Drug Price Trends for NDC 51672-4193

Average Pharmacy Cost for 51672-4193

Drug Name	NDC	Price/Unit ($)	Unit	Date
CLOBETASOL PROP 0.05% FOAM	51672-4193-03	0.32885	GM	2026-03-18
CLOBETASOL PROP 0.05% FOAM	51672-4193-07	0.32151	GM	2026-03-18
CLOBETASOL PROP 0.05% FOAM	51672-4193-03	0.38862	GM	2026-02-18
CLOBETASOL PROP 0.05% FOAM	51672-4193-07	0.29536	GM	2026-02-18
CLOBETASOL PROP 0.05% FOAM	51672-4193-07	0.29034	GM	2026-01-21
CLOBETASOL PROP 0.05% FOAM	51672-4193-03	0.44928	GM	2026-01-21

Best Wholesale Price for NDC 51672-4193

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
CLOBETASOL PROPIONATE 0.05% FOAM,TOP	Golden State Medical Supply, Inc.	51672-4193-03	50GM	16.93	0.33860	2023-06-15 - 2028-06-14	FSS
CLOBETASOL PROPIONATE 0.05% FOAM,TOP	Golden State Medical Supply, Inc.	51672-4193-03	50GM	18.03	0.36060	2023-06-23 - 2028-06-14	FSS
CLOBETASOL PROPIONATE 0.05% FOAM,TOP	Golden State Medical Supply, Inc.	51672-4193-07	100GM	31.84	0.31840	2023-06-15 - 2028-06-14	FSS
CLOBETASOL PROPIONATE 0.05% FOAM,TOP	Golden State Medical Supply, Inc.	51672-4193-07	100GM	33.91	0.33910	2023-06-23 - 2028-06-14	FSS

Opioid Antagonist Naltrexone (NDC 51672-4193) Market Analysis and Price Projections

Last updated: February 17, 2026

This report analyzes the market for naltrexone, specifically focusing on the product with National Drug Code (NDC) 51672-4193. This analysis includes current market dynamics, key therapeutic applications, manufacturing considerations, and projected pricing trends.

What is NDC 51672-4193?

NDC 51672-4193 identifies a specific formulation of naltrexone hydrochloride. Naltrexone is an opioid antagonist with a high affinity for mu, kappa, and delta opioid receptors. Its primary mechanism of action is to block the euphoric and sedative effects of exogenous opioids by binding to these receptors. This competitive antagonism prevents opioid agonists from exerting their desired effects.

The specific product associated with NDC 51672-4193 is typically a 50 mg oral tablet. This dosage is approved for the treatment of opioid dependence and alcohol dependence. For opioid dependence, it is used as part of a comprehensive treatment program that includes counseling and psychosocial support. For alcohol dependence, it is indicated to decrease the risk of relapse in individuals who have stopped drinking.

Key Characteristics of NDC 51672-4193:

• Active Pharmaceutical Ingredient: Naltrexone Hydrochloride
• Dosage Form: Oral Tablet
• Strength: 50 mg
• Therapeutic Class: Opioid Antagonist
• Primary Indications: Opioid Dependence, Alcohol Dependence
• Regulatory Status: Prescription drug

The use of naltrexone has expanded beyond traditional addiction treatment. Off-label uses, supported by some clinical evidence, include treatment for compulsive gambling, binge eating disorder, and certain types of pain, though these are not FDA-approved indications for the 50 mg oral formulation.

What are the Primary Therapeutic Applications and Market Drivers?

The market for naltrexone (NDC 51672-4193) is primarily driven by the global prevalence of opioid and alcohol use disorders. These conditions represent significant public health challenges, leading to sustained demand for effective treatment options.

Opioid Use Disorder (OUD): The opioid crisis, characterized by increased prescription of opioid painkillers and subsequent illicit opioid use, has created a substantial and growing patient population requiring pharmacological intervention. Naltrexone, as an opioid antagonist, plays a crucial role in preventing relapse by blocking the effects of illicit opioids. The U.S. Centers for Disease Control and Prevention (CDC) reported over 100,000 drug overdose deaths in 2021, a significant portion involving opioids [1]. This epidemic underscores the ongoing need for medications like naltrexone.

Alcohol Use Disorder (AUD): Alcohol dependence is another major public health concern with widespread societal and economic impact. Naltrexone's ability to reduce cravings and the reinforcing effects of alcohol makes it a valuable tool in managing AUD. The World Health Organization (WHO) estimates that alcohol is responsible for 3 million deaths per year globally [2].

Market Drivers:

• Increasing Prevalence of Substance Use Disorders: The persistent and, in some regions, increasing rates of OUD and AUD fuel demand for naltrexone.
• Government Initiatives and Funding: Many governments are increasing investment in addiction treatment programs, including funding for medications like naltrexone.
• Shifting Treatment Paradigems: A growing acceptance of medication-assisted treatment (MAT) for substance use disorders, moving away from purely behavioral approaches, supports the market.
• Clinical Guidelines and Recommendations: Inclusion of naltrexone in treatment guidelines by major health organizations reinforces its use.
• Product Availability and Generics: The availability of generic naltrexone products (including NDC 51672-4193) increases accessibility and affordability, potentially expanding the market.

Competitive Landscape:

While naltrexone is a key player, it competes with other medications used in addiction treatment. For OUD, buprenorphine and methadone are commonly used opioid agonists or partial agonists that work by reducing withdrawal symptoms and cravings. For AUD, acamprosate and disulfiram are alternative pharmacological treatments. However, naltrexone's unique antagonist mechanism, particularly its lack of abuse potential and ability to block opioid effects, positions it distinctly.

The market for naltrexone is mature, with established generic competition for oral formulations. However, extended-release injectable formulations (e.g., Vivitrol) represent a significant portion of the market revenue due to higher pricing, though oral naltrexone remains critical for accessibility. NDC 51672-4193 represents the oral tablet segment, characterized by higher volume and lower per-unit cost.

What are the Manufacturing and Supply Chain Considerations?

The manufacturing of naltrexone hydrochloride, including the product under NDC 51672-4193, involves standard pharmaceutical production processes. However, specific considerations impact its supply chain and cost.

Manufacturing Process:

The synthesis of naltrexone typically begins with naloxone, an opioid antagonist, which is demethylated to noroxymorphone and then further processed. The process requires specialized chemical synthesis expertise and adherence to Good Manufacturing Practices (GMP). Key stages include:

1. Synthesis of Intermediates: Chemical reactions to create precursor molecules.
2. Naltrexone Base Formation: Production of the naltrexone free base.
3. Salt Formation: Conversion of the free base to naltrexone hydrochloride.
4. Purification: Rigorous purification steps to remove impurities.
5. Formulation: Blending the active pharmaceutical ingredient (API) with excipients (e.g., fillers, binders, disintegrants) to create the tablet.
6. Tableting and Coating: Compressing the mixture into tablets and applying a coating if necessary.
7. Packaging: Blister packaging or bottling for distribution.

Supply Chain Dynamics:

• API Sourcing: The availability and cost of key starting materials and intermediates for naltrexone synthesis are critical. Manufacturers may source API from global suppliers, particularly in Asia, which can be subject to geopolitical and logistical disruptions.
• Regulatory Compliance: Manufacturing facilities must comply with stringent FDA regulations and international standards. Changes in regulatory requirements can impact production costs and timelines.
• Generic Competition: The market for oral naltrexone is highly competitive due to the presence of multiple generic manufacturers. This competition generally exerts downward pressure on prices.
• Distribution Channels: Naltrexone is distributed through pharmaceutical wholesalers to pharmacies, hospitals, and clinics. The efficiency and cost of these distribution networks influence the final product price.
• Inventory Management: Maintaining adequate inventory levels while minimizing waste due to expiration is a constant challenge.

Cost Factors:

• Raw Material Costs: Fluctuations in the prices of chemical precursors.
• Manufacturing Overhead: Labor, energy, equipment depreciation, and quality control.
• R&D Investment: While naltrexone is an older drug, ongoing process optimization and analytical method development require investment.
• Regulatory Costs: Compliance with GMP, drug master file submissions, and inspections.
• Competition: The pricing strategies of competing generic manufacturers.

The primary manufacturing challenges revolve around ensuring consistent API quality, managing the complex chemical synthesis, and navigating a highly regulated and competitive generic market.

How Will Market Demand and Competition Affect Pricing?

The pricing of naltrexone (NDC 51672-4193) is influenced by a complex interplay of market demand, manufacturing costs, competitive landscape, and payer policies. As a mature generic product, significant price volatility is less common compared to novel therapeutics, but market forces still exert considerable influence.

Demand Factors:

• Prevalence of SUDs: Continued or increasing rates of OUD and AUD will sustain or grow demand for naltrexone. Public health crises or shifts in diagnostic practices can impact this.
• Treatment Adherence: Patient adherence to oral naltrexone regimens is a factor. Relapse rates and the perceived efficacy of the drug in preventing them indirectly affect demand.
• Access to Care: Insurance coverage, availability of treatment centers, and public health programs that promote the use of naltrexone influence prescription volumes.

Competitive Landscape and Pricing:

• Generic Penetration: NDC 51672-4193 is available from numerous generic manufacturers. This robust generic competition is the primary determinant of price. As more manufacturers enter the market, prices tend to decrease due to competition.
• Manufacturer Strategies: Individual manufacturers may employ pricing strategies to gain market share, such as offering tiered pricing, volume discounts, or rebate programs to wholesalers and pharmacies.
• Reference Pricing: Payer formularies often employ reference pricing, where they will reimburse for a generic drug at a set rate, discouraging higher-priced alternatives.
• Contractual Agreements: Large pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs) negotiate significant discounts with manufacturers based on volume.

Payer and Reimbursement Policies:

• Formulary Placement: Inclusion on preferred drug lists within insurance plans heavily influences prescribing patterns. Generic naltrexone is typically well-positioned on formularies.
• Reimbursement Rates: Medicare and Medicaid reimbursement rates, as well as private payer reimbursement, set a baseline for what pharmacies can recoup, influencing their willingness to stock and dispense the drug.
• Prior Authorization and Step Therapy: While less common for established generics like naltrexone, some payers may impose utilization management controls, though this is more frequently seen for more expensive or novel treatments.

Projected Pricing Trends:

Given the mature generic status of oral naltrexone, significant price increases are unlikely unless there are substantial disruptions in manufacturing or supply. Conversely, continued generic competition and potential market consolidation could lead to modest price erosion over the next 3-5 years.

• Short-term (1-2 years): Stable to slightly declining prices, driven by ongoing competition. Average Wholesale Price (AWP) for a 30-day supply of 50 mg naltrexone tablets may range between $20-$50, with significant net price reductions through negotiated rebates and discounts.
• Medium-term (3-5 years): Continued gradual price decline or stabilization. Potential for minor price increases if specific manufacturing inputs become significantly more expensive or if a major supplier exits the market, but such events are improbable for a well-established generic.

Key factors influencing these projections include:

• Stability of API Costs: Continued stable sourcing of naltrexone API will be crucial.
• Regulatory Environment: Any new regulatory hurdles or changes in GMP requirements could impact manufacturing costs.
• Competitive Entry/Exit: The number of active generic manufacturers will dictate competitive pressure.
• Market Access Programs: The effectiveness and reach of patient assistance programs or manufacturer-sponsored rebates.

It is important to distinguish the pricing of NDC 51672-4193 (oral tablets) from extended-release injectable formulations, which command a premium price and operate under different market dynamics. The price trajectory for oral naltrexone will remain firmly within the established generic drug market paradigm.

What are the Key Regulatory and Patent Landscape Considerations?

The regulatory and patent landscape for naltrexone (NDC 51672-4193) is characterized by its status as an established, off-patent molecule, leading to a market dominated by generic competition.

Regulatory Landscape:

• FDA Approval: Naltrexone was first approved by the U.S. Food and Drug Administration (FDA) in the 1980s. The original New Drug Application (NDA) holder is no longer the primary market driver.
• ANDA Pathway: Generic manufacturers seeking to market naltrexone products, including the 50 mg oral tablet associated with NDC 51672-4193, must file an Abbreviated New Drug Application (ANDA) with the FDA. This pathway relies on demonstrating bioequivalence to the reference listed drug (RLD).
• GMP Compliance: All manufacturing facilities producing naltrexone API and finished dosage forms must adhere to current Good Manufacturing Practices (cGMP). Regular FDA inspections ensure ongoing compliance.
• NDC System: The NDC (National Drug Code) system is a unique 10 or 11-digit identifier for human drugs. NDC 51672-4193 is assigned by the manufacturer and reflects the specific product, strength, and packaging. It is not a patent identifier.
• Labeling Requirements: Generic drug labeling must be consistent with the RLD's labeling, including indications, contraindications, warnings, and precautions.

Patent Landscape:

• Exclusivity Periods: Naltrexone as a chemical entity and its original formulations are well beyond their patent exclusivity periods. The foundational patents have long expired.
• Generic Market Dominance: The absence of active patent protection allows multiple pharmaceutical companies to manufacture and market generic versions of naltrexone.
• No Market Exclusivity for NDC 51672-4193: The NDC code itself does not confer any patent or market exclusivity. It is a product identifier.
• Potential for New Patents (Limited): While highly unlikely for the 50 mg oral formulation, novel delivery systems, new combination therapies, or significantly improved manufacturing processes could, in theory, be patentable. However, these would likely lead to new NDCs and different market segments.
• Orange Book: The FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly known as the Orange Book) lists drugs with approved US marketing, including patent and exclusivity information. For naltrexone, this book would reflect its generic availability and lack of active patent protection for the core molecule and its approved indications.

Implications for Market Entry and Competition:

The expired patent landscape and established regulatory pathways for generics mean that the barriers to entry for manufacturing naltrexone 50 mg tablets are relatively low for companies with the necessary manufacturing capabilities and regulatory expertise. This has led to a competitive market with numerous suppliers.

• Low Barriers to Entry: Companies can enter the market by filing ANDAs, provided they can secure API sources and meet GMP standards.
• Price Pressure: Intense generic competition directly translates to significant downward pressure on pricing, as seen in the market analysis.
• Focus on Manufacturing Efficiency: Companies compete primarily on cost of goods, supply chain reliability, and market access rather than novel intellectual property.
• Product Differentiation (Limited): Differentiation for a generic oral tablet like NDC 51672-4193 is minimal and often limited to packaging, branding (for generic products), or distribution relationships.

The regulatory framework supports widespread generic access, while the lack of patent protection ensures a competitive market. This environment favors payers and patients by promoting affordability.

Key Takeaways

• NDC 51672-4193 represents a 50 mg oral tablet formulation of naltrexone hydrochloride.
• The primary market drivers are the global prevalence of opioid and alcohol use disorders, supported by government initiatives and evolving treatment paradigms.
• Manufacturing involves standard pharmaceutical processes but requires adherence to strict GMP and reliable API sourcing.
• The market for NDC 51672-4193 is characterized by robust generic competition, which exerts significant downward pressure on pricing.
• Projected pricing trends indicate stability to a gradual decline over the next 3-5 years, with typical net prices for a 30-day supply ranging from $20-$50 after discounts.
• Naltrexone is an off-patent molecule, meaning its patent exclusivity has expired, allowing for widespread generic manufacturing and market entry via the ANDA pathway.

Frequently Asked Questions

1. What is the difference between naltrexone and naloxone in terms of patent protection? While both are opioid antagonists, naloxone has seen some development in extended-release formulations and combination products that may have attracted recent patent filings. Naltrexone 50 mg oral tablets, however, are established generics with expired patent protection.
2. Can a new manufacturer easily enter the market for naltrexone 50 mg tablets (NDC 51672-4193)? Yes, barriers to entry are relatively low for generic manufacturers who can establish GMP-compliant manufacturing facilities, secure API, and successfully file an ANDA with the FDA.
3. How do payer formularies impact the price of naltrexone 50 mg tablets? Payer formularies typically place generic naltrexone on preferred drug lists with favorable reimbursement rates, which incentivizes pharmacies to dispense it and manufacturers to offer competitive pricing to secure formulary placement.
4. Does the NDC number 51672-4193 indicate any specific manufacturing facility or quality standard beyond standard FDA requirements? No, the NDC is a product identifier assigned by the manufacturer. It designates the specific drug, strength, and packaging but does not denote a particular manufacturing site or a higher quality standard than what is mandated by FDA's cGMP regulations for all approved drugs.
5. Are there any foreseeable supply chain disruptions that could significantly impact the price of naltrexone 50 mg tablets? While global supply chain disruptions can occur for any pharmaceutical ingredient, the broad availability of API sources and multiple generic manufacturers for naltrexone 50 mg tablets makes significant, prolonged price impacts due to supply shortages less probable compared to niche or single-source drugs.

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Citations

[1] U.S. Centers for Disease Control and Prevention. (2022, December 15). Drug Overdose Deaths in the U.S. Nearly Triple in a Decade. Retrieved from https://www.cdc.gov/nchs/products/databriefs/db457.htm

[2] World Health Organization. (2022, June 17). Alcohol. Retrieved from https://www.who.int/news-room/fact-sheets/detail/alcohol