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Last Updated: December 22, 2024

FANSIDAR Drug Patent Profile


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When do Fansidar patents expire, and what generic alternatives are available?

Fansidar is a drug marketed by Roche and is included in one NDA.

The generic ingredient in FANSIDAR is pyrimethamine; sulfadoxine. There are three drug master file entries for this compound. Additional details are available on the pyrimethamine; sulfadoxine profile page.

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Summary for FANSIDAR
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 10
Clinical Trials: 32
DailyMed Link:FANSIDAR at DailyMed
Drug patent expirations by year for FANSIDAR
Recent Clinical Trials for FANSIDAR

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

SponsorPhase
University of OxfordPhase 1/Phase 2
Kenya Medical Research InstitutePhase 1/Phase 2
University Hospital HeidelbergPhase 1/Phase 2

See all FANSIDAR clinical trials

US Patents and Regulatory Information for FANSIDAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche FANSIDAR pyrimethamine; sulfadoxine TABLET;ORAL 018557-001 Approved Prior to Jan 1, 1982 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

FANSIDAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fansidar

Introduction

Fansidar, a combination of sulfadoxine and pyrimethamine, has been a significant player in the antimalarial drug market, particularly for the treatment and prophylaxis of chloroquine-resistant Plasmodium falciparum malaria. However, its market dynamics and financial trajectory are influenced by several factors, including efficacy, resistance, and market competition.

Historical Context and Efficacy

Early Use and Efficacy

Fansidar was introduced as a potent antimalarial drug, especially effective against chloroquine-resistant P. falciparum malaria. However, its efficacy against other species of malaria, such as P. vivax, P. ovale, and P. malariae, has been limited due to widespread resistance to pyrimethamine[4].

Clinical Limitations

Clinical evidence has shown that Fansidar is not the most effective drug for treating or preventing P. vivax infections. This inefficacy is attributed to the resistance of P. vivax to pyrimethamine. Additionally, the drug's effectiveness against P. ovale and P. malariae has not been adequately evaluated[4].

Market Dynamics

Global Antimalarial Drugs Market

The global antimalarial drugs market, which includes Fansidar, is expected to grow at a CAGR of 4.6% from 2023 to 2030, reaching a valuation of USD 1,202.21 million by 2030. This growth is driven by the rising prevalence of malaria, government initiatives, increased awareness, and advancements in research and development[1].

Regional Market Performance

  • Asia Pacific: This region is the largest and fastest-growing market for antimalarial drugs, including Fansidar, due to the high prevalence of malaria in countries like India and China.
  • Latin America: Countries such as Brazil and Peru also contribute to the growing demand for antimalarial drugs.
  • Middle East and Africa: This region, particularly countries like Nigeria and the Democratic Republic of Congo, has a high burden of malaria, driving the demand for antimalarial drugs[1].

Financial Trajectory

Revenue and Market Share

While Fansidar was once a significant player, its market share has been impacted by the development of newer, more effective antimalarial drugs. The financial trajectory of Fansidar is characterized by a decline in market share due to its limited efficacy against certain malaria species and the emergence of drug resistance.

Cost and Pricing

The cost of Fansidar, like other antimalarial drugs, is influenced by production costs, distribution channels, and government subsidies. In many developing countries, user fees and out-of-pocket expenses play a significant role in the affordability of these drugs. However, the financial sustainability of health facilities relying on user fees is a concern, as reducing or eliminating these fees could impact the day-to-day operations of these facilities[5].

Challenges and Threats

Drug Resistance

One of the major challenges facing Fansidar is the increasing resistance of malaria parasites to the drug. This resistance, particularly in regions like the Thai-Kampuchean border and parts of Brazil, has reduced the drug's effectiveness and led to treatment failures[4].

Regulatory and Clinical Recommendations

The CDC and WHO have issued guidelines recommending the use of Fansidar only for the prophylaxis or treatment of chloroquine-resistant P. falciparum malaria. This limited indication has further reduced the drug's market share and financial viability[4].

Competitive Landscape

Market Competition

The antimalarial drugs market is highly competitive, with major players such as Novartis AG, Hoffmann-La Roche Ltd, Pfizer Inc., Sanofi, GlaxoSmithKline plc, Cipla Inc., and Ipca Laboratories Ltd. These companies are investing heavily in research and development to introduce new and more effective antimalarial drugs, which has further marginalized Fansidar's position in the market[1].

Technological Advancements

Diagnostic and Treatment Advancements

Advancements in diagnostic tools and treatments have increased the effectiveness of newer antimalarial drugs. This has led to a shift in market preference towards these newer drugs, impacting the financial trajectory of Fansidar negatively[1].

Government Initiatives and Public Awareness

Public Health Initiatives

Government initiatives to control and eliminate malaria, including funding for research and distribution programs, have driven the demand for antimalarial drugs. However, these initiatives often focus on the most effective treatments, which may not include Fansidar due to its limited efficacy[1].

Public Awareness

Increased public awareness of malaria and its impact on public health has led to a higher demand for effective treatments. This awareness, coupled with the availability of better alternatives, has reduced the reliance on Fansidar[1].

Key Takeaways

  • Fansidar's market dynamics are significantly influenced by its limited efficacy against certain malaria species and the emergence of drug resistance.
  • The drug's financial trajectory is characterized by a decline in market share due to these factors.
  • The global antimalarial drugs market is growing, but Fansidar's position within this market is diminishing.
  • Government initiatives and public awareness drive the demand for effective antimalarial treatments, which often favor newer drugs over Fansidar.

FAQs

What is Fansidar used for?

Fansidar is used for the prophylaxis or treatment of chloroquine-resistant Plasmodium falciparum malaria. It is not recommended for other species of malaria due to limited efficacy and resistance issues[4].

Why is Fansidar less effective against certain types of malaria?

Fansidar is less effective against P. vivax, P. ovale, and P. malariae due to widespread resistance to pyrimethamine, one of its active ingredients[4].

What are the major challenges facing Fansidar in the market?

The major challenges include drug resistance, limited efficacy, and the emergence of newer, more effective antimalarial drugs[1][4].

How does the competitive landscape affect Fansidar?

The competitive landscape, dominated by major pharmaceutical companies investing in research and development, has led to the introduction of new and more effective antimalarial drugs, marginalizing Fansidar's market position[1].

What role do government initiatives play in the antimalarial drugs market?

Government initiatives to control and eliminate malaria drive the demand for effective treatments, often focusing on newer and more effective drugs, which can reduce the reliance on Fansidar[1].

Sources

  1. Custom Market Insights: Global Antimalarial Drugs Market Size, Trends, Share 2030.
  2. IMF: Confronting the Challenges of Gender Equality and Fragile States.
  3. IQVIA: Drug Expenditure Dynamics 1995–2020: Understanding medicine spending.
  4. CDC: Problems Encountered with Using Fansidar as Prophylaxis for Malaria.
  5. The Global Fund: Thematic Review - The Global Fund.

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