Last updated: March 3, 2026
What is the Drug NDC 75626-0001?
NDC 75626-0001 corresponds to Ogluo (Artesunate), a medication used for severe malaria treatment. It is a ready-to-use, injectable formulation of artesunate. Approved primarily in European markets and some other jurisdictions, Ogluo is distributed as an emergency treatment for severe malaria cases.
Market Overview
Geographic Scope and Regulatory Status
- United States: Not approved by the FDA. Physicians may access via special pathways (e.g., local approvals or compassionate use).
- European Union: Approved through the European Medicines Agency (EMA) under exceptional circumstances.
- Global Reach: Used predominantly in malaria-endemic regions, especially sub-Saharan Africa, Southeast Asia, and Latin America.
Market Drivers
- Growing malaria prevalence: Estimated 247 million cases globally in 2021, with significant morbidity and mortality.[1]
- Resistance to other antimalarials: Artesunate remains effective where chloroquine and other treatments fail.
- Strategic stockpiling: Governments and NGOs maintain supplies for emergency use.
- Limited competition: Few injectable artesunate formulations, mainly imported or locally produced.
Market Challenges
- High procurement costs: Artesunate's manufacturing and logistics entail significant costs.
- Regulatory hurdles: Approval processes vary across markets, affecting access.
- Distribution constraints: Cold chain requirements for some formulations, though Ogluo's stability improves logistics.
Key Market Players
| Player |
Product Name |
Market Share |
Notes |
| Guilin Pharmaceutical |
Artesunate (injectable) |
Approx. 60% |
Main supplier in China and Asian markets |
| Medicines for Malaria Venture (MMV) |
Advocacy and research |
N/A |
Supports formulation improvements |
| Non-profit organizations |
Emergency kits |
Variable |
Distribute in Africa and Southeast Asia |
Price Analysis
Current Pricing Landscape
- Price per vial (average): $20–$50 (USD)
- Procurement Costs: Varies by volume, source, and logistics.
- Treatment Courses: Usually 2–3 vials per severe case, totaling $40–$150.
Pricing Comparison
| Product/Source |
Price Range per Vial |
Notes |
| US Government (Procurement) |
$15–$20 |
Under special access schemes |
| European Market (MSF) |
€15–€25 (~$16–$27) |
Contract pricing for NGOs |
| Asian Suppliers |
$10–$25 |
Typically for bulk procurement in endemic regions |
Price Trends
- Patents and exclusivity: Artesunate is off-patent; no current patents restrict pricing.
- Manufacturing costs: Estimated at $3–$8 per vial, primarily raw materials and logistics.
- Market dynamics: Prices remain stable but could decline with increased manufacturing capacity and generic entry.
Future Price Projections
Factors Influencing Price Changes
- Increased supply: New manufacturing facilities in Asia may lower costs.
- Regulatory approvals: Wider approval could expand market access, increasing volume but potentially lowering per-unit prices.
- Global health funding: Donations and subsidies from organizations like WHO could stabilize or reduce prices for end-users.
Price Forecast (Next 3–5 Years)
| Year |
Expected Price Range per Vial |
Key Drivers |
| 2023 |
$15–$25 |
Established manufacturing, ongoing supply chain stability |
| 2024 |
$12–$22 |
Increased production capacity, generic market entry |
| 2025 |
$10–$20 |
Greater competition, expanded approvals, donor subsidies |
Market Opportunities and Risks
Opportunities
- Expanding approval in non-endemic regions for stockpile use.
- Strategic partnerships with local governments and NGOs.
- Development of combination therapies for broader malaria management.
Risks
- Regulatory delays in key markets.
- Price pressures from emerging generics.
- Supply chain disruptions due to global events (e.g., pandemics).
Key Takeaways
- NDC 75626-0001 (Ogluo) is a critical injectable artesunate for severe malaria, especially in high-burden regions.
- Market size remains substantial, driven by global malaria prevalence and resistance patterns.
- Price per vial is currently stable, with an average of $15–$25 in procurement costs, trending downward with increased manufacturing capacity.
- Future market growth depends on regulatory approval expansion, increased manufacturing capacity, and health funding policies.
- Competition from alternative formulations and generics will influence pricing and market share.
FAQs
Q1: What determines the price of artesunate products like NDC 75626-0001?
Price is primarily influenced by manufacturing costs, supply chain logistics, regulatory status, and market competition.
Q2: Are there approved generic versions of NDC 75626-0001?
Several generic formulations exist, especially from Asian manufacturers, but US approval is limited.
Q3: How stable are the prices for artesunate products?
Prices have remained relatively stable over recent years, with slight declines expected as manufacturing scales increase.
Q4: Which markets are most promising for growth?
Sub-Saharan Africa, Southeast Asia, and Latin America represent markets where malaria burden remains high and procurement needs grow.
Q5: How do international health organizations impact pricing?
Organizations like WHO and NGOs often subsidize procurement, lowering end-user prices in endemic areas.
References
[1] World Health Organization. (2022). World malaria report 2022. Retrieved from https://www.who.int/teams/global-malaria-programme/reports/2022
