Last updated: February 12, 2026
Overview of NDC 51407-0622
The National Drug Code (NDC) 51407-0622 corresponds to Xyrem (sodium oxybate) oral solution, indicated primarily for narcolepsy with cataplexy in adults and off-label uses. The drug is produced by Jazz Pharmaceuticals.
Market Landscape
Market Size & Trends
Xyrem's global sales in 2022 reached approximately $1.4 billion, with the U.S. accounting for over 95% of revenue. The drug's core patient demographic consists of roughly 50,000 diagnosed narcolepsy patients in the U.S., with a notable growth rate of 3-5% annually due to increased awareness and improved diagnosis rates.
Regulatory Considerations
The drug is classified under Schedule III controlled substances, impacting prescribing patterns and potential market expansion. Its approval for off-label uses remains unapproved but clinically adopted in certain centers, expanding its utility but also regulatory scrutiny.
Competitive Positioning
Xyrem faces competition from other narcolepsy treatments such as sodium oxybate formulations, stimulants (e.g., modafinil), and newer drugs like pitolisant. However, it retains a dominant market share due to established efficacy, reimbursement coverage, and market inertia.
Pricing Dynamics and Projections
Current Pricing
The average wholesale price (AWP) for a 30 mL bottle (120 mg/mL concentration) is approximately $1,500, with retail prices around $1,800. The drug’s dosage varies; typical prescriptions are 4.5 g at bedtime, translating to a monthly cost of roughly $24,000 for patients on the standard dose.
Reimbursement and Cost Trends
Insurance coverage is extensive, leading to reimbursement rates near the retail price for most patients. Cost containment pressures from payers have prompted negotiations and discounts, reducing net prices for payers compared to list prices.
Price Projections (2023–2027)
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Short-term (2023–2024):
Price stability persists due to limited generic competition—no generics approved or marketed. Slight increases (~2-3%) in retail pricing are expected driven by inflation and manufacturing costs.
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Mid-term (2025–2026):
Potential introduction of generics could lower branded prices by 20-30% within the first year post-generic approval, depending on patent litigation outcomes and market share retention.
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Long-term (2027 and beyond):
Price declines are likely if generic competition captures significant market share. If biosimilar or alternative formulations gain approval or market penetration, the branded drug could see further discounts, potentially reducing prices by up to 50% over five years.
Factors Influencing Pricing
- Patent status and exclusivity expiration, typically in late 2025 based on patent filings.
- Competition from pharmaceutical companies developing similar or alternative treatments.
- Regulatory approvals for expanded indications.
- Payer negotiations, formulary placements, and rebate strategies.
Market Entry and Growth Opportunities
- Greater adoption of off-label uses in sleep disorders and psychiatric conditions could increase demand.
- Trends toward once-night dosing formulations or extended-release options may offer premium pricing opportunities.
- International markets are underdeveloped, with expansion potential in Europe and Asia, contingent on regulatory approvals.
Conclusion
The sustained market dominance of Xyrem suggests minor price increases through 2024. The entry of generics around 2026 could substantially reduce costs, affecting revenue projections unless new formulations or indications are commercialized.
Key Takeaways
- NDC 51407-0622 corresponds to Xyrem, a leading narcolepsy treatment with a $1.4 billion global market.
- Short-term pricing remains stable; mid-term projections depend heavily on patent expiry and generic competition.
- Prices are likely to decline by 20-50% over five years if generics are introduced or competitors gain market share.
- Growth prospects lie in expanded indications and international market entry.
- Reimbursement and rebate strategies influence real-world net prices.
FAQs
1. When is patent expiry expected for Xyrem?
Patent protections are primarily active until late 2025, with secondary patents possibly extending exclusivity until 2026. Patent litigation outcomes could alter these timelines.
2. What is the likelihood of generic competition?
High—expected to enter the market within 12-18 months after patent expiry, depending on FDA approval processes and patent challenges.
3. How does pricing compare internationally?
International prices are generally lower, with some European markets averaging 50-60% of U.S. prices due to different reimbursement policies.
4. Are there new formulations in development?
Yes, extended-release and alternative dosing formulations are under clinical investigation, which could influence future pricing and market share.
5. How significant is off-label use for market projections?
Off-label uses in other sleep and psychiatric disorders expand potential demand but are limited by regulatory considerations and clinical acceptance.
Sources
- Jazz Pharmaceuticals financial reports, 2022.
- IQVIA. Global Prescription Sales Data, 2022.
- FDA drug approval and patent data.
- Market research reports from EvaluatePharma and MedReleaf, 2022.
- Industry publications on narcolepsy treatment trends.
