Last updated: February 25, 2026
What is the Drug Identified by NDC 81033-0103?
NDC 81033-0103 refers to Xyrem (sodium oxybate), a central nervous system depressant used for narcolepsy with cataplexy and involved in the treatment of excessive daytime sleepiness. It is a Schedule III controlled substance in the United States.
Market Overview
Regulatory Status and Market Approval
Xyrem is marketed by Jazz Pharmaceuticals since FDA approval in 2002. Its utilization centers on narcolepsy and other off-label indications. The drug is designated as a controlled substance, which influences supply chain dynamics and pricing strategies.
Competitive Landscape
| Product Name |
Active Ingredient |
Approved Uses |
Market Share (approximate) |
Key Competitors |
| Xyrem |
Sodium oxybate |
Narcolepsy with cataplexy, sleep disorders |
70% |
Lack of direct competition, off-label alternatives involve off-label off-label sleep aids with lower effectiveness; no optimal substitutes for certain narcolepsy cases. |
| Wakix |
Pitolisant |
Narcolepsy-related EDS |
Limited |
Limited to EDS symptomatic relief. |
| Sunosi |
Solriamfetol |
Wakefulness in narcolepsy |
Growing |
Less prescribed than Xyrem. |
Market Size and Revenue
Worldwide revenue for sodium oxybate formulations peaked at approximately $800 million in 2021. US sales accounted for over 80% of the market. The market experienced compounded annual growth rate (CAGR) of 4% between 2017-2021.
Pricing Insights
| Price Component |
Price (USD) |
| Wholesale acquisition cost (WAC) per 30 mL bottle |
$2,000–$2,200 |
| Average wholesale price (AWP) per 30 mL bottle |
$2,600–$2,800 |
| Patient out-of-pocket (after insurance) per month |
$100–$500 |
Pricing is influenced by regulatory constraints, drug exclusivity, and manufacturing costs. The high price reflects the drug’s complex production, controlled substance status, and the significant clinical benefit for a limited patient population.
Price Projections
Short-Term (Next 1-2 Years)
- Price stability is expected due to patent and exclusivity protections until at least 2026, barring generic entry.
- Slight increase in wholesale prices (~2-3%) driven by inflation, manufacturing costs, and supply chain pressures.
Mid- to Long-Term (3-5 Years)
- Potential price erosion by 10-15% if generic or biosimilar competitors enter the market post patent expiry.
- Price reductions may also result from negotiated discounts, insurance contract influences, and formulary shifts.
- The expiration of market exclusivity, projected around 2026, is the key event affecting pricing.
| Scenario |
Expected Price Change |
Assumptions |
| Base case |
+2% annually |
No new competitors; supply chain remains stable |
| Conservative case |
-10% to -15% post-2026 |
Entry of generics; increased competition |
| Optimistic case |
Price stabilization due to market control |
Extended exclusivity or regulatory delays |
Impact of Regulatory and Policy Changes
FDA and DEA oversight influence high listing and reclassification risks, which could impact costs and pricing strategies. Changes in drug scheduling or stricter dispensing rules could limit supply or create bottlenecks, influencing prices.
Key Considerations for Stakeholders
- R&D Investment: Future pipeline candidates may alter market dynamics.
- Patent Landscape: Patent expiry dates are crucial for forecasting generics.
- Pricing Strategies: Manufacturers may introduce formulations or formulations with different packaging to retain market share.
Key Takeaways
- NDC 81033-0103 corresponds to Xyrem (sodium oxybate), primarily used for narcolepsy with cataplexy.
- The US market peaked at ~$800 million in annual revenue, with stable growth driven by clinical demand.
- Current pricing remains high, with wholesale prices around $2,000–$2,200 per 30 mL bottle.
- Prices are expected to remain stable in the short term, with potential declines post-2026 due to patent expiration.
- Supply chain issues, regulatory policies, and patent status are primary impact factors on market dynamics and pricing.
FAQs
1. When will generic versions of Xyrem enter the market?
Patent protections are expected to expire around 2026, opening the market to generic sodium oxybate products, which typically lead to price reductions.
2. How much can prices decrease after patent expiry?
Historical trends suggest price reductions of 10-15% initially, with potential further declines as competition increases.
3. Are there alternative treatments with similar efficacy?
No direct equivalents exist; drugs like Wakix or Sunosi address wakefulness but do not substitute for Xyrem’s specific benefits for narcolepsy with cataplexy.
4. What factors are most likely to influence the price in the next year?
Supply chain disruptions, regulatory changes, and negotiations with payers will have immediate impacts on pricing and access.
5. How does the controlled substance status affect market dynamics?
Strict regulation limits manufacturing, distribution, and prescribing, maintaining higher prices but restricting supply expansion.
References
[1] IQVIA. (2022). Market Insights on CNS Drugs.
[2] FDA. (2002). FDA Approval Letter for Xyrem.
[3] Jazz Pharmaceuticals. (2022). Annual Report.
[4] Statista. (2022). Global Market for Sleep Disorder Drugs.
[5] U.S. DEA Office of Diversion Control. (2022). Schedule Classification and Regulations.
