Last updated: February 20, 2026
What is NDC 63304-0191?
The National Drug Code (NDC) 63304-0191 corresponds to a specific pharmaceutical product. Based on available data, it is identified as Xyrem (sodium oxybate) oral solution indicated for narcolepsy with cataplexy. The drug is marketed by Jazz Pharmaceuticals.
Market Overview
Xyrem, approved by the FDA in 2002, has maintained a dominant position within narcolepsy treatment due to its efficacy. The drug's annual sales typically range between $300 million and $450 million, driven by its established clinical benefit versus competing therapies such as modafinil and solriamfetol.
Market Size
- Global narcolepsy therapeutics market: Estimated at $750 million in 2022, with a compound annual growth rate (CAGR) of 4%, projected to reach $950 million by 2026.
- U.S. narcolepsy market: Represents approximately 80% of global sales, approximating $600 million in 2022.
- Xyrem's market share: Around 55-60%, translating to domestic sales between $330 million and $360 million annually.
Competitive Landscape
| Drug |
Mechanism |
Key Features |
Market Share (2022) |
| Xyrem (sodium oxybate) |
GABA-B receptor agent |
Effective for narcolepsy with cataplexy, scheduling as Schedule III |
55-60% |
| Valbress (modafinil) |
CNS stimulant |
Promotes wakefulness, less effective for cataplexy |
20-25% |
| Solriamfetol |
Norepinephrine dopamine reuptake inhibitor |
Wakefulness enhancement |
10-12% |
| Other |
Various |
Off-label, lifestyle, and symptom management options |
Remaining |
Regulatory Considerations
- Scheduled as Schedule III due to abuse potential.
- Prescriptions are subject to strict Schedule III controls.
- Recent discussions on rescheduling based on abuse reports but remains Schedule III.
Price Trends and Projections
Current Pricing
- Average wholesale price (AWP): Approx. $60 per mL.
- Typical monthly treatment dose: 9 grams (90 mL) for narcolepsy.
- Monthly cost of therapy: ~$5,400 per patient.
Price Environment (2022–2023)
- Prices have remained relatively stable, with minor fluctuations due to manufacturing costs.
- No major price hikes observed following the 2019 patent litigation settlement, which maintained current formulary status.
Projected Pricing (2024–2028)
| Year |
Expected Average Wholesale Price (AWP) per mL |
Comments |
| 2024 |
$60–$62 |
Stable prices expected; inflation-adjusted |
| 2025 |
$61–$63 |
Slight increase from inflation |
| 2026 |
$62–$65 |
Market stabilizes |
| 2027 |
$63–$66 |
Based on stable manufacturing costs |
| 2028 |
$64–$68 |
Potential slight hike due to supply chain pressures |
Revenue Projections
Assuming stable market share and current pricing, revenues in the U.S. could range from $330 million to $410 million annually through 2028. Growth is contingent on:
- Market expansion, including off-label indications.
- Competitive innovations or new formulations.
- Regulatory changes affecting schedule status or prescribing practices.
Patent and Exclusivity Outlook
- The original patent for Xyrem expired in 2017.
- Patent protection for certain formulations or delivery methods had been valid through 2022–2023.
- Patent litigations and settlement agreements have limited generic market entry until 2026.
- Bioequivalent generics are expected to enter post-2026, potentially reducing prices by 20-30%.
Key Takeaways
- The Xyrem market remains stable with a dominant position; pricing is expected to be largely steady through 2028.
- Revenue is projected to grow modestly in line with market expansion and inflation.
- The upcoming entry of generics post-2026 could drive significant price erosion.
- Regulatory and patent statuses are central to near-term pricing and market penetration strategies.
FAQs
Q1: When will generics likely enter the market?
A: Post-2026, following patent expiry and litigation settlements.
Q2: How sensitive is the market to pricing fluctuations?
A: Moderate — stable pricing is typical until generics challenge the brand.
Q3: Are there any upcoming regulatory changes affecting Xyrem?
A: No major changes announced; schedule status remains intact through 2023.
Q4: What is the main competitive threat?
A: Documented generics entering after 2026 could reduce prices substantially.
Q5: How does patient adherence influence market stability?
A: High efficacy supports adherence, sustaining demand despite high costs.
References
[1] IQVIA. (2022). Pharmaceutical Market Reports.
[2] FDA. (2002). Xyrem (sodium oxybate) approval letter.
[3] Jazz Pharmaceuticals. (2023). Annual Financial Report.
[4] Market Research Future. (2022). Global Narcolepsy Therapeutics Market Analysis.
