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Last Updated: December 22, 2024

Artemether; lumefantrine - Generic Drug Details


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What are the generic sources for artemether; lumefantrine and what is the scope of freedom to operate?

Artemether; lumefantrine is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for artemether; lumefantrine
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 179
DailyMed Link:artemether; lumefantrine at DailyMed
Recent Clinical Trials for artemether; lumefantrine

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

SponsorPhase
Ifakara Health InstitutePhase 1
Global FundPhase 4
Muhimbili University of Health and Allied SciencesPhase 2/Phase 3

See all artemether; lumefantrine clinical trials

Pharmacology for artemether; lumefantrine
Drug ClassAntimalarial

US Patents and Regulatory Information for artemether; lumefantrine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis COARTEM artemether; lumefantrine TABLET;ORAL 022268-001 Apr 7, 2009 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

Artemether; lumefantrine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Artemether and Lumefantrine

Introduction to Artemether and Lumefantrine

Artemether and Lumefantrine are key components of Artemisinin Combination Therapy (ACT), a highly effective treatment for malaria, particularly for the most dangerous strain, Plasmodium falciparum. This combination therapy has become a cornerstone in the global fight against malaria due to its superior efficacy and safety profile.

Global Market Overview

Market Size and Growth

The global artemisinin combination therapy market, which includes Artemether and Lumefantrine, was valued at USD 597.2 million in 2023. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 8.2% from 2024 to 2030[1].

Dominant Combination Therapy

Artemether+Lumefantrine (AL) dominates the market, accounting for 37.1% of the market share in 2023. This dominance is attributed to its high effectiveness and safety in treating uncomplicated malaria, as well as its recommendation by the World Health Organization (WHO) and widespread adoption in national malaria control strategies[1].

Regional Market Dynamics

North America

The North America region held the largest market revenue share of 37.7% in 2023. This is primarily due to the increasing number of imported malaria cases among travelers and immigrants from endemic regions. The U.S. market, in particular, has seen significant growth due to the emphasis on providing the best available treatments for malaria[1].

Europe

Europe is identified as a lucrative region, driven by the commitment to global malaria eradication efforts and the rise in travel-related malaria cases. Germany, with its advanced healthcare system and strong public health awareness campaigns, is expected to see rapid growth in the adoption of ACTs[1].

Asia Pacific

The Asia Pacific region is anticipated to grow at the fastest CAGR over the forecast period. This growth is driven by the resurgence of malaria and the increasing resistance to traditional antimalarial drugs in Southeast Asia. India, in particular, has been actively promoting ACT as the first-line treatment for Plasmodium falciparum malaria, contributing significantly to the regional market share[1].

Financial Trajectory

Cost-Effectiveness

Despite the higher cost of ACTs compared to traditional monotherapies, studies have shown that Artemether+Lumefantrine is more cost-effective. For instance, a cost-effectiveness analysis in Zambia indicated that AL produces successful treatment at a lower cost than sulfadoxine-pyrimethamine (SP), with an incremental cost-effectiveness ratio of $4.10 per treatment success[2].

Market Forecast

The global Artemether market is estimated to grow from USD 449 million in 2023 to USD 666.9 million by 2030, with a CAGR of 4.2% during the forecast period. This growth is driven by the increasing demand for effective antimalarial treatments and the expanding reach of healthcare services in malaria-endemic regions[4].

Revenue Segmentation

The market for Artemether+Lumefantrine is segmented by application (hospital pharmacy, retail pharmacy, online pharmacy) and geography. North America, Europe, and the Asia Pacific are key regions driving the market growth. The report also highlights that key companies such as Novartis, Sanofi, and Cipla are focusing on strategic initiatives to expand their customer base and gain a competitive edge[3].

Key Players and Competitive Landscape

Major Companies

Key players in the artemisinin combination therapy market include Novartis AG, Sanofi S.A., and Cipla Ltd. These companies are engaged in various strategic initiatives such as mergers and acquisitions, and partnerships to enhance their market presence and customer base[1].

Competitive Strategies

Companies are also focusing on improving accessibility and affordability of ACTs in low-income countries. For example, partnerships with local health organizations and governments help in reducing the cost barriers and increasing the adoption of these therapies[3].

Efficacy and Safety

Clinical Efficacy

Artemether+Lumefantrine has been proven to be highly efficacious in treating uncomplicated malaria. A clinical trial in Tanzania showed that AL was highly effective even after unsupervised administration, with significantly lower lumefantrine concentrations compared to supervised intake. The therapy was also well-tolerated and safe after initial and repeated treatment[5].

Safety Profile

The safety profile of Artemether+Lumefantrine is robust, with vomiting being the most commonly reported drug-related adverse event, occurring in only about 1% of patients. This makes it a preferred choice for treating malaria, especially in vulnerable populations such as children and pregnant women[5].

Regulatory and Public Health Support

WHO Recommendations

The World Health Organization (WHO) highly recommends Artemether+Lumefantrine as a first-line treatment for uncomplicated malaria. This recommendation has been instrumental in its widespread adoption in national malaria control strategies across endemic regions[1].

Public Health Campaigns

Public health awareness campaigns and increased knowledge among healthcare professionals about the benefits of ACTs in preventing drug resistance and providing effective treatment have also contributed to their growing use. In countries like Germany and India, these campaigns have been particularly effective in boosting the demand for ACTs[1].

Key Takeaways

  • Market Growth: The global artemisinin combination therapy market is projected to grow at a CAGR of 8.2% from 2024 to 2030.
  • Dominant Therapy: Artemether+Lumefantrine dominates the market due to its superior efficacy and safety.
  • Regional Dynamics: North America, Europe, and the Asia Pacific are key regions driving market growth.
  • Cost-Effectiveness: Artemether+Lumefantrine is more cost-effective compared to traditional monotherapies.
  • Key Players: Companies like Novartis, Sanofi, and Cipla are leading the market with strategic initiatives.
  • Efficacy and Safety: Artemether+Lumefantrine is highly efficacious and safe, even in unsupervised administration.

FAQs

Q1: What is the current market size of the artemisinin combination therapy market?

The global artemisinin combination therapy market was valued at USD 597.2 million in 2023[1].

Q2: Which region holds the largest market revenue share for artemisinin combination therapy?

North America holds the largest market revenue share, accounting for 37.7% in 2023[1].

Q3: Why is Artemether+Lumefantrine preferred over traditional monotherapies?

Artemether+Lumefantrine is preferred due to its superior effectiveness, safety, and ability to reduce the risk of drug resistance development[1].

Q4: What is the projected growth rate of the global Artemether market?

The global Artemether market is forecast to grow at a CAGR of 4.2% from 2024 to 2030[4].

Q5: Which companies are key players in the artemisinin combination therapy market?

Key players include Novartis AG, Sanofi S.A., and Cipla Ltd.[1].

Sources

  1. Grand View Research: Artemisinin Combination Therapy Market Size Report, 2030[1].
  2. PubMed: A cost-effectiveness analysis of artemether lumefantrine...[2].
  3. Market Research Intellect: Global Coartem (Artemether/Lumefantrine) Market Size, Share and Forecast[3].
  4. Valuates Reports: Artemether - Market, Report Size, Worth, Revenue, Growth, Industry...[4].
  5. Oxford Academic: Efficacy and Effectiveness of Artemether-Lumefantrine after Initial...[5].

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