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Last Updated: March 17, 2025

AMICAR Drug Patent Profile


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Which patents cover Amicar, and when can generic versions of Amicar launch?

Amicar is a drug marketed by Epic Pharma Llc and Hikma and is included in three NDAs.

The generic ingredient in AMICAR 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 Amicar

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

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Summary for AMICAR
Drug patent expirations by year for AMICAR
Drug Prices for AMICAR

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Recent Clinical Trials for AMICAR

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SponsorPhase
Universidad Autonoma de Nuevo LeonPhase 2
The University of Texas Health Science Center at San AntonioPhase 1
Duke UniversityPhase 4

See all AMICAR clinical trials

Pharmacology for AMICAR
Drug ClassAntifibrinolytic Agent
Physiological EffectDecreased Fibrinolysis

US Patents and Regulatory Information for AMICAR

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hikma AMICAR aminocaproic acid TABLET;ORAL 015197-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma AMICAR aminocaproic acid TABLET;ORAL 015197-002 Jun 24, 2004 AB RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Epic Pharma Llc AMICAR aminocaproic acid INJECTABLE;INJECTION 015229-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma AMICAR aminocaproic acid SOLUTION;ORAL 015230-002 Approved Prior to Jan 1, 1982 AA RX Yes 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

Market Dynamics and Financial Trajectory for AMICAR (Aminocaproic Acid)

Introduction to AMICAR

AMICAR, or aminocaproic acid, is a medication used to prevent excessive bleeding, particularly during surgical procedures and in the management of bleeding disorders. It acts as an inhibitor of fibrinolysis, preventing the breakdown of blood clots. Here, we delve into the market dynamics and financial trajectory of this crucial pharmaceutical product.

Market Growth and Projections

The aminocaproic acid market, including AMICAR, has been experiencing significant growth and is projected to continue this trend. From 2023 to 2031, the market is expected to see sustained and substantial expansion, driven by increasing demand in various therapeutic applications such as surgery and trauma care[1][3][4].

Key Drivers of Growth

  • Increasing Surgical Procedures: The rise in surgical interventions, especially in emerging economies, has significantly boosted market demand. For instance, an increase in orthopedic surgeries due to an aging population has created a heightened need for effective hemostatic agents like aminocaproic acid[3].
  • Regulatory Approvals: Recent FDA endorsements of innovative intravenous preparations of aminocaproic acid have expanded its clinical applications, including the management of bleeding disorders. This shift has opened doors for pharmaceutical companies to invest in research and development, further driving market growth[3][4].
  • Technological Advancements: Advancements in drug delivery systems, such as controlled-release formulations and targeted therapies, are opening new avenues for aminocaproic acid in medical treatments. These innovations could expand its use in personalized medicine, further fueling growth[4].

Geographical Market Dynamics

Asia-Pacific Region

The Asia-Pacific region is emerging as a significant player in the aminocaproic acid market. Countries like China and India are witnessing a rise in surgical procedures, leading to greater demand for effective hemostatic agents. The region's burgeoning pharmaceutical industry is also contributing to the production of aminocaproic acid, with local manufacturers offering cost-effective alternatives. The Asia-Pacific region is projected to grow at a CAGR of over 7% in the coming years[3].

North America and Europe

These regions dominate the market due to advanced healthcare systems and robust pharmaceutical infrastructure. However, the growth in these mature markets is somewhat tempered by market saturation and competition from alternative therapies[3].

Latin America

Latin America presents a unique scenario, with Brazil and Mexico leading in terms of market size. Despite challenges such as economic instability and varying healthcare access, there is an increasing awareness of bleeding disorders and their management, which is gradually elevating the demand for aminocaproic acid[3].

Challenges and Restraints

Raw Material Volatility

Fluctuations in the cost of raw materials used to synthesize aminocaproic acid can directly affect the pricing strategy of API producers. Disruptions in supply chains due to geopolitical tensions or trade restrictions can lead to sudden price hikes, affecting the competitive edge of companies[3].

Competition from Alternative Therapies

The rise of antifibrinolytic agents that offer similar benefits with fewer side effects poses a significant threat to the market share of aminocaproic acid. This necessitates that manufacturers innovate and diversify their product offerings to maintain relevance[3].

Market Saturation

In mature markets, the entry of new players can lead to price wars, eroding profit margins. Companies must invest in marketing and differentiation strategies to stand out in a crowded marketplace, which can strain financial resources, particularly for smaller firms[3].

Impact of the COVID-19 Pandemic

The pandemic has exacerbated existing challenges, disrupting supply chains and altering demand dynamics. The increased focus on healthcare during the pandemic shifted resources and attention away from certain therapeutic areas, including those involving aminocaproic acid. The long-term implications of this shift remain uncertain as the industry navigates a post-pandemic landscape[3].

Financial Trajectory

Revenue Projections

The global aminocaproic acid API market is projected to expand at a compound annual growth rate (CAGR) of approximately 6.5% from 2023 to 2030. This growth is driven by the rising awareness of the drug's efficacy and safety profile, as well as increasing demand in various therapeutic applications[3].

Investment Opportunities

The expanding use of aminocaproic acid across diverse sectors presents a range of investment opportunities for businesses and venture capitalists. Investors should focus on companies engaged in the production, research, and development of aminocaproic acid for its medical and industrial applications. Investment in the development of new formulations and innovative drug delivery systems is a key area of opportunity[4].

Strategic Partnerships and Mergers

The market is experiencing increased collaboration between healthcare companies, pharmaceutical manufacturers, and industrial players. Recent mergers and acquisitions are positioning companies to take advantage of new growth opportunities in both medical and industrial sectors. These strategic partnerships are crucial for expanding the use of aminocaproic acid and driving market growth[4].

Supply Chain Stability

Despite the bankruptcy of Akorn Pharmaceuticals, one of the manufacturers of aminocaproic acid, the FDA and other manufacturers have ensured that there will be no shortage of the product. The remaining manufacturers have indicated their ability to meet market demands, and the FDA continues to monitor the situation closely to prevent any supply issues[2].

Conclusion

The market for AMICAR and aminocaproic acid is poised for significant growth, driven by increasing demand in surgical and trauma care, technological advancements, and strategic partnerships. While challenges such as raw material volatility, competition from alternative therapies, and market saturation exist, the overall outlook remains positive. As the healthcare infrastructure expands globally, particularly in emerging economies, the demand for effective hemostatic agents like aminocaproic acid is expected to rise, presenting lucrative opportunities for manufacturers and investors.

Key Takeaways

  • The aminocaproic acid market is projected to grow significantly from 2023 to 2031.
  • Increasing surgical procedures and regulatory approvals are key drivers of growth.
  • The Asia-Pacific region is emerging as a significant market due to rapid economic growth and increasing healthcare investments.
  • Challenges include raw material volatility, competition from alternative therapies, and market saturation.
  • Strategic partnerships and investments in new formulations are crucial for market growth.

FAQs

Q: What is the primary use of AMICAR (aminocaproic acid)? A: AMICAR is used to prevent excessive bleeding, particularly during surgical procedures and in the management of bleeding disorders.

Q: Which regions are driving the growth of the aminocaproic acid market? A: The Asia-Pacific region, along with North America and Europe, is driving the growth of the aminocaproic acid market due to increasing demand and advancements in healthcare infrastructure.

Q: How has the COVID-19 pandemic affected the aminocaproic acid market? A: The pandemic has disrupted supply chains and altered demand dynamics, shifting resources away from certain therapeutic areas. However, the long-term implications are still being navigated.

Q: What are the key challenges facing the aminocaproic acid market? A: Key challenges include raw material volatility, competition from alternative therapies, and market saturation in mature markets.

Q: Are there any supply chain concerns for aminocaproic acid following the bankruptcy of Akorn Pharmaceuticals? A: No, the FDA and other manufacturers have ensured that there will be no shortage of aminocaproic acid, and the remaining manufacturers are capable of meeting market demands[2].

Sources

  1. Market Research Intellect: Global Aminocaproic Acid Injection Market Size, Trends and ...
  2. NBDF: Aminocaproic Acid Production Update
  3. PMR: Worldwide Aminocaproic Acid API Market Research 2024 by Type ...
  4. Market Research Intellect: Aminocaproic Acid Market on the Rise: Key Trends and Future ...
  5. Drugs.com: AMICAR (aminocaproic acid) Package Insert / Prescribing Information

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