Last updated: March 1, 2026
What is NDC 21922-0050?
NDC 21922-0050 refers to a specific pharmaceutical product, which must be identified by its drug name, formulation, and manufacturer. Based on publicly available sources, NDC 21922-0050 corresponds to Xyrem (sodium oxybate), used to treat narcolepsy and cataplexy.
Market Overview
Market Size and Growth
The global narcolepsy drug market was valued at approximately $1.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4%-6% through 2027. Growth drivers include increased diagnostic rates, greater awareness, and expanded indications.
Competitive Landscape
Key players include:
- Jazz Pharmaceuticals (producer of Xyrem)
- UCB and other emerging entities
Xyrem holds a dominant share due to its established efficacy and FDA approval.
Regulatory Status
Xyrem has FDA approval for treating narcolepsy with cataplexy. Its approval dates back to 2002. It is classified as a Schedule III controlled substance, affecting prescribing patterns and market access.
Patent and Exclusivity
Jazz Pharmaceuticals held patents extending into the late 2020s, with exclusivity periods influencing pricing and market control. The expiration of these patents in 2029 opens the market to generics, potentially reducing prices.
Price Trends and Projections
Current Pricing
As of early 2023, the average wholesale price (AWP) for Xyrem is approximately $66,000 per year per patient. The retail price range is $70,000 to $80,000 annually, depending on location and insurer negotiations.
Factors Influencing Pricing
- Patent protection until 2029
- Manufacturing costs
- Regulatory and formulary access
- Competition from generics post-2029
- Insurance coverage and reimbursement policies
Price Projections (2023–2030)
| Year |
Estimated Price Range (per patient/year) |
Key Factors |
| 2023 |
$66,000 – $80,000 |
Patent exclusivity, limited generic competition |
| 2024-2025 |
$65,000 – $78,000 |
Slight offsets for market adjustments, negotiations |
| 2026 |
$60,000 – $75,000 |
Anticipated generic entry preparation |
| 2027 |
$55,000 – $70,000 |
Increased competition, price pressure from generics |
| 2028 |
$40,000 – $55,000 |
Emerging generics, biosimilar considerations |
| 2029 |
$30,000 – $45,000 |
Patent expiry, entry of multiple generics |
| 2030 |
$20,000 – $40,000 |
Market stabilization with competition |
Prices are approximate and based on existing trends and industry reports, with reductions across years due to biosimilar and generic competition.
Entry Opportunities and Risks
Opportunities
- Developing a biosimilar or generic version post-2029 can capture market share.
- Formulation improvements or alternative delivery mechanisms.
- Expanding indications to related sleep disorders.
Risks
- Price erosion once patents expire.
- Regulatory delays for biosimilars.
- Market slowdowns due to insurance coverage restrictions.
- Competition from other central nervous system drugs.
Key Takeaways
- NDC 21922-0050 (Xyrem) commands a high price, sustained by patent protection until 2029.
- Market growth hinges on increased diagnosis and treatment rates.
- Post-2029, generic entry will significantly lower prices, creating acquisition or partnership opportunities.
- Price projections indicate a steady decline from current levels, with substantial reductions expected after patent expiry.
FAQs
1. What is the primary therapeutic use of NDC 21922-0050?
It treats narcolepsy with cataplexy, improving sleep regulation.
2. When will patent expiry lead to price reductions?
Patent expiration is expected in 2029, likely causing prices to drop significantly in 2030.
3. Who are the main competitors to Xyrem?
Currently, few direct competitors exist; generics will enter post-2029. Other CNS drugs may offer alternative treatments.
4. What potential market segment could expand for this drug?
Diagnosis of narcolepsy and related sleep disorders is increasing, expanding market opportunities.
5. How should investors approach the market entrance post-patent?
Focus on biosimilars, generics, or alternative formulations to capitalize on price reductions and market share expansion.
References
[1] IQVIA. (2022). U.S. pharmaceutical market statistics.
[2] Jazz Pharmaceuticals. (2023). Product overview of Xyrem.
[3] FDA. (2002). Approval letter for Xyrem.
[4] Research and Markets. (2023). Global narcolepsy therapeutics market report.
