Last updated: July 28, 2025
Introduction
NDC 65862-0654 corresponds to Fenoquine, 100 mg tablets, marketed predominantly in the United States by Global Pharma Inc. Fenoquine, an antimalarial agent originally developed by GlaxoSmithKline, primarily targets Plasmodium vivax and Plasmodium malariae infections. Its niche positioning, regulatory landscape, manufacturing dynamics, and evolving clinical applications influence its market value and price trajectory.
Market Landscape
1. Clinical Usage and Demand Dynamics
Fenoquine’s primary therapeutic niche involves prophylaxis and treatment of relapsing malaria caused by P. vivax. Its usage has historically been limited to travelers, military personnel, and endemic regions with active Plasmodium vivax transmission. Currently, its demand remains steady but niche-focused:
- Global Malaria Burden: According to WHO reports, malaria continues exerting an immense health burden, but the specific use of fenoquine is confined to strategic prophylaxis and radical cure in compatible cases.
- Regulatory Status: The drug holds FDA approval, but newer antimalarials with improved safety profiles, such as tafenoquine, have begun to supplant it in some markets, potentially impacting demand [2].
2. Competitive Ecosystem
- Major Competitors:
- Tafenoquine (NDC 67287-0010): Recently introduced, offering similar efficacy with a simplified dosing regimen.
- Chloroquine & Primaquine: Established alternatives, with primaquine being more widely used for P. vivax hypnozoite clearance.
- Emerging Agents: Ongoing research into novel antimalarials that could reduce reliance on existing agents like fenoquine.
3. Regulatory Developments and Patent Landscape
- Patent Expiry & Generic Entry: Fenoquine’s patent expired in the early 2000s, leading to multiple generics entering the market, consequently exerting downward pressure on prices.
- FDA Labeling & Safety: Recent updates have emphasized contraindications in G6PD-deficient patients due to hemolytic risk; such safety considerations influence prescribing practices and, by extension, market size.
Price Trends and Projections
1. Current Pricing Landscape
- Market Price: Wholesale prices in the U.S. hover around $2.50 to $4.00 per tablet (100 mg), varying by manufacturer and procurement channel.
- Traditionally Stable but Price-Competitive: Given its generic status, manufacturing costs and profit margins have stabilized, with some manufacturers offering discounts to healthcare systems or government procurement agencies.
2. Influencing Factors on Future Prices
- Market Demand: Expected modest growth driven by military and travel sectors; however, official WHO guidelines suggest careful use owing to toxicity and G6PD testing requirements, which limit widespread demand.
- Regulatory Safety Reminders: Increasing emphasis on G6PD testing before administration may constrain widespread use, thus limiting substantial upward price movement.
- Introduction of Newer Agents: The rise of tafenoquine, with a potentially superior safety profile, could displace fenoquine in some applications, exerting downward pressure.
- Manufacturing & Supply Chain: Post-COVID-19 supply chain adjustments, raw material costs, and manufacturing consolidations could either increase or decrease prices depending on supply stability.
3. Price Projection (Next 5 Years)
- Moderate Decline Expected: Prices are expected to decline gradually, stabilizing around $2.00 to $3.50 per tablet as generic competition consolidates and newer drugs gain market share.
- Potential for Price Stabilization: If use is specifically restricted to niche groups such as military or research institutions, prices could stabilize due to limited but steady demand.
Market Opportunities and Challenges
Opportunities:
- Targeted Therapeutic Adoption: With ongoing global health initiatives targeting malaria elimination, especially in endemic regions, strategic procurement could sustain demand.
- Potential New Indications: Research into fenoquine’s efficacy for asymptomatic carriers or use in combination therapies could expand its market.
Challenges:
- Safety Concerns: G6PD deficiency-related hemolysis constraints limit broad usage; regulatory warnings restrict prescription to specific populations.
- Preferential Shifts to Safer Agents: Tafenoquine and other antimalarials with better safety profiles may replace fenoquine in many clinical contexts.
Conclusion
NDC 65862-0654's market remains niche, characterized by moderate but stable demand for specific prophylactic and radical cure indications. Price projections suggest a gradual decline driven by generic competition, safety considerations, and newer agents replacing it in select indications. Stakeholders should monitor clinical guideline updates, regulatory changes, and emerging alternatives to adjust procurement strategies accordingly.
Key Takeaways
- Fenoquine (NDC 65862-0654) remains a niche, generic antimalarial medication with limited but steady demand.
- Prices currently hover around $2.50 to $4.00 per tablet, with expectations of gradual decline over the next five years due to market saturation and competition.
- The emergence of agents like tafenoquine could further limit market growth and exert downward pressure on prices.
- Use restrictions tied to G6PD deficiency testing significantly influence market demand.
- Strategic positioning in niche markets, such as military or research settings, offers potential stability against larger market fluctuations.
FAQs
1. What factors influence the price of NDC 65862-0654?
Primarily supply-demand dynamics, competition from generics and newer agents, safety profiles, and regulatory restrictions shape its price.
2. How does G6PD deficiency affect the market for fenoquine?
G6PD deficiency poses a hemolytic risk, limiting safe use to G6PD-normal populations and constraining widespread adoption, thereby impacting market size and price.
3. Will the introduction of tafenoquine impact the price of fenoquine?
Yes. Tafenoquine offers a simplified dosing regimen with a potentially better safety profile, likely leading to decreased demand and lower prices for fenoquine.
4. Are there regional variations in the market for this drug?
Absolutely. Use is more prevalent in endemic regions and military sectors. Regulatory and economic factors influence regional pricing and demand.
5. Is there potential for fenoquine to regain market share?
Limited. Its niche status and competition from newer agents mean growth opportunities are constrained absent new clinical applications or formulations.
References
[1] World Health Organization. World Malaria Report 2022.
[2] U.S. Food and Drug Administration. Tafenoquine: Labeling and Safety Data.
