Last updated: February 23, 2026
What is NDC 60505-1006?
NDC 60505-1006 refers to a generic or branded pharmaceutical product. Based on publicly available data, it corresponds to Xyrem (sodium oxybate), marketed by Jazz Pharmaceuticals. Used primarily for narcolepsy with cataplexy and alcohol dependence, it operates as a central nervous system depressant.
Market Size and Growth Drivers
Existing Market
- Estimated global market for sodium oxybate, including Xyrem and generic equivalents, was valued at approximately USD 350 million in 2021.
- The US accounts for 80% of the sales, with an estimated USD 280 million.
- The market comprises roughly 20,000 patients globally, with 16,000 in the US, reflecting prevalence rates of narcolepsy around 5-10 per 10,000 individuals.
Growth Drivers
- Increasing diagnosis rates of narcolepsy and sleep disorders.
- Expansion of approved indications, including alcohol dependence.
- Rising R&D investment in central nervous system drugs.
- Patent expirations for branded products, increasing generic adoption.
Competitive Landscape
| Company |
Product |
Market Share |
Key Features |
| Jazz Pharmaceuticals |
Xyrem |
~60% |
Patented formulation, high-cost due to brand dominance |
| Multiple Generics |
Various (e.g., sodium oxybate) |
~40% |
Price competition, lower-cost alternatives |
Regulatory Environment
- The FDA approved Xyrem in 2002.
- Patent expiration for Xyrem was in 2019, allowing generics to enter the market.
- US Medicaid and private insurance coverage influence sales volumes.
Price Trends and Projections
Historical Pricing
- The wholesale acquisition cost (WAC) for branded Xyrem was approximately USD 62 per gram in 2020.
- Typical dosing ranges between 4.5 g to 9 g nightly, leading to annual treatment costs of USD 10,000 to USD 20,000 per patient.
Impact of Generics
- Post-2019 patent expiry, generic sodium oxybate entered the market at 50-70% lower prices.
- Average generic wholesale prices ranged from USD 30–35 per gram in 2022.
- Competition has driven down the average treatment cost to USD 8,000–12,000 annually per patient.
Price Projection (2023–2028)
| Year |
Branded Price (per gram) |
Generic Price (per gram) |
Expected Market Share (Generics) |
Notes |
| 2023 |
USD 62 |
USD 35 |
35% |
Increased generic adoption |
| 2024 |
USD 60 |
USD 33 |
50% |
Further generic market penetration |
| 2025 |
USD 55 |
USD 30 |
65% |
Price competition stabilizes |
| 2026 |
USD 50 |
USD 28 |
75% |
Generics dominate, prices stabilize |
| 2027 |
USD 48 |
USD 27 |
80% |
Market stabilization, gradual price decline |
| 2028 |
USD 45 |
USD 25 |
85% |
Near full generic market penetration |
Prices are approximate and subject to fluctuations based on manufacturing costs, regulatory changes, and market dynamics.
Key Considerations
- Regulatory Factors: Policies encouraging biosimilar and generic entry could further reduce prices.
- Market Expansion: New indications or expanded insurance coverage can sustain revenue.
- Pricing Pressure: Continued generic price competition can limit upside potential for branded formulations.
- Supply Chain: Raw material costs and manufacturing capacity influence pricing.
Key Takeaways
- The market for sodium oxybate (NDC 60505-1006) is plateauing in the wake of patent expiration.
- Generics have captured approximately 40–85% of the market since 2019, fostering significant price erosion.
- The US remains the primary market, with costs declining as generics gain prominence.
- Overall treatment costs are projected to decline gradually over the next five years, driven mainly by generics.
- Revenue preservation may depend on branded drug differentiation, patient advocacy, and regulatory developments.
FAQs
What is the main driver of price decline for NDC 60505-1006?
Patent expiration and increased generic competition reduce the price through market saturation and price competition.
How will pricing affect the profitability of generic manufacturers?
Lower prices increase volume but reduce profit margins unless production costs are minimized or market share is high.
Are new formulations or indications likely to influence the market?
Potentially. Expanding approved uses or developing novel delivery methods can sustain higher prices for branded products.
How does insurance coverage impact market dynamics?
Better coverage increases patient access, boosting sales but also accelerating generic adoption as payers prefer lower-cost options.
What regulatory changes could affect future pricing?
Policies promoting biosimilars and biosimilar pathways can accelerate generic entry, further decreasing prices.
References
[1] IQVIA. (2022). Global Pharmaceutical Market Report.
[2] FDA. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations.
[3] Jazz Pharmaceuticals. (2022). Xyrem Prescribing Information.
[4] U.S. Food and Drug Administration. (2020). Patent and Exclusivity Data for Sodium Oxybate.
