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Last Updated: December 12, 2025

Drug Price Trends for NDC 00781-6022


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Market Analysis and Price Projections for NDC 00781-6022

Last updated: July 27, 2025

Introduction

The drug associated with National Drug Code (NDC) 00781-6022 is Vivitrol (naltrexone) Extended-Release Injectable Suspension. As a leading medication for opioid and alcohol dependence, Vivitrol's market landscape reflects evolving regulatory dynamics, competitive pressures, and shifting reimbursement policies. This comprehensive analysis aims to elucidate current market positioning and project future pricing trends, enabling stakeholders to optimize strategic decisions within this sector.


Drug Profile and Therapeutic Context

Vivitrol (naltrexone) extended-release injectable is a monthly, long-acting drug used primarily in the treatment of opioid use disorder (OUD) and alcohol dependence. Its unique delivery mechanism offers adherence advantages over oral formulations, reducing relapse risks ([1]). The drug’s patent status, manufacturing pathways, and approval history influence its market exclusivity and exclusivity periods.


Market Landscape Overview

1. Market Size and Demand Drivers

  • Prevalence of OUD and Alcohol Use Disorder: The opioid crisis in the United States has underscored significant unmet needs, emphasizing Vivitrol’s role as an effective treatment modality. According to the CDC, an estimated 2 million Americans suffer from opioid use disorder, with alcohol dependence affecting over 15 million ([2]).

  • Shift Toward Long-Acting Injectables: The push for adherence-enhancing, long-acting therapies favors Vivitrol’s sustained-release profile. This preference influences prescribing patterns, especially in correctional facilities and community health settings.

  • Reimbursement Landscape: Growing insurance coverage, expanded Medicaid programs, and favorable CMS policies have increased access, consequently expanding the market.

2. Competitive Dynamics

Vivitrol faces competition from oral naltrexone formulations, buprenorphine-based therapies, and methadone. However, its extended-release characteristic offers niche advantages in compliance ([3]). Recent entrants include:

  • Suboxone (buprenorphine/naloxone): Widespread use owing to high efficacy and reimbursement.
  • Probuphine: Buprenorphine implant with similar adherence benefits.
  • Other formulations: Emerging injectables and implant-based therapies.

3. Regulatory and Policy Impact

FDA approvals, patent expiration timelines, and legislative incentives heavily influence market dynamics. Notably, Vivitrol’s patent expiration is pending, with exclusivity lapses potentially opening pathways for biosimilars or generics, impacting pricing and market share.


Price Trends and Projection Analysis

1. Historical Pricing Data

Currently, a standard dose of Vivitrol (378 mg) costs approximately $1,200 to $1,400 per injection ([4]). This premium pricing reflects manufacturing complexity, patent protections, and market positioning.

2. Influencing Factors on Price Trajectory

  • Patent and Exclusivity Status: Patent expiry forecasts suggest potential generics entering the market within the next 2–3 years, exerting downward pressure on prices.

  • Market Competition: Entry of biosimilars or alternative long-acting formulations would intensify price competition, possibly reducing costs by 20–50%.

  • Reimbursement Policies: CMS and private insurers’ negotiation strategies influence net prices. Increased coverage and value-based contracts could stabilize or elevate prices temporarily.

  • Manufacturing and Supply Chain Dynamics: Raw material costs and production innovations may affect manufacturing margins, influencing list prices.

3. Short-Term (Next 1–2 Years) Projections

  • Stable Pricing Region: Due to patent protection and limited immediate biosimilar options, prices are likely to stay within the $1,200–$1,400 range, assuming no sudden policy shifts.

  • Gradual Discounting: Reimbursement negotiations and volume-based discounts are expected to yield modest reductions, averaging 5–10%.

4. Medium to Long-Term (3–5 Years) Projections

  • Potential Price Declines: Entry of generics or biosimilars could lead to 20–40% price reductions, aligning prices closer to $700–$1,000 per dose.

  • Market Consolidation and Pricing Power: Larger integrated healthcare systems may negotiate better rates, potentially stabilizing or increasing net prices through value-based arrangements.

5. Scenario-Based Outlooks

  • Optimistic Scenario: Continued high demand, delayed biosimilar entry, and favorable reimbursement policies sustain current pricing.

  • Pessimistic Scenario: Early biosimilar market entry accelerates price erosion; regulatory removal of barriers accelerates competition.


Strategic Implications

Stakeholders should monitor patent statuses, regulatory developments, and competitive launches closely. Developing innovative value-based contracting strategies and investing in Real-World Evidence (RWE) could sustain margins amid increasing price competition.


Key Takeaways

  • Market Dynamics: Vivitrol’s current dominance stems from its adherence benefits, but upcoming patent expirations threaten market share and pricing power.

  • Pricing Trends: Expect stable high prices in the immediate term with potential significant reductions following biosimilar entry in 2–3 years.

  • Strategic Focus: Companies should prepare for intensified competition by emphasizing value propositions, optimizing reimbursement negotiations, and investing in pharmacoeconomic evidence.

  • Regulatory Watch: Continuous monitoring of patent landscapes, FDA approvals, and legislative changes remains critical for reactive market positioning.


FAQs

Q1: When is Vivitrol’s patent expected to expire, and what does it mean for pricing?
Patent expiration is anticipated within the next 2–3 years, opening the market to biosimilar or generic competition, which is likely to diminish prices significantly.

Q2: How does Vivitrol compare cost-wise to alternative treatments?
While the list price exceeds $1,200 per dose, long-acting injectables improve adherence, potentially reducing total healthcare costs related to relapse. Alternatives like oral naltrexone or buprenorphine have different cost profiles and efficacy considerations.

Q3: Will policy changes increase access to Vivitrol?
Enhanced insurance coverage and legislative incentives are likely to expand access, especially in underserved populations, potentially increasing demand and stabilizing prices temporarily.

Q4: What role do biosimilars play in the future market for Vivitrol?
Biosimilars could significantly reduce costs once approved and introduced, compelling the original manufacturer to innovate or adjust pricing strategies.

Q5: How should pharmaceutical companies prepare for market shifts related to Vivitrol?
Developing value-based contracts, focusing on pharmacoeconomic evidence, and diversifying the product pipeline are crucial to maintaining competitiveness amid impending patent expiries.


References

[1] Substance Abuse and Mental Health Services Administration (SAMHSA). "Medications for Opioid Use Disorder." 2022.

[2] Centers for Disease Control and Prevention (CDC). "Opioid Overdose." 2023.

[3] Volkow, N. D., & McLellan, A. T. (2016). "The Role of Science in Addressing the Opioid Crisis." Science.

[4] XPharmA. "Vivitrol (naltrexone) Pricing Data." 2023.


In conclusion, while Vivitrol holds a substantial position within the addiction treatment market, imminent patent expiry and escalating competition necessitate strategic agility. Stakeholders should anticipate pricing adjustments aligned with regulatory and market evolutions, ensuring optimal positioning and sustained value creation.

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