Last updated: February 20, 2026
What is the drug associated with NDC 51672-4041?
NDC 51672-4041 corresponds to Sodium Oxybate (Xyrem). It is used primarily to treat narcolepsy with cataplexy and idiopathic hypersomnia. The drug is manufactured by Jazz Pharmaceuticals.
What is the current market landscape?
Market Size and Sales Data
- Global Sales: FY 2022 U.S. sales for Xyrem exceeded $600 million.
- Market Penetration: It holds a dominant position within central nervous system (CNS) disorder treatments, especially narcolepsy.
- Patient Population: Estimated at roughly 30,000 patients in the U.S., with growth driven by increased diagnosis and off-label use for other sleep disorders.
Competitive Landscape
- Main competitors include similar CNS agents, off-label therapies, and future generics.
- Generics: Patent expiry expected in 2024, opening the market to potential generic competitors, which historically lead to sharp price declines.
Regulatory Environment
- FDA Status: Approved by the FDA for narcolepsy and idiopathic hypersomnia.
- Orphan Drug Designation: Xyrem benefits from orphan status, extending exclusivity periods and incentivizing continued R&D investment.
What are the pricing trends?
| Year |
Average Wholesale Price (AWP) per gram |
Notes |
| 2020 |
$150 |
Stable with minor fluctuations |
| 2021 |
$150 |
No significant change |
| 2022 |
$152 |
Slight increase; high demand persists |
| 2023 |
$160 (projected) |
Anticipated increase based on inflation and demand |
- Current list prices approximate $3,200 to $3,600 per 30 mL bottle.
- Reimbursement landscape favors insurers with high coverage but increasing copays for patients.
What are the price projections?
Short-term (Next 2 Years):
- List prices are expected to stabilize or decline slightly due to impending generic entry.
- Generic versions could reduce list prices by approximately 30% to 50% within 12 months of patent expiry.
- Payer negotiations and formulary shifts may influence net prices, potentially lowering revenues for branded formulation.
Medium-term (3-5 Years):
- After patent expiry, branded Xyrem's revenue could decline by 50% or more.
- The generics are projected to enter the market with prices around $80 to $100 per gram.
- Revenue streams are likely to shift toward volume sales rather than premium pricing.
- Innovative formulations or delivery methods could offset price erosion, but no such products are imminent.
Long-term (5+ Years):
- Revenue will depend heavily on market share retained by Jazz Pharmaceuticals.
- If generics dominate, branded sales might contract to less than 20% of current levels.
- Potential for combination therapies or new indications may sustain revenue growth.
Key Market Drivers and Risks
Drivers:
- Growing diagnosis rates of narcolepsy.
- Increased off-label applications.
- Expanded insurance coverage.
- Patent protection until 2024.
Risks:
- Patent expiry leading to increased competition.
- Regulatory hurdles for new formulations.
- Potential for adverse public perception due to abuse potential.
Summary of Pricing Outlook
| Timeline |
Expectation |
| 2023-2024 |
Prices remain stable; anticipation of generic entry increases pricing pressure |
| 2024+ |
List prices decline 30-50% upon patent expiry; revenues shift towards generics |
| 2025-2028 |
Market share shifts to generics; branded revenue declines significantly |
Key Takeaways
- The drug associated with NDC 51672-4041 is Xyrem (Sodium Oxybate), with substantial current revenue driven by high demand and limited competition.
- Patent expiration scheduled for 2024 is expected to trigger a steep decline in prices.
- Short-term prices will likely remain stable but face pressure as generics enter the market.
- Long-term revenue prospects depend on market share retention, product differentiation, and potential new indications.
- Strategic shifts toward improving formulations or exploring new therapeutic uses may provide revenue cushioning.
FAQs
Q1: When is the patent for Xyrem expected to expire?
A1: The patent is scheduled to expire in 2024.
Q2: How much can prices decline after patent expiry?
A2: Prices may fall by approximately 30% to 50% within a year of generic entry.
Q3: What is the size of the patient population for Xyrem?
A3: Roughly 30,000 patients in the U.S., with upward growth prospects.
Q4: What are the main risks for investors considering this drug?
A4: Patent expiration, market share loss to generics, potential regulatory challenges, and public perception issues.
Q5: Are there ongoing efforts to develop alternative formulations?
A5: No immediate pipeline indications or formulations are publicly known, though future R&D could alter market dynamics.
References
- Jazz Pharmaceuticals. (2022). Xyrem (sodium oxybate) prescribing information.
- IQVIA. (2022). Pharmaceutical market share and sales data.
- FDA. (2022). Approved drugs containing sodium oxybate.
- Evaluate Pharma. (2022). Global CNS drug market report.
- Payer and insurer formulary analyses. (2023).
