Last updated: March 21, 2026
What is NDC 00115-2790?
NDC 00115-2790 is the National Drug Code for Xyrem (sodium oxybate), a prescription medication primarily used to treat narcolepsy with cataplexy and excessive daytime sleepiness. It is marketed by Jazz Pharmaceuticals.
Market Overview
Market Size and Growth
- The global narcolepsy drugs market was valued at approximately USD 1.5 billion in 2022.
- Compound annual growth rate (CAGR) is estimated between 6% and 8% through 2030, driven by increased diagnosis rates and off-label uses.
Patient Population
- Estimates suggest 135,000 to 200,000 narcolepsy cases in the United States.
- Clinical data indicates approximately 70% of diagnosed cases receive Xyrem or alternatives.
Competitor Landscape
- Primary competitors include Sodium oxybate formulations, Stimulant medications (e.g., modafinil, armodafinil), and emerging therapies like orexin receptor antagonists.
- Market share held predominantly by Jazz Pharmaceuticals, with limited direct competition until the emergence of novel therapies.
Pricing Landscape
Current Pricing (U.S. Market)
| Formulation |
Average Wholesale Price (AWP) |
Annual Cost (per patient) |
| Xyrem (Xyrem solution, 500 mg/mL) |
USD 68.50 per mL |
USD 35,000 – USD 45,000 |
- The retail price for a typical 180 mL bottle averages USD 12,000 to USD 15,000.
- Insurance reimbursements vary; however, net prices often fall in the USD 25,000 to USD 50,000/year range after rebates and discounts.
Pricing Drivers
- The drug's status as a controlled substance (Schedule III) influences distribution costs.
- Drug formulation, dosing regimen, and patient adherence impact overall expenses.
- High manufacturing costs due to strict storage and handling requirements.
International Pricing Comparison
- European markets peg prices between EUR 15,000 to EUR 25,000 annually.
- Pricing policies are influenced by national healthcare systems and reimbursement policies.
Price Projections (Next Horizon: 2024–2028)
Factors Influencing Future Prices
- Patent Expiry: Existing patents extend until 2028, limiting generic entry.
- Regulatory Approvals: FDA approvals of generics or biosimilars could pressurize prices.
- Market Penetration: Expanded indications or off-label use could increase demand, supporting higher prices.
- Reimbursement Dynamics: Changes in insurance coverage or government policy can alter net prices.
Projected Trends
| Year |
Estimated Average Price (USD) |
Notes |
| 2024 |
USD 60,000 – USD 75,000 |
Stable, limited generic competition |
| 2025 |
USD 60,000 – USD 75,000 |
Patents likely hold, slight inflation impact |
| 2026 |
USD 55,000 – USD 70,000 |
Entry of generics unlikely before patent expiry |
| 2027 |
USD 50,000 – USD 65,000 |
Approaching patent expiry, potential for biosimilar entry |
| 2028 |
USD 35,000 – USD 50,000 |
Patent expiration possibly opens generic market |
Revenue Impact Upon Patent Expiry
- Assuming a market share decline of 60–80% upon generic entry, revenues would contract sharply.
- Price reductions are estimated between 40% and 60% for generics.
Risks and Opportunities
Risks
- Regulatory challenges delaying generic approval.
- Policy reforms reducing drug reimbursement.
- Slow adoption of new indications.
Opportunities
- Expansion into new indications (e.g., alcohol dependence).
- Development of biosimilars or alternative formulations.
- Increased global demand due to rising narcolepsy awareness.
Key Takeaways
- Demand for NDC 00115-2790 remains robust within narcolepsy treatment, with expected steady prices until patent expiration in 2028.
- The current U.S. annual treatment cost ranges between USD 25,000 and USD 50,000 after rebates.
- Price decreases are anticipated post-patent expiry, with potential for significant revenue decline.
- Market entry of generics or biosimilars remains the primary risk to pricing stability.
- International markets may adopt lower prices, influenced by healthcare policies.
FAQs
1. When do patents for Xyrem expire?
Patent protections extend until 2028, after which generics could enter the market.
2. What factors could accelerate generic entry?
Regulatory approvals, patent challenges, and manufacturing capacity expansion.
3. How do international markets price Xyrem?
European prices range between EUR 15,000–25,000 annually, influenced by national reimbursement policies.
4. Can new therapies replace Xyrem?
Emerging treatments like orexin receptor antagonists offer alternatives but currently have limited market share.
5. How might policy changes affect pricing?
Reimbursement reforms and drug pricing legislation could reduce net prices and access.
References
[1] Market Research Future. (2023). Narcolepsy drugs market forecast.
[2] IQVIA. (2022). U.S. prescription drug market data.
[3] European Medicines Agency. (2022). Pricing policies for narcolepsy medications.
[4] Jazz Pharmaceuticals. (2022). Xyrem prescribing information and patent data.
