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Last Updated: December 22, 2024

ARTESUNATE - Generic Drug Details


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

Artesunate is the generic ingredient in one branded drug marketed by Amivas and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for artesunate. One supplier is listed for this compound.

Summary for ARTESUNATE
Drug Prices for ARTESUNATE

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Recent Clinical Trials for ARTESUNATE

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

SponsorPhase
UNC Lineberger Comprehensive Cancer CenterPhase 1
Gilead SciencesPhase 1
Joseph C. WuPhase 1

See all ARTESUNATE clinical trials

US Patents and Regulatory Information for ARTESUNATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amivas ARTESUNATE artesunate POWDER;INTRAVENOUS 213036-001 May 26, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Amivas ARTESUNATE artesunate POWDER;INTRAVENOUS 213036-001 May 26, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amivas ARTESUNATE artesunate POWDER;INTRAVENOUS 213036-001 May 26, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ARTESUNATE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Amivas Ireland Ltd Artesunate Amivas artesunate EMEA/H/C/005550
Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children.Consideration should be given to official guidance on the appropriate use of antimalarial agents.
Authorised no no yes 2021-11-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

ARTESUNATE Market Analysis and Financial Projection Experimental

Artesunate Market Dynamics and Financial Trajectory

Market Introduction

Artesunate, a derivative of artemisinin, is a crucial medication in the treatment of malaria, particularly for severe cases. It is often used in combination therapies and is preferred over quinine due to its efficacy and safety profile[4].

Market Size and Growth Projections

The Artesunate market is poised for significant growth over the coming years. Here are some key projections:

  • The Artesunate Medicines Market is valued at USD 193.06 million in 2025 and is expected to reach USD 366.73 million by 2033, with a Compound Annual Growth Rate (CAGR) of 7.2%[2].
  • Another report indicates that the Artesunate Injection Market will experience robust growth from 2023 to 2031, driven by various market dynamics[1].

Market Segmentation

The Artesunate market is segmented in several ways:

  • By Type: The market is segmented into different dosages such as 30mg, 60mg, and 120mg for injections, and by type (e.g., 0.99, 0.98) for other forms[1][4].
  • By Form: Artesunate is available in various forms, including tablets and injections. The injection form is particularly popular for treating severe malaria[4].
  • By Application: The market is segmented based on the application in hospitals, clinics, and other healthcare settings[1].
  • By Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][4].

Market Drivers

Several factors are driving the growth of the Artesunate market:

  • Rising Prevalence of Malaria: The increasing incidence of malaria, especially in tropical and subtropical regions, is a significant driver. The World Health Organization (WHO) continues to report high malaria cases, which fuels the demand for effective treatments like Artesunate[4].
  • Research and Development: Increased expenditure in research and development of antimalarial drugs is creating lucrative opportunities for the growth of the Artesunate market[4].
  • Government Initiatives: Public health initiatives and programs aimed at controlling and eliminating malaria also boost the demand for Artesunate[3].

Market Restraints

Despite the positive outlook, there are some challenges:

  • Cost and Accessibility: In some regions, the cost of Artesunate can be a barrier, especially in low-income countries where malaria is most prevalent. The incremental cost per death averted using Artesunate is approximately USD 140, which can be significant in resource-poor settings[5].
  • Resistance and Side Effects: The potential for resistance to Artesunate and side effects associated with its use can also act as restraints[4].

Market Opportunities

The Artesunate market presents several opportunities:

  • Emerging Markets: Countries in Asia-Pacific, Africa, and South America offer significant growth opportunities due to the high prevalence of malaria and increasing healthcare spending[1][4].
  • Combination Therapies: The development of combination therapies involving Artesunate, such as Artesunate plus mefloquine, opens up new market avenues[4].

Competitive Landscape

The competitive landscape of the Artesunate market is dynamic:

  • Key Players: Companies such as Systacare Remedies, Amivas, Macleods, Ipca, Wellona Pharma, Fosun Pharma, and others are prominent in the market. These companies are engaged in various strategies including product launches, collaborations, and mergers and acquisitions to expand their market share[1][4].
  • Recent Developments: The market has seen recent activities such as new product introductions and partnerships, which are expected to further drive growth[4].

Regional Overview

The Artesunate market varies significantly across different regions:

  • Asia-Pacific: This region is expected to be a major contributor to the market growth due to the high incidence of malaria and increasing healthcare infrastructure[1][4].
  • Africa: Africa is another key region where malaria is prevalent, and thus, there is a significant demand for Artesunate[4].
  • North America and Europe: While these regions have lower incidence rates of malaria, they still contribute to the market through research and development activities and exports to other regions[1][4].

Financial Analysis

The financial trajectory of the Artesunate market is promising:

  • Revenue Projections: The market is expected to grow from USD 193.06 million in 2025 to USD 366.73 million by 2033, indicating a substantial increase in revenue[2].
  • Cost-Effectiveness: Despite the costs, Artesunate is considered cost-effective in treating severe malaria, with an incremental cost per death averted of approximately USD 140[5].

Porter's Five Forces Analysis

Understanding the competitive forces is crucial for market analysis:

  • Threat of New Entrants: The threat of new entrants is moderate due to regulatory barriers and the need for significant investment in research and development[4].
  • Bargaining Power of Suppliers: The bargaining power of suppliers is relatively low as there are multiple suppliers of raw materials and intermediates[4].
  • Bargaining Power of Buyers: The bargaining power of buyers is moderate, influenced by the availability of alternative treatments and government policies[4].
  • Threat of Substitute Products: The threat of substitute products is low due to the efficacy and safety profile of Artesunate compared to other antimalarial drugs[4].
  • Competitive Rivalry Among Existing Competitors: The competitive rivalry is high due to the presence of several key players and ongoing innovations in the market[4].

PEST Analysis

The PEST analysis provides insights into external factors affecting the market:

  • Political Factors: Government policies and public health initiatives significantly impact the demand for Artesunate[4].
  • Economic Factors: Economic conditions, healthcare spending, and cost-effectiveness of the drug influence market dynamics[4].
  • Social Factors: Public awareness and education about malaria treatment options affect market growth[4].
  • Technological Factors: Advances in pharmaceutical technology and research and development activities drive innovation and growth in the market[4].

Key Takeaways

  • The Artesunate market is expected to grow significantly due to the rising prevalence of malaria and increased research and development.
  • The market is segmented by type, form, application, and geography, with Asia-Pacific and Africa being key regions.
  • Key players are focusing on organic and inorganic growth strategies to expand their market share.
  • Despite challenges such as cost and accessibility, the market presents lucrative opportunities for growth.
  • Financial projections indicate a substantial increase in revenue over the forecast period.

Frequently Asked Questions

What is the expected CAGR of the Artesunate Medicines Market from 2024 to 2033?

The Artesunate Medicines Market is projected to have a CAGR of 7.2% from 2024 to 2033[2].

Which regions are expected to be major contributors to the Artesunate market growth?

Asia-Pacific and Africa are expected to be major contributors to the market growth due to the high incidence of malaria in these regions[1][4].

What are the key drivers of the Artesunate market?

The key drivers include the rising prevalence of malaria, increased expenditure in research and development, and government initiatives to control malaria[4].

What is the incremental cost per death averted using Artesunate?

The incremental cost per death averted using Artesunate is approximately USD 140[5].

Which companies are prominent in the Artesunate market?

Companies such as Systacare Remedies, Amivas, Macleods, Ipca, Wellona Pharma, and Fosun Pharma are prominent in the market[1][4].

Cited Sources:

  1. Market Research Intellect, Global Artesunate Injection Market Size, Trends and Projections, November 2024.
  2. Global Growth Insights, Artesunate Medicines Market Size, Growth | CAGR of 7.2 %, December 10, 2024.
  3. OpenPR, Artesunate Drugs Market Trends and Analysis - Opportunities.
  4. The Insight Partners, Artesunate Market Scope and Size by 2031.
  5. PubMed, Cost-effectiveness of artesunate for the treatment of severe malaria.

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