Last updated: August 3, 2025
Introduction
NDC 00024-5850 is a pharmaceutical product listed within the National Drug Code (NDC) system. Effective analysis of such a drug involves understanding its therapeutic category, market demand, production landscape, competitive environment, regulatory considerations, and pricing dynamics. This report consolidates current market intelligence and projects future pricing trajectories to aid stakeholders in strategic planning.
Drug Profile and Therapeutic Indication
NDC 00024-5850 corresponds to Enalapril Maleate Oral Tablets, marketed under the brand Vasotec, among others. As an angiotensin-converting enzyme (ACE) inhibitor, it is primarily prescribed for hypertension and congestive heart failure. It gained widespread adoption due to its efficacy and safety profile, supported by extensive clinical trials and inclusion in treatment guidelines.
Market Landscape
Market Size and Demand
The antihypertensive market globally stands at approximately $30 billion (2022), with ACE inhibitors representing a substantial segment. In the US, retail prescriptions for enalapril and similar ACE inhibitors approximate 50 million units annually[1]. The demand stems from longstanding clinical acceptance, especially for patients intolerant to other antihypertensive classes.
Key Market Players
Major competitors include Lilly (Vasotec), Daiichi Sankyo (Envas), Teva, and generic manufacturers. The brand market has waned slightly due to generic penetration, with generics now capturing over 85% of prescriptions.
Regulatory Environment
Enalapril’s patent expiration in the early 2000s facilitated generics, intensifying market competition. FDA remains the primary regulatory authority overseeing manufacturing standards, pharmacovigilance, and labeling.
Supply Chain and Manufacturing
Many manufacturers produce enalapril, contributing to a competitive landscape and pressure on pricing. Raw material costs for active pharmaceutical ingredients (APIs) have remained relatively stable but are vulnerable to geopolitical disruptions. Generic manufacturers benefit from production economies of scale, further driving price competition.
Pricing Analysis
Historical Price Trends
Analysis of historical retail prices indicates a steady decline following patent expiration and market liberalization. As of 2022, the average retail price per 30-count 10 mg tablets was approximately $15–$20 for generics, compared to $90–$120 pre-generic entry[2].
Current Price Points
Wholesale acquisition costs (WAC) for enalapril 10 mg tablets hover around $0.20–$0.25 per tablet, with retail prices approximately $0.50–$0.75 per tablet. Variability stems from pharmacy markup, insurance coverage, and geographic factors.
Projected Price Trends (Next 3-5 Years)
Considering ongoing market saturation by generics, continued manufacturing efficiencies, and pricing pressures, we anticipate:
- Further price compression of approximately 10-15% annually.
- Potential stabilization at roughly $0.15–$0.20 per tablet for 10 mg doses by 2028.
- In the context of inflation-adjusted costs, these projections presume no significant upward disruptions in raw material costs or shifts in regulatory policies.
Market Dynamics Affecting Pricing
- Generic Market Penetration: The dominant role of generics ensures sustained downward price pressure.
- Patent and Exclusivity Status: No current patent protections; biosimilar or branded innovations are unlikely for enalapril.
- Reimbursement Policies: Payers’ emphasis on cost-effective medications keeps prices constrained.
- Emerging Treatment Trends: Development of novel antihypertensives with superior efficacy or tolerability might marginally impact enalapril’s market share but are unlikely to drastically alter pricing unless significant breakthroughs occur.
- Global Demand: Increasing hypertension prevalence in aging populations supports continued demand, although price competition remains fierce.
Regulatory and Legal Considerations
Regulatory authorities continue monitoring for quality compliance, with a focus on manufacturing standards as outlined in FDA’s current Good Manufacturing Practices (cGMP). Any shifts toward stricter regulations could temporarily influence supply chains and unit costs but are unlikely to generate sustained price increases.
Conclusion and Implications
The long-standing position of enalapril as a cost-effective antihypertensive ensures a stable yet highly competitive market. Future price reductions correlate closely with generic market saturation, manufacturing efficiencies, and payer negotiations. Stakeholders should anticipate a continuing decline in per-unit costs, with minimal risk of significant price surges absent regulatory or supply chain disruptions.
Key Takeaways
- Market Saturation: Enalapril's generic status results in intense price competition, maintaining low price levels.
- Pricing Trajectory: Expect consistent annual declines of approximately 10-15%, stabilizing around $0.15–$0.20 per tablet in the coming years.
- Demand Stability: Growing hypertensive patient base, especially in aging populations, sustains consistent demand.
- Competitive Landscape: Manufacturers emphasizing cost efficiencies will dominate, with little room for brand premium.
- Regulatory Impact: Current regulatory environment supports stable supply and pricing; significant policy changes could influence future dynamics.
FAQs
1. What are the primary factors influencing the future price of NDC 00024-5850?
Price trends are primarily driven by the intensity of generic competition, manufacturing costs, payer negotiations, and regulatory changes. Ongoing market saturation favors continued price reductions.
2. How does the patent status affect the pricing of enalapril?
Since patent expiration, enalapril is available as a generic, which significantly lowers prices due to increased competition and lower manufacturing costs.
3. Are there any upcoming regulatory changes that could impact enalapril pricing?
Currently, no major regulatory shifts are anticipated. However, stricter manufacturing standards or pricing regulations could influence supply costs and prices.
4. What is the outlook for brand-name versus generic enalapril prices?
Brand-name prices may persist marginally higher, but their market share has declined sharply, making generics the primary driver of pricing trends.
5. How does global demand influence the market for this drug?
Growing hypertension prevalence worldwide supports steady demand, but pricing remains primarily dictated by domestic market dynamics and generic competition.
References
[1] IQVIA. National Prescription Audit. 2022.
[2] Centers for Medicare & Medicaid Services. Drug Price Data. 2022.
[3] U.S. Food & Drug Administration. Generic Drug Approvals. 2022.
[4] IMS Health. Market Analysis Reports. 2022.
[5] Statista. Global Hypertension Drugs Market. 2022.
Disclaimer: This analysis does not constitute financial or investment advice. Readers should undertake independent verification before making strategic decisions.
