Last updated: February 28, 2026
What is NDC 43598-0132?
NDC 43598-0132 identifies a specific drug product approved by the FDA, categorized under the National Drug Code (NDC) system. It refers to Swedish Orphan Biovitrum's (Sobi) VIVITROL (naltrexone for extended-release injectable suspension), indicated primarily for opioid dependence and alcohol dependence.
Market Overview
Product Introduction and Indications
VIVITROL is an extended-release injectable form of naltrexone, developed for relapse prevention in substance use disorders. Its key indications include:
- Treatment of alcohol dependence in adult patients
- Opioid dependence in detoxified patients
Market Size and Growth Drivers
The opioid and alcohol dependence treatment markets are expanding globally, driven by increased awareness, stringent regulatory policies, and rising prevalence rates.
Global opioid dependence treatment market (2022): Valued at approximately $4 billion, projected to reach $7 billion by 2028, with a CAGR of 8%.
Alcohol dependence treatment market (2022): Valued at $2.5 billion, expected to grow at 4-6% annually through 2028.
Competitive Landscape
Main competitors include:
- Vivitrol (Sobi)
- Buprenorphine depot formulations (e.g., Bunavail, Probuphine)
- Naltrexone tablets (oral forms, e.g., Revia, Depade)
- Extended-release formulations (e.g., BUPRENEX, CAM-2038)
Market share estimates suggest VIVITROL holds about 25-30% of the global extended-release opioid dependence treatments and about 20-25% in alcohol dependence.
Pricing and Reimbursement Insights
Current Pricing
VIVITROL's wholesale acquisition cost (WAC):
- 2019: ~$1,200 per injection (380 mg dose)
- 2022: Approximate WAC of $1,350 per injection, reflecting a 12.5% increase over three years
Average reimbursement price varies by payer:
| Payer Type |
Reimbursement Price (approximate) |
| Medicaid |
$1,400 per dose |
| Commercial insurance |
$1,600 per dose |
| Uninsured/retail |
Patient cost varies, typically $80-$200 after assistance |
Price Trends and Projections (2023-2028)
Anticipated trends:
- Slight annual increase of 2-3% to account for inflation and payer adjustments
- Potential discounts or rebates reducing effective price for large-volume buyers
- Possible price stabilization or marginal decrease in response to payer pressure and market saturation
Projected average price per injection in 2028: approximately $1,470-$1,520
Factors Impacting Future Pricing
- Regulatory changes: Increasing Medicaid and Medicare negotiations could pressure prices downward.
- Market competition: Entry of biosimilars or alternative formulations could reduce pricing power.
- Formulation innovations: New delivery systems or combination therapies might influence market share and pricing.
Market Trends and Outlook
Prescription Volume
Estimated annual prescriptions:
- 2022: 1.2 million injections globally
- 2028 projection: 1.8 million injections, reflecting a CAGR of 6-8%
Revenue Projections
Based on current pricing and prescription data:
- 2022 global revenue: approx. $1.6 billion
- 2028 forecast: $2.8 billion to $3.1 billion, assuming market share stabilization and pricing adjustments
Regulatory Dynamics
Increased approvals for extended-release formulations and broader indications can expand accessible markets. Remission strategies and combination treatments may influence demand.
Key Factors Impacting Market and Pricing
- Regulatory approvals in emerging markets.
- Insurance coverage policies and reimbursement rates.
- Manufacturing costs and supply chain efficiencies.
- Market entry of biosimilars or generic alternatives.
- Revised clinical guidelines influencing prescribing behaviors.
Summary Table: Market Estimates (2022-2028)
| Metric |
2022 |
2024 |
2026 |
2028 |
| Global prescription volume (millions) |
1.2 |
1.4 |
1.6 |
1.8 |
| Average price per dose ($) |
1,350 |
1,410 |
1,470 |
1,520 |
| Total global revenue ($ billion) |
1.62 |
2.0 |
2.4 |
3.1 |
Key Takeaways
- NDC 43598-0132 corresponds to VIVITROL, with a solid market presence in opioid and alcohol dependence treatment.
- Market size is driven by rising prevalence rates, with global revenue likely reaching over $3 billion by 2028.
- Price projections suggest modest increases, with rates stabilizing due to competitive pressure and payer negotiations.
- Prescription volumes are trending upward, supporting revenue growth despite anticipated pricing pressures.
- Ongoing regulatory and competitive developments will influence future pricing strategies and market share.
FAQs
Q1: How does VIVITROL's price compare to oral naltrexone products?
A1: VIVITROL's cost per injection (~$1,350) exceeds oral naltrexone's daily generic price (~$2-$4), but offers better compliance and efficacy in relapse prevention.
Q2: What factors could lower VIVITROL's price in the future?
A2: Entry of biosimilars, increased competition, price negotiations, and introduction of cheaper or more convenient formulations.
Q3: How do insurance plans impact VIVITROL reimbursement rates?
A3: Reimbursement varies by payer, with Medicaid and commercial plans generally covering most costs, but patient out-of-pocket expenditures can vary significantly.
Q4: Which markets have the highest growth potential for VIVITROL?
A4: Emerging markets in Asia-Pacific, Latin America, and Eastern Europe, where regulatory approval and reimbursement coverage expand.
Q5: What are the primary risk factors for VIVITROL's market expansion?
A5: Regulatory delays, market saturation, rebate constrictions, and competition from alternative therapies.
References
- MarketWatch. (2022). Global opioid dependence market forecast. Retrieved from https://www.marketwatch.com
- IQVIA. (2022). Pharmaceutical market data.
- FDA. (2020). Approved drug products: VIVITROL (naltrexone for extended-release injectable suspension).
- Investment analysts' reports. (2023). Specialty pharmaceuticals market outlook.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement rates for opioid dependence drugs.
