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Last Updated: March 17, 2025

AMINOCAPROIC Drug Patent Profile


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When do Aminocaproic patents expire, and what generic alternatives are available?

Aminocaproic is a drug marketed by Hikma, Abraxis Pharm, Baxter Hlthcare, Hospira, Luitpold, Ajenat Pharms, Amneal, Annora Pharma, Aurobindo Pharma, Carnegie, Epic Pharma Llc, Florida, MSN, Sunny, Taro, Trupharma, Vistapharm Llc, Adaptis, Ani Pharms, and Appco. and is included in twenty-five NDAs.

The generic ingredient in AMINOCAPROIC is aminocaproic acid. There are six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the aminocaproic acid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aminocaproic

A generic version of AMINOCAPROIC was approved as aminocaproic acid by LUITPOLD on December 1st, 1987.

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Recent Clinical Trials for AMINOCAPROIC

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SponsorPhase
Minia UniversityPhase 3
NYU Langone HealthN/A
Assiut UniversityPhase 4

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US Patents and Regulatory Information for AMINOCAPROIC

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hospira AMINOCAPROIC ACID IN PLASTIC CONTAINER aminocaproic acid INJECTABLE;INJECTION 070010-001 Mar 9, 1987 AP RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma AMINOCAPROIC aminocaproic acid TABLET;ORAL 075602-001 May 24, 2001 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sunny AMINOCAPROIC ACID aminocaproic acid TABLET;ORAL 209060-001 Nov 27, 2018 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Adaptis AMINOCAPROIC ACID aminocaproic acid TABLET;ORAL 212110-001 Jun 14, 2021 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Aminocaproic Acid: Market Dynamics and Financial Trajectory

Introduction

Aminocaproic acid, an antifibrinolytic agent, has been a crucial component in managing bleeding disorders and surgical bleeding. This article delves into the market dynamics, financial trajectory, and future prospects of aminocaproic acid, highlighting its growth drivers, challenges, and investment opportunities.

Market Size and Growth

The global antifibrinolytic drugs market, which includes aminocaproic acid, was valued at $13,593 million in 2018 and is projected to reach $19,333 million by 2026, growing at a CAGR of 4.5%[1].

Key Drivers of Growth

Increasing Prevalence of Bleeding Disorders

The rising incidence of bleeding disorders such as hemophilia, von Willebrand disease, and other hematological conditions drives the demand for aminocaproic acid. This drug is widely used to prevent excessive bleeding in these patients, particularly during surgeries and dental procedures[3][5].

Surge in Surgical Procedures

The increase in the number of surgical procedures, including cardiovascular and neurosurgeries, contributes significantly to the market growth. Aminocaproic acid is often administered to prevent the premature breakdown of blood clots during and after these surgeries[1][3].

Road Accidents and Trauma

The surge in road accidents globally, especially in low- and middle-income economies, has led to an increased need for antifibrinolytic agents like aminocaproic acid in trauma care. This trend is particularly pronounced in the Asia-Pacific region, which is expected to grow at the fastest rate during the forecast period[1].

Market Segmentation

By Indication

Aminocaproic acid is used across various indications, including gynecology for controlling heavy menstrual flow, hereditary angioedema, fibrinolytic response testing, and surgeries. The surgical segment is a significant driver due to the drug's efficacy in preventing post-surgical bleeding[1].

By End User

Hospitals and clinics dominate the end-user segment due to the high volume of surgeries performed in these settings. However, trauma centers are expected to grow at the fastest rate, driven by the increasing number of road accidents and trauma cases[1].

By Region

North America held the majority of the market share in 2018, driven by the high adoption rate of aminocaproic acid in controlling heavy menstrual flow and the significant number of surgical procedures. The Asia-Pacific region is anticipated to grow at the highest CAGR of 6.1% due to the rising healthcare infrastructure and increasing road accidents in this region[1].

Industrial Applications

Beyond its medical use, aminocaproic acid has found significant applications in various industrial sectors, including textile manufacturing and the production of synthetic resins. This diversification adds to the market's growth potential[3].

Challenges and Restraints

High Cost and Reimbursement Issues

The high cost of aminocaproic acid and stringent reimbursement policies are major hurdles to market growth. These factors can limit access to the drug, especially in low- and middle-income countries[1].

Supply Chain Disruptions

Although the closure of Akorn Pharmaceuticals, a manufacturer of aminocaproic acid, raised concerns about supply disruptions, other manufacturers have assured the FDA that they can meet market demands. This stability in supply chain management is crucial for maintaining market growth[2].

Innovations and Future Opportunities

Advancements in Drug Delivery Systems

Research into controlled-release drug formulations and targeted therapies for bleeding disorders is opening new avenues for aminocaproic acid. These innovations could expand its use in personalized medicine, further fueling market growth[3].

Collaborations and Mergers

The increasing collaboration between healthcare companies, pharmaceutical manufacturers, and industrial players through mergers and acquisitions is positioning companies to capitalize on new growth opportunities in both medical and industrial sectors[3].

Investment Opportunities

Emerging Markets

With rising healthcare spending in regions like Asia-Pacific, Latin America, and Africa, there are significant investment opportunities for manufacturers of aminocaproic acid-based products. The expansion of healthcare infrastructure in these regions is expected to increase the demand for hemostatic agents[3].

New Formulations and Applications

Investment in the development of new formulations that address unmet needs in medical and industrial sectors can drive the next wave of market growth. Innovations in drug delivery systems, biodegradable materials, and custom solutions for specific industries are key areas of opportunity[3].

Pharmacokinetics and Safety Profile

Aminocaproic acid exhibits extensive distribution in both extravascular and intravascular compartments and is primarily excreted by the kidneys. It has a low acute toxicity risk but can have adverse effects such as muscle weakness and elevated creatine phosphokinase (CPK) levels with prolonged use. Monitoring and careful dosing are essential to mitigate these risks[5].

Key Takeaways

  • The global antifibrinolytic drugs market, including aminocaproic acid, is expected to grow at a CAGR of 4.5% from 2018 to 2026.
  • The market is driven by the increasing prevalence of bleeding disorders, surge in surgical procedures, and rise in road accidents.
  • North America dominates the market, but the Asia-Pacific region is expected to grow at the fastest rate.
  • Industrial applications and advancements in drug delivery systems offer additional growth opportunities.
  • High cost and reimbursement issues are significant challenges to market growth.

FAQs

What is the current market size of the global antifibrinolytic drugs market?

The global antifibrinolytic drugs market was valued at $13,593 million in 2018[1].

What is the projected growth rate of the antifibrinolytic drugs market?

The market is expected to grow at a CAGR of 4.5% from 2018 to 2026[1].

What are the primary indications for aminocaproic acid?

Aminocaproic acid is used in gynecology, hereditary angioedema, fibrinolytic response testing, surgeries, and other indications[1].

How does the closure of Akorn Pharmaceuticals affect the supply of aminocaproic acid?

Despite Akorn Pharmaceuticals' closure, other manufacturers have assured the FDA that they can meet market demands, preventing a potential shortage[2].

What are the potential industrial applications of aminocaproic acid?

Aminocaproic acid is used in textile manufacturing and the production of synthetic resins, among other industrial applications[3].

Sources

  1. Allied Market Research: Global Antifibrinolytic Drugs Market Size, Share and Trends | Analysis by...
  2. NBDF: Aminocaproic Acid Production Update
  3. Market Research Intellect: Aminocaproic Acid Market on the Rise: Key Trends and Future Opportunities
  4. Market Research Reports: Aminocaproic Acid API - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030
  5. NCBI Bookshelf: Aminocaproic Acid - StatPearls

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