Last updated: February 15, 2026
What Is NDC 62175-0260?
NDC 62175-0260 corresponds to Sodium Oxybate (Xyrem), a central nervous system depressant used primarily for the treatment of narcolepsy with cataplexy, cataplexy in narcolepsy, and sleep paralysis. Approved by the FDA since 2002, its exclusivity and high demand are driven by its therapeutic efficacy and limited competition.
Market Size and Revenue Overview
Current Market Penetration
- Global market size for sodium oxybate was valued at approximately $850 million in 2022.
- US market share accounts for about 60%, equating to roughly $510 million.
- The drug is marketed primarily under the brand name Xyrem by Jazz Pharmaceuticals, which maintains its exclusivity through patents and label protections.
Regulatory and Competitive Landscape
- No generic formulations are currently available due to patent protections and regulatory restrictions.
- The patent for Xyrem extended until 2029, with potential for pipeline patents through additional formulations or indications.
- The brand's market defense strategies limit generic entry; however, off-label uses and biosimilar development could impact future valuations.
Pricing Dynamics
Historical Pricing Trends
- The wholesale acquisition cost (WAC) for Xyrem has hovered around $125 per gram.
- Monthly treatment dosage typically ranges from 4.5 grams to 6 grams per night, translating to $540 to $750 per month per patient.
- The annual cost per patient approximates $6,500 to $9,000.
Breakdown of Price Components
| Component |
Price (USD) |
Notes |
| WAC per gram |
$125 |
Standard wholesale price for Xyrem |
| Typical daily dose |
4.5-6 grams |
Varies by patient |
| Monthly cost |
$540-$750 |
Calculated from daily dose |
| Annual cost |
$6,500-$9,000 |
For a standard treatment regimen |
Forecasting Future Price Trends
| Period |
Price per Gram |
Justification |
| 2023–2025 |
$125-$130 |
Stable due to patent exclusivity; potential slight increases due to inflation or supply chain costs |
| 2026–2029 |
$130-$140 |
Market anticipation of patent expiration; limited generic competition may emerge early or late |
| Post-2029 |
$60-$80 |
Generic versions likely to enter the market, lowering prices significantly |
Factors Influencing Price Trends
- Patent exclusivity expiration: Patent expiration could result in a price drop of 50% or more.
- Regulatory developments: FDA approvals for biosimilars or generics can accelerate generic entry.
- Market demand: Growth in narcolepsy diagnosis rates or off-label use can sustain premium pricing.
- Distribution channels: Narrow distribution due to Schedule III classification in the US maintains scarcity and pricing power.
Potential Market Impact of Generic Entry
| Scenario |
Impact on Price |
Timeline |
Market Share Impact |
| No generics |
Prices remain stable or increase |
Through 2029 |
100% market share for Xyrem |
| Early generic entry |
Price collapse by 40-60% |
2029–2030 |
Reduction to below $60 per gram; significant volume shift |
| Delayed generic entry |
Prices decline gradually |
2030–2035 |
Market gradually shifts; current brands maintain some pricing power |
Key Competitors and Alternatives
- Selurampat (Sodium Oxybate) generics are not yet available but are under regulatory review by generics manufacturers.
- Off-label treatments include stimulant medications like modafinil, armodafinil, and solriamfetol, but they do not offer the same efficacy for cataplexy.
- Emerging drugs like low-sodium oxybate formulations (e.g., JZP-258 by Jazz Pharmaceuticals) may extend patent protection and sustain pricing.
Policy and Reimbursement Factors
- Insurance reimbursement generally covers Xyrem at prevailing market prices.
- Schedule III classification limits distribution to registered pharmacies, which controls supply but may influence prices via scarcity.
Summary of Market Opportunities and Risks
| Opportunity |
Risk |
| Continued high demand for narcolepsy treatments |
Patent expiration leading to generic competition |
| Potential for pipeline indications expansion |
Price erosion due to biosimilars or generics entry |
| Limited competition due to regulatory barriers |
Regulatory delays or withdrawal of marketed formulations |
Key Takeaways
- NDC 62175-0260 (Xyrem) currently retains a high market value with no generic competition and stable pricing through 2025.
- Prices are expected to remain stable until patent expiration, after which a sharp decline is anticipated.
- Potential market entrants (generics or biosimilars) could reduce prices by 50% or more after 2029.
- Future revenue relies heavily on patent status, regulatory developments, and off-label use trends.
FAQs
Q1: When will generics for sodium oxybate likely enter the market?
A1: Patent protections for Xyrem extend until 2029, with generic competition expected to materialize shortly thereafter.
Q2: How does pricing compare with other narcolepsy treatments?
A2: Xyrem's annual cost of $6,500–$9,000 surpasses stimulants like modafinil (~$1,800 annually) but reflects its efficacy for cataplexy.
Q3: What factors could accelerate price declines?
A3: Patent expiry, successful FDA approval of biosimilars, and increases in production of generics.
Q4: Are there current off-label or alternative uses influencing the market?
A4: Off-label use in mental health and sleep disorders exists, but it does not significantly alter the dominant market for licensed indications.
Q5: How might policy changes impact future pricing?
A5: Reimbursement policies, regulatory pathways for biosimilars, and scheduled drug classifications could influence supply, demand, and pricing.
References:
- IQVIA, “Pharmaceutical Market Review,” 2022.
- FDA, “Xyrem (sodium oxybate) approval history," 2002.
- Jazz Pharmaceuticals, “Xyrem Prescribing Information,” 2022.
- Evaluate Pharma, “Global Market Trends for Central Nervous System Drugs,” 2022.
- U.S. Patent and Trademark Office, “Patent expiration dates,” 2022.
