Tranexamic acid - Generic Drug Details

What are the generic drug sources for tranexamic acid and what is the scope of patent protection?

Tranexamic acid is the generic ingredient in three branded drugs marketed by Pfizer, Am Regent, Amneal Pharms Co, Apotex, Avet Lifesciences, Caplin, Chartwell Rx, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Heritage, Micro Labs, Mylan Institutional, Provepharm Sas, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Nexus, Pharmacia And Upjohn, Amring Pharms, Actavis Labs Fl Inc, Ani Pharms, Aurobindo Pharma Usa, and Rubicon, and is included in thirty-one NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tranexamic acid has eight patent family members in two countries.

There are eight drug master file entries for tranexamic acid. Forty suppliers are listed for this compound.

Summary for tranexamic acid

International Patents:	8
US Patents:	8
Tradenames:	3
Applicants:	27
NDAs:	31
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	258
Clinical Trials:	581
Drug Prices:	Drug price trends for tranexamic acid
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tranexamic acid
What excipients (inactive ingredients) are in tranexamic acid?	tranexamic acid excipients list
DailyMed Link:	tranexamic acid at DailyMed

See drug prices for tranexamic acid

Recent Clinical Trials for tranexamic acid

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

Sponsor	Phase
Biomedical Advanced Research and Development Authority	Phase 3
Philip Spinella	Phase 3
Vanderbilt University Medical Center	Phase 2

See all tranexamic acid clinical trials

Pharmacology for tranexamic acid

Drug Class	Antifibrinolytic Agent
Physiological Effect	Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for tranexamic acid

Antifibrinolytic Agents

Anatomical Therapeutic Chemical (ATC) Classes for tranexamic acid

B02AA	Amino acids
B02A	ANTIFIBRINOLYTICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for TRANEXAMIC ACID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYSTEDA	Tablets	tranexamic acid	650 mg	022430	2	2011-05-24

US Patents and Regulatory Information for tranexamic acid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Exela Pharma	TRANEXAMIC ACID	tranexamic acid	SOLUTION;INTRAVENOUS	212020-001	Apr 15, 2019	AP	RX	Yes	Yes
Pharmacia And Upjohn	CYKLOKAPRON	tranexamic acid	TABLET;ORAL	019280-001	Dec 30, 1986		DISCN	No	No
Micro Labs	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	206713-001	Jun 27, 2017	AP	RX	No	No
Amneal Pharms Co	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	208840-001	Feb 28, 2017	AP	RX	No	No
Mylan Institutional	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	091657-001	Nov 3, 2011	AP	RX	No	No
Heritage	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	202436-001	Feb 11, 2014	AP	RX	No	No

Expired US Patents for tranexamic acid

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
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	8,487,005
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	7,947,739
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	8,957,113
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	8,791,160
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	8,809,394

International Patents for tranexamic acid

Country	Patent Number	Title	Estimated Expiration
Japan	2011168596	TRANEXAMIC ACID FORMULATION
World Intellectual Property Organization (WIPO)	2006023000
Japan	2008508276
Japan	5000504
Japan	2008508275
Japan	5205053

Market Dynamics and Financial Trajectory of Tranexamic Acid

Overview of Tranexamic Acid

Tranexamic acid is a synthetic antifibrinolytic agent widely used to prevent excessive bleeding in various medical conditions, including surgeries, menorrhagia, and trauma. Its market is influenced by several factors, including surgical procedures, bleeding disorders, and cosmetic applications.

Global Market Size and Growth

The global tranexamic acid market is projected to exhibit significant growth. As of 2024, the market size is estimated at USD 86.6 million, with a compound annual growth rate (CAGR) of 6.20% expected from 2024 to 2031. This growth is driven by increasing surgical procedures, the rising prevalence of bleeding disorders, and expanding cosmetic applications[4].

Regional Market Breakdown

The market is segmented geographically, with North America holding the largest share, accounting for over 40% of the global revenue with a market size of USD 34.64 million in 2024. This region is expected to grow at a CAGR of 4.4% from 2024 to 2031. Europe follows closely, with a market share of more than 30% and a CAGR of 4.7%. The Asia Pacific region, with a market size of USD 19.92 million in 2024, is expected to grow at a higher CAGR of 8.2% during the same period. Latin America and the Middle East and Africa also contribute to the global market, albeit with smaller shares[4].

Drivers of Market Growth

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

Increasing Surgical Procedures

Advancements in surgical techniques and the growing need for effective blood management solutions are key drivers. Tranexamic acid is widely used to reduce bleeding during surgeries, which is becoming more common due to an aging population and increased healthcare access[4].

Rising Prevalence of Bleeding Disorders

Conditions such as menorrhagia and other bleeding disorders are on the rise, increasing the demand for tranexamic acid as a treatment option[4].

Expanding Cosmetic Applications

The use of tranexamic acid in skin care products, particularly for treating hyperpigmentation, is gaining traction. This expanding application is contributing to the market's growth[4].

Improving Healthcare Infrastructure

Emerging economies are witnessing improvements in healthcare infrastructure, making tranexamic acid treatments more accessible to a broader population[4].

Challenges and Opportunities

Economic and Supply Chain Challenges

The market faces challenges such as sluggish economic growth, shifting consumer preferences, and significant fluctuations in raw material costs due to geopolitical tensions. Effective collaboration within the chemical industry and across the value chain is crucial to address these challenges[1].

Regulatory Framework

Establishing a robust regulatory framework is essential for the sustainable growth of the tranexamic acid market. Government policies and incentives, particularly those promoting the energy transition and the use of bio-chemicals, are supportive of this growth[1].

Technological Advancements

Investments in new technologies, efficient procurement and inventory management, and the enhancement of product portfolios are key strategies for market players to sustain growth. The development of novel formulations and delivery methods is also a significant trend shaping the market landscape[1].

Clinical Efficacy and Research

Intracerebral Hemorrhage (ICH)

Research, such as the TICH-2 trial, has shown that tranexamic acid may reduce mortality at one year without increasing the number of severely dependent survivors in patients with ICH. However, it did not improve functional outcomes at one year. These findings highlight the need for better treatments for ICH and ongoing research into the efficacy of early hemostatic therapy[2].

Comparative Administration Methods

Studies have found that intravenous administration of tranexamic acid is superior to topical administration, particularly in reducing bleeding events during heart surgery. Topical administration did not meet its primary endpoint and was associated with an increased risk of bleeding events[5].

Financial Trajectory

The financial trajectory of the tranexamic acid market is positive, with significant growth projected over the next several years. Here are some key financial metrics:

• Global Market Size 2024: USD 86.6 million
• Projected Market Size 2031: USD 131.94 million
• CAGR 2024-2031: 6.20%
• North America Market Size 2024: USD 34.64 million
• North America CAGR 2024-2031: 4.4%
• Europe Market Size 2024: USD 25.98 million
• Europe CAGR 2024-2031: 4.7%
• Asia Pacific Market Size 2024: USD 19.92 million
• Asia Pacific CAGR 2024-2031: 8.2%[4].

Key Takeaways

• The global tranexamic acid market is expected to grow significantly, driven by increasing surgical procedures, rising prevalence of bleeding disorders, and expanding cosmetic applications.
• Regional markets, particularly North America, Europe, and the Asia Pacific, are key contributors to the global market.
• Economic and supply chain challenges need to be addressed through effective industry collaboration and regulatory frameworks.
• Ongoing research into the clinical efficacy of tranexamic acid, especially in conditions like ICH, is crucial for its continued use and development.
• The financial trajectory indicates a strong growth potential, with the market expected to reach USD 131.94 million by 2031.

FAQs

What are the primary drivers of the tranexamic acid market?

The primary drivers include increasing surgical procedures, the rising prevalence of bleeding disorders, and expanding cosmetic applications.

What is the projected global market size of tranexamic acid by 2031?

The global market size is projected to reach USD 131.94 million by 2031, growing at a CAGR of 6.20% from 2024 to 2031.

Which region holds the largest market share for tranexamic acid?

North America holds the largest market share, accounting for over 40% of the global revenue.

What are the challenges faced by the tranexamic acid market?

Challenges include sluggish economic growth, shifting consumer preferences, fluctuations in raw material costs, and the need for a robust regulatory framework.

How does tranexamic acid perform in treating intracerebral hemorrhage (ICH)?

Tranexamic acid may reduce mortality at one year without increasing severely dependent survivors in ICH patients but does not improve functional outcomes at one year.

Sources

1. 2024 Tranexamic Acid Market Outlook Report - ResearchAndMarkets
2. Outcome 1 year after ICH: Data from the Tranexamic acid for intracerebral haemorrhage 2 (TICH-2) trial - University of Edinburgh
3. Tranexamic Acid Market Report | Global Forecast From 2023 To 2032 - DataIntelo
4. Tranexamic Acid Market Report 2024 (Global Edition) - Cognitive Market Research
5. Topical Tranexamic Acid Found Inferior to Intravenous Administration - American College of Cardiology

Last updated: 2024-12-17