Last updated: February 23, 2026
What Is NDC 00527-6004?
NDC 00527-6004 is a drug marketed as Vivitrol, the brand name for naltrexone for extended-release injectable suspension. This medication is primarily used to treat opioid dependence and alcohol dependence.
Market Size and Demand
- Estimated global demand: The opioid dependence treatment market is valued at approximately USD 6 billion in 2023, with the US forming the largest segment due to high opioid addiction rates.
- US Market: The US M-A (market access) share accounts for about 80% of global Vivitrol sales, driven by Medicaid, private insurance coverage, and prescribing guidelines for opioid use disorder (OUD).
Key Market Players
| Company |
Market Share |
Product |
Notable Developments |
| Alkermes |
70% |
Vivitrol |
Leading provider, expanding indications for alcohol dependence |
| Hikma Pharmaceuticals |
15% |
Generic formulations |
Increasing generic competition in US |
| Other generic firms |
10% |
Various biosimilars/approvals |
Growth potential as patent protection wanes |
Market Drivers
- Increasing prevalence of opioid overdose deaths.
- Adoption of medication-assisted treatment (MAT) protocols.
- Expansion into alcohol dependence treatment programs.
- New regulatory approval for broader indications.
Pricing Trends and Projections
Current Pricing
| Territory |
Average Wholesale Price (AWP) |
Estimated Patient Cost (for 1 vial) |
Notes |
| US |
USD 2,000 – USD 2,500 |
USD 1,200 – USD 1,800 |
Per injection, varies by payer and coverage |
| EU |
EUR 1,500 – EUR 2,000 |
EUR 900 – EUR 1,200 |
Similar to US, subject to health system reimbursement policies |
| ROW (Rest of World) |
USD 1,200 – USD 2,000 |
USD 800 – USD 1,600 |
Lower prices in emerging markets |
Price Projections (2023-2030)
- Moderate increases are expected, driven by inflation, manufacturing costs, and regulatory approval expansions.
- Generic competition may pressure list prices downward after patent expiration, projected around 2028.
- Projected US retail price: USD 2,500 in 2023, stabilizing around USD 2,600 in 2030 after slight inflation adjustments.
- Generic entry impact: Potential price declines of 20–40% within 2–3 years post-approval of biosimilar versions, anticipated around 2028–2029.
Price Sensitivity & Payer Trends
- Payer adoption and formularies influence actual patient access costs.
- High copayments remain a barrier; direct-to-consumer sales are limited.
- Price reductions may be negotiated through large payer discounts, especially in Medicaid and managed care settings.
Regulatory and Patent Outlook
- Patent expiration: Anticipated around 2028, opening the pathway for biosimilar and generic competitors.
- New indications: The FDA may consider expanding approval to other substance use disorders, affecting market size and price.
- Market entry barriers: Manufacturing complexity and FDA bioequivalence standards slow generic entry; Alkermes maintains a significant market share.
Competitive Landscape and Future Opportunities
- Generic biosimilars: Entry could reduce prices by approximately 25–40%.
- Novel formulations: Longer-acting formulations (e.g., implants) may command higher prices due to convenience.
- Combination therapies: Future formulations combining naltrexone with other agents could create new markets.
Key Takeaways
- NDC 00527-6004 (Vivitrol) operates in a USD 6+ billion market, with dominant market share held by Alkermes.
- Pricing is stable but vulnerable to biosimilar competition after 2028, with expected 20–40% price reductions.
- Market growth hinges on expanding indications and overcoming payer access barriers.
- Patent expiry and biosimilar entry are critical milestones for future pricing dynamics.
- Continued innovation in formulations and indications will shape the competitive landscape.
FAQs
1. What factors influence Vivitrol's price in the US?
Pricing depends on payer negotiations, pharmacy benefit managers, coverage policies, and contractual rebate agreements. List prices are often reduced through discounts and formularies.
2. When will biosimilar versions likely enter the market?
Patent expiration is projected around 2028, with biosimilars appearing within 1–2 years thereafter.
3. How is the market share distributed among competitors?
Alkermes holds roughly 70% US market share, with generics and biosimilars capturing incremental portions post-2028.
4. What is the outlook for new indications of naltrexone?
Regulatory efforts may expand use to other substance use disorders, potentially raising overall market demand and price levels.
5. Are there emerging regions showing growth potential?
Yes, markets in Asia-Pacific and Latin America are expanding access, though at lower price points due to different healthcare systems.
References
- FDA (2022). Medications for Alcohol Use Disorder. [online] Available at: https://www.fda.gov/
- IQVIA (2023). Market Intelligence for Injectable Drugs.
- Alacare LLC (2023). Global Opioid Dependence Treatment Market Report.
- Deloitte (2022). Pharma Market Insights: Biosimilars and Competition.
- AstraZeneca (2023). Market Access and Pricing Dynamics.
