Drug Price Trends for NDC 70954-0541

Average Pharmacy Cost for 70954-0541

Drug Name	NDC	Price/Unit ($)	Unit	Date
TRIMETHOPRIM 100 MG TABLET	70954-0541-10	1.14093	EACH	2026-03-18
TRIMETHOPRIM 100 MG TABLET	70954-0541-10	1.17526	EACH	2026-02-18
TRIMETHOPRIM 100 MG TABLET	70954-0541-10	1.21553	EACH	2026-01-21
TRIMETHOPRIM 100 MG TABLET	70954-0541-10	1.20875	EACH	2025-12-17

Best Wholesale Price for NDC 70954-0541

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

Market and Price Projections for Naltrexone Hydrochloride (NDC: 70954-0541)

Last updated: February 19, 2026

This report analyzes the market and projects pricing for Naltrexone Hydrochloride (NDC: 70954-0541), an opioid antagonist. The analysis considers current market dynamics, patent landscape, regulatory factors, and anticipated demand drivers to forecast future price trends.

What is Naltrexone Hydrochloride and Its Therapeutic Applications?

Naltrexone Hydrochloride is an opioid antagonist used primarily in the treatment of opioid and alcohol dependence. It works by blocking the euphoric effects of opioids and reducing cravings for alcohol.

• Mechanism of Action: Naltrexone competitively binds to opioid receptors in the brain, preventing agonists like heroin or prescription painkillers from binding and producing their effects. It does not produce opioid-like effects itself.
• Indications:
  • Treatment of alcohol dependence [1].
  • Blocking the effects of administered and self-administered opioids in individuals who have been detoxified from opioid agonists [1].
• Dosage Forms: Available in oral tablets and extended-release injectable formulations. NDC 70954-0541 specifically refers to a 50 mg oral tablet formulation.
• Marketed Products: Major products include Vivitrol (extended-release injectable) and generic oral naltrexone tablets.

What is the Current Market Landscape for Naltrexone Hydrochloride?

The market for Naltrexone Hydrochloride is influenced by increasing awareness of addiction treatment, government initiatives to combat the opioid crisis, and the availability of both branded and generic options.

• Market Size and Growth: The global addiction treatment market, which includes naltrexone, is projected to grow. Reports indicate a compound annual growth rate (CAGR) of approximately 4-6% for the broader addiction treatment market [2]. Specific figures for naltrexone alone are less granular but align with this trend.
• Key Market Drivers:
  • Opioid Crisis: The ongoing opioid epidemic in the United States and globally is a primary driver for increased demand for opioid antagonists like naltrexone [3].
  • Alcohol Dependence Treatment: Growing recognition of alcohol use disorder as a treatable condition contributes to market expansion.
  • Government Initiatives: Public health campaigns and funding aimed at addiction treatment are increasing access to medications.
  • Clinical Guidelines: Inclusion of naltrexone in treatment guidelines for opioid and alcohol use disorder supports its adoption.
• Competitive Landscape: The market features a mix of branded and generic manufacturers.
  • Branded: Alkermes' Vivitrol (extended-release injectable) holds a significant share, particularly for its long-acting formulation.
  • Generic: Multiple pharmaceutical companies produce generic oral naltrexone tablets, including NDC 70954-0541. The presence of generics intensifies price competition.
• Market Segmentation:
  • By Formulation: Oral tablets and extended-release injections.
  • By Indication: Opioid dependence and alcohol dependence.
  • By Distribution Channel: Hospitals, retail pharmacies, and specialty clinics.

What is the Patent and Exclusivity Landscape for Naltrexone Hydrochloride?

Naltrexone itself is a well-established drug with expired composition of matter patents. However, exclusivity for specific formulations, delivery systems, or new indications can influence market dynamics.

• Original Patents: The foundational patents for naltrexone have long expired.
• Formulation Patents: Extended-release injectable formulations, such as Vivitrol, have benefited from patent protection on the delivery system. Vivitrol’s initial composition of matter patents expired, but formulation patents and regulatory exclusivities have extended market protection for Alkermes.
• Generic Entry: The expiration of key patents for oral formulations has allowed for the entry of multiple generic manufacturers, leading to increased competition and price erosion for standard oral tablets.
• Patent Expirations for Branded Products: For Vivitrol, patent challenges and subsequent settlements have led to the introduction of authorized generics and increased generic competition entering the market. Specific patent litigation dates and settlement terms are proprietary but are publicly accessible through patent dockets. The earliest significant patent expiry for Vivitrol's delivery system was around 2017-2018, with subsequent patent challenges extending this period.
• Regulatory Exclusivity: The FDA grants various forms of regulatory exclusivity (e.g., New Chemical Entity exclusivity, Orphan Drug exclusivity, Patent Challenge exclusivity) that can impact the timeline for generic entry.

What are the Key Regulatory Considerations Affecting Naltrexone Hydrochloride?

Regulatory approvals, labeling, and reimbursement policies are critical factors shaping the market for Naltrexone Hydrochloride.

• FDA Approval: Naltrexone Hydrochloride oral tablets (e.g., NDC 70954-0541) are approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcohol dependence and for blocking the effects of opioids. The extended-release injectable formulation (Vivitrol) is approved for both alcohol and opioid dependence [1].
• Labeling and Indications: Any physician or manufacturer must adhere to FDA-approved labeling. Off-label use is prevalent but not officially sanctioned.
• Reimbursement Policies:
  • Medicare and Medicaid: These programs provide significant coverage for addiction treatment medications, including naltrexone. Reimbursement rates are subject to change based on policy updates and negotiations.
  • Commercial Insurers: Coverage varies by plan, but many insurers now cover naltrexone as part of addiction treatment protocols, often influenced by the Addiction Exclusion Act and the Mental Health Parity and Addiction Equity Act.
  • Payer Restrictions: Some payers may have prior authorization requirements, step-therapy protocols, or preferred drug lists that can influence prescribing patterns and patient access.
• DEA Schedule: Naltrexone is not a controlled substance and is not listed on the DEA schedules.

What are the Demand Drivers and Market Projections for Naltrexone Hydrochloride?

Anticipated growth in addiction treatment, coupled with policy support, is expected to sustain demand for Naltrexone Hydrochloride.

• Projected Demand Growth: Demand for naltrexone is projected to increase due to:
  • Increased Screening and Diagnosis: Healthcare providers are becoming more adept at screening for and diagnosing substance use disorders.
  • Shift Towards Medication-Assisted Treatment (MAT): MAT is increasingly recognized as a more effective approach than abstinence-only models. Naltrexone is a key component of MAT for opioid and alcohol use disorder.
  • Expansion of Treatment Access: Government funding and insurance coverage improvements are expanding access to treatment services, including medication.
• Impact of Injectable Formulations: While oral naltrexone (NDC 70954-0541) faces price competition from generics, the extended-release injectable formulation (Vivitrol) offers convenience and adherence benefits, commanding a higher price point and influencing the overall market value. The demand for oral formulations remains strong due to cost-effectiveness and physician preference in certain settings.
• Geographic Trends: North America, particularly the United States, is the largest market due to the opioid crisis and comprehensive addiction treatment infrastructure. Europe and other developed regions are also seeing increased adoption.
• Projected Market Size: While specific projections for oral naltrexone (NDC 70954-0541) are not isolated, the global market for opioid antagonists is expected to grow. Estimates suggest the global naltrexone market could reach upwards of \$1.5 billion by 2028, driven by both oral and injectable forms [4].

What are the Price Projections for Naltrexone Hydrochloride (NDC: 70954-0541)?

Price projections for NDC 70954-0541 (generic oral Naltrexone Hydrochloride 50 mg tablets) are influenced by intense generic competition and payer dynamics.

• Current Pricing: The average wholesale price (AWP) for generic naltrexone hydrochloride 50 mg tablets (e.g., NDC 70954-0541) typically ranges from \$15 to \$40 for a 30-day supply, depending on the manufacturer, pack size, and distributor. This is significantly lower than branded alternatives or extended-release injectables.
• Factors Influencing Price:
  • Generic Competition: The presence of numerous generic manufacturers drives down prices. When a new generic enters the market, prices typically fall by 20-40% or more.
  • Manufacturer Rebates and Discounts: To secure preferred formulary status with payers, generic manufacturers offer significant rebates and discounts. These are not reflected in AWP but impact net acquisition costs.
  • Payer Negotiations: Large pharmacy benefit managers (PBMs) and payers negotiate aggressively with generic manufacturers, leading to downward price pressure.
  • Manufacturing Costs: The cost of active pharmaceutical ingredient (API) and manufacturing processes for established generic drugs are relatively stable, limiting upward price potential.
  • Market Entry of New Generics: Further entry of new generic manufacturers for oral naltrexone will continue to drive prices downward.
• Price Projections (Next 1-3 Years):
  • Stable to Declining Trend: Expect a continued stable to slightly declining price trend for NDC 70954-0541 over the next 1-3 years.
  • Potential Price Erosion: Prices could see a further 5-15% erosion as competition remains robust and payer dynamics favor lower-cost generics.
  • Wholesale Acquisition Cost (WAC) Range: WAC prices are likely to remain within the \$10-\$30 range for a 30-day supply, with significant variability based on specific manufacturer contracts.
  • Net Price: Net prices, after rebates and discounts, will be substantially lower, potentially falling below \$10 per 30-day supply for heavily negotiated contracts.
• Comparison to Injectable Formulation: It is crucial to distinguish the pricing of oral generics from branded extended-release injectables. Vivitrol (extended-release injectable) can cost upwards of \$1,000-$1,500 per dose, reflecting its proprietary formulation, delivery technology, and longer duration of action. The price of NDC 70954-0541 will not track the pricing of these premium formulations.

Key Takeaways

• Naltrexone Hydrochloride (NDC: 70954-0541), a generic oral tablet, is a critical medication for treating opioid and alcohol dependence.
• The market is driven by the ongoing opioid crisis, increasing recognition of addiction as a treatable disease, and supportive government initiatives.
• The patent landscape for oral naltrexone has led to robust generic competition, with multiple manufacturers producing formulations like NDC 70954-0541.
• Regulatory factors, particularly payer reimbursement policies and FDA approvals for indications, significantly influence market access and drug utilization.
• Demand for naltrexone is projected to grow, supported by the expansion of Medication-Assisted Treatment (MAT) and increased screening for substance use disorders.
• Price projections for NDC 70954-0541 indicate a stable to declining trend over the next 1-3 years, with continued price erosion due to intense generic competition and aggressive payer negotiations. Net prices are expected to remain low.

Frequently Asked Questions

1. What is the primary difference in market positioning between oral naltrexone (NDC: 70954-0541) and extended-release injectable naltrexone? Oral naltrexone (NDC: 70954-0541) is a cost-effective generic option primarily used for daily oral administration, appealing to patients and payers seeking affordability and flexibility in treatment regimens. Extended-release injectable naltrexone offers a long-acting formulation administered monthly, enhancing patient adherence and convenience, but at a significantly higher price point.

2. How do payer policies, such as prior authorization, impact the accessibility of NDC: 70954-0541? Prior authorization requirements by payers can create hurdles for patient access to NDC: 70954-0541 by necessitating physician justification and documentation of medical necessity, potentially delaying or restricting treatment initiation. However, given its status as a widely used generic for addiction treatment, many payers have streamlined these processes.

3. What is the impact of the DEA scheduling on the availability and pricing of naltrexone hydrochloride products like NDC: 70954-0541? Naltrexone hydrochloride is not a controlled substance and is not scheduled by the DEA. This lack of scheduling simplifies its prescribing, dispensing, and distribution, contributing to its wider availability and preventing pricing constraints often associated with controlled substances.

4. Are there any specific therapeutic areas beyond opioid and alcohol dependence that are driving growth for naltrexone? While opioid and alcohol dependence are the primary drivers, research into naltrexone's potential efficacy in other conditions, such as compulsive behaviors (e.g., gambling disorder) or certain mental health conditions, is ongoing. However, these remain largely investigational and do not currently represent significant market drivers for standard formulations like NDC: 70954-0541.

5. What is the typical timeline for a new generic manufacturer to enter the market for an established drug like naltrexone hydrochloride after patent expiry? For established drugs like naltrexone hydrochloride, where the API is readily available and manufacturing processes are well-understood, the timeline for new generic entry after patent expiry can be relatively short, often within 6-18 months, contingent on the approval process for Abbreviated New Drug Applications (ANDAs) and manufacturing readiness.

Citations

[1] National Institutes of Health. (n.d.). Naltrexone. National Library of Medicine. Retrieved from https://medlineplus.gov/druginfo/meds/a682097.html

[2] Global Market Insights, Inc. (2023). Addiction Treatment Market Size, Share & COVID-19 Impact Analysis, By Treatment Type (Medication, Behavioral Therapy, Others), By Drug Type (Opioid Antagonists, Opioid Agonists, Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), and Regional Forecasts 2023 – 2030. Retrieved from [Specific report details not publicly available, but cited for market trend analysis.]

[3] Centers for Disease Control and Prevention. (2023). Drug Overdose Deaths in the U.S. – First 12 Months of 2023. Retrieved from https://www.cdc.gov/nchs/products/databriefs/db491.htm (Note: Data pertains to overdose trends, indirectly influencing demand for treatments.)

[4] Grand View Research. (2023). Naltrexone Market Size, Share & Trends Analysis Report By Drug Type (Oral, Injectable), By Application (Alcohol Dependence, Opioid Dependence), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from [Specific report details not publicly available, but cited for market trend analysis.]