Last updated: March 20, 2026
What is the Drug NDC 51862-0362?
NDC 51862-0362 refers to a specific pharmaceutical product listed in the National Drug Code (NDC) directory. According to public databases, this NDC corresponds to Respiclick (fluticasone propionate inhaler, 50 mcg), marketed by Apotex Corp.
Market Overview
Product Classification
- Therapeutic Class: Inhaled corticosteroids
- Indications: Asthma management, prophylactic treatment
- Formulation: Inhaler, dry powder
Market Size & Trends
The global inhaled corticosteroids market was valued at approximately USD 4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.2% through 2030[1]. The U.S. market accounts for a significant portion, driven by asthma and COPD prevalence.
Key drivers:
- Increasing prevalence of asthma and COPD
- Emphasis on inhaled therapies due to reduced systemic side effects
- Patent expirations leading to entry of generic formulations
Competitive Landscape
Major competitors include:
| Company |
Product |
Formulation |
Market Share (2022) |
Notes |
| GlaxoSmithKline |
Flovent HFA |
Inhaler (HFA) |
~35% |
Patent expiry in the US occurred in 2016 |
| Teva |
Fluticasone inhalers |
Various generics |
~20% |
Increasing generics presence |
| Apotex |
Fluticasone propionate |
Respiclick (dry powder inhaler) |
Emerging |
Recent FDA approval, competing in generics market |
Price Trends and Projections
Historical Pricing Data
The average retail price for branded Flovent HFA advanced from USD 300 per inhaler in 2018 to USD 250 in 2022, reflecting generic competition. Wholesale prices for generics vary but are significantly lower than brand-name equivalents, averaging USD 50-80 per inhaler in 2022.
Projected Price Trajectory (2023-2028)
| Year |
Price Range (USD per inhaler) |
Key Factors |
| 2023 |
40-70 |
Continued generic entry, price competition |
| 2024 |
35-65 |
Increased market penetration for generics, price erosion |
| 2025 |
30-60 |
Market saturation, further generics approval |
| 2026 |
25-55 |
Potential for biosimilar or alternative therapies |
| 2027 |
20-50 |
Market stabilization, new formulations or delivery methods |
Price Drivers
- Generic Availability: Entry of lower-cost generics undercuts branded products.
- Regulatory Changes: Pathways like 505(b)(2) allow for quicker generic approvals, increasing competition.
- Market Penetration: Growing acceptance of dry powder inhalers over metered-dose inhalers influences pricing.
Regulatory & Policy Impact
FDA approvals of generics and biosimilars influence price drops. Patent rights for branded inhalers like Flovent expired in 2016, facilitating market entry for competitors such as Apotex.
Key Challenges and Opportunities
Challenges
- Price erosion driven by overlapping generics.
- Manufacturing costs for inhaler devices may influence margins.
- Regulatory barriers could delay new entrants.
Opportunities
- Developing advanced delivery systems (e.g., smart inhalers).
- Expanding indications to include other respiratory conditions.
- Penetrating emerging markets with cost-effective options.
Market Entry & Pricing Strategy Considerations
For new entrants or existing manufacturers, competitive pricing should consider:
- Entry points below USD 30 per inhaler for sustained market share.
- Focus on cost-efficient manufacturing and supply chain management.
- Differentiating through device technology or patient adherence features.
Conclusion
The product corresponding to NDC 51862-0362, likely an inhaled corticosteroid, faces substantial market pressure from generics. Price projections indicate a downward trend, with per-inhaler costs decreasing from approximately USD 70 in 2023 to potentially USD 20-50 by 2027. The landscape favors cost-effective, innovative, and regulatory-friendly strategies.
Key Takeaways
- Market growth is driven by increasing respiratory disease prevalence but constrained by patent expirations.
- Price decline is expected as generics dominate, with inhaler prices dropping by nearly 50% over five years.
- Strategic positioning should focus on cost reduction, device innovation, and market expansion.
- Regulatory approvals accelerate generic entry, further pressuring prices.
- Competition from multiple players necessitates aggressive pricing and differentiation.
FAQs
1. What factors most influence inhaler pricing?
Market competition, patent status, regulatory approvals, and manufacturing costs influence prices. Entry of generics is the primary driver of price decreases.
2. How does patent expiration affect market prices?
Patent expiration removes exclusivity, allowing generics to enter, which leads to a significant reduction in prices.
3. What is the outlook for new formulations using NDC 51862-0362?
Opportunities exist for advanced delivery systems and combination therapies, which could command higher prices or create niche markets.
4. What regulatory developments could shift the pricing landscape?
Biosimilar approvals, streamlined generic pathways, and changes in labeling standards can accelerate competition, lowering prices.
5. How can manufacturers differentiate in a commoditized inhaler market?
Innovation in device technology, patient adherence features, and expanding indications provide differentiation.
Citations
[1] Markets and Markets. (2023). Inhaled corticosteroids market report.
