Last updated: February 20, 2026
What is the drug designated by NDC 00003-0494?
The NDC 00003-0494 refers to Naltrexone Hydrochloride Extended-Release Injection, 380 mg/1.5 mL (Vivitrol), marketed by Alkermes. It is used to treat opioid dependence and alcohol dependence.
Market Overview
Market size and demand
- Opioid dependence treatment: The global opioid use disorder treatment market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a CAGR of 7.5%, reaching USD 6.7 billion by 2030 (Grand View Research, 2022).
- Alcohol dependence market: The alcohol use disorder market is valued at roughly USD 2.3 billion in 2022, with a CAGR of 4.8%, expected to reach USD 3.4 billion by 2030 (MarketWatch, 2022).
Key competitors
| Product |
Form |
Approval Year |
Manufacturer |
Indications |
| Vivitrol |
IM injection |
2006 |
Alkermes |
Opioid and alcohol dependence |
| Revia |
Oral tablet |
1994 |
Reckitt Benckiser |
Opioid dependence |
| Depade |
Oral tablet |
1994 |
Reckitt Benckiser |
Alcohol dependence |
Market share dynamics
- Vivitrol maintains a leading position due to its monthly injection, improving adherence and compliance.
- Oral formulations like Revia and Depade face challenges impacting their market penetration.
- Prescription volume trends show increasing adoption of extended-release formulations in addiction treatment centers.
Price analysis
Current Pricing Data
- Average wholesale price (AWP): Approx USD 1,200 per dose of Vivitrol (per 380 mg/1.5 mL vial).
- Average selling price (ASP): Estimated USD 940 per dose, considering discounts and rebates.
- Reimbursement: Medicaid, Medicare, and private insurers typically reimburse USD 950–1,100 per dose.
- Patient out-of-pocket: Approximately USD 5–50 per dose depending on insurance coverage.
Cost components
- Manufacturing costs: Estimated at USD 150–200 per dose, subject to economies of scale.
- Distribution and dispensing fees: Additional USD 50–100 per dose.
- Price trends: Slight decrease over the past five years attributed to increased competition and generic entry potential.
Projections
Short-term (2023–2025)
- Market growth: Continued growth at 5–8% annually, driven by expanding indications and increased awareness.
- Pricing: Stable pricing with slight downward pressure owing to payer negotiations and generic competition.
- Market penetration: Projected to reach 65–70% in inpatient and outpatient addiction settings.
Long-term (2026–2030)
- Market expansion: Growth to USD 6.5–6.8 billion globally.
- Price trajectory: Slight decrease, with unit prices declining to USD 850–900 by 2030 due to patent expirations and biosimilar development.
- New formulations: Potential introduction of shorter-acting or bi-specific injectables could influence pricing and market dynamics.
Regulatory and patent considerations
- Patent timeline: Original patent expired in 2019 in the U.S., with patent extensions through formulations or delivery mechanisms projected to last until 2024.
- Biosimilars: Entry expected post-patent expiration, likely to reduce prices by 10–25%.
Summary
| Aspect |
Detail |
| Market size (2022) |
USD 6.5 billion (opioid + alcohol dependence) |
| CAGR (2023–2030) |
6%, driven by increased access and expanded indications |
| Average price per dose |
USD 940, with a range of USD 850–1,000 in reimbursement settings |
| Entry of biosimilars |
Expected post-2024, likely reducing prices |
Key Takeaways
- The drug faces a growing market driven by rising opioid and alcohol dependence treatment needs.
- Prices are currently stable but expected to decline slightly due to patent expiration and biosimilar competition.
- Revenues will depend on reimbursement policies, payer negotiations, and new formulation developments.
FAQs
1. What factors influence the pricing of Naltrexone injectable formulations?
Pricing depends on manufacturing costs, competitive dynamics, payer negotiations, reimbursement policies, and patent status.
2. How does the market for Naltrexone extended-release injections compare globally?
The U.S. leads due to higher opioid epidemic prevalence and reimbursement infrastructure; European and Asian markets expand more slowly.
3. What is the potential impact of biosimilars on the market?
Biosimilars could reduce prices by 10-25%, increasing access but also intensifying competition.
4. When is patent expiration expected for Vivitrol?
Patents expired in 2019, but formulation patents may extend exclusivity through 2024.
5. Are there opportunities for new formulations?
Yes, there is research into shorter-acting injectables and combination therapies for enhanced adherence and efficacy.
References
[1] Grand View Research. (2022). Opioid Use Disorder Treatment Market Size, Share & Trends Analysis Report.
[2] MarketWatch. (2022). Alcohol Use Disorder Treatment Market Trends.
