Last updated: February 24, 2026
What Is the Drug Identified by NDC 43598-0583?
NDC 43598-0583 corresponds to a specific formulation of a prescription medication. Based on FDA records, this NDC code is associated with Vivitrol (naltrexone), an extended-release injectable used primarily for alcohol dependence and opioid addiction treatment. The drug is marketed by Alkermes, Inc.
Market Position and Sales Performance
Market Segments
- Opioid Use Disorder (OUD): Vivitrol is approved as a medication-assisted treatment (MAT) for opioid dependence, targeting a market estimated at roughly 4 million Americans with OUD.
- Alcohol Use Disorder (AUD): Increasing prescriptions for alcohol dependence also expand its market, especially with higher utilization in co-morbid cases.
Market Trends and Drivers
- Regulatory approvals: Vivitrol carries FDA approval for both OUD and AUD, broadening its scope.
- Epidemic influence: The opioid epidemic has heightened demand for treatment options, including long-acting injectables.
- Coverage and reimbursement: Medicare, Medicaid, and private insurers provide coverage, but reimbursement levels influence prescribing rates.
- Competitor landscape: Suboxone (buprenorphine), methadone, and oral naltrexone compete for market share, with injectable formulations like Vivitrol aiming to improve adherence.
Historical Sales Data
| Year |
Sales (USD millions) |
Growth Rate |
| 2020 |
422 |
- |
| 2021 |
509 |
20.6% |
| 2022 |
610 |
20.0% |
| 2023 (Projected) |
735 |
20.3% |
Source: IQVIA, 2022, 2023 reports.
Market Share
- Vivitrol holds approximately 15% of the injectable OUD medication market.
- Its share is gradually increasing due to expanded indications and increasing awareness.
Price Structure and Trends
Current Pricing
- Average Wholesale Price (AWP): approximately $1,200 per injection.
- Reimbursement cost: insurers typically reimburse $950–$1,050 per dose, depending on negotiated contracts.
- Patient copay: $0–$150, based on insurer policies and patient assistance programs.
Pricing Trends
- Slight annual increases (~3%) over past five years, driven by manufacturing costs and inflation.
- Price stabilization observed in 2022 and 2023, reflecting market saturation and competitive pressure.
Cost-Effectiveness and Reimbursement Dynamics
- Cost per treatment cycle: approximately $3,600 for a three-month regimen.
- Reimbursement rates vary by payer and region but have remained fairly stable amid inflation.
Price Projections (2024–2028)
Assumptions
- Moderate annual growth in sales volume (~15%) driven by expanding indications and acceptance.
- Price remains relatively stable with minor increases, around 2% annually.
- Increased competition from oral formulations and newer injectable options may exert downward pressure later.
Projected Average Price
| Year |
Estimated Price per Injection (USD) |
Notes |
| 2024 |
$1,050 |
Stable with previous trend |
| 2025 |
$1,070 |
Slight increase, market stability |
| 2026 |
$1,090 |
Ongoing inflation adjustments |
| 2027 |
$1,110 |
Potential competition influence |
| 2028 |
$1,130 |
Market saturation effects |
Revenue Forecasts
| Year |
Sales Volume (Million injections) |
Total Revenue (USD millions) |
| 2024 |
8.0 |
$8,400 |
| 2025 |
9.2 |
$9,860 |
| 2026 |
10.6 |
$11,500 |
| 2027 |
12.2 |
$13,542 |
| 2028 |
14.0 |
$15,820 |
These projections assume continued growth in prescribed doses, expanded coverage, and no significant regulatory or patent challenges.
Competitive Landscape and Policy Impact
- Generic availability: No approved generics as of early 2023, maintaining pricing power.
- Regulatory pressures: Risk of Medicare Part D adjustments affecting reimbursement.
- Market entrance: Other formulations like buprenorphine implants or oral medications may challenge Vivitrol's market share over the next five years.
Regulatory and Policy Outlook
- FDA considerations: Ongoing reviews of new formulations and biosimilars could alter the landscape.
- Policy trends: Increased emphasis on medication-assisted treatment access may support growth but could also lead to price negotiations.
Key Takeaways
- The drug associated with NDC 43598-0583 is Vivitrol (naltrexone ER injection), with a growing market driven by opioid and alcohol dependence treatments.
- Sales are projected to grow at roughly 20% annually over the next five years, with prices increasing marginally (~2% annually).
- The market benefits from high reimbursement rates, but evolving policy, potential competitors, and market saturation could influence long-term trajectory.
- Current clinical and regulatory stability indicates predominantly stable pricing and revenue forecasts through 2028.
FAQs
-
Can the price of Vivitrol change significantly outside of annual inflation adjustments?
- Yes, changes are possible due to policy shifts, patent litigations, or entry of generics.
-
How do reimbursement levels impact actual patient costs?
- Reimbursement varies; insured patients often pay reduced copays, sometimes negligible, depending on coverage.
-
What are the main competitors to Vivitrol?
- Oral naltrexone, buprenorphine formulations (Suboxone, Sublocade), and methadone.
-
Has the patent for Vivitrol expired?
- No, patent protections extend beyond 2025, protecting pricing power.
-
Are there upcoming regulatory developments that could impact pricing?
- Future biosimilar approvals and policy reforms could influence market dynamics and prices.
Citations
[1] IQVIA. (2022). Pharmaceutical Market Analysis Reports.
[2] U.S. Food and Drug Administration. (2023). Drug Approvals and Labeling.
[3] FDA Drug Database. (2023). Naltrexone Extended-Release Injectable.
[4] Medicare & Medicaid Services. (2023). Reimbursement Guidelines.
