AMINOCAPROIC ACID - Generic Drug Details

What are the generic drug sources for aminocaproic acid and what is the scope of freedom to operate?

Aminocaproic acid is the generic ingredient in four branded drugs marketed by Epic Pharma Llc, Abraxis Pharm, Baxter Hlthcare, Gen Ilac, Hospira, Luitpold, Hikma, Ajenat Pharms, Amneal, Annora Pharma, Aurobindo Pharma, Carnegie, MSN, Regcon Holdings, Sciegen Pharms Inc, Sunny, Taro, Tp Anda Holdings, Vistapharm Llc, Adaptis, Ani Pharms, Pharmobedient, and Somerset Theraps Llc, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for aminocaproic acid. Nineteen suppliers are listed for this compound.

Summary for AMINOCAPROIC ACID

US Patents:	0
Tradenames:	4
Applicants:	23
NDAs:	30
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	39
Drug Prices:	Drug price trends for AMINOCAPROIC ACID
What excipients (inactive ingredients) are in AMINOCAPROIC ACID?	AMINOCAPROIC ACID excipients list
DailyMed Link:	AMINOCAPROIC ACID at DailyMed

See drug prices for AMINOCAPROIC ACID

Recent Clinical Trials for AMINOCAPROIC ACID

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

Sponsor	Phase
Zagazig University	NA
Minia University	Phase 3
NYU Langone Health	N/A

See all AMINOCAPROIC ACID clinical trials

Pharmacology for AMINOCAPROIC ACID

Drug Class	Antifibrinolytic Agent
Physiological Effect	Decreased Fibrinolysis

Medical Subject Heading (MeSH) Categories for AMINOCAPROIC ACID

Antifibrinolytic Agents

Anatomical Therapeutic Chemical (ATC) Classes for AMINOCAPROIC ACID

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

US Patents and Regulatory Information for AMINOCAPROIC ACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Carnegie	AMINOCAPROIC ACID	aminocaproic acid	SOLUTION;ORAL	214140-001	Jan 26, 2021	AA	RX	No	No
Msn	AMINOCAPROIC ACID	aminocaproic acid	SOLUTION;ORAL	215100-001	Sep 26, 2024	AA	RX	No	No
Hikma	AMINOCAPROIC	aminocaproic acid	TABLET;ORAL	075602-001	May 24, 2001		DISCN	No	No
Annora Pharma	AMINOCAPROIC ACID	aminocaproic acid	SOLUTION;ORAL	216464-001	Nov 4, 2022	AA	RX	No	No

Market Dynamics and Financial Trajectory for Aminocaproic Acid

Last updated: July 27, 2025

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Introduction

Aminocaproic acid (ACA), a potent antifibrinolytic agent, has established a significant foothold within hemostasis management across various clinical settings. Approved primarily for controlling bleeding associated with hyperfibrinolytic states, ACA’s evolution in the pharmaceutical landscape reflects ongoing medical needs, regulatory frameworks, and pricing strategies. This article examines the complex market dynamics shaping ACA’s trajectory, alongside its financial prospects within the broader pharmaceutical ecosystem.

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Market Overview and Clinical Demand

Aminocaproic acid’s core indication involves mitigating excessive bleeding episodes stemming from surgeries, trauma, or hematologic disorders. Its mechanism—reversible inhibition of plasminogen activation—renders it effective against hyperfibrinolytic conditions such as primary fibrinolysis, post-surgical bleeding, and certain bleeding disorders (e.g., post-tooth extraction in hemophilia patients).

The global antifibrinolytic drugs market, estimated at over USD 800 million in 2022, is expected to grow at a CAGR of approximately 6% (source [1]), driven by rising surgical procedures, aging populations, and the increasing incidence of bleeding disorders. ACA’s segment remains competitive, complemented by newer agents like tranexamic acid; however, ACA retains preference in specific indications due to its proven efficacy and regulatory approvals in key markets such as the US, Europe, and Japan.

Regulatory and Patent Landscape

ACA’s regulatory landscape is relatively mature, with longstanding approvals that facilitate steady market access. Notably, generic formulations dominate the market, keeping prices under pressure but ensuring widespread accessibility. The expiration of patents for branded formulations has intensified price competition, limiting revenue growth potential for innovator companies. For instance, American Regent’s Amicar—a widely recognized brand—faced patent expiry in the early 2000s, leading to proliferation of generics.

Emerging markets, particularly in Asia, demonstrate expanding regulatory approvals, bolstering sales volumes. Conversely, in the US and Europe, stringent pharmacovigilance regulations and off-label use monitoring influence market development.

Market Drivers and Restraints

Drivers:

• Growing surgical procedures: The increase in major surgeries, including cardiac, orthopedic, and trauma services, elevates demand.
• Aging population: Older adults are more susceptible to bleeding complications and require hemostatic interventions.
• Bleeding disorder prevalence: Conditions like hemophilia and fibrinolytic states demand effective antifibrinolytics.
• Global expansion: Improved healthcare infrastructure in emerging markets broadens ACA’s reach.

Restraints:

• Competing agents: Tranexamic acid, being more potent and having a better safety profile in some contexts, has eroded ACA’s market share.
• Safety concerns: Potential thromboembolic risks associated with ACA necessitate cautious use, impacting market acceptance.
• Pricing pressures: Generic proliferation translates to thin profit margins, restricting revenue growth.
• Limited indications: Unlike broader spectrum anticoagulants, ACA’s narrow approval scope constrains market expansion.

Competitive Landscape

Several pharmaceutical companies dominate ACA production through generics, including American Regent, Hospira (a Pfizer division), and Teva Pharmaceuticals. These companies focus on cost-effective manufacturing, ensuring accessibility in price-sensitive markets.

The emergence of tranexamic acid (TXA) has particularly challenged ACA. Due to its higher potency, longer shelf-life, and wider approval base, TXA has become the antifibrinolytic of choice globally. Nevertheless, ACA maintains niche applications, especially where specific patient profiles or institutional protocols favor its use.

Financial Trajectory and Revenue Projections

Given the current market conditions—prevalence of generics, increased surgical volume, and emerging market penetration—the financial outlook for ACA remains moderate but stable:

• Revenue stability: For leading producers, revenues hover around USD 50–100 million annually, with modest growth prospects.
• Margins: Limited due to price erosion but compensated by high-volume sales in emerging markets.
• Innovation and pipeline: No substantial new formulations or indications are on the immediate horizon, constraining significant revenue jumps.

Long-term financial forecasts predict a compound annual growth rate (CAGR) of approximately 2-3% over the next five years, primarily driven by volume expansion rather than price increases. Companies integrating ACA into comprehensive bleeding management portfolios stand to benefit from cross-selling and institutional protocols.

Emerging Opportunities and Challenges

Opportunities:

• Combination therapies: Synergistic use with other hemostatic agents to enhance efficacy.
• New indications: Off-label expansion in trauma or cardiopulmonary settings could broaden usage, pending safety validation.
• Biosimilars and generics: Entry of low-cost generics in emerging markets will sustain volume growth.

Challenges:

• Safety and efficacy concerns: Long-standing data support ACA’s use, but side effect profiles demand ongoing surveillance.
• Competitive landscape: The rise of TXA and other advanced agents limits ACA’s market share.
• Pricing pressures: High generic competition continues to compress margins.

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Conclusion

Aminocaproic acid’s market remains characterized by stability, driven by medical necessity and widespread approval. However, its growth trajectory faces headwinds from increasing competition, evolving safety profiles, and regulatory considerations. Companies adept at leveraging emerging markets, optimizing cost efficiencies, and exploring novel combination therapies may sustain or modestly expand their financial footprint.

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Key Takeaways

• ACA sustains a stable niche in antifibrinolytic treatment, primarily benefiting from predictable demand in surgical and bleeding disorder management.
• Generic competition has intensified pricing pressures, limiting margin expansion but ensuring broad access.
• The rise of tranexamic acid presents a significant competitive challenge, relegating ACA predominantly to specialized indications.
• Emerging markets offer increased volume potential; companies should focus on regulatory approvals and distribution channels in these regions.
• Future growth hinges on expanding indications, enhancing safety profiles, and integrating ACA within multimodal hemostatic strategies.

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FAQs

1. What are the main clinical indications for aminocaproic acid?
ACA is primarily indicated for controlling bleeding associated with hyperfibrinolytic states, such as post-surgical hemorrhage, traumatic bleeding, and bleeding in hemophilia patients.

2. How does aminocaproic acid compare to tranexamic acid?
While both are antifibrinolytics, tranexamic acid is more potent, has a longer half-life, and is approved for a broader range of conditions, making it more popular globally. ACA remains favored in specific contexts based on clinical protocols or institutional preferences.

3. What is the impact of generic competition on ACA’s market?
It leads to significant price erosion, limiting revenue growth but ensuring widespread affordability and access. It also discourages large investments in new formulations or indications.

4. Are there new developments or formulations in the pipeline for ACA?
Currently, no major innovations or additional indications are in advanced development stages. The focus remains on optimizing existing formulations and expanding regulatory approvals in emerging markets.

5. What are future opportunities for ACA manufacturers?
Opportunities include expanding use in niche indications, leveraging emerging markets for volume growth, exploring combination therapies, and ensuring safety profiles to maintain institutional trust.

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Sources:
[1] MarketsandMarkets. "Antifibrinolytic Drugs Market," 2022.