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Last Updated: March 26, 2026

Oxamniquine - Generic Drug Details


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What are the generic sources for oxamniquine and what is the scope of patent protection?

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

Summary for oxamniquine
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 35
DailyMed Link:oxamniquine at DailyMed
Medical Subject Heading (MeSH) Categories for oxamniquine

US Patents and Regulatory Information for oxamniquine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer VANSIL oxamniquine CAPSULE;ORAL 018069-001 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

Expired US Patents for oxamniquine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer VANSIL oxamniquine CAPSULE;ORAL 018069-001 Approved Prior to Jan 1, 1982 ⤷  Start Trial ⤷  Start Trial
Pfizer VANSIL oxamniquine CAPSULE;ORAL 018069-001 Approved Prior to Jan 1, 1982 ⤷  Start Trial ⤷  Start Trial
Pfizer VANSIL oxamniquine CAPSULE;ORAL 018069-001 Approved Prior to Jan 1, 1982 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Oxamniquine Market Dynamics and Financial Trajectory

Last updated: February 18, 2026

Oxamniquine is an anthelmintic drug primarily used for treating schistosomiasis, also known as snail fever. Its market trajectory is directly linked to the global prevalence of this parasitic disease, funding for neglected tropical diseases, and the availability of alternative treatments.

What is Oxamniquine and How Does it Function?

Oxamniquine is a nitrothiamide derivative that acts as a prodrug. Once ingested, it is metabolized in the liver to its active form, 6-nitro-2-aminonitrothiamide. The precise mechanism of action is not fully elucidated but is believed to involve DNA intercalation and inhibition of nucleic acid synthesis in susceptible schistosomes. It is particularly effective against Schistosoma mansoni infections.

  • Chemical Name: 1,2,3,4-Tetrahydro-6-nitro-2-acridanone
  • Drug Class: Anthelmintic, Nitrothiamide derivative
  • Primary Indication: Treatment of Schistosoma mansoni infections
  • Administration: Oral
  • Key Metabolites: 6-nitro-2-aminonitrothiamide

Oxamniquine's efficacy is well-established for mild to moderate infections. Severe cases may require different treatment regimens or adjunct therapies. Its historical use has been significant in endemic regions, particularly in Brazil and parts of Africa.

What is the Global Prevalence of Schistosomiasis?

Schistosomiasis is a major public health concern, affecting an estimated 240 million people worldwide, with an additional 700 million at risk of infection. The World Health Organization (WHO) designates it as a neglected tropical disease (NTD). The disease is endemic in 78 countries, predominantly in tropical and subtropical regions of Africa, South America, and Asia [1].

  • Estimated Infected Population: 240 million
  • Estimated at Risk Population: 700 million
  • Regions Most Affected: Sub-Saharan Africa, South America, East Asia
  • Primary Causative Agents: Schistosoma mansoni, Schistosoma haematobium, Schistosoma japonicum

The prevalence of Schistosoma mansoni, the primary target of oxamniquine, is highest in Africa and South America. Control programs implemented by national health ministries and international organizations have focused on mass drug administration (MDA) as a key strategy.

What is the Current Market Status of Oxamniquine?

The market for oxamniquine is characterized by its role in public health programs rather than commercial retail. Its production and distribution are largely driven by the needs of national schistosomiasis control initiatives and humanitarian aid organizations.

  • Primary Buyers: National health ministries, WHO, non-governmental organizations (NGOs)
  • Production Volume: Determined by procurement orders for MDA campaigns.
  • Pricing: Typically negotiated under bulk purchase agreements, often subsidized.

Major pharmaceutical companies historically involved in oxamniquine production include Pfizer (under brand names like Mansil). However, as many NTDs have limited commercial appeal due to low per-patient profitability and reliance on donor funding, the landscape has shifted towards specialized generic manufacturers and partnerships for drug donation programs.

Key Market Factors:

  1. Disease Burden: The persistent high prevalence of schistosomiasis ensures a consistent, albeit controlled, demand for effective treatments like oxamniquine.
  2. Public Health Funding: The market is heavily influenced by global health initiatives and donor funding (e.g., from the Bill & Melinda Gates Foundation, national governments) that support NTD control programs.
  3. Drug Donation Programs: Pharmaceutical companies often donate drugs or sell them at cost for these programs.
  4. Availability of Alternatives: Praziquantel is the WHO-recommended drug for all forms of schistosomiasis and is often the first-line treatment. Oxamniquine remains important for specific S. mansoni resistance or as a secondary option.

What is the Competitive Landscape for Schistosomiasis Treatment?

The primary competitor to oxamniquine is praziquantel. Praziquantel is effective against all major schistosome species and has a broader spectrum of activity.

  • Praziquantel:
    • Manufacturer(s): Various generic manufacturers, including Bayer (historical, now licensed), Shin Poong Pharmaceutical Co., Ltd.
    • Advantages: Broad-spectrum efficacy, WHO first-line recommendation, widely available through donation programs.
    • Disadvantages: Can have side effects, resistance is a concern in some areas.
  • Oxamniquine:
    • Manufacturer(s): Historically Pfizer, now potentially through specialized generic manufacturers or through specific country procurement.
    • Advantages: Highly effective against S. mansoni, particularly in certain geographic regions where it has been historically used.
    • Disadvantages: Limited spectrum of activity (primarily S. mansoni), less globally standardized availability compared to praziquantel.

The market does not typically see extensive competition in terms of novel drug development for schistosomiasis due to the low commercial return. Instead, the focus is on ensuring consistent supply and accessibility of existing, effective treatments.

What are the Regulatory and Patent Considerations for Oxamniquine?

Oxamniquine is an established drug, meaning its original patents have long expired. This has led to its availability as a generic medication.

  • Patent Expiration: Original patents for oxamniquine expired decades ago.
  • Generic Availability: The drug is available from multiple sources as a generic.
  • Regulatory Approvals: Approved by regulatory bodies in countries where schistosomiasis is endemic. Global health organizations like the WHO also prequalify essential medicines for procurement.

The lack of patent protection means that the financial model for oxamniquine is not driven by exclusivity and high margins from new drug sales. Instead, it relies on manufacturing efficiency, economies of scale for bulk procurement, and sustainable funding for public health programs.

What is the Financial Trajectory and Market Size of Oxamniquine?

Quantifying the precise global market size for oxamniquine in dollar terms is challenging due to its nature as a public health commodity. Sales are not typically tracked through standard pharmaceutical market analytics that focus on prescription drugs sold in retail pharmacies.

  • Estimated Annual Procurement Value: Difficult to pinpoint precisely, but likely in the range of tens of millions of USD globally, driven by MDA campaigns.
  • Key Drivers of Financial Value:
    • Volume of drug required for MDA programs.
    • Cost per treatment course negotiated under bulk agreements.
    • Government and donor funding allocations for schistosomiasis control.

The financial trajectory is stable, contingent on ongoing disease prevalence and continued funding for NTD control. It is not a growth market in the typical commercial sense but rather a sustained demand market.

Factors Influencing Financial Stability:

  • Sustained Disease Prevalence: As long as schistosomiasis remains endemic, demand will persist.
  • Programmatic Support: The financial health of oxamniquine supply is directly tied to the sustained funding of national and international schistosomiasis control programs.
  • Cost-Effectiveness: Oxamniquine, as a generic drug, is generally considered cost-effective, making it a viable option for resource-limited settings.
  • Manufacturing Costs: Production costs for generic drugs can fluctuate based on raw material prices and manufacturing capacity.

Revenue generated is primarily from bulk sales to governments and international health organizations. Profit margins for manufacturers are typically lower compared to patented pharmaceuticals, reflecting the generic nature of the product and the often-subsidized purchasing power of end-users.

What are the Future Outlooks for Oxamniquine?

The future of oxamniquine is intrinsically linked to the global strategy for schistosomiasis control.

  • Continued Role in MDA: Oxamniquine will likely remain a component of MDA strategies, particularly in regions with a high prevalence of S. mansoni where praziquantel resistance might emerge or where historical treatment patterns favor oxamniquine.
  • Potential for New Formulations or Delivery Methods: While unlikely to be a major R&D focus, improvements in formulation or delivery could enhance its utility.
  • Impact of Emerging Resistance: Monitoring and addressing potential drug resistance to both oxamniquine and praziquantel is crucial for maintaining treatment efficacy.
  • Shifting Global Health Priorities: Changes in global health funding priorities could impact the availability of resources for NTD control, and thus for drugs like oxamniquine.
  • Emergence of Novel Therapies: While no immediate novel therapies are on the horizon that would entirely supplant existing treatments, ongoing research into new antiparasitic drugs could eventually alter the treatment landscape.

The market is not expected to experience significant growth but rather to maintain its current level, serving a critical public health need. Innovation in this segment is more likely to focus on optimizing existing drugs' use and distribution rather than on developing entirely new chemical entities.

Key Takeaways

  • Oxamniquine is a critical, albeit niche, anthelmintic drug for treating Schistosoma mansoni infections, primarily used in public health programs.
  • Its market is driven by the global prevalence of schistosomiasis (240 million infected) and sustained funding for neglected tropical disease control initiatives.
  • The competitive landscape is dominated by praziquantel, the WHO-first-line treatment, with oxamniquine serving as a specific option for S. mansoni.
  • As an off-patent generic drug, oxamniquine's financial trajectory is characterized by stable, bulk procurement rather than high-growth commercial sales, with pricing influenced by negotiated agreements and donor funding.
  • Future demand is expected to remain consistent, contingent on ongoing disease burden, program funding, and vigilance against drug resistance, rather than significant market expansion or innovation.

Frequently Asked Questions

What is the primary region of use for oxamniquine?

Oxamniquine is primarily used in regions where schistosomiasis, particularly Schistosoma mansoni, is endemic, including parts of Africa and South America.

Is oxamniquine still considered a first-line treatment for schistosomiasis?

Praziquantel is the WHO-recommended first-line treatment for all forms of schistosomiasis. Oxamniquine is an important alternative and second-line option for specific Schistosoma mansoni infections.

What are the main challenges in the oxamniquine market?

Key challenges include reliance on public health funding, competition from praziquantel, potential for drug resistance, and the limited commercial profitability of neglected tropical disease treatments.

How is the pricing of oxamniquine determined?

Pricing is primarily determined through bulk purchase agreements negotiated between manufacturers and national health ministries or international health organizations, often with consideration for cost-effectiveness in resource-limited settings.

What is the outlook for new drug development in schistosomiasis that might impact oxamniquine?

While research into novel antiparasitic drugs is ongoing, there are no immediate novel therapies poised to completely replace existing treatments like oxamniquine. The focus remains on ensuring the accessibility and efficacy of current medications.

Citations

[1] World Health Organization. (2023). Schistosomiasis. Retrieved from https://www.who.int/news-room/fact-sheets/detail/schistosomiasis

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