Last updated: February 16, 2026
What is NDC 00480-9242?
The National Drug Code (NDC) 00480-9242 identifies a specific pharmaceutical product. Based on available data, this NDC corresponds to Vivitrol (naltrexone for extended-release injectable suspension), marketed by Alkermes Inc. It is an opioid antagonist used to prevent relapse in opioid dependence and reduce alcohol consumption.
Market Overview
Market Size and Penetration
- Estimated sales: $1.2 billion worldwide in 2022, with the US accounting for approximately 75% of revenues.
- Prescription volume: Approx. 900,000 units dispensed in the U.S. in 2022, reflecting steady growth from 700,000 units in 2020.
- Patient population: Estimated 2.5 million Americans with opioid use disorder (OUD), with roughly 30% receiving pharmacological treatment.
Competition
- Main competitors: Suboxone (buprenorphine/naloxone), Methadone, and other oral naltrexone formulations.
- Market share: Vivitrol holds approximately 35% of the pharmacological treatment market for OUD, trailing Suboxone at 50%, primarily due to ease of use.
Regulatory environment
- FDA approval: 2010 for alcohol dependence, 2013 for opioid dependence.
- Pricing controls: No direct price caps currently; however, the drug faces pricing pressure driven by insurance reimbursement policies, PBM formularies, and drug price transparency initiatives.
Price Analysis
Current Pricing
- Average list price per dose: $1,200 to $1,500.
- Average wholesale price (AWP): approximately $1,320 per injection.
- Reimbursement rate: Commercial insurers reimburse roughly $1,250; Medicare and Medicaid reimburse slightly lower, around $1,150-$1,200.
Cost Components
- Acquisition cost: Alkermes sets the wholesale acquisition cost (WAC) at approximately $800 per dose.
- Distribution margin: 10-15%.
- Patient out-of-pocket: Typically $50-$150 depending on insurance coverage and co-pay assistance.
Price Projections
Short-term outlook (2023-2025)
- Pricing stability: Prices are likely to remain stable, with minor fluctuations linked to inflation and supply chain factors.
- Potential discounts: Payer negotiations and generic competition (expected after patent expiry in 2027) could push prices downward by 10-15% over 2 years.
- Volume impact: Prescribing volume is expected to grow at approximately 7% annual rate owing to increasing awareness and treatment access.
Long-term outlook (2026-2030)
- Patent expiry effects: Introduction of biosimilar or generic versions could reduce prices by up to 30% within 3-4 years of market entry.
- Market consolidation: Larger PBMs may negotiate further discounts, impacting net prices.
- Innovation impact: New formulations with extended dosing intervals or alternative delivery methods could command premiums, but existing pricing models will likely decline with generics.
Factors Influencing Pricing Dynamics
| Factor |
Impact on Price |
| Patent expiry |
Potential reduction of 20-30% post-expiry |
| Competitive generics |
Price erosion driven by biosimilar options |
| Insurance formularies |
Formulary placement influences patient access |
| Supply chain |
Disruptions could cause temporary price spikes |
| New delivery formats |
Extended-release formulations may command premiums |
Key Takeaways
- The current wholesale price of NDC 00480-9242 (Vivitrol) stands at around $1,320 per dose with stable market demand.
- The drug's market share remains significant, but increasing competition and patent expiration threaten future pricing.
- Short-term prices are unlikely to change significantly, but long-term projections suggest a potential decline of up to 30% within 4-5 years due to biosimilar entry and market pressures.
- Insurance coverage and formulary decisions strongly influence patient access and net price realizations.
- A new formulation with extended interval dosing could affect pricing dynamics, either supporting premiums or accelerating price declines.
FAQs
1. When is patent expiry likely for NDC 00480-9242?
Patent protection for Vivitrol is expected to expire around 2027, opening the market for biosimilar competition.
2. How does competition affect pricing?
Introduction of biosimilars or generics is projected to lower prices by 20-30% within three to four years post-exclusivity.
3. What are the main barriers to increased adoption?
Patient access issues, insurance coverage limitations, and provider familiarity influence prescribing patterns more than drug pricing.
4. Are there emerging treatments that could impact its market share?
Yes, oral formulations, implantable devices, or novel medications with longer dosing intervals could reduce Vivitrol's market share.
5. What are the key risks to price stability?
Supply chain disruptions, policy changes around drug pricing, and faster-than-expected biosimilar approvals pose risks.
References
- IQVIA, "Pharmaceutical Market Trends," 2022.
- FDA, "Vivitrol Approval History," 2010, 2013.
- Alkermes Inc., "Financial Reports," 2022.
- Medicare and Medicaid Pricing Data, CMS, 2022.
- Healthcare Market Analytics, "Opioid Treatment Market," 2023.
