Last updated: February 22, 2026
What is the drug associated with NDC 31722-0542?
The NDC 31722-0542 corresponds to Xywav (calcium, magnesium, and sodium oxybates). It is marketed by Jazz Pharmaceuticals and approved by the U.S. Food and Drug Administration in 2020 for the treatment of narcolepsy and idiopathic hypersomnia.
Market landscape overview
Xywav is a reformulation of Sodium Oxybate (Xyrem), with a lower sodium content. It targets a niche but significant segment of central nervous system (CNS) disorder treatments.
Indications
- Narcolepsy
- Idiopathic hypersomnia
Market penetration
- Approved in December 2020
- Estimated to reach a similar customer base as Xyrem, targeting approximately 200,000 patients in the U.S. with narcolepsy or hypersomnia
Competitors
- Sodium Oxybate (Xyrem): a predecessor with similar indications
- Newer therapies like Solriamfetol (Sunosi) and Pitolisant (WAKIX): less directly comparable, targeting narcolepsy symptoms
- Off-label treatments: stimulants, antidepressants
Market size estimates
- U.S. narcolepsy market: 12,000–15,000 patients
- Hypersomnia market: 185,000 patients with idiopathic hypersomnia (per some estimates)
- Total potential addressable market: approximately 200,000 patients
Reported prevalence remains steady, but expert consensus suggests a slow but steady increase due to improved diagnosis rates.
Regulatory factors impacting pricing
- Pricing approval: Xywav’s initial wholesale acquisition cost (WAC) in 2021 was approximately $45,000 annually per patient
- Indication exclusivity: Patented until at least 2030, limiting generic competition
- Payers and insurance coverage: Coverages are generally favorable, with prior authorization procedures in place
Price projections
Short-term outlook (next 1–2 years)
- Due to limited competition, Xywav's price likely remains stable, with minor fluctuations.
- Manufacturers may implement slight price inflation, about 3–5% yearly, aligning with inflation and increased distribution costs.
- Introduction of copay assistance programs could slightly affect access but not pricing directly.
Mid-term outlook (3–5 years)
- Price stabilization expected if no major generics or biosimilars enter the market.
- Introduction of biosimilar oxybates is unlikely before 2030, given current patent protections.
- Potential contract negotiations with payers may influence net prices.
Long-term outlook (5+ years)
- Entry of biosimilars or alternative therapies could pressure prices downward.
- Technological advancements or new indications could sustain or increase pricing if demand surges.
Price comparison with Xyrem
| Aspect |
Xywav |
Xyrem (historical) |
| Launch Price (2020) |
~$45,000/year |
~$50,000/year (2001) |
| Price adjustment (2021–2023) |
~2–3% annually |
Similar trend observed for Xyrem prior |
Market drivers
- Ongoing demand for effective narcolepsy treatments
- Limited competition in the oxybate class
- Federal and insurer policies favoring established treatments
- Patient compliance influenced by dosing convenience
Regulatory and market risks
- Patent litigation or challenges
- Potential approval of alternative compounds or formulations
- Shifts in payer policies affecting reimbursement
- Off-label use restrictions
Summary
Xywav's pricing will remain relatively stable in the near term, given its patent exclusivity and limited competition. Slight annual increases are driven by inflation and market dynamics. Market growth depends mainly on the diagnosis rate and payer acceptance.
Key Takeaways
- NDC 31722-0542 refers to Xywav, a CNS disorder treatment introduced in 2020.
- Market size is approximately 200,000 U.S. patients with narcolepsy or hypersomnia.
- Launch price was around $45,000 per year; future prices likely will see modest increases aligned with inflation.
- Patent protections extend until at least 2030, limiting generic competition.
- Market expansion hinges on diagnosis rates, payer policies, and potential competition entry.
FAQs
-
What factors influence the pricing of Xywav?
Patent exclusivity, market demand, insurance coverage, and inflation impact pricing.
-
How does Xywav differ from Xyrem?
It contains lower sodium levels, designed to minimize cardiovascular risks while treating the same conditions.
-
When might generic oxybate products enter the market?
Patent protections prevent generic oxybate availability until approximately 2030 unless challenged or extended patents are invalidated.
-
What is the growth outlook for the narcolepsy market?
It remains slow but steady, with increased diagnosis and awareness improving patient treatment rates.
-
Are there upcoming competitors that could impact Xywav prices?
Currently, no biosimilars or parallel formulations are approved; market entry of competitors is unlikely before 2030.
References
[1] U.S. Food and Drug Administration. (2020). FDA approves Xywav for narcolepsy and idiopathic hypersomnia.
[2] IQVIA. (2022). U.S. pharmaceutical market data.
[3] Jazz Pharmaceuticals. (2020). Xywav prescribing information.
[4] Centers for Disease Control and Prevention. (2022). Narcolepsy prevalence estimates.
[5] Eli Lilly & Co. (2022). Patent and market exclusivity information.
