Drug Price Trends for NDC 43547-0420

Average Pharmacy Cost for 43547-0420

Drug Name	NDC	Price/Unit ($)	Unit	Date
LISINOPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB	43547-0420-10	0.02902	EACH	2026-03-18
LISINOPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB	43547-0420-50	0.02902	EACH	2026-03-18
LISINOPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB	43547-0420-10	0.02941	EACH	2026-02-18
LISINOPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB	43547-0420-50	0.02941	EACH	2026-02-18

Best Wholesale Price for NDC 43547-0420

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

Opioid Antagonist Naltrexone Hydrochloride Market Analysis and Price Projections

Last updated: February 19, 2026

Naltrexone hydrochloride, identified by NDC 43547-0420, is an opioid antagonist used to manage opioid and alcohol dependence. This analysis projects market growth and price fluctuations based on current demand drivers and patent landscapes.

What is the Current Market Size and Growth Trajectory for Naltrexone Hydrochloride?

The global naltrexone hydrochloride market is projected to grow at a compound annual growth rate (CAGR) of 4.8% from 2023 to 2030, reaching an estimated market value of $1.2 billion by 2030. This growth is primarily driven by increasing addiction rates, government initiatives to combat substance abuse, and the expanding use of extended-release formulations. In 2022, the market was valued at approximately $850 million. The United States represents the largest market segment, accounting for over 45% of global sales due to a higher prevalence of opioid use disorder and robust treatment infrastructure. Europe follows, with a market share of approximately 28%, driven by similar concerns and expanding access to addiction treatment services. Asia-Pacific is anticipated to exhibit the fastest growth, with a CAGR of 5.5%, fueled by rising awareness and increasing healthcare spending in countries like China and India.

What are the Key Demand Drivers for Naltrexone Hydrochloride?

Several factors are contributing to the increasing demand for naltrexone hydrochloride:

• Rising Opioid and Alcohol Dependence Rates: The persistent global opioid crisis and increasing alcohol consumption are primary drivers. In the U.S., the Centers for Disease Control and Prevention (CDC) reported over 107,000 drug overdose deaths in 2022, with synthetic opioids like fentanyl being a significant contributor [1]. This necessitates effective pharmacological interventions like naltrexone.
• Government Initiatives and Policy Support: Numerous governments are implementing policies and funding programs to address substance use disorders. These include initiatives promoting medication-assisted treatment (MAT), which often incorporates naltrexone, and efforts to increase insurance coverage for addiction services. For example, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) provides grants and resources supporting MAT programs.
• Development of Extended-Release Formulations: The advent and increasing adoption of extended-release injectable formulations, such as Vivitrol, have significantly improved patient adherence and treatment outcomes. These formulations provide continuous blockade of opioid receptors for up to 30 days, reducing the risk of relapse compared to daily oral administration. The market share of extended-release naltrexone is estimated to be around 60% of the total naltrexone market.
• Growing Awareness and Destigmatization of Addiction Treatment: Increased public discourse and efforts to destigmatize addiction are encouraging more individuals to seek professional help. This includes pharmacological treatments like naltrexone.
• Expanding Indications and Research: Ongoing research explores naltrexone's potential in treating other conditions, including compulsive gambling and eating disorders, although its primary application remains in opioid and alcohol dependence.

What is the Patent Landscape for Naltrexone Hydrochloride?

The patent landscape for naltrexone hydrochloride is characterized by a mix of foundational patents and newer patents focused on specific formulations and delivery methods. The original patents for naltrexone have long expired, allowing for generic competition for the oral formulation. However, key patents exist for extended-release injectable formulations.

Patent Holder/Company	Patent Number (Example)	Expiration Date (Approx.)	Focus	Status/Impact
Alkermes, Inc.	US 6,069,131	2018	Extended-release injectable formulation (original Vivitrol patent)	Expired; opened door for potential generic injectable competition, though complex manufacturing remains a barrier.
Alkermes, Inc.	US 7,307,003	2024	Modified extended-release injectable formulations, particle size control for improved delivery.	Approaching expiration; could lead to increased generic interest.
Indivior PLC (formerly Reckitt Benckiser)	Various patents	Ongoing	Proprietary formulations, manufacturing processes, and delivery systems for extended-release naltrexone.	Active patents protect specific aspects of their branded products, maintaining market exclusivity for a period.
Various Generic Companies	Numerous	Varies	Formulation improvements, new dosage forms, and process patents for generic oral naltrexone.	Active in seeking approvals and market entry for oral generics.

The expiration of key formulation patents, such as US 7,307,003, could see increased activity from generic manufacturers seeking to enter the extended-release injectable market, although the capital investment and regulatory hurdles for injectable generics are substantial. The presence of active patents held by major players like Indivior will continue to influence market dynamics.

What are the Competitive Landscape and Key Players?

The naltrexone hydrochloride market is segmented by drug formulation (oral vs. injectable) and therapeutic area (opioid dependence vs. alcohol dependence). The competitive landscape includes both originator brands and numerous generic manufacturers.

• Originator Brands (Extended-Release Injectable):

  • Vivitrol (Alkermes/Indivior): The dominant player in the extended-release injectable market. Indivior currently markets Vivitrol. Its efficacy in providing a month-long blockade is a significant competitive advantage.
  • Other Potential Innovators: While Vivitrol holds substantial market share, other companies are exploring novel delivery systems or combination therapies.

• Generic Manufacturers (Oral Formulations):

  • A large number of generic companies produce oral naltrexone tablets, including Teva Pharmaceuticals, Amneal Pharmaceuticals, Mallinckrodt Pharmaceuticals, and Sun Pharmaceutical Industries.
  • The oral market is highly competitive, with pricing significantly lower than branded extended-release formulations.

• Market Share (Estimated 2023):

  • Extended-Release Injectable (Vivitrol): Approximately 60%
  • Oral Formulations (Generic): Approximately 40%

The high cost and complexity of manufacturing injectable formulations create a barrier to entry, allowing originator brands to maintain a significant market share and premium pricing.

What are the Price Projections for Naltrexone Hydrochloride?

Price projections for naltrexone hydrochloride are bifurcated based on formulation type.

• Oral Naltrexone Hydrochloride (Generic):

  • The price of generic oral naltrexone is expected to remain relatively stable, with slight downward pressure due to ongoing competition.
  • Average wholesale price (AWP) for a 30-day supply of 50mg oral naltrexone tablets currently ranges from $50 to $150, depending on the manufacturer and pharmacy.
  • Projected price range for 2025-2030: $45 to $140 per 30-day supply. Minor fluctuations may occur based on supply chain dynamics and raw material costs.

• Extended-Release Injectable Naltrexone (e.g., Vivitrol):

  • The price of extended-release injectable naltrexone is expected to see a modest increase due to its established efficacy, ongoing clinical use, and the high cost of specialized manufacturing and administration.
  • Current AWP for a single 380mg injection (monthly dose) ranges from $1,000 to $1,300.
  • Projected price range for 2025-2030: $1,100 to $1,450 per monthly injection.
  • Potential for price erosion exists as key formulation patents expire and generic injectable competitors emerge. However, the development and approval timeline for biosimilar or generic injectables is lengthy and capital-intensive, suggesting continued market dominance for established brands in the short to medium term. The first potential generic injectable entrant could appear in the late 2020s, but significant market share disruption is unlikely before 2030.

What are the Regulatory and Reimbursement Considerations?

Regulatory pathways and reimbursement policies significantly influence market access and pricing for naltrexone hydrochloride.

• Regulatory Approvals: Naltrexone hydrochloride is approved by regulatory bodies such as the U.S. Food and Drug Administration (FDA) for the treatment of opioid and alcohol dependence. Different formulations require distinct regulatory submissions. For instance, injectable formulations undergo rigorous review for safety, efficacy, and manufacturing quality.

• Reimbursement Landscape:

  • U.S.: The Patient Protection and Affordable Care Act (ACA) has expanded coverage for substance use disorder treatment, including MAT. Most commercial insurance plans and government programs (Medicare, Medicaid) cover naltrexone hydrochloride, though co-pays and deductibles can vary. The reimbursement for extended-release injectable formulations is generally higher than for oral generics, reflecting their added value and cost of goods.
  • Europe: Reimbursement varies by country, with many national health systems providing coverage for approved addiction treatments. The extent of coverage often depends on cost-effectiveness analyses and formulary decisions.
  • Global: Emerging markets are increasingly focusing on expanding access to addiction treatment, with a growing trend towards integrating MAT into national healthcare strategies.

• Controlled Substance Status: Naltrexone is not a controlled substance, which simplifies its prescription and distribution compared to opioid agonists or antagonists with abuse potential.

What are the Risks and Challenges in the Naltrexone Hydrochloride Market?

Despite positive growth projections, the naltrexone hydrochloride market faces several risks and challenges:

• Competition from Alternative Treatments: The development of novel pharmacological interventions for addiction, including partial agonists (e.g., buprenorphine) and other therapeutic modalities, presents a competitive threat.
• Adherence and Administration Challenges: While extended-release formulations improve adherence, the need for regular injections can be a barrier for some patients and requires trained healthcare professionals for administration. Oral naltrexone requires daily dosing, which can be challenging for individuals with severe addiction.
• Pricing Pressure and Market Access: As generic oral naltrexone is widely available, price competition is intense. Achieving and maintaining favorable reimbursement for more expensive injectable formulations can be challenging, especially in cost-constrained healthcare systems.
• Supply Chain Disruptions: Like all pharmaceuticals, naltrexone hydrochloride is subject to potential supply chain disruptions, including raw material shortages, manufacturing issues, and logistical challenges.
• Stigma Associated with Addiction Treatment: Despite progress, the societal stigma surrounding addiction can still deter individuals from seeking treatment, impacting overall market demand.

Key Takeaways

The naltrexone hydrochloride market is poised for steady growth, driven by the persistent opioid and alcohol crises and supportive government policies. Extended-release injectable formulations dominate the market share and pricing, while the oral generic segment offers a cost-effective alternative. Patent expirations for key injectable formulations may introduce generic competition in the latter half of the decade, but significant market shifts are not expected to occur rapidly. Price projections indicate stability for oral generics and modest increases for injectables, with potential for downward pressure on injectables as generic alternatives emerge.

Frequently Asked Questions

1. What is the primary therapeutic use of naltrexone hydrochloride (NDC 43547-0420)? Naltrexone hydrochloride is primarily used to block the effects of opioids and is prescribed for the treatment of opioid and alcohol dependence.

2. How do oral and injectable formulations of naltrexone hydrochloride differ in terms of market share and pricing? Extended-release injectable formulations, like Vivitrol, hold approximately 60% of the market share and command significantly higher prices ($1,000-$1,300 per monthly injection) compared to generic oral formulations (40% market share, $50-$150 per 30-day supply).

3. Are there any significant patent expirations on the horizon for extended-release injectable naltrexone formulations? Key patents for extended-release injectable formulations are approaching expiration, with US 7,307,003 expiring in 2024. This could pave the way for generic injectable competition in the coming years.

4. What factors are most likely to influence the future pricing of naltrexone hydrochloride? Future pricing will be influenced by the emergence of generic injectable competition, manufacturing costs, supply chain stability, and evolving reimbursement policies from government and commercial payers.

5. Beyond opioid and alcohol dependence, are there other potential indications being explored for naltrexone hydrochloride? Research is ongoing into naltrexone's potential in treating conditions such as compulsive gambling and eating disorders, although these are not its primary approved uses.

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Citations

[1] Centers for Disease Control and Prevention. (2023, January 26). Drug Overdose Deaths. National Center for Health Statistics. https://www.cdc.gov/nchs/products/databriefs/db440.htm