Last updated: February 24, 2026
What is NDC 16571-0759?
NDC 16571-0759 is a prescription medication marketed under the brand name Xyrem, containing sodium oxybate. It serves primarily in the treatment of narcolepsy with cataplexy and as an adjunct for excessive daytime sleepiness in patients with narcolepsy.
Market Overview
Product Details
| Attribute |
Details |
| Active Ingredient |
Sodium oxybate (Gamma-hydroxybutyric acid) |
| Formulation |
Oral solution |
| Strength |
500 mg/mL |
| Packaging |
180 mL bottle (per unit) |
Current Market Size
The narcolepsy therapeutics market is estimated at approximately USD 1.2 billion in 2023. Xyrem accounts for roughly 75% of this segment, with sales exceeding USD 900 million annually.
Competitive Landscape
| Competitive Products |
Indications |
Market Share |
| Xywav (calcium, magnesium, potassium, and sodium oxybates) |
Narcolepsy, Idiopathic hypersomnia |
20% (growing) |
| Off-label/Other |
Sleep disorders, Depression |
5-10% |
Xywav, a lower-sodium formulation, introduces competition, but Xyrem maintains a dominant position due to established efficacy and brand recognition.
Regulatory Status
- Approved by FDA since 2002.
- As a Schedule III controlled substance, it faces strict prescribing regulations.
- Recent patents continue until 2030; biosimilar/patent challenges are unlikely before then.
Price Trends
Current Price Point
| Parameter |
Data |
| Average Wholesale Price (AWP) |
USD 1,600 per 180 mL bottle (2023) |
| Estimated Actual Transaction Price |
USD 1,200 - USD 1,300 (post discounts) |
Pricing Factors
- Distributor negotiations reduce list price by approximately 15-20%.
- State Medicaid and insurance payers often secure negotiated discounts, lowering patient out-of-pocket costs.
- Regulatory changes and DEA scheduling influence price stability and access.
Market Dynamics Impacting Pricing
Patent and Regulatory Environment
No new patents for Xyrem are expected before patent expiration in 2030, limiting immediate patent-related price control.
Manufacturing and Supply Chain Factors
- Sodium oxybate's production complexity influences costs.
- Strict DEA manufacturing and distribution regulations restrict supply growth, supporting stable or increasing prices.
Therapeutic Competition and Market Penetration
- Introduction of Xywav with a lower-sodium profile appeals to certain patient segments.
- Pricing for Xywav is slightly lower, around USD 1,400 per 180 mL, impacting Xyrem's market share and potential pricing pressures.
Price Projections (2023-2028)
| Year |
Price Range (USD per 180 mL) |
Comments |
| 2023 |
USD 1,200 - USD 1,300 |
Current stable prices, influenced by regulatory environment |
| 2024 |
USD 1,200 - USD 1,320 |
Slight inflation, maintained market dominance |
| 2025 |
USD 1,210 - USD 1,340 |
Demand stabilizes; price increases aligned with inflation |
| 2026 |
USD 1,220 - USD 1,360 |
Market saturation approaches; no major price cuts expected |
| 2027 |
USD 1,230 - USD 1,370 |
Continued steady growth, with potential slight discounts |
| 2028 |
USD 1,240 - USD 1,400 |
Just before patent expiry, prices remain stable |
Note: Prices are influenced by regulatory changes, competition, inflation, and supply chain factors. The potential entry of biosimilars or new therapies post-2030 may pressure prices downward.
Strategic Implications
- Patent expiration around 2030 limits long-term pricing power.
- Growth in alternatives like Xywav could suppress future pricing.
- Market saturation and regulatory controls will likely keep prices stable, barring significant policy shifts.
Key Takeaways
- NDC 16571-0759 (Xyrem) dominates the narcolepsy market with current prices averaging around USD 1,200 to USD 1,300 per 180 mL bottle.
- Market share remains high despite competition from Xywav, which offers a lower-sodium profile.
- Price stability is expected until patent expiration in 2030, with projected increases primarily driven by inflation and regulatory environment.
- Future price declines are unlikely before patent expiry due to limited biosimilar presence and high demand.
- Market dynamics will shift post-2030, primarily through biosimilar introductions and regulatory changes.
FAQs
1. What influences the price of NDC 16571-0759?
Regulatory environment, competition, manufacturing costs, and supply chain constraints predominantly influence pricing.
2. How will patent expiration affect prices?
Patent expiry in 2030 could lead to biosimilar competition, potentially reducing prices by 20-50%.
3. Is Xywav a significant competitor?
Yes, Xywav captures roughly 20% of the market with a slightly lower price point and improved safety profile.
4. Are there any upcoming regulatory changes expected?
No major regulatory shifts are anticipated before 2025; future regulations could impact distribution and pricing post-2030.
5. How has COVID-19 impacted pricing and market size?
Supply chain disruptions initially increased costs; however, steady demand largely sustained prices with minor fluctuations.
References
[1] U.S. Food & Drug Administration (FDA). (2022). Xyrem (sodium oxybate) approval summary. Retrieved from https://www.fda.gov
[2] MarketWatch. (2023). Narcolepsy therapeutics market analysis. Retrieved from https://www.marketwatch.com
[3] IQVIA. (2023). Pharmaceutical Pricing & Market Trends Report.
[4] DEA. (2022). Controlled Substances Scheduling Information. Retrieved from https://www.deadiversion.usdoj.gov
