Last updated: March 22, 2026
What is NDC 69315-0911?
NDC 69315-0911 is the National Drug Code identifier for Xyrem (sodium oxybate), a central nervous system depressant indicated for the treatment of narcolepsy, specifically excessive daytime sleepiness and cataplexy. Approved by the FDA in 2002, Xyrem is marketed by Jazz Pharmaceuticals.
Market Overview
Indication and Usage
Xyrem targets a niche market within sleep disorder treatments. As the only FDA-approved medication for narcolepsy with specific FDA labeling, its use remains highly specialized, limiting broader market penetration.
Market Size and Patient Population
Estimated global narcolepsy prevalence ranges from 25,000 to 50,000 cases. The U.S. accounts for roughly 20,000 diagnosed patients. The typical adult dose ranges between 4.5 grams to 9 grams daily, equating to annual per-patient drug consumption of approximately 1,300-2,600 grams.
Competitive Landscape
No direct biosimilar or generic versions of sodium oxybate are currently available in the U.S. due to patent protections and reformulations. All current marketed forms are branded Xyrem, forming a monopoly-controlled market environment.
Regulatory and Patent Status
- Patent protection for Xyrem expired in 2020 but was extended via supplementary patent protections until 2025.
- Jazz Pharmaceuticals holds exclusive distribution rights for Xyrem in the U.S.
Price Analysis
Current Pricing: Historical Trends
Per the latest available data, the wholesale acquisition cost (WAC) for Xyrem is approximately $1,800 to $2,200 per 450 mL bottle (5 grams per mL), with each bottle priced around $12,600. Typical treatment involves 50 mL to 150 mL per night, translating to annual treatment costs of $150,000 to $400,000 per patient.
| Parameter |
Value |
| Price per 450 mL bottle (WAC) |
~$12,600 |
| Daily dose (mL) |
50-150 |
| Annual cost per patient (approximate) |
$150,000 – $400,000 |
Cost per Milligram
At current prices, the cost per milligram of sodium oxybate exceeds $1.50.
Competitive Influences
- No generic alternatives exist.
- Pricing remains stable due to the lack of competition.
- State Medicaid and Medicare pricing reductions are limited due to patent protections.
Price Projections
Short-Term (Next 1-2 Years)
- No imminent entry of biosimilars or generics.
- Pricing likely stable, with potential minor adjustments for inflation, distribution costs, or supply chain factors.
- Price erosion remains unlikely unless a patent challenge or regulatory change occurs.
Medium to Long-Term (3-5 Years)
- Possible price erosion following patent expiration in 2025.
- Entry of generics could reduce prices by 20-50%, depending on market competition.
- Market entry might be delayed if patent extensions or regulatory hurdles occur.
Factors Affecting Future Prices
- Patent litigation outcomes.
- Development and FDA approval of biosimilars.
- Policy initiatives targeting drug pricing and biosimilar adoption.
- Market demand adjustments driven by patient access programs or insurance negotiations.
Conclusion
Xyrem (NDC 69315-0911) maintains a high-price, monopoly-driven market with stable current pricing. Expected price declines are tied to patent expiry and potential generic entry, projected around 2025. The market's narrow scope limits competitive downward pressure in the near term.
Key Takeaways
- NDC 69315-0911 (Xyrem) is a high-cost narcolepsy treatment with no current generics.
- Pricing is approximately $12,600 per bottle, supporting annual per-patient costs exceeding $200,000.
- Market exclusivity extends until patents potentially expire in 2025.
- Price erosion is unlikely before patent expiration; significant reductions expected post-2025 with generic entry.
- Market size is limited, constrained by a small diagnosed patient population.
FAQs
1. What are the primary factors driving Xyrem's high price?
Patent protections, lack of generic competition, and the drug's status as the only approved treatment for narcolepsy contribute to its elevated cost.
2. Could biosimilars significantly reduce the price of Xyrem?
Biosimilar competition post-2025 could reduce prices by 20-50%, depending on market penetration and regulatory approvals.
3. How does the pricing of Xyrem compare with similar treatments?
Other narcolepsy treatments, such as modafinil or armodafinil, cost significantly less ($300-$600 annually). Xyrem's cost is notably higher due to formulation complexity and regulation.
4. Are there regulatory or legal risks that could impact prices?
Patent litigation or regulatory changes could delay generic entry, maintaining high prices longer.
5. What strategies could improve patient access to Xyrem?
Insurance negotiations, patient assistance programs, and policy incentives can facilitate access within the current pricing framework.
References
[1] Food and Drug Administration. (2002). FDA approves Xyrem for narcolepsy.
[2] IQVIA. (2022). US Sales and Market Data for narcolepsy medications.
[3] Jazz Pharmaceuticals. (2023). Xyrem prescribing information.
[4] U.S. Patent and Trademark Office. (2021). Patent status and expiration dates for sodium oxybate formulations.
