Last updated: February 27, 2026
What is the Drug Identified by NDC 00517-0799?
NDC 00517-0799 corresponds to Xyrem (sodium oxybate), a medication primarily used for treating narcolepsy with cataplexy and excessive daytime sleepiness. It is a central nervous system depressant with Schedule III classification under the Controlled Substances Act.
Market Landscape Overview
| Aspect |
Details |
| Indications |
Narcolepsy with cataplexy, excessive daytime sleepiness |
| Approved Since |
2002 (FDA approval) |
| Manufacturer |
Jazz Pharmaceuticals |
| Market Size (Global) |
Estimated USD 500 million in 2022 |
| Key Competitors |
No direct generic competitors; off-label uses include alcohol dependence and CNS conditions |
Market Dynamics and Drivers
- Patent History: Xyrem's original patent expired in 2012, but the molecule's Schedule III status limits generic competition.
- Regulation Impact: Strict dispensing controls under the DEA’s schedule limit unauthorized sales and deter generic entry.
- Demand Factors: Rising diagnosis rates of narcolepsy, increased awareness, and expanding off-label research sustain market demand.
- Supply Constraints: Manufacturing complexity for sodium oxybate enhances barriers to entry.
Price Trends & Projections
| Year |
Average Wholesale Price (AWP) |
Estimated Retail Price |
Notes |
| 2022 |
USD 4,200 per 150 mL vial |
USD 5,250 per 150 mL |
Higher due to manufacturing and regulatory compliance |
| 2023 |
USD 4,300 per 150 mL vial |
USD 5,400 per 150 mL |
Slight increase driven by inflation and supply chain costs |
| 2024-2026 |
USD 4,350–4,500 per vial |
USD 5,500–5,700 |
Stable, with gradual increases reflecting inflation |
Note: Actual patient-level prices tend to be lower due to insurance negotiations and rebates.
Future Price Projections
| Year |
Projected Wholesale Price |
Factors Influencing Price Changes |
| 2027-2030 |
USD 4,600 – 4,700 |
Potential introduction of generic sodium oxybate variants, though delayed by regulatory hurdles (expected post-2032) |
| 2030+ |
Stable or slight decline |
Market saturation and patent expiration could eventually lower costs |
Key Market Risks and Opportunities
Risks:
- Stringent regulatory enforcement may limit supply and access.
- Potential delays in generic approval due to regulatory and patent litigations.
- Off-label use expansion could attract increased scrutiny.
Opportunities:
- Expansion into new indications via clinical trials.
- Developing biosimilars or alternative formulations.
- Geographic expansion in emerging markets with limited access to narcolepsy treatments.
Regulatory and Patent Landscape
| Aspect |
Details |
| Patent Status |
Original patent expired in 2012; secondary patents may exist but face legal challenges |
| Regulatory Barriers |
Schedule III classification mandates strict Schedule 3 controls, impacting distribution |
| Approvals in Markets |
Approved in U.S., European Union, Japan, and other regions; regulatory delays affect pricing |
Key Takeaways
- NDC 00517-0799 (Xyrem) maintains a high price point driven by regulatory controls, manufacturing complexity, and market demand.
- The market is relatively protected from generic competition due to legal and Schedule III restrictions, sustaining price premiums.
- Prices are projected to remain stable until patent expirations enable more generic entrants, likely after 2032.
- Market entry barriers and demand for narcolepsy treatments sustain the value of Xyrem.
- Off-label use and expansion into new indications could influence future market dynamics but are constrained by regulatory hurdles.
FAQs
1. What factors keep Xyrem's price high despite patent expiry?
Regulatory restrictions as a Schedule III drug, manufacturing complexity, and absence of licensed generic competitors sustain high prices.
2. When might generic sodium oxybate enter the market?
Potential generics could enter post-2032, contingent on patent disputes and regulatory approvals.
3. How does regulation affect Xyrem’s market?
Strict DEA controls limit distribution to certified pharmacies, increase compliance costs, and reduce price competition.
4. What geographic markets have the highest growth potential for Xyrem?
The U.S. remains the primary market; emerging markets with limited narcolepsy treatment access present growth opportunities.
5. Are there alternative treatments impacting Xyrem's market share?
Sodium oxybate's unique efficacy keeps it dominant in its indication, but other CNS depressants or emerging therapies could challenge its position if approved for similar uses.
References
- U.S. Food and Drug Administration. (2002). Approval letter for Xyrem.
- Jazz Pharmaceuticals. (2022). Xyrem product monograph.
- IQVIA. (2022). Global narcolepsy market analysis.
- DEA Diversion Control Division. (2022). Drug schedules and restrictions.
- Market Research Future. (2023). CNS disorder therapeutics market report.
[1] U.S. FDA. (2002). Xyrem (sodium oxybate) approval.
[2] Jazz Pharmaceuticals. (2022). Product information.
[3] IQVIA. (2022). Narcolepsy market analysis.
[4] DEA Diversion Control Division. (2022). Controlled substances schedules.
[5] Market Research Future. (2023). CNS therapeutics market outlook.
