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:	258
Clinical Trials:	54
Patent Applications:	1,437
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	3,950,405
Pharmacia And Upjohn	CYKLOKAPRON	tranexamic acid	TABLET;ORAL	019280-001	Dec 30, 1986	3,950,405

International Patents for CYKLOKAPRON

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

Country	Patent Number	Title	Estimated Expiration
Sweden	346990
Germany	1443755
Netherlands	6414942
Belgium	657492
Germany	1793841	trans-4-Aminomethylcyclohexan-1-carbonsaeure und Verfahren zur Herstellung
France	1455813	Procédé de préparation du stéréo-isomère trans de l'acide 4-aminométhylcyclohexane-1-carboxylique
Netherlands	149784

CYKLOKAPRON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of CYKLOKAPRON (Tranexamic Acid)

Introduction to CYKLOKAPRON

CYKLOKAPRON, known generically as tranexamic acid, is a medication that belongs to the category of antifibrinolytic agents. It is widely used to prevent and treat excessive bleeding in various medical conditions. Here, we will delve into the market dynamics and financial trajectory of CYKLOKAPRON.

Market Size and Growth

The global tranexamic acid market, which includes CYKLOKAPRON, is experiencing significant growth. As of 2024, the global market size was estimated at USD 86.6 million, with a projected compound annual growth rate (CAGR) of 6.2% from 2024 to 2031[4].

Regional Market Share

• North America: This region holds a major market share, accounting for more than 40% of the global revenue, with a market size of USD 34.64 million in 2024. The North American market is expected to grow at a CAGR of 4.4% from 2024 to 2031[4].
• Europe: Europe accounts for over 30% of the global revenue, with a market size of USD 25.98 million in 2024, and is expected to grow at a CAGR of 4.7% from 2024 to 2031[4].
• Asia Pacific: This region holds around 23% of the global revenue, with a market size of USD 19.92 million in 2024, and is expected to grow at a CAGR of 8.2% from 2024 to 2031, making it one of the fastest-growing regions[4].

Market Drivers

Several factors are driving the growth of the tranexamic acid market, including:

• Increasing Surgical Procedures: The rise in surgical procedures, particularly in cardiovascular, orthopedic, and gynecological surgeries, is increasing the demand for tranexamic acid to prevent and reduce bleeding[4].
• Rising Prevalence of Bleeding Disorders: Conditions such as hemophilia and menorrhagia are contributing to the increased demand for tranexamic acid[4].
• Skincare and Cosmetic Applications: Tranexamic acid is gaining popularity in skincare treatments for conditions like melasma and hyperpigmentation, further boosting market demand[1].

Market Restraints

Despite the growth, there are several restraints to consider:

• Adverse Effects: Tranexamic acid can cause significant side effects, including seizures, headaches, backache, abdominal pain, and visual disturbances. These adverse effects can limit its adoption in certain patient groups[3][5].
• Thromboembolic Risks: The drug may increase the risk of venous and arterial thrombosis or thromboembolism, which is a significant concern for patients and healthcare providers[5].
• Limitations in Certain Cases: Tranexamic acid has limitations in cases of allergies, pregnancy, and breastfeeding, which can restrict its use in these populations[1].

Key Applications

CYKLOKAPRON is used in a variety of medical applications:

• Surgical Procedures: It is widely used to prevent bleeding after surgeries, including liver, heart, and vascular surgeries[1].
• Menstrual Disorders: Tranexamic acid is effective in treating menorrhagia, reducing excessive menstrual bleeding[1].
• Dentistry: It is used as a mouth rinse after dental surgery to prevent bleeding[1].
• Obstetrics: The drug is used to limit blood loss after childbirth and in research to reduce maternal death rates[1].
• Genetic Blood Disorders: Tranexamic acid is used to treat conditions such as hemophilia and angioedema[1].

Market Competition

The global tranexamic acid market is highly fragmented, with numerous players:

• Key Players: Pfizer, Wockhardt Ltd., FDC Limited, Taicang Pharmaceutical Factory, Asahi Kasei Finechem, Cipla, and others are major competitors in the market[1].
• Regional Players: Companies like Pfizer and Wockhardt Ltd. have a significant presence in North America and Europe, while other companies are prominent in emerging economies like India, China, and Brazil[1].

Financial Performance

• Global Revenue: The global tranexamic acid market was valued at USD 86.6 million in 2024[4].
• Regional Revenue: North America accounted for USD 34.64 million, Europe for USD 25.98 million, and Asia Pacific for USD 19.92 million in 2024[4].
• Growth Projections: The market is expected to grow at a CAGR of 6.2% from 2024 to 2031, indicating a robust financial trajectory[4].

Brand Specifics - CYKLOKAPRON

• Pfizer’s CYKLOKAPRON: Pfizer markets tranexamic acid under the brand name CYKLOKAPRON, available in forms such as 100 mg/mL single-dose ampoules and vials[1].
• Dosage and Administration: The drug can be administered orally, intravenously, or topically, depending on the application. Patients with renal impairment require dose adjustments[5].

Future Outlook

The future of CYKLOKAPRON and the broader tranexamic acid market looks promising due to:

• Increasing Health Concerns: Rising health concerns and financial development in economies are leading to increased adoption of tranexamic acid to lower the risk of blood loss-related diseases[1].
• Emerging Markets: Growing demand in emerging economies such as India, China, and Brazil is expected to augment market growth[1].
• R&D and New Applications: Ongoing research and development are expected to open new avenues for the use of tranexamic acid, further driving market growth[1].

"Studies have shown that if administered within one hour of injury, tranexamic acid decreases the relative risk of death from bleeding by 32%," highlighting its critical role in emergency medicine[3].

Key Takeaways

• The global tranexamic acid market, including CYKLOKAPRON, is expected to grow significantly due to increasing surgical procedures and the rising prevalence of bleeding disorders.
• The market is driven by its applications in surgeries, menstrual disorders, dentistry, and obstetrics.
• Despite growth, the market faces restraints due to adverse effects and limitations in certain cases.
• The market is highly competitive with key players like Pfizer and Wockhardt Ltd.
• Emerging economies are expected to play a crucial role in the future growth of the market.

FAQs

What is CYKLOKAPRON used for?

CYKLOKAPRON, or tranexamic acid, is used to prevent and treat excessive bleeding in various medical conditions, including surgeries, menstrual disorders, and genetic blood disorders.

What are the common side effects of CYKLOKAPRON?

Common side effects include seizures, headaches, backache, abdominal pain, nausea, vomiting, and visual disturbances. It may also increase the risk of thromboembolic events[3][5].

Which regions are driving the growth of the tranexamic acid market?

North America, Europe, and Asia Pacific are the key regions driving the growth of the tranexamic acid market, with Asia Pacific showing the highest growth rate[4].

Who are the major players in the tranexamic acid market?

Major players include Pfizer, Wockhardt Ltd., FDC Limited, Taicang Pharmaceutical Factory, Asahi Kasei Finechem, and Cipla among others[1].

What is the projected CAGR for the global tranexamic acid market from 2024 to 2031?

The global tranexamic acid market is expected to grow at a CAGR of 6.2% from 2024 to 2031[4].

Sources

1. Grand View Research: Tranexamic Acid Market Size & Share | Global Industry Report, 2025
2. MDPI: 1,2,3-Triazole Derivatives as Novel Antifibrinolytic Drugs
3. NCBI Bookshelf: Tranexamic Acid - StatPearls
4. Cognitive Market Research: Tranexamic Acid Market Report 2024 (Global Edition)
5. Pfizer Medical Information: CYKLOKAPRON® (tranexamic acid) Patient information - US