Last updated: July 28, 2025
Introduction
NDC 00002-1484 corresponds to a pharmaceutical product registered within the National Drug Code (NDC) system. This particular code pertains to a medication with established therapeutic indications, widespread utilization, and defined market parameters. To inform strategic decisions, it’s essential to evaluate its current market dynamics, competitive landscape, pricing trends, and future projections.
Product Overview
NDC 00002-1484 identifies Hydrochlorothiazide (HCTZ), a widely used thiazide diuretic primarily prescribed for hypertension and edema management. As one of the most generic and affordable antihypertensives, Hydrochlorothiazide enjoys broad utilization within outpatient settings globally.
This drug's long-standing presence in the market, low manufacturing costs, and extensive patent expiration mark it as a cornerstone generic in cardiovascular treatment protocols. Its established efficacy and safety profile enhance its market penetration, especially in the United States, where hypertension remains prevalent.
Current Market Landscape
Supply Chain and Production
Hydrochlorothiazide's classification as a generic medication results in an extensive manufacturing network. Major pharmaceutical manufacturers, including Mylan, Teva, Sun Pharma, and Hikma, contribute to an oversaturated supply market. This competition results in declining unit costs and compresses profit margins for pharmaceutical companies involved.
Market Demand Dynamics
According to IQVIA data, Hydrochlorothiazide maintains a significant volume of prescriptions, with annual U.S. prescription counts approximately 25 million. Despite the advent of newer antihypertensives, HCTZ’s low cost and favorable side effect profile sustain its market foothold.
Competitive Products
While HCTZ faces competition from combination therapies (e.g., ACE inhibitors with diuretics), generic monotherapy remains a mainstay. The recent trend towards fixed-dose combinations with better safety profiles and increased adherence slightly dampens standalone diuretic demand but overall ensures continued utilization.
Regulatory and Patent Status
Hydrochlorothiazide’s patent expiry in the late 1990s has facilitated entry of multiple generics, leading to diminished pricing power and a mature market environment. Regulatory scrutiny remains stable, with no recent major hurdles affecting supply.
Pricing Trends and Historical Data
Historical Pricing Trajectory
The average wholesale price (AWP) for Hydrochlorothiazide 25 mg tablets has steadily declined over the past decade, with recent AWP figures circa $0.01 - $0.02 per tablet. Medicaid and pharmacy benefit managers (PBMs) have further driven prices down through negotiated rebates and discounts.
Current Market Price Points
- Wholesale Acquisition Cost (WAC): Approximately $0.03 - $0.05 per tablet (depending on pack size and supplier)
- Average Selling Price (ASP): Marginally higher, around $0.05 per tablet
- End-User Price: Often less than $0.10 per tablet in retail pharmacies after rebates and discounts
This pricing compression underscores the product's tremendous commoditization in the generic space.
Future Price Projections
Factors Impacting Future Prices
- Market Saturation & Competition: Continued proliferation of generic manufacturers results in persistent price pressures.
- Regulatory Environment: Stringent quality standards and potential consolidation could influence supply costs.
- Healthcare Policy: Policy initiatives to reduce drug costs, including increased price transparency and negotiated reimbursement models, will likely sustain low prices.
- Innovative Alternatives: The emergence of combination therapies could marginally displace monotherapy demand but are unlikely to replace the core generic market.
Projected Market Trends for the Next 3-5 Years
Based on current trends, Hydrochlorothiazide's unit price is expected to remain stable or decline marginally within the next five years, driven primarily by competitive pressures.
- Price Range: Estimated to fluctuate around $0.01 to $0.02 per tablet.
- Market Share: Expected to retain a substantial share due to clinical familiarity and low cost, with minor declines possible from newer therapy options.
Implications for Stakeholders
- Manufacturers: Price margins will remain thin; focus should shift toward cost-efficient manufacturing and supply chain resilience.
- Payers and PBMs: Further negotiations and formulary management will reinforce the downward pricing trend.
- Pharmacies: Profit margins will continue to be minimal; operational efficiencies and high-volume sales remain critical.
- Innovators: Little incentive exists for brand-name or novel formulations in this class due to price erosion.
Conclusion
NDC 00002-1484 (Hydrochlorothiazide) operates within a highly commoditized, mature market characterized by intense competition and declining prices. Over the next five years, expect minimal price fluctuations, sustained high-volume prescribing, and marginal long-term price declines. Stakeholders should strategize accordingly—focusing on supply chain efficiencies, market share retention, and leveraging the product’s cost advantage.
Key Takeaways
- Hydrochlorothiazide’s market is saturated with numerous generic manufacturers, sustaining low price points.
- Prices are expected to stabilize or decrease modestly over the next five years due to fierce competition.
- The drug’s core demand remains robust for hypertension management, but newer therapies may exert marginal pressure.
- Cost-efficient manufacturing, supply chain stability, and strategic pricing remain essential for profit maximization.
- Stakeholders should monitor regulatory and policy shifts that could subtly influence market dynamics.
FAQs
1. What factors have historically influenced Hydrochlorothiazide’s pricing?
Market saturation, generic competition, and regulatory policies have driven prices downward. The high number of manufacturers producing similar formulations exerts continuous price pressure.
2. Will the price of NDC 00002-1484 increase with new patent protections?
Unlikely. Hydrochlorothiazide’s patent expired decades ago, and no recent patent protections are in place. The market remains highly competitive, favoring low prices.
3. How does the rise of combination antihypertensive drugs affect Hydrochlorothiazide’s market?
Combination therapies may slightly reduce standalone diuretic demand but do not drastically diminish Hydrochlorothiazide’s overall market share due to its affordability and established efficacy.
4. Are there any regulatory concerns that might impact the supply or pricing?
Currently, no major regulatory hurdles threaten the supply chain. However, increased quality standards and potential consolidations may influence future production costs.
5. What strategies should manufacturers adopt to remain profitable?
Focus on reducing manufacturing costs, securing supply chain stability, expanding market coverage, and maintaining quality standards to differentiate amidst low-price competition.
Sources
- IQVIA National Prescription Audit Data.
- U.S. Food and Drug Administration (FDA) Drug Approvals and Regulations.
- Pharma Market Research Reports (2022-2023).
- Wholesale Acquisition Cost (WAC) and Average Selling Price (ASP) Data from Medi-Span.
- Centers for Medicare & Medicaid Services (CMS) Drug Price Trends.