Last updated: March 13, 2026
What is NDC 00713-0280?
NDC 00713-0280 corresponds to Xyrem (sodium oxybate), a drug primarily used to treat narcolepsy with cataplexy and idiopathic hypersomnia. It is marketed by Jazz Pharmaceuticals.
Overview of the Product and Market Dynamics
Xyrem's active ingredient, sodium oxybate, is a Schedule III controlled substance with potential for misuse, regulatory scrutiny, and distribution restrictions impacting market size and pricing strategies.
The drug's approval dates and regulatory milestones:
- Approved by the FDA in 2002.
- Designated as an orphan drug for narcolepsy.
- Reclassified under Schedule III in 2019, affecting prescribing and distribution.
Market Size and Growth Drivers
Factors influencing the market include:
- Prevalence rates: Estimated 135,000 Americans with narcolepsy.
- Diagnosis rates: Approximately 25% are diagnosed, limiting patient pool.
- Pricing policy: Due to strict controls, pricing is set high to accommodate manufacturing, distribution, and regulatory compliance costs.
- Competitive landscape: Few alternatives; sodium oxybate remains a unique treatment.
Pricing Landscape
Historically, Xyrem has been one of the most expensive drugs in its class, with wholesale acquisition costs (WAC):
| Year |
Average Wholesale Price (AWP) per 30 mL bottle |
Notes |
| 2020 |
$600 |
For 30 mL bottle |
| 2022 |
$620 |
Slight increase |
| 2023 |
$650 |
Price stabilization |
The typical dosage regimen involves two doses nightly, translating into approximately 60 mL daily, costing roughly $1,300 daily or about $39,000 annually per patient.
Price Projection Methodology
Price projections incorporate:
- Regulatory environment and potential re-scheduling impact.
- Market size and growth.
- Competitive threats or biosimilars (none currently exist).
- Cost of manufacturing and distribution.
Given regulatory stability and consistent demand, a compound annual growth rate (CAGR) estimate of 1-2% is appropriate. Price increases are expected to be capped by payer negotiations and patient affordability policies.
Forecasted Price (Next 5 Years)
| Year |
Estimated AWP per 30 mL |
Assumed CAGR |
Rationale |
| 2024 |
$655 |
0.8% |
Modest inflation and stable regulations |
| 2025 |
$660 |
0.8% |
Slight increases due to operational costs |
| 2026 |
$670 |
1.0% |
Possible regulatory tightening or inflation |
| 2027 |
$680 |
1.0% |
Market stabilization |
| 2028 |
$690 |
1.0% |
Potential small adjustments |
Total revenue projection depends on the number of patients, with current estimates of 10,000 to 15,000 narcolepsy patients receiving therapy.
Key Risk Factors
- Regulatory changes: Shake-ups in scheduling or restrictions could increase costs or limit accessibility.
- Market competition: No direct biosimilar yet, but new medications or formulations could emerge.
- Pricing pressures: Payer negotiations and formulary placements impact actual net prices.
- Manufacturing costs: Fluctuations in raw materials or supply chain disruptions can influence prices.
Competitive Context
No generic sodium oxybate product exists in the U.S. due to patent protections and regulatory barriers. Previously, companies attempted to develop alternative formulations, but none currently market a generic.
Key Takeaways
- NDC 00713-0280 (Xyrem) remains a high-cost, niche therapy.
- The market size is constrained by underdiagnosis and strict regulations.
- Price increases are modest, driven by inflation and operational costs, with projections around 1% annually.
- Long-term revenue is sensitive to regulatory shifts and potential new competitors.
Frequently Asked Questions
Q1: How does regulatory status impact pricing for sodium oxybate?
Reclassification under Schedule III in 2019 allowed broader prescribing but maintained high dispensing restrictions, sustaining high pricing levels.
Q2: Are there biosimilar options for sodium oxybate?
No biosimilars are available; patent protections and regulatory hurdles prevent generic entry.
Q3: What are the key drivers of cost for Xyrem?
Manufacturing complexity, strict distribution controls, and regulatory compliance increase production costs.
Q4: How might new treatments affect the market?
Development of alternative therapies could reduce Xyrem's market share and pressure prices.
Q5: What is the per-patient annual revenue estimate?
Approximately $39,000 based on current dosing and prices, assuming full adherence.
References
[1] U.S. Food and Drug Administration. (2002). FDA approval of Xyrem.
[2] IQVIA. (2022). U.S. drug pricing data.
[3] Jazz Pharmaceuticals. (2023). Xyrem prescribing information.
