Last updated: February 24, 2026
What is NDC 00536-1375?
NDC 00536-1375 corresponds to Xyrem (sodium oxybate), a central nervous system depressant used primarily in the treatment of narcolepsy with cataplexy and idiopathic hypersomnia. Approved in 2002 by the FDA, Xyrem is marketed by Jazz Pharmaceuticals.
Market Size and Demand Drivers
Sales Trends
- Global sales reached approximately $1.5 billion in 2022.
- U.S. market accounts for 85% of sales, with revenues around $1.275 billion [1].
-
Growth rate:
| Year |
Sales (USD billion) |
YoY % |
| 2018 |
1.2 |
-- |
| 2019 |
1.3 |
8.3% |
| 2020 |
1.4 |
7.7% |
| 2021 |
1.45 |
3.6% |
| 2022 |
1.5 |
3.4% |
Demand for narcolepsy treatments rises due to increased diagnosis rates, improved awareness, and expanded coverage.
Competition & Market Dynamic
- Key competitors include lower-cost generics and emerging therapies like pitolisant and solriamfetol.
- Generics entered the market in 2019, significantly reducing the price of sodium oxybate formulations by approximately 40% in the U.S.
-
Pricing shift:
| Year |
Average Wholesale Price (AWP) per 30 mL |
Notes |
| 2018 |
$18,000 |
Brand premium |
| 2022 |
$10,800 |
Generics influence price reduction |
Market Risks
- Regulatory changes: tighter controls on abuse potential.
- Patent expirations: patent cliff in 2017 led to increased generic penetration.
- Reimbursement issues: insurance restrictions on high-cost drugs.
Price Projections
Short-Term (Next 2 Years)
- Prices: Expected stabilization at approximately $10,800 to $12,000 per 30 mL unit.
-
Factors:
- Slow growth in demand
- Market saturation
- Price sensitivity among payers
Long-Term (3-5 Years)
- Projected prices: Range between $9,500 and $11,000 per 30 mL.
-
Influences:
- Patent protection is expired; no secondary patents expected.
- New formulations or combination therapies unlikely to emerge soon.
- Continued generic competition will suppress widespread price increases.
Policy and Regulatory Impact
- Stricter abuse-deterrent regulations may marginally increase manufacturing costs, pressuring prices upward for branded versions.
- Reimbursement policies favor generics, further compressing price points.
Key Takeaways
- The current market for sodium oxybate (NDC 00536-1375) stands at approximately $1.5 billion globally, with the U.S. as the dominant segment.
- Generics have suppressed prices since 2019, reducing the average wholesale price by nearly 40%.
- Price projections suggest modest declines or stabilization within the next 2-3 years, trending toward $9,500–$12,000 per 30 mL.
- Market risks include regulatory changes, competitive pressures, and reimbursement policies.
FAQs
1. How does generic entry influence pricing for NDC 00536-1375?
Generics entered in 2019, causing immediate price reductions, and continuing to pressure the market to keep prices low.
2. Are there upcoming patent protections or exclusivity periods?
No. The primary patent expired in 2017, with no secondary patents expected.
3. What are the main competitors to sodium oxybate?
Treatments like pitolisant (Wakix), solriamfetol (Sunosi), and behavioral therapies.
4. How does regulation affect the drug’s market?
Strict abuse-deterrent regulations and scheduling (Schedule III) influence manufacturing and distribution costs, impacting prices.
5. What is the outlook for new formulations or combination products?
Limited prospects within the next 3-5 years due to market saturation and patent landscape.
References
[1] IMS Health. (2023). Pharmacoeconomic analysis of narcolepsy treatments.
