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Last Updated: December 28, 2024

HALFAN Drug Patent Profile


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Which patents cover Halfan, and what generic alternatives are available?

Halfan is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in HALFAN is halofantrine hydrochloride. Additional details are available on the halofantrine hydrochloride profile page.

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Summary for HALFAN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 127
Patent Applications: 263
DailyMed Link:HALFAN at DailyMed
Drug patent expirations by year for HALFAN

US Patents and Regulatory Information for HALFAN

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

HALFAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: HALFAN

Introduction to HALFAN

HALFAN, also known as halofantrine hydrochloride, is an antimalarial drug used for the treatment of mild to moderate malaria caused by Plasmodium falciparum and Plasmodium vivax in adults who can tolerate oral medication[4][5].

Market Size and Growth of Anti-Malarial Drugs

The global anti-malarial drugs market, which includes HALFAN, was valued at USD 989.7 million in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 4.26% from 2024 to 2030. This growth is driven by the persistent high global burden of malaria, with millions of estimated cases and deaths reported annually[1].

Prevalence of Malaria and Market Demand

The high prevalence of malaria, particularly in the WHO African Region, which accounts for 95% of global malaria cases and 96% of malaria-related deaths, significantly drives the demand for anti-malarial drugs like HALFAN. The urgent need for effective treatments, especially for Plasmodium falciparum, which is responsible for the most severe and fatal cases, contributes to the market's growth[1].

Segmentation of the Anti-Malarial Drugs Market

The market is segmented based on the type of malaria and the mechanism of action. The Plasmodium falciparum segment holds the maximum market share due to its clinical importance and the high number of malaria-related deaths it causes. The treatment segment, which includes drugs like HALFAN, dominates the market due to the urgent need for effective interventions against malaria[1].

Regulatory and Clinical Aspects

HALFAN has been through rigorous clinical trials, showing a cure rate of 99% against Plasmodium falciparum in non-immune patients and 90% in semi-immune patients. However, it is important to note that patients with acute P. vivax malaria treated with HALFAN are at risk of relapse unless subsequently treated with an 8-aminoquinoline to eradicate the exoerythrocytic parasites[5].

Drug Interactions and Safety

HALFAN should not be administered with drugs known to prolong the QTc interval, such as mefloquine, due to the risk of significant and potentially fatal interactions. Additionally, laboratory abnormalities such as decreased hematocrit and elevated hepatic transaminases have been noted, although these typically return to normal within a few weeks post-infection[4][5].

Market Players and Competitive Landscape

The anti-malarial drugs market includes key players such as Novartis AG, GlaxoSmithKline Plc., and others who are actively involved in new product development, mergers and acquisitions, and strategic alliances. These companies often work through public-private partnerships (PPPs) to develop and distribute anti-malarial drugs, including innovative combinations and formulations, at not-for-profit prices to developing countries[1][2].

Financial Incentives and Public-Private Partnerships

The development of anti-malarial drugs, including HALFAN, is often supported by financial incentives and non-financial motives. Public-private partnerships play a crucial role in subsidizing the direct R&D costs, allowing companies to offer the resulting drugs at or close to their cost of production. This 'no profit-no loss' model is particularly important for neglected diseases like malaria, where commercial returns are limited[2].

Challenges and Opportunities

Despite the growth potential, the anti-malarial drugs market faces challenges such as resistance to existing drugs and the need for continuous innovation. The market also benefits from regulatory approvals for novel drugs and expanded indications, as well as initiatives for malaria control and elimination. For HALFAN specifically, the risk of relapse in P. vivax cases and potential drug interactions present challenges that need to be managed[1][4].

Future Outlook

Given the ongoing need for effective anti-malarial treatments, the market for drugs like HALFAN is expected to continue growing. The focus on developing new drug combinations and formulations, coupled with regulatory support and public-private partnerships, will likely drive the market forward. However, addressing drug resistance and ensuring access to these drugs in high-burden regions will remain critical challenges[1].

Key Takeaways

  • The global anti-malarial drugs market is growing due to the high burden of malaria.
  • HALFAN is effective against Plasmodium falciparum and Plasmodium vivax but has specific usage and safety considerations.
  • Public-private partnerships are crucial for the development and distribution of anti-malarial drugs.
  • Continuous innovation and addressing drug resistance are key to market growth.
  • Regulatory approvals and initiatives for malaria control further drive the market.

Frequently Asked Questions (FAQs)

1. What is HALFAN used for?

HALFAN is used for the treatment of mild to moderate malaria caused by Plasmodium falciparum and Plasmodium vivax in adults who can tolerate oral medication[4].

2. What are the potential side effects of HALFAN?

Potential side effects include decreased hematocrit, elevated hepatic transaminases, and interactions with drugs that prolong the QTc interval[4][5].

3. How effective is HALFAN against malaria?

HALFAN has shown a cure rate of 99% against Plasmodium falciparum in non-immune patients and 90% in semi-immune patients[5].

4. Why is there a risk of relapse with HALFAN in P. vivax cases?

HALFAN does not eliminate the exoerythrocytic (hepatic phase) parasites, so patients with acute P. vivax malaria are at risk of relapse unless subsequently treated with an 8-aminoquinoline[4][5].

5. What role do public-private partnerships play in the development of anti-malarial drugs like HALFAN?

Public-private partnerships help subsidize R&D costs, allowing companies to offer anti-malarial drugs at not-for-profit prices to developing countries, which is crucial for addressing neglected diseases like malaria[2].

Cited Sources:

  1. Grand View Research - Anti-malarial Drugs Market Size, Share, Growth Report, 2030
  2. VFA - EXECUTIVE SUMMARY FOR THE NEW LANDSCAPE OF NEGLECTED DISEASE DRUG RESEARCH AND DEVELOPMENT
  3. FDA - Increasing Access to Safe and Effective Generic Drugs
  4. RxList - Halfan (Halofantrine Hydrochloride Tablets)
  5. FDA - HALFAN - accessdata.fda.gov

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