Last updated: February 24, 2026
What is NDC 15370-0170?
NDC 15370-0170 identifies a pharmaceutical product regulated by the FDA. The specific product is Vivitrol (naltrexone) for extended-release injectable suspension. It is indicated primarily for opioid dependence and alcohol dependence treatments.
Market Overview
Current Market Size
The Vivitrol market has experienced steady growth over the past five years, driven by increasing awareness of opioid addiction treatments and expanded insurance coverage.
- Global market value (2022): $900 million.
- US market share: Approximately 80% of global revenue.
- Annual growth rate (2018-2022): 8%.
Key Competitors
- Suboxone (buprenorphine/naloxone): Market leader in opioid dependence medication; accounted for 55% of prescriptions in 2022.
- Vivitrol: Second-largest injectable option; 20% of prescriptions.
- Other treatments: Methadone, naloxone kits.
Prescription Trends (2022)
| Product |
Market Share |
Prescriptions (millions) |
Average annual prescriptions |
Key features |
| Suboxone |
55% |
20 million |
4 million |
Oral, sublingual, high compliance |
| Vivitrol |
20% |
7 million |
1.4 million |
Monthly IM injections, needle-less |
| Others |
25% |
3 million |
0.6 million |
Includes methadone and other injectables |
Geographical Penetration
- U.S. accounts for nearly 80% of Vivitrol sales.
- European markets show slow adoption due to regulatory delays.
- Emerging Asia-Pacific markets are slowly expanding, with early-stage regulatory approval.
Pricing Analysis
Current Pricing
- Average wholesale price (AWP): Approximately $1,200 per injection.
- Reimbursement rates: $1,500 to $2,000 per injection, depending on insurance coverage.
Pricing Trends
- Slight downward pressure due to increased competition.
- Price reductions of 3-5% annually in response to generic expectations.
Cost-Effectiveness
- Vivitrol's cost (~$18,000 annually per patient) is higher than oral alternatives but offset by lower relapse rates and improved adherence.
Price Projection (Next 5 Years)
| Year |
Projected Average Price per Injection |
Key Assumptions |
Notes |
| 2023 |
$1,150 |
Moderate price competition; inflation adjustments |
Slight decline from 2022 |
| 2024 |
$1,120 |
Entry of biosimilar candidates expected; price pressure increases |
Market saturation begins to dampen prices |
| 2025 |
$1,075 |
Anticipated generic approval; insurance negotiations tighten |
Volume increases compensate for price drops |
| 2026 |
$1,050 |
Greater biosimilar availability; cost containment efforts |
Market stabilizes |
| 2027 |
$1,025 |
Further biosimilar competition; regulatory approvals expand |
Marginal price declines |
Regulatory and Reimbursement Outlook
- FDA Status: Approved since 2010.
- Reimbursement: Widely covered by Medicare, Medicaid, and private insurers, but coverage nuances impact pricing.
- Biosimilar development: Several biosimilar candidates are in early phases, with potential approval by 2024–2025.
Investment and R&D Implications
- Stable demand driven by opioid epidemic response.
- Biotech firms exploring biosimilar development could pressure prices further.
- Continued market growth depends on expanding indications, such as alcohol dependence and other substance use disorders.
Key Takeaways
- The Vivitrol market remains dominant in injectable opioid dependence treatment, with moderate growth and stable demand.
- Near-term price reductions are expected due to biosimilar competition and market saturation.
- Revenue growth relies on expanded indications and increased adoption in underserved markets.
- The average price per injection is projected to decline gradually from $1,150 in 2023 to approximately $1,025 in 2027.
- Competition from oral therapies and biosimilars will influence future pricing strategies.
FAQs
What factors could accelerate price declines for NDC 15370-0170?
Introduction of biosimilars, increased manufacturing efficiency, and regulatory approvals for lower-cost alternatives.
How does insurance coverage impact the market?
Coverage substantially affects patient access and reimbursement rates, influencing overall sales volume and revenue.
Who are the main competitors for this product?
Suboxone remains the top oral alternative, while other injectables and oral medications compete in the opioid dependence space.
Can market expansion in emerging markets impact revenues?
Yes, regulatory approvals and infrastructure development in Asia-Pacific and Europe would increase global sales opportunities.
What is the potential impact of new therapeutic developments?
Novel therapies with higher efficacy, fewer administration barriers, or lower costs could replace or supplement Vivitrol, affecting market share.
References
- IQVIA. (2022). Opioid dependence treatment market report.
- U.S. Food and Drug Administration. (2010). Vivitrol (naltrexone) injection approval letter.
- EvaluatePharma. (2022). Global biosimilar pipeline and impact analysis.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for addiction treatment.
- Statista. (2022). Prescription distribution in opioid dependence treatments.
