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Last Updated: April 3, 2026

Pyrimethamine; sulfadoxine - Generic Drug Details


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What are the generic sources for pyrimethamine; sulfadoxine and what is the scope of patent protection?

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
Recent Clinical Trials for pyrimethamine; sulfadoxine

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

SponsorPhase
Kamuzu University of Health SciencesPhase 4
Swiss Pharma Nigeria LimitedPHASE1
Medicines for Malaria VenturePHASE1

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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

Last updated: February 16, 2026

What is the Market Potential for Pyrimethamine and Sulfadoxine?

Pyrimethamine and sulfadoxine are antibiotics primarily used as anti-malarial agents. Their combined use is common for preventing and treating malaria, especially in resource-limited settings. The global anti-malarial drug market was valued at approximately $2.3 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 6.2% through 2028*, driven by rising malaria prevalence and evolving resistance patterns.

How Do Market Dynamics Influence Demand for Pyrimethamine and Sulfadoxine?

Disease Burden and Geographic Focus

The majority of malaria cases occur in Africa, where the World Health Organization (WHO) reports over 200 million cases annually. Sub-Saharan Africa accounts for about 94% of malaria deaths*. This creates a persistent demand for effective prophylaxis and treatment options like pyrimethamine-sulfadoxine (SP).

Antimalarial Resistance and Treatment Policies

Increasing resistance to artemisinin-based combination therapies (ACTs) shifts focus back to older drugs in some regions. Pyrimethamine and sulfadoxine retain efficacy in certain areas, notably when combined with other agents. WHO recommends sulfadoxine-pyrimethamine for intermittent preventive treatment in pregnant women (IPTp) and infants in regions with confirmed efficacy**.

Regulatory and Funding Landscape

Major funding sources include the Global Fund and Gavi, the Vaccine Alliance, which prioritize malaria interventions. Regulatory approvals are stable for SP in many endemic countries; however, rising resistance threatens future approval status and usage volumes.

What Is the Financial Trajectory of the Pyrimethamine-Sulfadoxine Market?

Revenue Projections

The market, currently valued around $200 million globally for pyrimethamine-sulfadoxine formulations, is expected to grow modestly, with a CAGR of approximately 4–5% through 2030. Growth drivers include increased preventive use in sub-Saharan Africa and potential expansion into new indications where resistance suits.

Pricing Trends

Prices per treatment course range broadly from $0.50 to $2.50, depending on formulation, dosage, and region. Patent protections largely expired decades ago, leading to a low-cost generic market. However, supply disruptions and quality control issues can influence prices.

Manufacturing and Supply Chain

Most formulations are produced by generic manufacturers in India and China, with large-volume procurement for government and NGO programs. Supply chain stability is critical, as manufacturing interruptions can influence availability and market dynamics.

What Are Potential Risks and Opportunities?

Resistance and Policy Changes

Rising resistance could reduce the drug’s efficacy, prompting formulation updates or alternative therapies. Conversely, renewed policy support for SP in preventive protocols can drive demand.

Development of New Formulations

Formulations combining pyrimethamine-sulfadoxine with novel agents or delivery methods may extend market lifespan, especially if they address resistance or compliance issues. Investment in such R&D is limited but could be strategically valuable.

Regulatory Environment

Stricter quality controls and global health policies influence market stability. Changes in approval status or post-marketing surveillance may impact revenues.


Key Takeaways

  • The global anti-malarial market is expanding, with pyrimethamine-sulfadoxine maintaining a role in prevention, particularly in Africa.
  • Market growth remains moderate, with revenues around $200 million and a CAGR of approximately 4–5%.
  • Resistance development presents a significant risk, potentially necessitating new formulations or alternative agents.
  • The supply chain relies heavily on generic manufacturers, which poses both cost advantages and vulnerability to disruptions.
  • Policy and funding shifts influence demand, with ongoing support from international health agencies critical for market stability.

FAQs

1. How does resistance impact the future of pyrimethamine-sulfadoxine?
Resistance reduces drug efficacy, limiting use in existing protocols. Continued monitoring and possible formulation modifications are necessary to sustain demand.

2. Are new formulations of pyrimethamine-sulfadoxine in development?
Limited research focuses on new formulations, but combining SP with other agents or developing sustained-release forms are areas of interest, particularly if resistance escalates.

3. What are the main markets for pyrimethamine-sulfadoxine?
Sub-Saharan Africa accounts for the bulk of use, especially in prophylactic and treatment protocols. Other regions with endemic malaria, such as parts of Southeast Asia, also represent smaller markets.

4. How do global health initiatives influence the market?
Funding and procurement policies from organizations like Gavi and the Global Fund drive demand and shape supply chains, especially for low-cost generics.

5. What is the impact of regulatory policies on market stability?
Stable approval statuses support ongoing use; however, any restrictions linked to resistance or quality issues can reduce market size and require adaptation.


Sources
[1] WHO. "World Malaria Report 2022."
[2] MarketResearch.com. "Global Anti-Malarial Drugs Market Forecast."
[3] Gavi, The Vaccine Alliance. "Malaria Prevention Funding Data."
[4] Global Fund. "Funding Disbursements for Malaria."
[5] U.S. FDA. "Approved Antimalarial Drugs List."

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