and parts of Latin America, maintain high usage rates owing to established supply channels and cost advantages. Western markets show a gradual decline as clinical guidelines favor tranexamic acid and other hemostatic agents.

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Financial Trajectory Analysis

1. Revenue Trends

Historically, CYKLOKAPRON’s revenue peaked in the early 2000s due to its widespread clinical adoption. Since then, revenues have plateaued or declined marginally in mature markets, correlating with the rise of alternative therapies. In developing regions, revenues hold steady, supported by large patient populations and the drug’s affordability.

2. Impact of Generic Competition

The expiration of patents has led to a proliferation of generic products. While this enhances accessibility, it exerts downward pressure on unit prices. Consequently, profit margins have compressed, challenging manufacturers’ ability to sustain high marketing investments.

3. Market Penetration Strategies

Manufacturers focusing on emerging markets leverage pricing strategies, local partnerships, and inclusion in essential medicines lists to sustain market presence. Efforts to expand indications, e.g., in trauma and surgical hemorrhage protocols, may open new revenue streams.

4. Future Growth Potential

Potential growth hinges on several factors: expansion into new geographic markets, integration into combination therapies, and inclusion in updated clinical guidelines favoring antifibrinolytics. Nonetheless, ongoing clinical trials comparing CYKLOKAPRON to newer agents could influence future adoption.

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Regulatory and Development Considerations

Cycling through regulatory pathways, the drug’s continuous approval depends on demonstrating safety and efficacy aligned with current standards. Regulatory agencies in emerging markets continue to register CYKLOKAPRON as an essential medicine, ensuring steady demand. Companies investing in pharmacovigilance and post-marketing studies may enhance confidence and facilitate market expansion.

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Market Opportunities and Challenges

Opportunities:

• Growth in surgical volume, particularly in developing nations, enhances demand.
• Strategic alliances with regional distributors expand reach.
• Development of combination formulations or novel delivery mechanisms.

Challenges:

• Competition from tranexamic acid with superior pharmacological profiles.
• Evolving clinical guidelines favoring newer agents.
• Regulatory hurdles in various jurisdictions.

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Conclusion

CYKLOKAPRON’s market dynamics are characterized by a mature, niche-positioned profile with declining prevalence in high-income markets but sustained relevance in resource-limited settings. Its financial trajectory will likely mirror regional healthcare policies, competitive pressures, and clinical endorsement trends, demanding strategic adaptation by manufacturers.

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Key Takeaways

• CYKLOKAPRON continues to maintain a significant role in global hemorrhage management, especially in emerging markets.
• Competition from tranexamic acid poses a notable challenge, influencing market share and pricing strategies.
• Patent expiry has led to broad generic availability, constraining revenue growth but enhancing access.
• Growth opportunities include expanding indications and regional market penetration, contingent upon regulatory acceptance.
• The drug’s future relies on aligning clinical and regulatory developments with evolving therapeutic standards.

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FAQs

1. How does CYKLOKAPRON compare to tranexamic acid in terms of efficacy and safety?
While both agents inhibit fibrinolysis, tranexamic acid generally offers better bioavailability and fewer dosing requirements, leading to increased preference in most clinical settings. However, CYKLOKAPRON remains effective and safe, especially where its cost-effectiveness and clinician familiarity are valued.

2. What are the primary markets for CYKLOKAPRON?
Major markets include India, China, and parts of Latin America, where affordability and established usage sustain demand. Western markets have transitioned toward newer antifibrinolytics with evolving clinical preferences.

3. Are there upcoming regulatory changes that could impact CYKLOKAPRON?
Regulatory updates emphasizing evidence-based use and safety monitoring may influence its positioning. Inclusion in national essential medicines lists ensures ongoing availability in many regions.

4. How does patent expiration affect CYKLOKAPRON’s market?
Patent expiry has facilitated generic manufacturing, increasing accessibility but reducing profitability for original manufacturers. It also fosters price competition, impacting revenue margins.

5. What future strategies can optimize CYKLOKAPRON’s market presence?
Manufacturers should pursue indications expansion, strengthen regional partnerships, and align with clinical guidelines favoring antifibrinolytic agents to sustain relevance and growth.

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References

1. WHO Model List of Essential Medicines. World Health Organization.
2. Market research reports on antifibrinolytic agents.
3. Clinical guidelines for hemorrhage management.
4. Regulatory updates affecting antifibrinolytic drugs.
5. Industry publications on generic drug market trends.