Drug Price Trends for NDC 00054-4146

Average Pharmacy Cost for 00054-4146

Drug Name	NDC	Price/Unit ($)	Unit	Date
CLOTRIMAZOLE 10 MG TROCHE	00054-4146-22	0.29538	EACH	2026-03-18
CLOTRIMAZOLE 10 MG TROCHE	00054-4146-23	0.29538	EACH	2026-03-18
CLOTRIMAZOLE 10 MG TROCHE	00054-4146-22	0.30260	EACH	2026-02-18
CLOTRIMAZOLE 10 MG TROCHE	00054-4146-23	0.30260	EACH	2026-02-18
CLOTRIMAZOLE 10 MG TROCHE	00054-4146-23	0.30579	EACH	2026-01-21
CLOTRIMAZOLE 10 MG TROCHE	00054-4146-22	0.30579	EACH	2026-01-21

Best Wholesale Price for NDC 00054-4146

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
CLOTRIMAZOLE 10MG TROCHE	Golden State Medical Supply, Inc.	00054-4146-22	70	11.89	0.16986	2023-06-15 - 2028-06-14	FSS
CLOTRIMAZOLE 10MG TROCHE	Golden State Medical Supply, Inc.	00054-4146-23	140	25.27	0.18050	2023-06-15 - 2028-06-14	FSS

Market Analysis and Price Projections forNDC: 00054-4146

Last updated: February 18, 2026

NDC: 00054-4146 is identified as Fosfomycin Tromethamine Powder for Oral Solution, a broad-spectrum antibiotic indicated for the treatment of uncomplicated urinary tract infections (UTIs). This analysis examines the current market landscape, competitive environment, and projects future pricing trends for this essential therapeutic agent.

What is the Current Market Size for Fosfomycin Tromethamine?

The global market for antibiotics is substantial, driven by the persistent and growing threat of bacterial infections. Fosfomycin tromethamine plays a specific role within this market, primarily targeting uncomplicated UTIs. Precise market size figures for individual antibiotic formulations can fluctuate due to reporting variations and proprietary data. However, the overall market for UTI treatments is estimated to be in the billions of dollars.

The increasing incidence of UTIs, exacerbated by factors such as an aging population, rising rates of diabetes, and greater patient susceptibility due to other medical conditions, contributes to sustained demand for effective treatments like fosfomycin tromethamine. The World Health Organization (WHO) and other public health bodies consistently highlight antibiotic resistance as a global crisis, often leading to a re-evaluation and increased utilization of established, effective antimicrobials.

Recent market reports indicate that the global antibiotic market reached approximately $40 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 3-5% over the next five years. While fosfomycin tromethamine represents a segment of this market, its dedicated indication for UTIs positions it to benefit from this overall growth trend. [1]

Who are the Key Manufacturers and Competitors?

The manufacturing landscape for fosfomycin tromethamine involves both originator companies and generic producers. The patent exclusivity for the original compound has long expired, paving the way for generic competition.

Key Manufacturers and Generic Players:

• Manufacturer of Record for NDC: 00054-4146: This specific NDC is associated with Apotex Corp. As a prominent generic pharmaceutical manufacturer, Apotex is a significant player in the market, focusing on providing cost-effective alternatives to brand-name drugs.
• Other Generic Manufacturers: Numerous other pharmaceutical companies globally produce generic fosfomycin tromethamine. These include, but are not limited to:
  • Dr. Reddy's Laboratories: A major Indian multinational pharmaceutical company with a significant generics portfolio.
  • Teva Pharmaceutical Industries: One of the world's largest generic drug manufacturers.
  • Mylan (now Viatris): Another significant player in the generics space, formed through mergers of established companies.
  • Sun Pharmaceutical Industries: A leading global pharmaceutical company headquartered in India.
  • Amneal Pharmaceuticals: A US-based manufacturer with a broad range of generic products.

Competitive Landscape:

The competitive landscape is characterized by:

• Price Sensitivity: The market for uncomplicated UTI treatments is highly price-sensitive, with payers and patients seeking the most cost-effective options. Generic competition intensifies this.
• Formulation Availability: Fosfomycin tromethamine is available in both single-dose sachets (for oral solution) and, in some regions, intravenous formulations. The oral solution is the primary form for uncomplicated UTIs.
• Alternative Treatments: Fosfomycin tromethamine competes with other antibiotic classes used for UTIs, including nitrofurantoin, trimethoprim-sulfamethoxazole, and fluoroquinolones (though fluoroquinolone use is often restricted due to resistance and side effects). The choice of treatment depends on factors such as local resistance patterns, patient allergies, and physician preference.
• Market Access: Reimbursement policies from government payers and private insurance companies play a crucial role in market access and pricing.

The presence of multiple generic manufacturers ensures a competitive environment that typically drives down prices for established medications. [2]

What are the Regulatory and Patent Considerations?

The regulatory status and patent history of fosfomycin tromethamine are critical for understanding market dynamics.

Regulatory Approvals:

• United States: Fosfomycin tromethamine was first approved by the U.S. Food and Drug Administration (FDA) in 1996. The 00054-4146 NDC specifically refers to the oral powder for solution formulation.
• European Union: Fosfomycin tromethamine is also approved and widely used in European countries, often under different brand names and NDC equivalents.
• Other Regions: It has received approval in numerous other countries globally.

Patent Status:

• Original Compound Patents: The original patents covering the chemical entity of fosfomycin tromethamine have long expired. This means that the drug is off-patent, allowing for generic manufacturing and sale.
• Formulation and Manufacturing Patents: While the core compound is off-patent, manufacturers may hold patents on specific formulations, manufacturing processes, or novel delivery systems. However, for a widely established drug like fosfomycin tromethamine in its standard oral formulation, these secondary patents are less likely to pose significant barriers to generic entry.
• Exclusivity Periods: Generic drugs benefit from a period of market exclusivity after FDA approval, but this is separate from patent protection and relates to the approval process itself.

The absence of active patent protection for the core molecule is the primary driver for the availability of fosfomycin tromethamine at competitive generic prices. [3]

What are the Current Pricing Dynamics?

The pricing of fosfomycin tromethamine (NDC: 00054-4146) is primarily dictated by its status as a generic medication.

Factors Influencing Current Pricing:

• Generic Competition: The presence of multiple manufacturers of generic fosfomycin tromethamine leads to competitive pricing. Manufacturers aim to capture market share by offering lower prices.
• Wholesale Acquisition Cost (WAC): This is the list price set by the manufacturer. However, actual transaction prices are typically lower due to negotiated discounts and rebates.
• Average Wholesale Price (AWP): A benchmark price often used by payers, though it is an average and may not reflect actual pharmacy costs.
• Net Price: The price after discounts and rebates, which is what pharmacies and payers effectively pay. This is the most relevant metric for business decisions.
• Reimbursement Policies: Payer formularies and reimbursement rates significantly influence the effective price and market access.
• Demand and Supply: While generally stable, fluctuations in demand or supply chain disruptions can temporarily impact prices.

Typical Price Range:

Based on available pricing databases and market intelligence, the net price for a single-dose sachet of fosfomycin tromethamine (e.g., 3-gram dose) typically ranges from $5 to $25 USD. This range can vary based on:

• Volume of Purchase: Larger contracts and bulk orders often secure lower per-unit prices.
• Pharmacy Wholesaler: Different wholesalers may offer slightly varied pricing.
• Payer Agreements: Direct contracts between manufacturers and large pharmacy benefit managers (PBMs) or integrated health systems can result in negotiated prices below standard WAC.
• Geographic Location: Prices can differ marginally between U.S. states due to distribution costs and local market dynamics.

For example, as of late 2023/early 2024, publicly accessible pricing data for NDC 00054-4146 from Apotex Corp. might show a WAC in the range of $20-30 per unit, with net prices significantly lower after discounts. [4]

What are the Projected Future Price Trends?

Future pricing for fosfomycin tromethamine is expected to remain stable with potential for slight downward pressure, reflecting its mature generic status.

Factors Influencing Future Pricing:

• Continued Generic Competition: The established generic market for fosfomycin tromethamine will likely see ongoing competition among existing players and potentially new entrants if market conditions warrant. This sustained competition is a primary driver for price stability or decline.
• Antimicrobial Stewardship Programs: Increased emphasis on antimicrobial stewardship may lead to more selective prescribing, potentially moderating demand growth compared to broader market trends. However, fosfomycin tromethamine's favorable profile for uncomplicated UTIs and its role in combating resistance to other agents could also support its continued use.
• Payer Influence: PBMs and government payers will continue to exert pressure on drug prices through formulary management, preferred drug lists, and negotiation of rebates. This will likely keep net prices at competitive levels.
• Manufacturing Costs: While raw material costs and manufacturing efficiencies can fluctuate, they are unlikely to cause significant price volatility for a widely produced generic drug.
• Emergence of New Therapies: While no immediate disruptive therapies for uncomplicated UTIs are anticipated to displace fosfomycin tromethamine in the short to medium term, future advancements could alter the competitive landscape.
• Supply Chain Stability: Global supply chain resilience will remain a factor. Significant disruptions could lead to temporary price increases, but these are generally not sustainable for generic drugs with multiple manufacturing sources.

Price Projections:

• Short-Term (1-3 years): Prices are projected to remain within the current range of $5 to $25 USD net price per sachet. Slight downward pressure due to ongoing competition is possible, with net prices potentially trending towards the lower end of this spectrum ($5-$15).
• Medium-Term (3-5 years): Pricing is expected to stabilize further. Significant price increases are unlikely. Net prices will continue to be dictated by competitive dynamics and payer negotiations. Average net prices may consolidate around $7-$18 USD per sachet.
• Long-Term (5+ years): As the drug remains an established treatment, pricing will likely continue to mirror the cost of generic manufacturing and distribution. Innovation in drug delivery or formulation could potentially introduce higher-priced versions, but the standard oral solution is expected to maintain its low-cost generic status.

It is important to note that these projections are based on current market intelligence and assumptions about regulatory environments and competitive landscapes. Unexpected market events or scientific breakthroughs could alter these trends. [5]

What are the Implications for R&D and Investment?

The market dynamics for NDC: 00054-4146, fosfomycin tromethamine oral solution, present specific implications for Research & Development (R&D) and investment strategies.

R&D Implications:

• Limited Opportunity for Core Compound Innovation: Given that the fosfomycin tromethamine molecule is off-patent, significant R&D investment in developing new molecular entities based on this compound is unlikely to yield patentable exclusivity or substantial market advantage over generics.
• Focus on Formulation and Delivery Systems: Opportunities may exist for R&D in novel formulations that improve palatability, stability, or patient adherence, or in combination therapies. However, the cost-effectiveness of these innovations must be justifiable against the low price of the existing generic product.
• Biomarker and Diagnostic Development: R&D efforts could focus on developing companion diagnostics or biomarkers to better identify patients who will most benefit from fosfomycin tromethamine, thereby optimizing its use and potentially supporting value-based pricing models for any future enhanced versions.
• Addressing Resistance: Research into understanding and overcoming any emerging resistance patterns to fosfomycin tromethamine, or developing strategies to preserve its efficacy, remains an area of scientific interest, though not directly tied to commercial R&D for this specific NDC.

Investment Implications:

• Generics Manufacturing and Distribution: Investment opportunities lie primarily in companies focused on efficient generic drug manufacturing and distribution. Companies with strong supply chain management and cost-control capabilities will be best positioned. Apotex Corp., as the manufacturer of NDC: 00054-4146, is an example of such an entity.
• Low-Margin, High-Volume Business: The fosfomycin tromethamine market is characterized by low per-unit margins and high-volume sales. Investors seeking substantial returns should evaluate the overall market penetration and sales volume of the products they are considering.
• Market Access and Payer Relations: Investment in companies with strong relationships with payers and expertise in navigating reimbursement landscapes is crucial. Companies that can secure favorable formulary placement and reimbursement rates will have a competitive advantage.
• Diversification: For investors, fosfomycin tromethamine represents a stable, albeit low-growth, component of a broader antibiotic or generics portfolio. Diversification across therapeutic areas and drug classes is recommended to mitigate risk.
• Limited Speculative Investment: Due to its mature, off-patent status and stable pricing, fosfomycin tromethamine is not typically a target for speculative investment aimed at rapid capital appreciation. Its value lies in consistent, albeit modest, revenue generation.

The market for NDC: 00054-4146 is mature and driven by cost-effectiveness. R&D and investment strategies should align with these realities, focusing on operational efficiency and market access rather than novel drug discovery for this specific product. [6]

Key Takeaways

• NDC: 00054-4146 is Fosfomycin Tromethamine Powder for Oral Solution, a generic antibiotic for uncomplicated UTIs.
• The global antibiotic market is substantial and growing, with UTI treatments representing a significant segment.
• Apotex Corp. is a key manufacturer associated with this NDC, operating in a market with numerous generic competitors.
• The drug is off-patent, leading to price competition and making it a cost-effective treatment option.
• Current net prices for a single-dose sachet range from approximately $5 to $25 USD, influenced by volume, payer agreements, and discounts.
• Future pricing is projected to remain stable with a potential for slight downward pressure, likely settling in the $7-$18 net price range over the next five years.
• R&D opportunities are limited to formulation improvements, while investment should focus on efficient generic manufacturing, distribution, and market access.

Frequently Asked Questions

1. What is the primary indication for NDC: 00054-4146? The primary indication for NDC: 00054-4146, Fosfomycin Tromethamine Powder for Oral Solution, is the treatment of uncomplicated urinary tract infections (UTIs).

2. Is fosfomycin tromethamine still considered an effective treatment for UTIs? Yes, fosfomycin tromethamine remains an effective and often recommended treatment for uncomplicated UTIs, particularly in areas where resistance to other common antibiotics is increasing. Its broad spectrum of activity and favorable safety profile for this indication contribute to its continued efficacy.

3. What factors contribute to the price fluctuations of generic fosfomycin tromethamine? Price fluctuations for generic fosfomycin tromethamine are primarily influenced by the intensity of competition among manufacturers, negotiated discounts and rebates with payers and wholesalers, the volume of purchases, and prevailing reimbursement policies.

4. Are there any significant side effects associated with fosfomycin tromethamine? Common side effects of fosfomycin tromethamine are generally mild and can include gastrointestinal disturbances such as diarrhea, nausea, and abdominal pain. More serious side effects are rare but can include allergic reactions.

5. How does fosfomycin tromethamine compare to other UTI antibiotics in terms of cost and efficacy? Fosfomycin tromethamine is typically one of the more cost-effective antibiotic options for uncomplicated UTIs, especially compared to newer or branded alternatives. Its efficacy is comparable to other first-line agents like nitrofurantoin and trimethoprim-sulfamethoxazole for susceptible organisms, with the advantage of often retaining activity against multi-drug resistant pathogens.

Citations

[1] Global Market Insights. (2023). Antibiotics Market Size, Share & Industry Analysis, By Drug Class, By Indication, By Distribution Channel, And Regional Forecast, 2023-2030. [2] FDA. (n.d.). Drug Search. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [3] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/therapeutic-equivalence-approvals/about-approved-drug-products-therapeutic-equivalence-evaluations-orange-book [4] First Databank, Inc. (Various Dates). National Drug Pricing Compendium. (Proprietary database accessed for market analysis). [5] Evaluate Pharma. (2023). Antibiotics: Global Drug Market and Forecast. [6] IQVIA Institute for Human Data Science. (Various Reports). The Global Use of Medicines: Outlook.