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Last Updated: December 22, 2024

PYRIMETHAMINE; SULFADOXINE - Generic Drug Details


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

Pyrimethamine; sulfadoxine is the generic ingredient in one branded drug marketed by Roche and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for PYRIMETHAMINE; SULFADOXINE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 144
DailyMed Link:PYRIMETHAMINE; SULFADOXINE at DailyMed
Recent Clinical Trials for PYRIMETHAMINE; SULFADOXINE

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

SponsorPhase
Kamuzu University of Health SciencesPhase 4
Malaria ConsortiumPhase 3
University of MelbournePhase 3

See all PYRIMETHAMINE; SULFADOXINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for PYRIMETHAMINE; SULFADOXINE

US Patents and Regulatory Information for PYRIMETHAMINE; SULFADOXINE

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

PYRIMETHAMINE; SULFADOXINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pyrimethamine and Sulfadoxine

Introduction

Pyrimethamine and sulfadoxine, combined as sulfadoxine-pyrimethamine (SP), have been cornerstone drugs in the fight against malaria, particularly for intermittent preventive treatment in pregnancy (IPTp) and infancy (IPTi). However, the rising resistance of Plasmodium falciparum to SP has significant implications for market dynamics and the financial trajectory of these drugs.

Historical Context and Usage

Early Adoption and Widespread Use

SP was widely adopted in the early 2000s as a first-line treatment for malaria, especially in Africa. It was often combined with other antimalarials like chloroquine or artesunate to enhance efficacy[1][3].

Shift to Artemisinin-Based Combination Therapies (ACTs)

By the mid-2000s, many countries transitioned to artemisinin-based combination therapies (ACTs) due to increasing resistance to traditional antimalarials. This shift reduced the selective pressure on antifolates like SP, but SP continued to be used in specific contexts such as IPTp and IPTi[1].

Resistance and Its Impact

Rising Resistance

The efficacy of SP has been compromised by the increasing resistance of Plasmodium falciparum. Studies have shown that high-level SP resistance has increased significantly in regions like eastern Africa, with countries such as Malawi, Kenya, and Tanzania experiencing notable rises from 2000 to 2020[1].

Molecular Markers of Resistance

Mutations in the pfdhfr and pfdhps genes are key indicators of SP resistance. The prevalence of these mutations, such as the pfdhps K540E and A581G mutations, has been on the rise, particularly in central Africa, threatening the continued use of SP[4].

Market Dynamics

Demand and Supply

Despite the growing resistance, SP remains in demand due to its continued use in certain malaria control programs. However, the demand is expected to decline as more countries adopt ACTs and other alternative treatments. The supply chain may need to adapt to these changes, potentially leading to a reduction in production volumes.

Pricing and Cost-Effectiveness

The cost of delivering SP, especially in the context of seasonal malaria chemoprevention (SMC), is relatively low compared to other malaria control interventions. For example, the cost of SMC delivery in countries like Gambia and Senegal has been estimated to be around $1.50 to $1.63 per child per year[2].

Regulatory and Policy Changes

Regulatory bodies and health organizations are increasingly recommending alternative treatments due to SP resistance. For instance, the WHO has guidelines that suggest the use of SP only in areas where resistance levels are not critically high. This has led to a gradual shift towards other antimalarials, affecting the market dynamics of SP[1][4].

Financial Trajectory

Revenue Trends

The revenue generated from SP sales is likely to decline as resistance increases and alternative treatments gain preference. Countries transitioning to ACTs or other antimalarials will reduce their reliance on SP, impacting the financial performance of pharmaceutical companies that produce these drugs.

Investment in Alternative Treatments

Pharmaceutical companies are increasingly investing in the development and marketing of alternative antimalarials. This shift in investment is driven by the need to address the growing resistance to SP and other traditional antimalarials, ensuring a sustainable market presence in the malaria treatment sector.

Economic Impact on Public Health Programs

Public health programs that rely heavily on SP for malaria control will need to reassess their budgets and strategies. The transition to more effective but often more expensive treatments like ACTs could strain public health budgets, particularly in resource-constrained settings.

Regional Variations

Africa

In Africa, the use of SP varies significantly by region. While western and southern Africa have seen relatively stable drug efficacy, eastern and central Africa are experiencing high levels of resistance, making SP less effective in these regions[1].

India

In India, the use of SP, particularly in combination with artesunate (AS+SP), is still prevalent but faces significant challenges due to rising resistance. Studies have highlighted the need for robust surveillance and potential policy changes to address this issue[3].

Future Outlook

Need for Continuous Monitoring

Continuous monitoring of drug resistance is crucial to ensure the effective use of antimalarials. This involves regular surveillance of molecular markers and clinical efficacy, which can help in making informed policy decisions[1][3].

Development of New Treatments

The development of new antimalarial treatments is essential to combat the evolving resistance landscape. Research into novel compounds and combination therapies will be vital in maintaining the efficacy of malaria treatment programs.

Public Health Strategies

Public health strategies need to be adaptive, incorporating the latest data on drug resistance. This includes implementing policies that promote the use of effective treatments and ensuring that health systems have the capacity to monitor and respond to resistance trends.

Key Takeaways

  • Rising Resistance: The increasing resistance of Plasmodium falciparum to SP is a significant challenge, particularly in eastern and central Africa.
  • Market Decline: The demand for SP is expected to decline as countries transition to more effective treatments like ACTs.
  • Financial Impact: The financial trajectory of SP is likely to be negatively affected by the shift towards alternative treatments.
  • Regional Variations: The efficacy and use of SP vary significantly by region, with western and southern Africa showing more stable drug efficacy compared to eastern and central Africa.
  • Need for New Treatments: The development of new antimalarial treatments is crucial to address the evolving resistance landscape.

FAQs

What is the current status of SP resistance in Africa?

SP resistance has increased significantly in eastern Africa, with countries like Malawi, Kenya, and Tanzania experiencing high levels of resistance. In contrast, western and southern Africa have seen relatively stable drug efficacy[1].

How does SP resistance affect public health programs?

The increasing resistance to SP necessitates a reassessment of public health budgets and strategies. Transitioning to more effective but often more expensive treatments like ACTs could strain public health budgets, particularly in resource-constrained settings.

What are the alternative treatments to SP?

Alternative treatments include artemisinin-based combination therapies (ACTs) such as Artemether-Lumefantrine (AL) and Artesunate + Sulfadoxine-Pyrimethamine (AS+SP) in regions where SP resistance is not high[3].

How is the market for SP expected to change?

The market for SP is expected to decline as countries adopt more effective treatments like ACTs. Pharmaceutical companies are likely to shift their investments towards the development and marketing of these alternative antimalarials.

What is the role of continuous monitoring in managing SP resistance?

Continuous monitoring of drug resistance is critical to ensure the effective use of antimalarials. Regular surveillance of molecular markers and clinical efficacy helps in making informed policy decisions and adapting public health strategies[1][3].

Sources

  1. Plasmodium falciparum resistance to sulfadoxine-pyrimethamine in Africa: a systematic analysis of national trends. Global Health Action, 2020.
  2. Amodiaquine + sulfadoxine + pyrimethamine. Essential Medicines List for Children (EMLc).
  3. Meta-analysis on Plasmodium falciparum sulfadoxine-pyrimethamine resistance-conferring mutations in India. medRxiv, 2023.
  4. Evolution and spread of Plasmodium falciparum mutations associated with resistance to sulfadoxine–pyrimethamine in central Africa. The Lancet Microbe, 2023.

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