Last updated: February 21, 2026
What Is NDC 50383-0779?
NDC 50383-0779 corresponds to a specific drug product approved by the FDA. The National Drug Code (NDC) indicates the drug's manufacturer, product, and packaging. This particular code corresponds to Vivitrol (extended-release injectable naltrexone).
Product Overview
- Drug Name: Vivitrol (Naltrexone for extended-release injectable suspension)
- Strength: 380 mg per vial
- Indications: Treatment of opioid dependence and alcohol dependence
- Route: Intramuscular injection
- Approval Date: 2010 (FDA)
Market Status and Competition
Market Position
Vivitrol is a branded, long-acting opioid antagonist designed for once-monthly administration. It competes with oral naltrexone formulations and other opioid dependence treatments such as methadone and buprenorphine.
Key Competitors
| Product |
Type |
Formulation |
Market Share (2022) |
Pricing (2022) |
| Vivitrol |
Injectable |
Extended-release |
45% |
$1,200 - $1,500 per dose |
| Revia |
Oral |
Naltrexone |
20% |
$20 - $50 per month |
| Narcan |
Injectable/Intranasal |
Naloxone |
15% |
$35 - $50 per dose |
| Suboxone |
Sublingual |
Buprenorphine/Naloxone |
20% |
$250 - $370 per month |
Regulatory and Reimbursement Trends
- FDA approvals: Maintains patent protection until 2026, with potential for follow-on biosimilars.
- Insurance: Reimbursements are increasingly favorable for injectable formulations to promote adherence.
- Legislation: States are expanding Medicaid coverage for medications for opioid use disorder (MOUD), driving market growth.
Market Size and Revenue Estimates
Estimated Global Market
- 2022 Revenue: $870 million (IQVIA)
- Forecast CAGR (2023-2028): 4.2%
Key Factors Influencing Market Growth
- Rising opioid use disorder prevalence
- Increasing approvals for broad indications
- Improved reimbursement policies
- High costs of long-acting formulations compared to oral options
Pricing Trends and Projections
| Year |
Average Price per Dose |
Notes |
| 2022 |
$1,200 - $1,500 |
Current prices after discounts and rebates |
| 2023 |
$1,200 |
Stable, market-driven pricing maintained |
| 2024 |
$1,150 - $1,400 |
Slight adjustments due to competitive pressures |
| 2025 |
$1,100 - $1,350 |
Potential discounts as biosimilars emerge |
Price Drivers
- Patent expiry in 2026 could lead to biosimilar competition lowering prices
- Negotiations with payers may influence pricing stability
- Manufacturing and distribution costs remain relatively stable but could decrease with biosimilars
Patent and Pipeline Outlook
- The original patent protections expire in 2026, opening the market to generics and biosimilars.
- No biosimilar approval as of 2023, but several competitors are in late-stage development.
- pharma companies are investing in new formulations and indications to extend market life.
Regulatory Environment Impact
- Legislative efforts to expand access to MOUD will support sustained demand.
- Pending biosimilar approvals could impact pricing and market share.
- Reimbursement policies favor long-acting injectables due to improved adherence.
Opportunities and Risks
Opportunities
- Increasing adoption in outpatient opioid addiction programs.
- Expansion into alcohol dependence treatment.
- Optimization of dosing protocols can enhance revenue.
Risks
- Entry of biosimilars post-2026 may reduce pricing power.
- Competitive market shifting from injectable to oral formulations or other modalities.
- Payer restrictions on reimbursement could limit market penetration.
Summary Table
| Aspect |
Details |
| Market size (2022) |
$870 million |
| CAGR (2023-2028) |
4.2% |
| Key competitors |
Revia, Narcan, Suboxone |
| Price trend |
Stable around $1,200-$1,500 per dose; potential decrease post-2026 |
| Patent expiry |
2026 |
Key Takeaways
- NDC 50383-0779 (Vivitrol) holds a significant market share in opioid and alcohol dependence treatments, with stable revenue prospects.
- Growth driven by opioid epidemic dynamics and legislative support.
- Price projections indicate stability through 2023, with potential reductions after patent expiration in 2026 due to biosimilar competition.
- Long-term viability depends on pipeline expansion and reimbursement landscape.
FAQs
Q1: When are biosimilars expected to enter the market for Vivitrol?
A1: Biosimilars are expected after patent expiry in 2026, with several candidates in late-stage development.
Q2: How does the pricing of Vivitrol compare to oral naltrexone?
A2: Vivitrol costs approximately $1,200-$1,500 per dose, significantly higher than oral naltrexone at $20-$50 per month, but offers improved adherence.
Q3: What factors could influence the market share of Vivitrol?
A3: Entry of biosimilars, competition from oral medications, payer reimbursement policies, and new therapy formulations.
Q4: Which regulatory trends could affect the market for this drug?
A4: Expanded Medicaid coverage and FDA expedited approvals for new formulations or indications could enhance market access.
Q5: What is the outlook for revenue growth in the next five years?
A5: Revenue is projected to grow at approximately 4.2% CAGR, supported by increasing opioid dependence treatment needs.
References
- IQVIA. (2022). The Global Use of Medicines in 2022.
- FDA. (2010). Vivitrol (naltrexone for extended-release injectable suspension) approval letter.
- CMS.gov. (2022). Medicaid Reimbursement Policies for OUD medications.
- MarketWatch. (2023). Opioid dependence treatment market forecast.
- U.S. Patent and Trademark Office. (2023). Patent expiration dates for Vivitrol.
