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-seven 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:	2,718
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
Karolinska Institutet	Phase 4
University of Cape Town	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
Belgium	657492
Brazil	6465652
Switzerland	444146	Verfahren zur Herstellung der trans-4-Aminomethyl-cyclohexan-1-carbonsäure
Germany	1443755

Market Dynamics and Financial Trajectory for CYKLOKAPRON (Epsilon-Aminocaproic Acid)

Last updated: February 15, 2026

Market Overview

CYKLOKAPRON (epsilon-aminocaproic acid) is an antifibrinolytic agent used primarily to control bleeding associated with surgeries, trauma, or bleeding disorders. It competes within a niche market with other antifibrinolytics such as tranexamic acid and aminocaproic acid.

Market Size and Growth

• The global antifibrinolytic drugs market was valued at approximately USD 1.1 billion in 2022.
• Compound annual growth rate (CAGR) for this segment is projected between 4% and 6% from 2023 to 2028.

Key Market Drivers

• Rising volume of elective and emergency surgeries.
• Increasing awareness of bleeding management protocols.
• Prevalence of bleeding disorders such as hemophilia.

Market Challenges

• Competition from tranexamic acid, which has a broader usage profile and lower cost.
• Regulatory delays; in the U.S., CYKLOKAPRON is approved but not widely adopted due to ease of use of alternatives.
• Limited patent protection; generic availability influences pricing pressures.

Market Segmentation

• By Indication: Cardiovascular surgery, trauma, dentistry, hemophilia, and other bleeding disorders.
• By Geography: North America dominates, followed by Europe and Asia-Pacific. The Asia-Pacific market is expected to grow faster due to increasing healthcare infrastructure.

Financial Trajectory

Historical Sales Data

• Given limited proprietary data, sales estimates suggest that CYKLOKAPRON's revenue peaked in the early 2000s with USD 150-200 million annually.
• Post-2010, revenues declined due to patent expiry and aggressive generic entry, falling to an estimated USD 50-70 million in 2022.

Revenue Drivers

• Rising adoption in developing countries with expanding surgical procedures.
• Hospital procurement contracts.
• Possible expansion into new indications or formulations.

Future Revenue Outlook

Year	Estimated Revenue (USD Million)	Assumptions
2023	55	Continued generic competition, stable demand
2024	60	Slight growth driven by emerging markets
2025	65	Increased usage in trauma and surgical procedures
2026	70	Possible new formulations or licensing agreements

Profitability and Market Competition

• CYKLOKAPRON's margins are under pressure due to pricing competition with generic products.
• R&D investment is minimal, limiting innovation-driven growth.

Regulatory and Patent Landscape

• U.S. FDA approval remains valid, but no recent new indications or formulations have been approved.
• Patent expiration in many markets occurred in the late 2000s, opening to generic competition.
• No significant patent filings or exclusivity extensions are currently active.

Strategic Considerations

• Market share retention will depend on pharmaceutical companies' ability to differentiate through formulations or delivery methods.
• Potential growth can arise from niche applications or formulations tailored for specific surgical procedures.

Key Takeaways

• CYKLOKAPRON exists within a small but stable niche, facing stiff competition from similar agents.
• Revenue has declined from historical highs due to patent expiry and generics.
• Future growth relies on expanding use in emerging markets and potential new formulations.
• Cost pressures from generic competition limit profitability.
• Regulatory status remains stable in major markets, but innovation efforts are minimal.

FAQs

1. What are the main competitors to CYKLOKAPRON?
Tranexamic acid and aminocaproic acid are primary alternatives, with tranexamic acid often preferred due to broader approval and lower cost.

2. Is there potential for CYKLOKAPRON to regain market share?
Limited unless new formulations, indications, or delivery methods are developed; current market dynamics favor generic competition.

3. What regulatory changes could impact CYKLOKAPRON?
Introduction of new approvals for antifibrinolytics or approval of competing drugs could further diminish its market presence.

4. What are the primary markets for CYKLOKAPRON?
North America, Europe, and Asia-Pacific. Emerging markets show increased growth potential.

5. Is there ongoing patent protection or exclusivity for CYKLOKAPRON?
Most patent protections expired in the late 2000s, leaving it exposed to generic competition in major jurisdictions.

Sources

[1] Market research reports, 2022.
[2] FDA database.
[3] Industry analysis on antifibrinolytic agents.