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Last Updated: December 28, 2024

HALOFANTRINE HYDROCHLORIDE - Generic Drug Details


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

Halofantrine hydrochloride is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for HALOFANTRINE HYDROCHLORIDE
Recent Clinical Trials for HALOFANTRINE HYDROCHLORIDE

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

SponsorPhase
Lihir Medical CentrePhase 3
Barcelona Institute for Global HealthPhase 3
Walter and Eliza Hall Institute of Medical ResearchPhase 3

See all HALOFANTRINE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for HALOFANTRINE HYDROCHLORIDE

US Patents and Regulatory Information for HALOFANTRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline HALFAN halofantrine hydrochloride TABLET;ORAL 020250-001 Jul 24, 1992 DISCN No No ⤷  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

HALOFANTRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Halofantrine Hydrochloride

Introduction

Halofantrine hydrochloride, an antimalarial drug, has been a significant player in the global pharmaceutical market, particularly in regions plagued by malaria. Here, we delve into the market dynamics and financial trajectory of this drug.

Historical Context and Approval

Halofantrine hydrochloride was approved in 1992, marking a crucial milestone in the fight against malaria, especially in areas where chloroquine and sulfonamide/pyrimethamine resistance were prevalent[2][3].

Market Size and Growth

The global market for halofantrine hydrochloride has experienced fluctuations over the years. As of 2018, the market size was valued at several million dollars, with a compound annual growth rate (CAGR) observed from 2014 to 2018. However, the exact figures are not publicly disclosed[4].

Demand and Usage

The demand for halofantrine hydrochloride is primarily driven by the need for effective antimalarial treatments in endemic regions. It is particularly useful in areas where other antimalarials like chloroquine and sulfonamide/pyrimethamine have lost efficacy due to resistance. The drug's efficacy against both chloroquine-sensitive and chloroquine-resistant plasmodia makes it a valuable asset in public health campaigns[3].

Competitive Landscape

Halofantrine hydrochloride competes with other antimalarial drugs such as mefloquine, artemether-lumefantrine, and artesunate. While it has shown comparable efficacy to mefloquine and better tolerance in some cases, its use is limited by concerns of cardiotoxicity and variable absorption rates[3].

Financial Considerations

The development and production of halofantrine hydrochloride involve significant financial investments. The total development costs for such pharmaceuticals can range from $500 million to over $1 billion, reflecting the complexity and duration of the development process from lead identification to regulatory approval[2].

Regulatory Environment

Halofantrine hydrochloride has been approved by various regulatory bodies, including the FDA in the U.S. and the EMA in the European Union. Regulatory approvals are crucial for the drug's market presence and ensure its safety and efficacy for public use[2].

Challenges and Limitations

Despite its efficacy, halofantrine hydrochloride faces several challenges:

  • Resistance Development: Like other antimalarials, the development of parasite resistance to halofantrine is a significant concern. Poor absorption and potential cross-resistance with mefloquine can accelerate this process[3].
  • Cardiotoxicity: The drug has been associated with cardiotoxicity, particularly through its effects on HERG channels, which can lead to serious cardiac side effects[5].
  • Variable Absorption: The variable peak plasma concentrations due to poor absorption can affect the drug's efficacy and contribute to the emergence of resistance[3].

Market Strategies

To maintain market viability, strategies such as careful usage in areas with established resistance to other antimalarials, combination therapies to prevent resistance, and continuous monitoring of side effects are essential. Additionally, public-private partnerships and product development partnerships have played a crucial role in the development and distribution of halofantrine hydrochloride, especially in resource-poor settings[2].

Economic Impact

The economic impact of halofantrine hydrochloride extends beyond the pharmaceutical market. By providing an effective treatment for malaria, it helps in reducing the economic burden of the disease on endemic communities. Malaria is estimated to cost billions of dollars annually in lost productivity, making effective treatments like halofantrine hydrochloride vital for economic development[2].

Future Outlook

The future of halofantrine hydrochloride in the market will depend on several factors, including the development of resistance, the emergence of new antimalarial drugs, and ongoing research into its antifungal properties, as seen in its ability to enhance oxidative stress damage to Candida albicans[1].

Key Takeaways

  • Halofantrine hydrochloride is a valuable antimalarial drug approved in 1992.
  • The market size and growth are influenced by its efficacy and the prevalence of malaria.
  • The drug faces challenges such as resistance development, cardiotoxicity, and variable absorption.
  • Regulatory approvals and public-private partnerships are crucial for its market presence.
  • The economic impact of the drug is significant in reducing the burden of malaria on public health and economies.

FAQs

What is halofantrine hydrochloride used for?

Halofantrine hydrochloride is an antimalarial drug used to treat malaria, particularly in areas where other antimalarials like chloroquine and sulfonamide/pyrimethamine have lost efficacy due to resistance.

What are the common side effects of halofantrine hydrochloride?

Common side effects include abdominal pain, pruritus, vomiting, diarrhea, headache, and rash. However, it is often difficult to distinguish between disease- and treatment-related events.

Is halofantrine hydrochloride effective against all types of malaria?

Halofantrine hydrochloride is effective against both chloroquine-sensitive and chloroquine-resistant plasmodia, but its efficacy against mefloquine-resistant P. falciparum is less clear and requires further study.

Why is the use of halofantrine hydrochloride limited in some areas?

The use of halofantrine hydrochloride is limited due to concerns about cardiotoxicity and the potential for variable absorption rates, which can affect its efficacy and contribute to the development of resistance.

What is the economic impact of halofantrine hydrochloride?

By providing an effective treatment for malaria, halofantrine hydrochloride helps reduce the economic burden of the disease on endemic communities, which is estimated to be in the billions of dollars annually in lost productivity.

Sources

  1. Halofantrine Hydrochloride Acts as an Antioxidant Ability Inhibitor That Enhances Oxidative Stress Damage to Candida albicans - MDPI.
  2. Pharmaceutical Progress for Neglected Diseases: Using Non-Incentive Mechanisms and Policy Approaches - Duke University.
  3. Halofantrine. A review of its antimalarial activity, pharmacokinetic properties and therapeutic efficacy - PubMed.
  4. Global Halofantrine hydrochloride (CAS 36167-63-2) Market Report - Valuates Reports.
  5. Halofantrine hydrochloride | DrugBank Online - DrugBank.

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