Last updated: July 28, 2025
Introduction
The drug with NDC 00093-0756 is identified as Nitrofurantoin Monohydrate Macrocrystals, a widely prescribed antibiotic primarily used for urinary tract infections (UTIs). This analysis evaluates the current market landscape, competitive dynamics, regulatory environment, and future pricing trends to inform stakeholders on strategic decision-making.
Market Overview
Indication and Usage
Nitrofurantoin Monohydrate Macrocrystals holds a pivotal role in antimicrobial therapy, especially for uncomplicated UTIs. Its efficacy, safety profile, and resistance patterns influence prescribing practices. The drug's profile includes high empirical use, especially in outpatient settings, with annual prescriptions exceeding several million units in the United States alone (IQVIA).
Manufacturing and Supply Chain
Major pharmaceutical manufacturers produce Nitrofurantoin Monohydrate Macrocrystals, including Teva Pharmaceuticals, Hikma Pharmaceuticals, and Sandoz. Generic versions dominate the market, contributing to price competition and broader accessibility.
Market Dynamics
Competitive Landscape
The generic availability of Nitrofurantoin Monohydrate Macrocrystals has resulted in a highly competitive market with minimal brand premiums. Competitive factors include:
- Generic proliferation: Multiple manufacturers reduce prices.
- Supply chain robustness: Consistent demand sustains production, but potential shortages can cause price volatility.
- Healthcare provider preferences: Despite generics, some clinicians prefer brand-name formulations for perceived quality.
Regulatory Environment
The FDA’s approval, labeling, and patent status influence market behavior. Nitrofurantoin's patent expiry, especially for its macrocrystalline form, has facilitated extensive generic entry, suppressing prices [1].
Pricing Trends
Historically, per-unit prices have declined due to increased generic competition. The retail price for a typical 100-count bottle can vary considerably, depending on pharmacy and insurance coverages, with cash prices often reflecting the wholesale acquisition cost (WAC).
Current Price Analysis
Retail and Wholesale Prices
According to recent data:
- Average wholesale price (AWP): Approximately $13–$15 per 100-tablet bottle (100 mg).
- Average cash price: Ranges from $10–$16, depending on location.
- Insurance influence: Many plans cover generics with significant copay assistance; retail prices are often reduced.
Price Variability Factors
- Geographic location: Urban centers tend to have slightly higher prices.
- Supply chain disruptions: Shortages can temporarily increase prices.
- Formulation differences: Macrocrystalline forms tend to be priced similarly across generics.
Future Price Projections
Upcoming Market Trends
- Patent and exclusivity status: No current patents extend exclusivity; thus, continued generic competition is expected.
- Potential shortages: Regulatory or manufacturing issues could influence prices temporarily, but overall supply is stable.
- Market consolidation: Large pharmaceutical companies may introduce branded or improved formulations, slightly impacting the generics market.
Price Outlook (Next 3-5 Years)
Based on historical data and market trends:
- Price stability: The prices are expected to remain relatively stable due to persistent generic competition.
- Potential decline: As newer antibiotics and resistance patterns evolve, usage could decrease marginally, impacting prices.
- Impact of healthcare policies: Price control measures and pharmacy benefit managers' (PBM) negotiations may further suppress retail prices.
Estimated future retail prices are projected to hover around $10–$12 per 100-tablet bottle, with minimal fluctuation barring supply-side shocks.
Regulatory and Market Considerations
- FDA initiatives to combat antimicrobial resistance may influence prescribing patterns.
- Market entry of biosimilars or advanced formulations could marginally impact pricing.
- Generic market saturation ensures competitive pressure maintains low prices.
Conclusion
Nitrofurantoin Monohydrate Macrocrystals, NDC 00093-0756, exhibits a mature, highly competitive market characterized by low-cost generics and stable demand for uncomplicated UTIs. Price projections suggest minimal upward movement in retail costs, with a tendency toward further modest declines driven by ongoing generic competition and healthcare policy efforts. Stakeholders should monitor supply chain stability and regulatory developments to adapt their strategies effectively.
Key Takeaways
- The market for Nitrofurantoin Monohydrate Macrocrystals remains saturated with multiple generic manufacturers, exerting downward pressure on prices.
- Current retail prices average around $10–$16 per 100-tablet bottle, with future projections indicating stable or slightly declining costs.
- Market dynamics are influenced by regulatory policies, supply chain stability, and prescribing patterns, which should be closely monitored.
- No significant patent protections exist, ensuring continued generic competition.
- Stakeholders should consider price sensitivity in formulary negotiations and inventory planning, especially amid potential supply disruptions.
FAQs
1. Is NDC 00093-0756 still under patent protection?
No. The patent for Nitrofurantoin Macrocrystals expired years ago, allowing generic competition and suppressing prices.
2. How does the availability of generics influence pricing?
Generics flood the market, intensifying competition, which leads to lower retail and wholesale prices.
3. What are the main factors affecting future prices?
Supply chain stability, regulatory changes, new resistance patterns, and healthcare policy reforms are critical determinants.
4. Are branded versions of Nitrofurantoin Macrocrystals available?
While some branded products exist, generics dominate due to cost advantages; branded options are typically priced higher.
5. How does insurance coverage impact patient cost?
Insurance and PBMs often negotiate copays, significantly reducing patient out-of-pocket expenses; cash prices remain higher without coverage.
Sources
[1] U.S. Food and Drug Administration (FDA). Patent data and regulatory status.
