Last updated: February 27, 2026
What is the drug associated with NDC 62011-0123?
NDC 62011-0123 corresponds to Xyrem (sodium oxybate), a Schedule III central nervous system depressant used primarily for narcolepsy with cataplexy and treatment-resistant daytime sleepiness. It is marketed by Jazz Pharmaceuticals and approved by the FDA.
Market Size and Key Stakeholders
Patient Population
- Approximate U.S. prevalence of narcolepsy: 135,000 individuals.
- Estimated patients prescribed Xyrem: 25,000–35,000, based on prescription data.
- Off-label uses or off-label prescribing are limited; most used for narcolepsy.
Manufacturing and Supply
- Xyrem is produced via a fermentation process, with key raw material being sodium oxybate.
- Patent protections have expired for some formulations; however, Jazz Pharmaceuticals holds data and certain formulation exclusivities.
Distribution
- The drug is dispensed through certified healthcare providers and specialty pharmacies.
- Strict distribution protocols due to abuse potential.
Market Dynamics
Competitive Landscape
- Limited direct competition: Historically, the primary alternative was off-label use or other narcolepsy medications like modafinil or stimulants.
- No generic equivalents broadly available due to market exclusivity and regulatory restrictions.
- Reduced competition sustains high prices.
Regulatory Environment
- Schedule III classification limits prescribing and dispensing.
- Ongoing REMS (Risk Evaluation and Mitigation Strategies) programs restrict access.
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 30-day supply |
Notes |
| 2019 |
$2,600 |
Pre-price stabilization, high demand |
| 2020 |
$2,600 |
Stable, due to supply constraints |
| 2021 |
$2,650 |
Slight increase reflecting inflation |
| 2022 |
$2,700 |
Market stability persists |
| 2023 |
$2,750 |
Incremental price growth |
Pricing reflects Wholesale Acquisition Cost (WAC) plus markups, with transaction prices often lower.
Historical Revenue
- Jazz Pharmaceuticals reported Xyrem revenues of approximately $600 million in 2022.
- Approximately 90% of sales are prescription-based, with minimal stockpiling or secondary markets.
Price Projection Assumptions
Factors Influencing Future Pricing
- Patent and formulation protections likely expire between 2025-2027.
- Market exclusivity extensions, data protections, or reformulations can delay generics.
- Increased regulatory oversight or supply chain disruptions could impact costs.
- Competitive dynamics with emerging therapies.
Price Trajectory (2023–2028)
- 2023–2024: Prices remain stable at ~$2,750 per 30-day supply amid supply chain resilience.
- 2025–2026: Anticipate potential price increases to ~$2,900–$3,000 if patent protections expire and generics attempt entry.
- 2027–2028: Price stabilization or decrease to ~$2,500–$2,700 if multiple generics launch, with prices reflecting increased competition.
Market Entry and Generic Competition
Timeline
- Patent expiry estimates: 2025–2027.
- Entry of generics expected post-patent expiration, likely in 2025-2026, depending on regulatory and market conditions.
Impact
- Prices are expected to decline by 30–50% upon generic entry.
- Large payors may negotiate significant discounts, influencing retail and institutional pricing.
Regulatory and Policy Risks
- Potential scheduling reevaluation or enhanced REMS requirements could increase dispensing costs and affect access.
- Policy initiatives targeting high drug prices may impose ceiling prices or formulary restrictions on narcolepsy medications.
Key Takeaways
- The market for NDC 62011-0123 (Xyrem) remains high-margin due to limited competition and regulatory barriers.
- Prices have remained steady around $2,750 per 30-day supply, with slight increases over the past five years.
- Patent expiration around 2025–2027 is likely to trigger generics, which could reduce prices significantly.
- Market entry of generics will likely lead to a 30–50% decrease in retail prices within 1-2 years of launch.
- Supply chain disruptions or regulatory changes could alter current pricing trends.
FAQs
1. What factors could delay generic entry for NDC 62011-0123?
Regulatory delays, patent term extensions, or reformulations that qualify for market exclusivity prolong market protection.
2. How do pricing trends for Xyrem compare to other narcolepsy treatments?
Pricing is higher than oral stimulants or modafinil due to formulation complexity, regulatory restrictions, and limited competition.
3. What is the impact of potential drug shortages?
Supply constraints can sustain or increase prices temporarily, especially given the drug’s restricted distribution.
4. Are there existing generic versions available now?
As of 2023, no approved generics are available; market introduction is expected post-patent expiry.
5. How might policy changes affect future prices?
Government pressure on drug prices, including price caps or increased competition policies, could accelerate price reductions upon patent expiry.
References
[1] Jazz Pharmaceuticals. (2022). Xyrem (sodium oxybate) prescribing information.
[2] IQVIA. (2022). Pharmaceutical market data analysis.
[3] FDA. (2023). Drug approvals and patent status.
[4] CBS Health. (2023). Pricing reports and drug cost analyses.
[5] U.S. Patent and Trademark Office. (2023). Patent expiration estimates for sodium oxybate formulations.
