Last updated: February 26, 2026
What is NDC 49884-0214?
NDC 49884-0214 corresponds to a specific drug product listed in the National Drug Code database. Based on available data, this code identifies Xyrem (sodium oxybate), indicated primarily for narcolepsy with cataplexy.
Market Size and Demand
U.S. Market Overview
- Prevalence of Narcolepsy: Approximately 200,000 Americans, with only about 25% diagnosed.
- Xyrem Usage: Estimated to treat around 50,000 patients with narcolepsy-related symptoms, based on current prescriptions (IQVIA, 2022).
Competition Landscape
- Main Competitor: Kusim (solriamfetol)
- Off-label Off-Label Alternatives: Modafinil, sodium oxybate (Xyrem) remains the standard for narcolepsy with cataplexy.
- Patents & Exclusivity: Original patent expired in 2011; however, secondary patents and formulation protections extended market exclusivity until recent years.
Price History and Current Pricing
Past Pricing Trends
- 2008-2012: Average wholesale price (AWP) of Xyrem hovered around $8,000 per year per patient.
- 2013-2018: Slight increases due to inflation and supply chain factors, reaching approximately $12,000.
- 2019-2022: Stabilization at roughly $14,400 annually, with slight fluctuations.
Current Price (2023)
- Wholesale Acquisition Cost (WAC): Approximately $14,500 per patient annually.
- Average Sales Price (ASP): Around $16,000–$18,000, with commercial insurance often negotiating discounts.
- Out-of-Pocket Cost: Patients may face co-pays ranging from $0 to $5,000 annually, depending on insurance plans.
Market Drivers
- Increased diagnosis of narcolepsy leads to higher treatment rates.
- Expanded use for hypersomnia in off-label settings supports demand.
- Pricing pressures from biosimilar and alternative therapies.
Price Projections (Next 3-5 Years)
| Year |
Estimated WAC (Per Patient) |
Factors Impacting Price |
Notes |
| 2024 |
$15,000 – $15,500 |
Inflation, manufacturing costs |
Slight increase anticipated, driven by inflation. |
| 2025 |
$15,500 – $16,000 |
Patent protections near end |
Potential for patent challenges or biosimilar development. |
| 2026 |
$16,000 – $16,500 |
Biosimilar market entry |
Biosimilars could reduce prices by 20–30%. |
| 2027 |
$14,500 – $15,500 |
Competition and market saturation |
Stabilization or decline expected. |
Regulatory and Policy Factors
- Patent expirations and patent litigations influence market exclusivity.
- Pricing and reimbursement policies from CMS and private insurers impact actual patient costs and provider prescribing behaviors.
- Biosimilar pathway regulation efforts could introduce lower-cost alternatives, pressuring prices.
Risk Factors
- Patent litigation or extensions may delay biosimilar entry.
- Regulatory rulings could influence market access or approval of competitors.
- Market demand fluctuations driven by evolving treatment guidelines.
Conclusions
- The drug currently commands a WAC of approximately $14,500, aligned with historical data.
- Market growth driven by increased narcolepsy diagnosis could support modest price increases.
- Price stability is threatened by potential biosimilar competition, with possible reductions of 20–30% in the coming years.
- Overall, revenue projections suggest a plateau with possible slight declines in price depending on biosimilar market penetration and policy changes.
Key Takeaways
- NDC 49884-0214 (Xyrem) remains a cornerstone therapy for narcolepsy with significant market demand.
- Prices have stabilized around $14,500 WAC, with median out-of-pocket costs varying per insurance coverage.
- Patent expiration and biosimilar development pose risks of future price erosion.
- Market growth is driven by increased diagnosis and off-label uses, but constrained by competitive pressures.
- Price projections indicate modest increases in the short term, with potential declines depending on biosimilar entry.
FAQs
1. Are biosimilars likely to impact the price of NDC 49884-0214?
Yes. BiosUris targeting sodium oxybate could reduce prices by 20-30% once approved and market penetration occurs.
2. What are the primary drivers of demand for this drug?
Diagnosis of narcolepsy, off-label use for hypersomnia, and clinicians' preference for established therapies.
3. How does the pricing of Xyrem compare internationally?
Prices vary widely; in Europe, prices tend to be lower due to different reimbursement policies and market dynamics.
4. What regulatory changes could influence market exclusivity?
Patent litigation, FDA approvals of biosimilars, and policy reforms on drug pricing and reimbursement.
5. Is there potential for new therapies to replace Xyrem?
Emerging drugs with similar efficacy and better tolerability could challenge Xyrem, especially if priced lower.
References
- IQVIA. (2022). Market Dynamics and Usage Data for Narcolepsy Medications.
- U.S. Food and Drug Administration (FDA). (2023). Approved drugs and patent status.
- Medicare.gov. (2023). Prescription Drug Coverage and Cost Data.
- Health Economics Journal. (2021). Biosimilar Entry Impact on Pricing Strategies.
- Pharmaceutical Marketplace Analysis, 2022.
[1] U.S. Food and Drug Administration. (2023). Drug approvals and patent status.
