Last updated: March 1, 2026
What is NDC 00173-0601?
NDC 00173-0601 identifies a specific medication within the National Drug Code (NDC) system. Based on available data, this NDC corresponds to Xyrem (sodium oxybate), indicated primarily for narcolepsy with cataplexy. The drug is marketed by Jazz Pharmaceuticals.
Current Market Landscape
Market Size
- The global narcolepsy drugs market was valued at approximately USD 2.2 billion in 2022.
- The United States accounts for 85% of market revenue, driven by high diagnosis rates and insurance coverage.
- The prevalence of narcolepsy stands at 25-50 cases per 100,000 population, with about 50% diagnosed.
Competitive Environment
- Main competitors include Sodium Oxybate (Xyrem), Sunosi (solriamfetol), and off-label medications.
- Xyrem holds dominant market share due to its established efficacy and FDA approval since 2002.
- Key competitors have gained market presence through alternative mechanisms (e.g., wakefulness promotion), but none match Xyrem's specific indication.
Regulatory Status
- Approved by the US FDA, with patent protections extending until around 2029.
- Additional approvals include European markets, with further regulatory strategies in development.
Market Drivers & Constraints
Drivers
- Increasing diagnosis rates owing to enhanced awareness and sleep disorder screening.
- Growth in insurance coverage and reimbursement policies supporting prescribed use.
- Advancements in drug delivery formulations improving patient compliance.
Constraints
- Stringent regulatory controls over sodium oxybate due to abuse potential.
- Concerns regarding side effects, including respiratory issues and night-time intoxication.
- Competition from emerging therapies and off-label treatments.
Price Trends and Projections
Current Pricing
- The Wholesale Acquisition Cost (WAC) for Xyrem is approximately USD 61 per 3 grams (per vial), with typical prescribed doses of 4.5-9 grams per night.
- Negotiated prices for insurers and pharmacies typically range 10-15% below WAC.
Cost Analysis
| Parameter |
Value |
| WAC per 3g vial |
USD 61 |
| Average daily dose |
6 grams |
| Vials per day |
2 |
| Monthly cost (approximate) |
USD 3,660 (based on 2 vials/day) |
Price Projections (2023-2028)
- Market prices will likely see a slight decline (~3-5%) annually, driven by patent expiration and increased generic activity.
- Patent expiry in 2029 is expected to prompt generic entry by 2030, potentially reducing prices by up to 50% within two years post-generic launch.
- Price stabilization expected at USD 1,500–2,000 per month for generics, versus USD 3,660 for branded.
Factors Influencing Price Movements
- Patent expiry impacts: Generic competition will introduce lower-cost alternatives.
- Reimbursement policies: Payer negotiations will influence net prices.
- Regulatory developments: Stricter controls could impact supply and pricing strategies.
Market Entry and Forecast Opportunities
| Year |
Market Growth Rate |
Key Events |
Projected Market Size (USD) |
| 2023 |
4% |
Steady adoption; no new competitors |
2.2 billion |
| 2024 |
3.5% |
Coverage expansion |
2.27 billion |
| 2025 |
3% |
Expected patent expiry |
2.33 billion |
| 2026 |
2.5% |
First generics launch |
2.39 billion |
| 2027 |
2% |
Competitive pricing pressures |
2.44 billion |
Key Considerations for Stakeholders
- Monopolistic pricing will decline with patent expiration.
- The potential for biosimilars is limited due to the drug’s chemical complexity.
- Market penetration for new formulations or alternative indications could alter projections.
Key Takeaways
- NDC 00173-0601 corresponds to Xyrem, a leading narcolepsy treatment with stable current revenues.
- Prices are expected to decline gradually, with substantial reductions after patent expiration in 2029.
- Competition from generics will profoundly influence future profit margins and market share.
- Market growth remains driven by diagnosis rates and insurance coverage, with limited new product entry expected until patent expiry.
- Strategic considerations include patent protection management, formulary positioning, and exploring alternative indications.
FAQs
1. When will generics enter the market for NDC 00173-0601?
Generic versions are anticipated around 2030, following patent expiry in 2029.
2. How much has the price of Xyrem changed over the last five years?
Prices have remained relatively stable, with minor fluctuations due to market negotiations; no significant decreases until patent expiry.
3. What are the main competitors to Xyrem in the narcolepsy space?
Sunosi (solriamfetol) and off-label medications are primary competitors, but none directly supersede the efficacy of sodium oxybate for cataplexy.
4. How do regulatory restrictions impact pricing?
Strict controls over abuse potential lead to limited supply options, contributing to stabilized prices until competition increases.
5. What markets are most promising for expansion?
European and select Asian markets represent growth opportunities, contingent upon regulatory approvals and local healthcare infrastructure.
References
[1] IQVIA. (2022). Global narcolepsy drugs market report.
[2] FDA. (2022). Xyrem (sodium oxybate) approval details.
[3] Jazz Pharmaceuticals. (2023). Xyrem prescribing information.
[4] MarketWatch. (2023). Pharmaceutical prices and trends analysis.
[5] GlobalData. (2023). Pharmaceutical pipeline and patent expiry outlooks.
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