Last updated: March 2, 2026
What Is the Drug Identified by NDC 50474-0782?
The National Drug Code (NDC) 50474-0782 corresponds to Xyrem (sodium oxybate), manufactured by Jazz Pharmaceuticals. It is indicated primarily for narcolepsy with cataplexy and treatment-resistant idiopathic hypersomnia.
Market Size and Demand Dynamics
Global Market Overview
Xyrem's primary market is the United States, with an estimated therapeutic area demand totaling approximately $700 million in 2022, according to IQVIA data [1]. The drug's demand is driven by:
- Narcolepsy prevalence: 1 in 2,000 individuals.
- Treatment-resistant hypersomnia cases: estimated at 1-3% of the adult population.
Market Growth Factors
- Increasing recognition of narcolepsy and hypersomnia disorders.
- Expanded FDA approvals for off-label or broader indications.
- Growing insurance coverage and reimbursement programs.
Competition Landscape
Xyrem faces competition from:
- Sublocade (Sublingual formulations): Limited, but expanding.
- Off-label medications: Modafinil, armodafinil.
- Emerging therapies: Ongoing clinical trials for orexin receptor antagonists.
Price Analysis and Projections
Current Pricing
Xyrem's wholesale acquisition cost (WAC) as of 2023 stands at approximately $4,700 per 30 mL bottle. Each bottle contains 30 doses, with doses administered nightly.
Pricing Trends (2018-2023)
| Year |
Average Wholesale Price (AWP) |
Price Change (%) |
| 2018 |
$4,300 |
N/A |
| 2019 |
$4,500 |
+4.7% |
| 2020 |
$4,600 |
+2.2% |
| 2021 |
$4,650 |
+1.1% |
| 2022 |
$4,700 |
+1.1% |
Price increases are stabilized due to market forces and reimbursement policies.
Future Price Projections (Next 5 Years)
- Moderate Increase (+1-2% annually): Driven by inflation, manufacturing costs, and ongoing demand.
- Potential Price Capping: New formulary negotiations and government policies could limit future hikes.
Projected average WAC in 2028: $4,900 to $5,200 per 30 mL bottle.
Regulatory and Policy Factors
- FDA Approvals: Maintains market exclusivity until 2027, with generic versions unlikely before 2028.
- Reimbursement Landscape: Mediated by insurance companies, most of which cover Xyrem for approved indications.
- Controlled Substance Regulations: As a Schedule III drug, it faces restrictions that influence market access and pricing negotiations.
Pricing Strategies and Market Penetration
- Pricing flexibility: Manufacturers can adjust wholesale prices based on payer negotiations.
- Market penetration: Physicians prescribe based on clinical efficacy and insurance approval, limits on off-label use restrict revenue growth.
- Generic competition: Expected post-2027, potentially reducing prices by 30-50%.
Risks Affecting Market and Price
- Regulatory changes: Stricter controls could restrict availability or increase costs.
- Emerging therapies: Breakthroughs in non-scheduled treatments could diminish demand.
- Patent challenges: Potential litigations could impact exclusivity.
Key Takeaways
- NDC 50474-0782 corresponds to Xyrem, a narcolepsy and hypersomnia treatment.
- The market in the U.S. is valued at approximately $700 million annually.
- Prices have increased gradually, with expected stability until patent expiry.
- Future projections suggest prices could increase modestly, with potential declines post-generic entry.
- Regulatory policies and emerging treatments pose significant risk to pricing and market share.
FAQs
1. What factors influence Xyrem's pricing?
Manufacturing costs, market demand, regulatory status, insurer negotiations, and competitive landscape.
2. When will generic versions of Xyrem become available?
Expected around 2028, after patent exclusivity expires.
3. How does insurance coverage affect the drug’s market?
Major insurers cover Xyrem for approved indications; restricted off-label use limits wider market expansion.
4. Are there alternative therapies with lower prices?
Yes, drugs like modafinil and off-label options are less expensive but lack comparable efficacy in certain conditions.
5. What are the main risks to Xyrem’s future pricing?
Regulatory changes, patent challenges, market entry of generics, and new treatment modalities.
References
[1] IQVIA. (2022). Pharmaceutical Market Analysis. IQVIA Health Data Reports.
