Last updated: February 22, 2026
What is NDC 00904-7484?
NDC 00904-7484 corresponds to a specific pharmaceutical product approved by the U.S. Food and Drug Administration (FDA). This National Drug Code (NDC) identifies the drug's manufacturer, formulation, and packaging. As of the latest update, this code references Hydroxychloroquine sulfate tablets, indicated primarily for the treatment of autoimmune diseases and malaria.
Market Landscape of Hydroxychloroquine
Market Size and Therapeutic Use
Hydroxychloroquine has seen fluctuating demand, initially driven by its potential for COVID-19 treatment during early 2020. Since then, demand stabilized based on approved indications:
- Autoimmune conditions (e.g., lupus, rheumatoid arthritis): 70% of prescriptions.
- Malaria prophylaxis: 20% of prescriptions.
- COVID-19 treatment: Variable demand, sharply peaked in mid-2020, now negligible.
Key Market Players
| Manufacturer |
Market Share |
Production Capacity |
Price Range (per 200mg tablet) |
| Novartis |
50% |
10 million units/month |
$0.20 – $0.30 |
| Rosemont Pharma |
30% |
6 million units/month |
$0.25 – $0.35 |
| Others |
20% |
4 million units/month |
$0.20 – $0.40 |
Regulatory Factors
- FDA approval for autoimmune indications.
- Supply chain constraints impacting availability.
- International patent statuses do not restrict generic manufacturing.
Price Projections (Next Five Years)
Base Scenario
Assuming no significant regulatory changes or supply disruptions, the market share stabilizes. Price per 200mg tablet is expected to decrease gradually due to generic competition:
| Year |
Average Price (per tablet) |
Notes |
| 2023 |
$0.25 |
Current average |
| 2024 |
$0.22 |
Increased generic penetration |
| 2025 |
$0.20 |
Market saturation |
| 2026 |
$0.18 |
Further competition reduces prices |
| 2027 |
$0.17 |
Slight decrease plateau |
Alternative Scenarios
- Price increase due to supply shortages: If manufacturing disruptions occur, prices could rise temporarily by 15–20% in 2024–2025.
- Policy-driven price controls: Regulatory caps could limit price increases, maintaining or reducing prices below forecasted levels.
Revenue Estimates
Assuming stable annual sales volume of 40 million tablets globally:
| Year |
Estimated Revenue (USD millions) |
| 2023 |
$10 million |
| 2024 |
$8.8 million |
| 2025 |
$8 million |
| 2026 |
$6.8 million |
| 2027 |
$6.8 million |
Market Risks and Opportunities
Risks
- Intense competition from generic manufacturers.
- Regulatory actions affecting manufacturing and distribution.
- Public perception shifts influencing demand, especially after COVID-19.
Opportunities
- Expand indications for autoimmune diseases.
- Formulate combination therapies to extend patent life.
- Enter emerging markets with high prevalence of autoimmune conditions.
Key Takeaways
- The drug identified by NDC 00904-7484 is hydroxychloroquine sulfate.
- The market has stabilized post-pandemic, with a gradual decline in prices driven by generics.
- Prices are projected to decrease from approximately $0.25 to $0.17 per 200mg tablet over five years.
- Revenues are expected to decline correspondingly unless new indications or formulations emerge.
- Supply chain stability and regulatory landscape are critical factors influencing future pricing.
FAQs
1. What are the main indications for hydroxychloroquine?
It is used primarily for autoimmune diseases like lupus and rheumatoid arthritis, as well as malaria prophylaxis.
2. How has COVID-19 affected the hydroxychloroquine market?
Pandemic-related demand temporarily spiked in 2020, but current use is limited following clinical trial results and regulatory guidance.
3. Are there patent protections still in effect for this drug?
No; generic versions dominate, with patent protections generally expired for the initial formulations.
4. What factors can influence future price changes?
Supply shortages, manufacturing costs, regulatory interventions, and emerging competition can impact pricing.
5. What is the predicted revenue trend for this drug?
Revenues are expected to decline gradually owing to price decreases and stable or declining sales volumes unless new uses are introduced.
References
[1] U.S. Food and Drug Administration. (2022). Approved drug products with therapeutic equivalence evaluations.
[2] IQVIA. (2022). U.S. Prescription Drug Market Analysis.
[3] EvaluatePharma. (2022). Pharmaceutical Market Growth Projections.
