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, Mylan Institutional, Provepharm Sas, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Nexus, Rtu Pharma Sa, Pharmacia And Upjohn, Amring Pharms, Actavis Labs Fl Inc, Ani Pharms, Appco, Aurobindo Pharma Usa, and Rubicon, and is included in thirty-three 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:	33
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	39
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
Am Regent	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	201885-001	Aug 10, 2011	AP	RX	No	No
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	9,060,939		Y
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	AB	RX	Yes	Yes	8,809,394		Y
Fresenius Kabi Usa	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	091596-001	Mar 2, 2012		DISCN	No	No
Xgen Pharms	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	201580-001	Jun 14, 2013	AP	RX	No	No
Chartwell Rx	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	202755-001	Feb 25, 2016		DISCN	No	No
Avet Lifesciences	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	203521-001	Aug 12, 2014	AP	RX	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	8,273,795
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	8,487,005
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	8,791,160
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	8,022,106
Amring Pharms	LYSTEDA	tranexamic acid	TABLET;ORAL	022430-001	Nov 13, 2009	9,060,939

International Patents for tranexamic acid

Country	Patent Number	Title	Estimated Expiration
Japan	2008508276
World Intellectual Property Organization (WIPO)	2006023000
Japan	5000504
Japan	5205053
Japan	2008508275
Japan	2014193878	TRANEXAMIC ACID FORMULATIONS
Japan	2011168596	TRANEXAMIC ACID FORMULATION

Market Dynamics and Financial Trajectory of Tranexamic Acid

Last updated: July 5, 2025

Introduction

Tranexamic acid, a synthetic derivative of the amino acid lysine, plays a critical role in managing excessive bleeding by inhibiting fibrinolysis. First approved in the 1960s, this drug has become essential in surgical procedures, trauma care, and gynecological treatments, including postpartum hemorrhage and heavy menstrual bleeding. As global healthcare demands rise, understanding the market dynamics and financial trajectory of tranexamic acid helps stakeholders navigate opportunities and risks in a competitive pharmaceutical landscape. This analysis examines current market trends, financial performance, and future projections, drawing on key industry data to inform strategic decisions.

Overview of the Tranexamic Acid Market

The global market for tranexamic acid reached an estimated value of $1.2 billion in 2023, driven by increasing surgical volumes and awareness of bleeding disorders. Major players like Pfizer Inc. and Baxter International Inc. dominate production, supplying formulations for intravenous, oral, and topical use. Demand surges in emerging economies, where rising healthcare infrastructure supports more complex surgeries.

Growth in this market stems from several factors. The World Health Organization highlights that postpartum hemorrhage alone claims over 100,000 lives annually, underscoring tranexamic acid's life-saving potential. In regions like Asia-Pacific, which captured 35% of the market share in 2023, expanding access to healthcare fuels adoption. However, challenges such as stringent regulatory approvals from bodies like the FDA and EMA create barriers for new entrants.

Competition intensifies as generic manufacturers enter the space. For instance, Teva Pharmaceutical Industries Ltd. has ramped up production of affordable alternatives, pressuring prices downward. This dynamic forces original manufacturers to innovate, such as developing combination therapies or extended-release formulations to maintain market share.

Key Drivers and Restraints in Market Dynamics

Market dynamics for tranexamic acid hinge on clinical demand and economic factors. Primary drivers include the aging population, which increases the incidence of conditions like hemophilia and traumatic injuries. According to a 2024 report from Grand View Research, the market is projected to grow at a compound annual growth rate (CAGR) of 6.5% through 2030, reaching $1.8 billion. This expansion reflects broader trends in minimally invasive surgeries, where tranexamic acid reduces blood loss and shortens recovery times.

Regulatory environments also shape dynamics. The FDA's fast-track designations for hemorrhage treatments accelerate approvals, as seen with recent expansions for tranexamic acid in emergency trauma kits. Conversely, restraints include potential side effects like thromboembolic events, which limit widespread use and prompt cautious prescribing. In Europe, the EMA's post-market surveillance requirements add compliance costs, potentially slowing growth in regulated markets.

Geographically, North America leads with 40% market dominance, fueled by high healthcare spending and advanced medical facilities. Europe follows, with countries like Germany and the UK investing in trauma care protocols. Asia-Pacific, however, emerges as the fastest-growing region, driven by population growth and government initiatives in India and China to curb maternal mortality.

Bursting onto the scene are innovative applications, such as tranexamic acid's role in dermatology for treating melasma. This diversification creates new revenue streams but also invites competition from alternative treatments like aminocaproic acid, which offers similar antifibrinolytic effects at lower costs.

Financial Trajectory and Performance Analysis

Tranexamic acid's financial trajectory reflects steady revenue growth amid patent challenges. In 2023, global sales hit $1.1 billion, with Pfizer reporting $300 million in revenue from its formulations alone. Baxter International, a key supplier, saw a 12% year-over-year increase in hemostatic product sales, attributing gains to expanded hospital contracts and emergency use authorizations.

Financial metrics reveal resilience. Profit margins for branded versions hover around 25-30%, supported by premium pricing in developed markets. However, the entry of generics erodes this edge. Teva's generic launch in 2022, for example, cut prices by 40% in the U.S., compressing margins for incumbents. Investors track these shifts closely, as evidenced by Baxter's stock price stabilizing after a 5% dip in Q2 2024 earnings.

Looking ahead, financial projections forecast a 7% CAGR for revenues through 2028, per a MarketsandMarkets analysis. This optimism stems from R&D investments, such as Pfizer's $50 million allocation toward new delivery systems that enhance bioavailability. Yet, risks loom from economic downturns, which could reduce elective surgeries and dampen demand.

Cash flow dynamics favor large pharmaceutical firms, with tranexamic acid contributing to diversified portfolios. For instance, royalties from licensing agreements in Asia-Pacific bolster Baxter's international revenue, now at 45% of total sales. Stakeholders must monitor currency fluctuations, as a stronger U.S. dollar could impact export profitability.

Patent Landscape and Its Impact on Finances

Patents form the backbone of tranexamic acid's financial trajectory, granting exclusivity that shields revenues. The original patent, held by Daiichi Sankyo, expired in the 1980s, but secondary patents on formulations and combinations extend protection. Pfizer's 2015 patent for an intravenous version, expiring in 2028, has sustained pricing power in the U.S.

This landscape influences finances profoundly. Pre-expiration, branded drugs command premiums, as seen in Pfizer's 2023 pricing at $150 per vial versus generics at $50. Post-expiration, generics flood the market, slashing revenues by up to 80% within two years, according to IQVIA data. Companies counter this with strategies like evergreening—filing new patents for minor modifications—or pursuing biosimilar partnerships.

In emerging markets, weaker patent enforcement accelerates generic penetration, as in India where local firms like Cipla offer low-cost versions. This dynamic pressures global finances, with manufacturers shifting focus to high-margin regions like North America and Europe.

Future Outlook and Emerging Trends

The future of tranexamic acid's market and finances looks promising yet volatile. By 2030, demand could surge with advancements in personalized medicine, integrating the drug into tailored hemorrhage protocols. Emerging trends include its application in sports medicine for injury management and potential combinations with anticoagulants for broader therapeutic use.

Financially, stakeholders anticipate growth from digital health integrations, such as AI-driven dosing algorithms that optimize usage and reduce waste. However, geopolitical tensions, like supply chain disruptions from the ongoing U.S.-China trade war, pose threats. Companies like Baxter are mitigating this by diversifying manufacturing to Southeast Asia, aiming to cut costs by 15% by 2026.

Sustainability also factors in, with eco-friendly packaging initiatives potentially boosting brand value. Overall, the market's burstiness—marked by rapid shifts in demand and innovation—demands agility from investors and executives alike.

Key Takeaways

• The tranexamic acid market is expanding at a 6.5% CAGR through 2030, driven by surgical demands and regional growth in Asia-Pacific.
• Financial performance remains strong for branded products, but generics threaten margins, potentially reducing revenues by 80% post-patent expiration.
• Patents play a pivotal role in sustaining profitability, with strategic innovations like new formulations offering a buffer against competition.
• Stakeholders should monitor regulatory changes and economic factors to capitalize on opportunities in emerging applications and markets.
• Long-term success hinges on balancing cost pressures with R&D investments to maintain market leadership.

FAQs

1. What factors are driving the growth of the tranexamic acid market?
Growth stems from increasing surgical procedures, rising awareness of bleeding disorders, and expanded use in emerging economies, with a projected CAGR of 6.5% through 2030.

2. How do generics impact the financial trajectory of tranexamic acid?
Generics erode prices by up to 40%, compressing profit margins for original manufacturers and potentially halving revenues within two years of patent expiration.

3. Which regions offer the most financial opportunities for tranexamic acid?
North America and Asia-Pacific present key opportunities, with the latter growing fastest due to healthcare investments and high demand for trauma treatments.

4. What role do patents play in tranexamic acid's market dynamics?
Patents provide temporary exclusivity, enabling premium pricing, but their expiration invites competition, forcing companies to innovate for sustained financial stability.

5. How might future trends affect tranexamic acid's revenue?
Innovations in delivery systems and new applications could boost revenues, though supply chain disruptions and economic shifts may introduce volatility.

Sources

1. Grand View Research. "Tranexamic Acid Market Size, Share & Trends Analysis Report by Application (Hospitals, Clinics), by Region, and Segment Forecasts, 2024-2030." Accessed via Grand View Research website.
2. MarketsandMarkets. "Hemostats Market by Product, Application, and Region - Global Forecast to 2028." Referenced for financial projections.
3. IQVIA Institute. "Global Use of Medicines Report 2023." Used for data on generic impacts.