Last updated: February 14, 2026
What is the Drug NDC 58980-0823?
NDC 58980-0823 is a drug identified as Xyrem (sodium oxybate), a central nervous system depressant used primarily for narcolepsy treatment and managing cataplexy. It is marketed by Jazz Pharmaceuticals. The drug has received FDA approval for these indications since 2002 and is classified as a Schedule III controlled substance due to its potential for abuse.
Market Landscape Overview
Size and Segments
- Global Narcolepsy Treatment Market (2022): Estimated at $1.2 billion, with projections to reach $1.8 billion by 2030, growing at a CAGR of approximately 6.8% [1].
- U.S. Market Share: North America accounts for roughly 60% of sales, driven by high prevalence of narcolepsy and insurance coverage.
Key Competitors
- Xyrem (sodium oxybate) by Jazz Pharmaceuticals
- Sunosi (solriamfetol) by Jazz Pharmaceuticals
- Nuvigil (armodafinil) by Teva Pharmaceuticals
- Provigil (modafinil) by Cephalon (Teva)
Pricing Dynamics
- The average wholesale price (AWP) for Xyrem approximately $50 per gram.
- Typical patient dosage: 4.5 grams nightly (divided into two doses), leading to monthly medication costs of roughly $600.
Regulatory and Reimbursement Factors
- Strict scheduling restricts prescribing and dispensing.
- Insurance coverage varies; Medicaid and Medicare programs include Xyrem, but coverage policies influence market penetration.
Price Projections and Market Trends
Current Pricing
- Xyrem’s wholesale acquisition cost (WAC): Approximately $1,600 per 10 mL bottle.
- Average monthly retail cost: Approximately $1,700, considering dosage and administration.
Influence Factors on Price Trends
- Regulatory Constraints: Schedule III restrictions limit supply chain efficiencies and sales volume.
- Manufacturing Costs: Sodium oxybate production involves complex stabilization and purification, maintaining high manufacturing costs.
- Market Penetration of Competitors: Newer drugs like Sunosi, with different mechanisms, aim to reduce reliance on sodium oxybate but haven't significantly eroded Xyrem’s market share yet.
- Expiration of Orphan Drug Designation: No recent loss of exclusivity as of 2023; patent protections sustain pricing.
Future Price Projections (2023-2028)
| Year |
Estimated Price per Patient per Month |
Key Assumptions |
Notes |
| 2023 |
$1,700 |
Stable supply, no new approval |
Current market price |
| 2024 |
$1,750 |
Slight inflation, inflation in costs |
Patent protection remains, limited competition |
| 2025 |
$1,800 |
Regulatory compliance costs rise |
Possible patent or exclusivity extensions |
| 2026 |
$1,850 |
Increased demand, no significant new entrants |
Slight price increase driven by inflationary pressures |
| 2027 |
$1,900 |
Competition introduction minimal |
Market saturation limits drastic price fluctuation |
Market Drivers and Risks
Drivers
- Increasing diagnosed cases of narcolepsy and hypersomnia.
- Growing awareness among clinicians leading to more diagnoses.
- Insurance reimbursement policies favoring coverage of effective therapies.
Risks
- Emergence of resistant or alternative therapies.
- Regulatory changes impacting scheduling or manufacturing.
- Price sensitivity among payers leading to formulary restrictions.
Key Takeaways
- Market Size: The narcolepsy treatment market is expanding, with Xyrem maintaining dominant market share owing to its efficacy profile.
- Pricing: Prices are currently stable but subject to incremental increases driven by manufacturing costs, regulatory compliance, and inflation.
- Future Outlook: Moderate price growth expected, with a ceiling constrained by the competitive landscape and payer dynamics.
- Competitive Risk: Limited near-term competition may support sustained pricing.
FAQs
1. Is the price of Xyrem likely to decline in the near future?
Low likelihood due to ongoing regulatory restrictions, high manufacturing costs, and limited competition.
2. How do regulatory constraints impact the Xyrem market?
Strict scheduling limits distribution channels, increasing costs and constraining supply, which supports stable or rising prices.
3. Are biosimilars or generics expected to enter the market?
Current patent protections and manufacturing complexity delay generic entry; no significant biosimilar competitors are announced as of 2023.
4. How do insurance policies influence the drug’s pricing?
Reimbursement levels and formulary placement affect access, but high demand for effective narcolepsy treatments sustains pricing.
5. What factors could significantly alter price projections by 2030?
Regulatory changes, the emergence of new therapies, or patent challenges could impact future pricing trajectories.
References
[1] MarketWatch, “Global Narcolepsy Drugs Market Size, Share & Trends,” 2022.
