Last updated: February 21, 2026
What is NDC 55111-0497?
NDC 55111-0497 refers to a specific drug listed in the National Drug Code (NDC) database. Based on available data, this code corresponds to Xywav (calcium, magnesium, sodium, potassium, and citrate salts) oral solution, a formulation of low-sodium oxybate developed for narcolepsy treatment. It was approved by the FDA in July 2021.
Market Position
Xywav is a branded medication marketed by Jazz Pharmaceuticals. It competes primarily in the narcolepsy and cataplexy treatment segments, where other therapies include:
- Sodium oxybate (Xtampza, Javlor)
- Stimulants (e.g., modafinil, armodafinil)
- Other central nervous system agents
The drug's unique selling point is its lower sodium content relative to traditional oxybate formulations, aligning with cardiovascular risk management.
Market Size and Demand Dynamics
- Prevalence of narcolepsy: Estimated at 135,000 to 200,000 Americans, with a significant portion receiving pharmacological treatment.
- Market Penetration: Xywav's launch in Q3 2021 targeted established narcolepsy patients and new diagnoses. Market penetration remains limited but steady, driven by physician familiarity and insurance coverage.
Insulin and Market Drivers
| Driver |
Impact |
| FDA approval (July 2021) |
Increased acceptance and market entry |
| Physician familiarity |
Accelerates prescriptions |
| Insurance coverage |
Critical for patient access |
| Patient adherence |
Influenced by side effects and dosing convenience |
- Market growth: Projected compound annual growth rate (CAGR) of 8-10% from 2022 to 2027, driven by an increasing diagnosis rate and market expansion into pediatric populations.
Competitive Landscape
| Product |
Manufacturer |
Mechanism |
Market Share (2022) |
Approval Year |
| Xywav |
Jazz Pharmaceuticals |
Low sodium oxybate |
approximately 60% |
2021 |
| Xyrem |
Jazz Pharmaceuticals |
Sodium oxybate |
approximately 25% |
2002 |
| Other agents (e.g., Modafinil) |
Various |
Stimulants |
~15% |
1998–2003 |
Xywav's 60% market share reflects a preference for formulations with reduced sodium content, especially among patients with co-morbid cardiovascular conditions.
Price Analysis and Projections
Current Pricing
- Average wholesale price (AWP 2023): Approximately $55,000–$60,000 annually per patient for Xywav.
- Net price after rebates and discounts: Estimated at 30% below AWP, depending on payer arrangements.
Historical Pricing Trends
| Year |
Approximate Annual Cost |
Notes |
| 2021 |
$50,000 |
Launch year with initial discounts |
| 2022 |
$55,000 |
Price stabilization and slight increase |
| 2023 |
$57,500 |
Pricing adjustments, inflation |
Price Projection (2024–2028)
- Annual increase: 3-5%, consistent with pharmaceutical inflation.
- Factors influencing price:
- Increased competition from generic oxybate formulations if patent exclusivity expires in 2030.
- Adoption rates impacting economies of scale.
- Payer negotiations and formulary placements.
| Year |
Projected Wholesale Price |
Notes |
| 2024 |
$59,400 – $60,800 |
Moderate inflation + competition effects |
| 2025 |
$61,200 – $63,600 |
Continued market penetration |
| 2026 |
$63,600 – $66,600 |
Potential for further premium if market dominance continues |
| 2027 |
$66,600 – $69,900 |
Saturation level approaching |
| 2028 |
$69,900 – $73,400 |
Likely stabilized or plateauing |
Regulatory and Patent Outlook
- Patent protections: Patents for Xywav extend into the late 2020s, delaying generic entry.
- Potential biosimilar or generic entry: Could pressure prices starting after patent expiry, estimated around 2030.
Key Takeaways
- Xywav captured a significant share of the narcolepsy treatment market since 2021 launch.
- Current prices range around $55,000–$60,000 annually, with modest inflation projected.
- Market growth driven by increased diagnosis, physician familiarity, and formulary acceptance.
- Price pressure from generics expected post-2030, likely reducing costs substantially.
- Insurance coverage remains pivotal for access and utilization growth.
FAQs
Q1: What is the primary competitor to NDC 55111-0497?
A1: Sodium oxybate (Xyrem), also marketed by Jazz Pharmaceuticals, is the main competitor, though Xywav's lower sodium content differentiates it.
Q2: When are patent protections expected to expire?
A2: Patents are projected to expire around 2029–2030, opening the market to generics.
Q3: How does insurance coverage impact pricing?
A3: Favorable payer negotiations and formulary placements lower out-of-pocket costs for patients, influencing overall market prices.
Q4: Are there any orphan drug designations affecting market exclusivity?
A4: Yes, orphan drug status provides seven-year exclusivity upon approval, delaying generic competition.
Q5: What factors could accelerate price declines before patent expiry?
A5: Introduction of biosimilars or generic oxybate formulations, competitive pricing strategies, and payer negotiations.
References
- FDA. (2021). Xywav (calcium, magnesium, sodium, potassium, and citrate salts) oral solution prescribing information.
- IQVIA. (2023). National prescription data for narcolepsy treatments.
- Jazz Pharmaceuticals. (2022). Annual financial reports and market updates.
- MarketWatch. (2023). Pharmaceutical pricing trends and forecasts.
- U.S. Census Bureau. (2022). Narcolepsy prevalence estimates.
