Last updated: February 24, 2026
What Is the Drug Associated with NDC 51407-0389?
NDC 51407-0389 corresponds to Xyrem (sodium oxybate). Xyrem is used for treating narcolepsy with cataplexy and is classified as a Schedule III controlled substance. Manufactured by Jazz Pharmaceuticals, it has seen significant market presence since its approval.
Market Size and Key Drivers
Market Size
The global narcolepsy drug market was valued at approximately $2.1 billion in 2022. Xyrem accounts for around 65-70% of the revenue within this segment. The increasing diagnosis rates and expanded prescribing patterns post-approval for adjunct indications are primary growth drivers.
Key Drivers
- Expanded Indications: Use in pediatric narcolepsy since 2018 expands patient base.
- Reimbursement Policies: Coverage by major insurers, though with access restrictions.
- Research and Development: Investigations into off-label uses, such as for fibromyalgia and alcohol dependence, may impact future demand.
Market Competition
- The principal competitor is Soma (gamma-hydroxybutyrate), with limited commercial availability.
- Emerging therapies under development include modafinil derivatives and orexin receptor antagonists (e.g., Takeda’s Dayvigo).
Pricing Trends and Future Projections
Current Pricing (2023)
- Wholesale Acquisition Cost (WAC): Approximately $63,000 per year for a typical treatment course.
- Average Patient Out-of-Pocket (OOP): Adjusted by insurance, often in the $2,000-$5,000 range annually due to cost-sharing.
| Year |
WAC per Year |
Projected WAC |
Notes |
| 2023 |
$63,000 |
$63,000 |
Base year; high cost driven by manufacturing complexity. |
| 2024 |
$65,000 |
+3.2% |
Slight increase due to inflation and manufacturing costs. |
| 2025 |
$67,500 |
+4.0% |
Market pressures and potential biosimilar entry delays. |
| 2030 |
$75,000 |
+6.0% (Cumulative) |
Inflation adjustments, limited biosimilar competition. |
Future Price Drivers
- Regulatory pressures: Increased scrutiny on high drug prices may slow growth.
- Biosimilar development: No biosimilars are expected within next 5-7 years, maintaining exclusivity.
- Supply chain costs: Raw material shortages, especially for gamma-butyrolactone precursors, could influence price stability.
Revenue Projections
- 2023: $1.3 billion global sales.
- 2028: Estimated $1.65 billion based on sales growth of approximately 4% annually, factoring in market penetration and pricing.
Regulatory and Reimbursement Landscape
- FDA approval: 2002 for narcolepsy with cataplexy; expanded indications in 2018 for pediatric use.
- Controlled substance classification: Schedule III, limited prescribing to certified physicians.
- Reimbursement: Major insurers cover Xyrem post prior authorization; coverage restricts access in some regions due to abuse potential concerns.
Risks to Market and Price Trends
- Off-label use restrictions: Regulatory agencies scrutinize off-label prescribing patterns.
- Potential biosimilar entry: Though none are imminent, future biosimilar approvals could reduce prices.
- Policy changes: Policies targeting drug price inflation can affect future pricing and profitability.
Conclusion
NDC 51407-0389, corresponding to Xyrem, commands high prices driven by manufacturing complexity, limited competition, and regulatory constraints. It remains a dominant player in narcolepsy treatment, with steady revenue growth projected through 2030. Price increases are expected to slow but remain above inflation rates due to market dynamics and regulatory risks.
Key Takeaways
- Xyrem holds a dominant market share in narcolepsy treatment, with annual revenues exceeding $1 billion.
- Current prices average around $63,000 annually, with modest growth projections.
- Biosimilar competition is unlikely within the next 5-7 years, supporting sustained high prices.
- Regulatory, reimbursement, and supply chain risks will influence market evolution.
- Revenue growth will primarily derive from pricing and expanding indications rather than volume increases.
FAQs
1. How does Xyrem compare to other narcolepsy medications?
Xyrem's efficacy in reducing cataplexy is well-established but comes with high costs and strict prescribing regulations, unlike oral stimulants like modafinil, which have lower costs but different efficacy profiles.
2. What factors could lead to price decreases for Xyrem?
Introduction of biosimilars, regulatory price controls, or significant reimbursement restrictions could lower prices.
3. Are there any competing drugs in development?
Yes, orexin receptor antagonists such as Takeda’s Dayvigo and other wake-promoting agents are in various development phases, potentially impacting future market share.
4. What's the outlook for global sales?
Global sales will mirror U.S. trends, with steady growth in developed markets. Emerging markets may see delayed adoption due to reimbursement and regulatory hurdles.
5. How might policy changes affect the market?
Legislation aiming to curb high drug prices could result in price caps or increased biosimilar competition, reducing profit margins.
References
[1] IBISWorld. (2023). Narcolepsy Drug Market in the US.
[2] Jazz Pharmaceuticals. (2022). Xyrem Prescribing Information.
[3] IQVIA. (2023). Top-Line Market Data for Central Nervous System Drugs.
[4] FDA. (2018). Approval of Expanded Indications for Xyrem.
[5] U.S. Department of Health & Human Services. (2023). Drug Price Policies and Regulations.
