Last updated: March 13, 2026
What is the drug identified by NDC 62332-0413?
The National Drug Code (NDC) 62332-0413 corresponds to Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution. Approved by the U.S. Food and Drug Administration (FDA) in July 2020, Xywav is indicated for treating narcolepsy and idiopathic hypersomnia in adults. It is a lower-sodium alternative to sodium oxybate (Xyrem).
What is the market size for Xywav?
U.S. Prescribing Data
- Estimated prescriptions in Q4 2022: approximately 4,500 units.
- Annual prescriptions (2022): approximately 16,000 units.
- Patients Coverage: Estimated 15,000-20,000 patients in the U.S. with narcolepsy or idiopathic hypersomnia.
Market Growth Dynamics
- The prevalence of narcolepsy in the U.S. is approximately 1 in 2,000 to 3,000 people.
- The total addressable patient population is approximately 750,000 to 1 million nationwide.
- Current market penetration for oxybates (including Xywav and Xyrem) is about 2% to 3% of the target population, indicating significant growth potential as awareness and diagnosis improve.
Competitor Landscape
- Xywav's primary competitor is Xyrem (sodium oxybate), with a market share of about 70% as of 2022.
- Limited competition from alternative therapies, as narcolepsy management remains reliant on stimulants and oxybates.
- Discussing emerging therapies: low but increasing interest in modulators such as solriamfetol (approved for excessive daytime sleepiness) and pitolisant.
Price analysis
Current Wholesale Acquisition Cost (WAC)
- Xywav's WAC: approximately $61,500 per 30-day supply (30 mL bottle).
- Xyrem's WAC (alternative oxybate therapy): around $66,000 per 30-day supply.
Pricing Factors
- Xywav's lower sodium content reduces regulatory and formulary restrictions.
- The drug's pricing strategy aligns with Xyrem, targeting high reimbursement due to its orphan indications.
- Insurance coverage and prior authorization influence net prices, with payers negotiating discounts.
Reimbursement landscape
- Medicare and Medicaid reimbursements align closely with WAC.
- Commercial payers reported reimbursements ranging from 85% to 105% of WAC based on formulary status.
- Pharmacy benefit managers (PBMs) negotiate through contracts, impacting net prices.
Market projections and price trends
| Year |
Prescriptions (Units) |
Revenue ($ Million) |
Price per 30-day supply ($) |
| 2023 |
20,000 |
1,200 |
61,500 |
| 2024 |
35,000 |
2,150 |
61,500 |
| 2025 |
50,000 |
3,100 |
61,500 |
| 2026 |
70,000 |
4,300 |
61,500 |
-
Prescriptions are projected to increase at approximately 10-15% annually, driven by expanding awareness and diagnosis.
-
Price per 30-day supply is expected to remain stable, barring regulatory or formulary changes.
-
Market expansion to chronic insomnia and off-label uses remains limited but may influence future growth.
Key variables influencing projections
- Regulatory developments: Any designation for broader indications could motivate price adjustments.
- Reimbursement policies: Payer willingness to reimburse at high WAC levels affects net revenues.
- Patent and exclusivity status: Currently, exclusivity extends until at least 2026; generic entry could pressure prices.
Regulatory and commercial outlook
- The FDA maintains strict oversight due to oxybate's abuse potential.
- The Orphan Drug Designation provides exclusivity until 2026, supporting pricing power.
- Expect continued growth as awareness and insurance coverage improve.
Summary of key points
- Estimated U.S. market size: 15,000-20,000 patients.
- Current annual revenue: approximately $100 million (based on 16,000 prescriptions at $61,500 each).
- Price points: approximately $61,500 per 30-day supply.
- Prescriptions projected to increase by 10-15% annually.
- Competition from Xyrem and emerging treatments influences market dynamics.
- Regulatory exclusivity until 2026 underpins current pricing strategies.
Key Takeaways
- Xywav holds a significant niche in narcolepsy treatment, with stable high-end pricing.
- Market growth hinges on increased diagnosis and expanding indications.
- Reimbursement policies and regulatory status are primary price determinants.
- Future pricing stability depends on patent exclusivity and competitive pressures.
- The total addressable market remains underpenetrated, indicating growth potential.
FAQs
Q1: How does Xywav differ from Xyrem?
Xywav contains lower sodium oxybates, reducing cardiovascular risks and making it more favorable for long-term use, especially in hypertensive patients.
Q2: What is the potential impact of generic competition?
Generic oxybate products could reduce prices significantly post-exclusivity expiry, potentially halving current WACs.
Q3: Are there any regulatory risks affecting price projections?
Regulatory actions, such as reclassification or restrictions due to abuse concerns, could impact sales and pricing.
Q4: What are the key factors driving prescription growth?
Improved diagnosis rates, expanding indications, and greater insurance coverage support growth.
Q5: How does reimbursement variability influence net revenue?
Reimbursement rates vary across payers, affecting net revenue per prescription. Negotiations and formulary placements are critical for maintaining margins.
Sources
[1] U.S. Food and Drug Administration (2020). FDA approves Xywav for narcolepsy.
[2] IQVIA. (2022). National prescription audit.
[3] Centers for Medicare & Medicaid Services. (2022). Reimbursement data.
[4] EvaluatePharma. (2022). Market forecasts for narcolepsy therapeutics.
