Last updated: February 23, 2026
What is the drug associated with NDC 59385-0022?
NDC 59385-0022 corresponds to Rifampin Capsules (250 mg). Rifampin is an antibiotic primarily used to treat tuberculosis, leprosy, and certain bacterial infections. It is a broad-spectrum bactericidal agent that inhibits DNA-dependent RNA synthesis in susceptible organisms.
What is the current market landscape for rifampin?
Demand Drivers
- Tuberculosis (TB) treatment: Rifampin's inclusion as a core component of first-line therapy.
- Drug-resistant TB: Growing cases increase reliance on rifampin-based regimens.
- Combination therapies: Used with other anti-tuberculosis agents, maintaining steady demand.
- Global health initiatives: Efforts by WHO and CDC support widespread usage, especially in developing regions.
Competition
| Product Name |
Formulation |
Manufacturer |
Pricing (Approximate) |
Market Share |
| Rifadin (rifampin) |
150 mg, 300 mg |
Johnson & Johnson |
$0.30 - $1.00 per capsule |
Dominates US market |
| Generic Rifampin |
250 mg |
Multiple manufacturers |
$0.10 - $0.50 per capsule |
Significant worldwide |
Regulatory status
- FDA approval: Approved as a prescription drug for TB.
- Global approvals: Approved or included in WHO Essential Medicines List.
- Patent status: Expired, enabling generic manufacturing.
What are recent trends influencing market prices?
- Patent expirations in the early 2000s have led to increased generic competition, reducing prices.
- Global supply chain disruptions have occasionally caused supply shortages, impacting availability.
- Regulatory changes: Certain countries impose import restrictions or require additional quality controls.
- Pricing adjustments: Manufacturers adjust prices based on regional demand, procurement channels, and competition.
What are current price projections?
US pricing
- Brand-name Rifadin (Johnson & Johnson): $0.90 to $1.00 per capsule.
- Generic options: $0.10 to $0.50 per capsule, depending on supplier and volume.
Global pricing
- Low-income countries: $0.01 to $0.05 per capsule via donation and subsidy programs.
- Middle-income nations: $0.04 to $0.20 per capsule.
- High-income countries: Consistent with US pricing, generally $0.10 to $0.50 per capsule for generics.
Price trend outlook (next 3-5 years)
| Year |
Expected Price Range (per capsule) |
Key Factors |
| 2023 |
$0.10 - $0.50 |
Stable, high generics competition |
| 2024 |
$0.09 - $0.45 |
Slight decline, increased generic entry |
| 2025 |
$0.08 - $0.40 |
Market saturation and price competition |
Factors influencing future prices
- Expansion of generic manufacturing capacity.
- Consolidation among pharmaceutical suppliers.
- Demand fluctuations driven by TB control policies.
- Regulatory changes impacting distribution costs.
How does the drug's market position compare?
Rifampin 250 mg remains a staple in TB treatment, supported by widespread generic availability. Price decline due to market saturation, with the most cost-effective options available in low- and middle-income countries. The drug's essential status sustains consistent demand despite regional pricing differences.
What are the implications for stakeholders?
- Pharmaceutical companies: Focus on manufacturing efficiency to maintain margins amid price pressures.
- Payers and health programs: Benefit from low-cost generics but face supply stability concerns.
- Investors: Opportunities exist in generic manufacturing, with margins stabilizing as competition matures.
Summary
NDC 59385-0022 corresponds to rifampin capsules, facing a mature, highly competitive market with declining prices driven by generics. US retail prices hover around $0.10-$0.50 per capsule, with global prices lower in resource-limited settings. Demand remains steady owing to TB treatment needs, with prices expected to stay stable or decline marginally over the next five years.
Key Takeaways
- Rifampin capsules (250 mg) are widely available as generics.
- US prices average $0.10–$0.50 per capsule; globally, prices are lower.
- The market is mature, with competition pressuring prices downward.
- Demand persists due to the drug's role in TB therapy.
- Price stabilization is likely, with potential minor declines due to increased manufacturing capacity.
FAQs
Q1: Will rifampin prices increase due to supply shortages?
Supply disruptions may temporarily elevate prices, but ongoing generic competition caps long-term price increases.
Q2: Are there upcoming regulatory changes impacting rifampin pricing?
Regulatory shifts are unlikely to drastically alter prices but could influence distribution logistics and approval processes.
Q3: How does resistance impact market demand?
Emerging rifampin resistance can diminish demand, prompting shifts to alternative therapies or drug combinations.
Q4: Are newer formulations replacing rifampin?
No, rifampin remains standard in TB treatment; new formulations are still under development or evaluation but have not displaced existing use.
Q5: What are the major markets for rifampin?
The US, India, China, and regions in Africa and Southeast Asia constitute primary markets, driven by TB prevalence.
Citations
[1] World Health Organization. (2021). Treatment of tuberculosis: Guidelines. WHO.
[2] U.S. Food & Drug Administration. (2022). Rifampin Label. FDA.
[3] IQVIA. (2022). Global Antibiotics Market Report. IQVIA.
(Note: All data and projections are based on current market analysis as of 2023 and may fluctuate with emerging trends.)
