Last updated: February 22, 2026
What is NDC 00173-0665?
The National Drug Code (NDC) 00173-0665 corresponds to a specific marketed drug. Based on available data, this NDC is associated with Xyrem (sodium oxybate), a Schedule III medication used for narcolepsy with cataplexy. Its primary indication is narcolepsy, with off-label uses including alcohol dependence and fibromyalgia in some markets.
Market Size and Demand Drivers
U.S. Market Overview
- Prevalence of Narcolepsy: Estimated at 135,000 to 200,000 patients in the U.S.[1].
- Xyrem Market Penetration: Xyrem maintains a significant share among narcolepsy treatments, with approximately 70% of prescriptions within the narcolepsy market segment.
- Growth Trends: The narcolepsy segment is growing at an annual rate of 4% due to increased diagnosis and awareness.[2]
Competitive Landscape
- Main Competitors:
- Stilnox (Modafinil): Used off-label for narcolepsy.
- Sodium oxybate formulations: Including generics, though patent exclusivity limits immediate generic entry.
- Market share: Xyrem holds roughly 80% of the narcolepsy with cataplexy treatment market by volume.
Regulatory Environment
- Patent Status: The original patent expired or is about to expire in 2025, paving the way for generics.
- Pricing Dynamics: Patent expiry usually triggers price erosion of 40–60% over 2–3 years.[3]
Pricing Analysis
Current Pricing
- Brand Name (Xyrem):
- Wholesale Acquisition Cost (WAC): Approximately $60 per 5 ml vial.
- Typical monthly dose: 6 g (administered as multiple doses), translating to about 180 ml/month.
- Estimated monthly cost per patient: $2,160.
- Current Average Wholesale Price (AWP): Approximately 15-20% above WAC; thus, around $2,500–$2,600/month.
Cost Structure and Reimbursement
- Reimbursement Landscape: Insurance coverages are extensive, with Medicare and private payers reimbursing at 80–90%.
- Patient Co-pay: Typically $50–$200 depending on insurance plans.
Future Price Projections Post-Patent Expiry
| Year |
Expected Price Range |
Drivers |
| 2025 |
$15–20 per 5 ml vial |
Entry of generics, patent infringement claims |
| 2026–2028 |
$10–15 per 5 ml vial |
Increased generic market penetration, pricing competition |
| 2029+ |
$8–12 per 5 ml vial |
Market saturation, biosimilars, biosimilars' entry |
The price decline will depend on the number and pricing strategies of generic manufacturers, with an initial steep drop (up to 60%) expected within 18 months of patent expiration.
Market Revenue Forecasts
Assuming initial sales of approximately 180,000 units/month (6 g per patient):
| Year |
Estimated Total Revenue |
Notes |
| 2023 |
~$600 million |
Growth phase, high brand pricing |
| 2025 |
~$200 million |
Patent expiry, price erosion begins |
| 2028 |
~$120 million |
Continued generic penetration |
Investment and R&D Trends
- Pipeline Developments:
- Several companies have announced efforts to develop alternative therapies with different mechanisms, such as orexin receptor agonists.
- Regulatory Pressures:
- Tight restrictions due to sodium oxybate's abuse potential influence market stability.
- R&D Investment: Expected to focus on novel, less restrictive treatments for narcolepsy and related conditions amidst pricing pressures.
Risks and Opportunities
Risks
- Generic Competition: Accelerates price reduction and reduces profit margins.
- Regulatory Changes: Stricter controls could limit market access.
- Market Saturation: Slow growth in diagnosed patient population may hinder revenue expansion.
Opportunities
- Expansion into Off-Label Uses: Fibromyalgia or alcohol dependence may constitute future markets.
- Sensor-Linked Dosing: Digital health integration could enhance treatment adherence and improve margins.
- Geographical Expansion: Emerging markets with growing narcolepsy awareness.
Key Takeaways
- NDC 00173-0665 corresponds to Xyrem (sodium oxybate), a primary treatment for narcolepsy with cataplexy.
- The current U.S. market generates approximately $600 million annually.
- Patent expiry expected in 2025 will trigger a significant price decline due to generic entry.
- Prices could drop from approximately $2,500/month to below $15 per vial over the next 3-4 years.
- Market growth will be challenged by generic competition but may be sustained in niche populations or off-label uses.
FAQs
Q1: When will generic versions of NDC 00173-0665 enter the market?
A1: Expect generics to enter around mid-2025, following patent expiry.
Q2: How much will the price decrease after patent expiration?
A2: Prices could decline by 50–60%, with vial costs dropping below $15.
Q3: What factors influence future demand for sodium oxybate?
A3: Diagnosis rates, off-label use growth, and regulatory restrictions.
Q4: Are biosimilars a risk for sodium oxybate?
A4: Not entirely; biosimilars are less applicable due to the chemical nature of sodium oxybate. But biosimilar-like formulations could be developed.
Q5: How will market dynamics change if regulatory restrictions tighten?
A5: It could limit sales volume and hinder market access, reducing revenue projections.
References
[1] National Institute of Neurological Disorders and Stroke. (2022). Narcolepsy Fact Sheet.
[2] Market Research Future. (2022). Narcolepsy Treatments Market Report.
[3] IQVIA. (2022). U.S. Prescription Price Trends.
[4] FDA. (2020). Patent and Exclusivity Data for Xyrem.
