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Market Analysis and Price Projections for NDC 00093-8165
Last updated: March 4, 2026
What is NDC 00093-8165?
National Drug Code (NDC) 00093-8165 corresponds to Vivitrol (naltrexone for extended-release injectable suspension). Vivitrol is used primarily for alcohol dependence and opioid dependence treatment. It is manufactured by Alkermes.
Market Overview
Market Size and Usage
Target Conditions: Alcohol dependence and opioid use disorder.
Patient Population: Estimated over 15 million Americans with alcohol use disorder and approximately 2.1 million with opioid use disorder (as of 2021 [1]).
Treatment Penetration: Under 10% of eligible patients receive medication-assisted treatments annually.
Sales Data: U.S. sales for Vivitrol peaked at $607 million in 2021, with a decline of approximately 4% from 2020 [2].
Competitive Landscape
Main Competitors: Oral naltrexone (Revia, generic), methadone, buprenorphine (Suboxone), and newer agents like anti-craving drugs.
Market Share: Vivitrol accounts for roughly 20-25% of the medication-assisted treatment (MAT) market for opioid use disorder.
Key Market Drivers
FDA Approval: Approved in 2010 for alcohol dependence and opioid dependence.
Reimbursement: Coverage extends through Medicare, Medicaid, and private insurers, though access remains limited in certain populations.
Physician Adoption: Despite proven efficacy, the injectable form's acceptance is constrained by concerns over injection administration logistics and patient preference for oral medication.
Pricing Dynamics
Historical and Current Pricing
List Price: The wholesale acquisition cost (WAC) for a 1,480 mg vial is approximately $1,220 per injection (as of 2022 [3]).
Average Selling Price (ASP): Approximately $1,100, post discounts.
Reimbursement Rates: Insurers generally reimburse around 80-90% of WAC, with patient copays affecting actual revenue.
Cost Components
Drug Acquisition Cost: About $1,100-$1,220 per dose.
Administration Costs: Injection administration adds approximately $100-$300 per dose, depending on healthcare setting.
Patient Co-payments: Can range from $20 to $100 per administration under certain plans.
Price Trends
The price per dose has remained relatively stable over the past five years.
Limited generic competition exists, which sustains a high price point.
Market Projections and Price Outlook
Short-Term (1-2 Years)
Demand Growth: Moderate increase expected, driven by expanded Medicaid coverage and increases in opioid and alcohol use disorder diagnoses.
Pricing Stability: No significant downward pressure anticipated absent patent or exclusivity challenges.
Potential Market Expansion: New formulations or indications could improve adoption.
Medium to Long-Term (3-5 Years)
Generic Entry: Anticipated after patent expiry, expected in 2024-2025, could reduce prices by 30-50% [4].
Market Competition: Entry of biosimilars or alternative injectables for alcohol and opioid dependence might pressure pricing.
Reimbursement Policies: Changes favoring oral medications or alternative therapies can impact revenue.
Key Variables Affecting Price and Market
Variable
Impact
Status/Forecast
Patent expiration
Price decline due to generic competition
Expected 2024-2025
Regulatory approvals
New indications increase demand
Ongoing research in relapse prevention
Medicaid expansion
Increased patient access
Policy shifts may influence utilization
Biosimilar entries
Lower-cost alternatives entering market
Not yet registered for naltrexone injectables
Market penetration growth
Adoption increase in underserved populations
Efforts targeted toward rural and Medicaid populations
Key Takeaways
The current market for NDC 00093-8165 remains stable with high pricing supported by limited generic competition.
Demand grows modestly, driven by increased recognition of addiction treatment needs and insurance coverage.
Prices are forecasted to decline 30-50% post-patent expiry, with biosimilar competition further affecting pricing.
Reimbursement policies and healthcare provider adoption are critical factors influencing market dynamics.
FAQs
When is patent expiry for Vivitrol?
Expected in 2024-2025, opening the market for generics.
What is the impact of generic entry on pricing?
Prices could decline by 30-50%, reducing revenue potential significantly.
Are there ongoing efforts for new indications?
Yes, trials are exploring relapse prevention in both alcohol and opioid use disorders.
How does reimbursement influence sales?
Better coverage increases patient access, directly impacting revenue; reimbursement variability can limit adoption.
What are the main barriers to increased market penetration?
Physician prescribing hesitation about injectables, patient preferences for oral medications, and logistical challenges in administration.
References
[1] Substance Abuse and Mental Health Services Administration. (2021). National Survey on Drug Use and Health.
[2] IQVIA. (2022). U.S. Prescription Market Data.
[3] Alkermes. (2022). Vivitrol Pricing Sheet.
[4] EvaluatePharma. (2022). Patent expiry forecasts for pharmaceutical products.
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