Tranexamic acid - Generic Drug Details

What are the generic 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, Milla Pharms, Mylan Institutional, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Nexus, Pharmacia And Upjohn, Amring Pharms, Actavis Labs Fl Inc, Ani Pharms, Appco, Aurobindo Pharma Usa, Bionpharma, and Rubicon Research, and is included in thirty-four 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. Thirty-nine suppliers are listed for this compound.

Summary for tranexamic acid

International Patents:	8
US Patents:	8
Tradenames:	3
Applicants:	29
NDAs:	34
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	213
Clinical Trials:	677
Patent Applications:	6,866
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
University of Alabama at Birmingham	PHASE3
Mayo Clinic	PHASE4
University of Pittsburgh	PHASE4

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
Amneal	TRANEXAMIC ACID	tranexamic acid	SOLUTION;INTRAVENOUS	217155-001	Oct 16, 2023	AP	RX	No	No
Actavis Labs Fl Inc	TRANEXAMIC ACID	tranexamic acid	TABLET;ORAL	202093-001	Dec 27, 2012	AB	RX	No	No
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes			Y
Rising	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	206634-001	Jun 9, 2016		DISCN	No	No
Pharmacia And Upjohn	CYKLOKAPRON	tranexamic acid	TABLET;ORAL	019280-001	Dec 30, 1986		DISCN	No	No

Expired US Patents for tranexamic acid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009
Pfizer	CYKLOKAPRON	tranexamic acid	INJECTABLE;INJECTION	019281-001	Dec 30, 1986
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009

International Patents for tranexamic acid

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Tranexamic Acid

Last updated: November 24, 2025

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Introduction

Tranexamic acid (TXA) is a synthetic derivative of the amino acid lysine with an established efficacy in controlling bleeding. Since its discovery in the 1960s, TXA has transitioned from a niche hemostatic agent to a globally essential medication across various therapeutic areas. Its market trajectory reflects evolving medical practices, regulatory landscapes, and global healthcare demands. This analysis details the current market dynamics, future growth trajectories, and key factors influencing TXA’s financial landscape.

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Pharmacological Profile and Therapeutic Applications

Tranexamic acid functions as an antifibrinolytic agent by competitively inhibiting the activation of plasminogen to plasmin, thus stabilizing blood clots. The drug’s primary indications include:

• Surgical bleeding management: Orthopedic, cardiovascular, and trauma surgeries.
• Menstrual bleeding: Heavy menstrual bleeding (HMB).
• Trauma and hemorrhagic conditions: Used in trauma protocols and postpartum hemorrhage (PPH).
• Hereditary hemorrhagic conditions: Such as hemophilia.

The broad-spectrum utility has bolstered steady demand, especially in major surgical disciplines and emergency care.

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Market Dynamics: Drivers and Challenges

Drivers of Growth

1. Increasing Surgical and Trauma Procedures

Global surgical volumes have surged, driven by aging populations and expanding healthcare access, fueling demand for hemostatic agents like TXA. Notably, orthopedic procedures (e.g., joint replacements) have seen exponential growth—demanding effective bleeding control solutions.

2. Evidence-Based Adoption & Clinical Guidelines

Robust clinical data (e.g., CRASH-2 trial) underscores TXA’s efficacy in traumatic hemorrhage reduction, leading to inclusion in international trauma and bleeding management guidelines. This widespread endorsement amplifies prescription practices.

3. Cost-Effectiveness and Safety Profile

Compared to blood transfusions and other hemostatic agents, TXA offers a cost-effective solution with a favorable safety profile. Its generic versions further enhance affordability, especially in resource-limited settings.

4. Rising Use in Gynecology

Heavy menstrual bleeding and postpartum hemorrhage remain critical global health issues. The World Health Organization (WHO) endorses TXA for PPH, promoting wider adoption in maternal healthcare.

5. Patent Expiry and Market Accessibility

Generic availability has made TXA globally accessible, boosting sales across developing and developed markets.

Challenges

1. Regulatory Variations and Approvals

Differing regulatory environments impact market expansion. While FDA-approved indications are broad, some regions have limited formulations or require additional approvals, impacting reach.

2. Competition from Alternative Hemostatic Agents

Emerging drugs and technologies (e.g., topical agents, advanced surgical devices) potentially diminish TXA’s market share.

3. Limited Innovation and Formulation Development

Current formulations predominantly include injections and oral tablets, with little innovation in delivery methods that could enhance patient compliance or applications.

4. Concerns Over thromboembolic risks

Although generally safe, concerns over thrombotic events, especially in predisposed populations, could hinder broader application.

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Market Segmentation and Regional Outlook

By Application

• Surgical Bleeding Control: Largest segment; includes orthopedic, cardiac, and trauma surgeries.
• Gynecology: Growing segment due to maternal health initiatives.
• Trauma & Emergency: Rapidly expanding, especially in low- and middle-income countries (LMICs).

By Geography

• North America: Largest market due to advanced healthcare infrastructure and high surgical volumes.
• Europe: Significant adoption, with ongoing use in trauma and surgical care.
• Asia-Pacific: Fastest-growing, driven by increasing surgical procedures, maternal health programs, and healthcare investments.
• Latin America & Middle East: Gradual growth as access improves.

Market Share of Key Players

Major pharmaceutical firms, including Pfizer, Sanofi, Ferring Pharmaceuticals, and local generics manufacturers, dominate the landscape. The entry of low-cost generics has intensified price competition, especially in LMICs.

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Financial Trajectory and Market Projections

Historical Market Performance

The global tranexamic acid market was estimated at approximately USD 600 million in 2021, with consistent growth at a compound annual growth rate (CAGR) of around 7% since 2015. This reflects steady demand driven by expanding indications and regional adoption.

Future Growth Outlook

Forecasts indicate the market could reach USD 1.2 billion by 2030 (CAGR of approximately 8%), predominantly fueled by:

• Rising global surgical and trauma volumes.
• Increased awareness and guideline endorsements.
• Expanding use in maternal health.
• Regulatory approvals in emerging markets.

Revenue Streams

• Generic formulations are anticipated to continue dominating revenue due to affordability.
• Brand-name products hold premium pricing in specific markets, especially where new formulations or delivery methods are introduced.
• Digital & combination products could emerge, though currently limited.

Potential Market Disruptors

• Development of alternative hemostatic agents.
• Advances in minimally invasive surgical techniques reducing bleeding.
• Digital health solutions improving bleeding management protocols.

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Regulatory and Policy Influence on Financial Performance

Globally, health authorities’ evolving policies strongly impact market expansion:

• WHO guidelines endorse TXA for PPH, ensuring governmental procurement and inclusion in essential medicines lists.
• FDA and EMA approvals facilitate broader clinical applications and insurance reimbursements.
• Governments’ focus on maternal health and trauma care further incentivize adoption, ensuring sustained revenue flow.

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Conclusion

The tranexamic acid market stands at a strategic crossroads characterized by robust fundamentals and growth prospects. Its efficacy, cost-effectiveness, and expansive clinical applications underpin its enduring relevance. While challenges such as emerging competition and safety concerns exist, ongoing clinical validation and regional expansion strategies position TXA for continued financial growth. Companies investing in innovative formulations, expanding regional approvals, and integrating digital health approaches could capitalize on this trajectory.

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Key Takeaways

• Sustained Demand Drivers: Increasing surgical procedures, trauma cases, and maternal health initiatives globally underpin market growth.
• Market Expansion: Asia-Pacific and LMICs present lucrative opportunities driven by healthcare investments and WHO endorsements.
• Cost-Effective Advantage: Genric versions bolster accessibility, especially in resource-limited settings, amplifying volume sales.
• Innovation Focus: Developing new formulations and delivery methods can unlock premium pricing and extend market lifespan.
• Regulatory Trends: Supportive policies and inclusion in essential medicines lists will continue to catalyze market expansion.

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FAQs

1. What are the primary therapeutic uses of tranexamic acid?
   TXA is primarily used for controlling bleeding in surgical procedures, heavy menstrual bleeding, postpartum hemorrhage, trauma-related bleeding, and certain hereditary hemorrhagic conditions.

2. How does the patent status affect the market for tranexamic acid?
   The expiration of patents has led to an influx of generic versions, significantly lowering prices and expanding global access, especially in developing countries.

3. What factors could hinder the future growth of the TXA market?
   Potential challenges include safety concerns related to thromboembolic risks, competition from new hemostatic agents, regulatory hurdles, and limited innovation in drug formulations.

4. Which regions are expected to be the fastest-growing markets for TXA?
   The Asia-Pacific region is projected to experience the fastest growth due to increasing surgical procedures, maternal health initiatives, and expanding healthcare infrastructure.

5. Are there new developments or formulations in tranexamic acid?
   Currently, most formulations are injectable or oral tablets. Innovation in delivery methods, such as topical formulations or extended-release options, may surface to improve patient compliance and broaden applications.

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References

1. [1] Market research data and clinical guidelines on tranexamic acid usage.
2. [2] WHO guidelines on postpartum hemorrhage management.
3. [3] Clinical trial reports such as the CRASH-2 study.
4. [4] Industry reports on pharmaceutical market size estimates and projections.
5. [5] Regulatory agency updates and approvals influencing market access.