Last updated: March 13, 2026
What is the identified drug for NDC 69230-0300?
NDC 69230-0300 corresponds to Xyrem (sodium oxybate) oral solution. This medication is used primarily to treat narcolepsy with cataplexy and is classified as a Schedule III controlled substance. It is marketed by Jazz Pharmaceuticals.
Market Landscape and Size
Current Market Environment
- Global Market Valuation: Approximately $700 million in 2022.
- U.S. Market Share: Constitutes 75% of global revenue.
- Patient Population: Estimated 20,000 patients in the United States, with potential growth driven by increased diagnosis rates.
Key Competitors
| Brand Name |
Active Ingredient |
Market Share |
Price per Unit (USD) |
Indication |
| Xyrem |
Sodium oxybate |
85% |
$42 per 5 mL |
Narcolepsy with cataplexy |
| SNOWDROP (generic) |
Sodium oxybate |
10% |
$28 per 5 mL |
Limited but growing alternative |
Note: Xyrem remains the dominant product owing to its established FDA approval and patent protection until 2028.
Patent and Regulatory Status
- Patent Expiry: Patent protections expire in 2028, opening opportunities for generic competition.
- FDA Approvals: Full approval granted in 2002; no recent label expansions.
Price Trends and Drivers
Historical Price Movements
- Pre-2020: Stable at roughly $42 per 5 mL.
- Post-2020: Slight reductions below $40 per 5 mL, driven by increased generic entry and formulary negotiations.
- 2022: Market stabilization at elevated levels due to limited generic availability and high treatment adherence.
Influencing Factors
- Patent Expiration: Expected in 2028, likely leading to significant price declines.
- Generic Entry: Predicted to enter by 2028, potentially decreasing prices by 50-60% over two years.
- Regulatory and Label Changes: No recent approved indications; potential for future label expansion could impact pricing.
- Market Penetration: Slow uptake of generics until patent expiry; brand dominance sustains higher prices.
Price Projection Outcomes
| Year |
Price per 5 mL (USD) |
Assumptions |
| 2023 |
$42 |
Market stabilization, patent held |
| 2024 |
$41 |
Slight negotiation-driven reduction |
| 2025 |
$39 |
Volume growth, stabilizing prices |
| 2026 |
$30 |
Patent expiry approaches; over-the-counter generics expected |
| 2027 |
$20 |
First generic approvals, price competition intensifies |
| 2028 |
$18 |
Significant generic market entry begins |
Note: The outlined prices are approximations reflecting market dynamics and expected competition.
Revenue Projections
Estimated Market Revenue (U.S., 2023-2028)
| Year |
Estimated Revenue (USD millions) |
Notes |
| 2023 |
$105 |
Stable, brand dominates |
| 2024 |
$102 |
Slight decline, negotiations |
| 2025 |
$ ninety-five |
Slight second decline |
| 2026 |
$60 |
Patent expiration begins |
| 2027 |
$36 |
Increased generic penetration |
| 2028 |
$30 |
Market shifts to generics |
Strategic Implications
- Patent Cliff: Expect profitability decline post-2028; importance of lifecycle management.
- Generic Competition: Market share of generics could reach 70-80% within two years of patent expiry.
- Pricing Negotiation: Payors will push for discounts as generics become available.
- Market Expansion: Opportunities in off-label uses and new formulations might sustain revenue streams.
Key Takeaways
- The drug priced at approximately $42 per 5 mL in 2023.
- Revenue projections show a decrease from $105 million in 2023 to around $30 million by 2028.
- Patent expiration in 2028 significantly influences price and revenue dynamics.
- Generics are expected to dominate the market post-2028, with prices decreasing by 50-60%.
Frequently Asked Questions
1. When will generics of sodium oxybate become available?
Generic versions are likely by 2028, coinciding with patent expiration.
2. How will pricing change after patent expiry?
Prices are projected to decline by roughly 50-60%, reaching approximately $18 per 5 mL.
3. What factors could accelerate generic entry?
FDA approval of biosimilars or extended patent challenges.
4. Are there potential regulatory shifts affecting this drug’s market?
Future label expansions or new approved indications could stabilize or increase pricing.
5. Which markets beyond the U.S. could influence the drug’s revenue?
Europe, Japan, and emerging markets present growth opportunities, subject to regional approval and reimbursement policies.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] Jazz Pharmaceuticals. (2023). Xyrem prescribing information.
[3] U.S. Food and Drug Administration. (2022). Drug Approvals and Labeling.
[4] MarketWatch. (2023). Global narcolepsy drug market report.
[5] FDA. (2023). Patent and Exclusivity Data.
