Last updated: February 27, 2026
What is NDC 24658-0350?
NDC 24658-0350 is a proprietary drug marketed under the brand Xyrem. It is a sodium oxybate formulation used to treat narcolepsy with cataplexy. Xyrem is produced by Jazz Pharmaceuticals Inc. It received FDA approval in 2002, with subsequent label updates expanding its indications.
Market Overview
Market Size and Demand
The U.S. narcolepsy population is estimated at approximately 200,000 cases, with around 20% using prescription medications such as Xyrem [1]. The drug's primary competitors include sodium oxybate generics, off-label therapies, and emerging treatments for narcolepsy and cataplexy.
Revenue Performance
Jazz Pharmaceuticals reported $677 million in net product sales in 2022, primarily driven by Xyrem and its successor, Soma [2]. The COVID-19 pandemic temporarily affected sales but rebounded in subsequent quarters.
Key Market Drivers
- Increased diagnosis rates and awareness about narcolepsy.
- Expansion into other indications like idiopathic hypersomnia.
- Growing preference for pharmacological management over lifestyle modifications.
Market Challenges
- Stringent prescribing regulations.
- Strict storage and handling requirements due to abuse potential.
- Competition from generic sodium oxybate formulations, which began entering the market post-patent expiration.
Patent and Regulatory Status
Xyrem's exclusivity lasted until December 2027, with patent protections expiring in that period [3]. Generics entered the market in 2028, likely impacting pricing and volume volumes. The drug is scheduled for re-evaluation by the FDA for new indications and formulations, which could influence market size.
Price Trends
Historical Pricing
The average wholesale price (AWP) for Xyrem was approximately $950 per 30 mL bottle in 2020. The price per gram of sodium oxybate was roughly $2,750, based on a typical prescribing dose of 4.5 grams nightly [4].
Market Impact of Generics
Following patent expiry, generic sodium oxybate products entered at prices 40-60% lower than the branded drug. Volume increased as prescriptions shifted to generics, reducing overall market revenue for Jazz Pharmaceuticals.
Forecasted Price Projections (Next 5 Years)
| Year |
Brand Price (per 30 mL) |
Generic Price (per 30 mL) |
Volume Estimates (Units) |
Comments |
| 2023 |
$950 |
$400–$600 |
2 million |
Branded sales decline; generics capture market share. |
| 2024 |
$900 |
$350–$550 |
2.2 million |
Continued shift towards generics; slight price reduction. |
| 2025 |
$850 |
$300–$500 |
2.4 million |
Increased generic penetration; price stabilization expected. |
| 2026 |
$800 |
$250–$450 |
2.5 million |
Market reaches equilibrium; new formulations may influence prices. |
| 2027 |
$750 |
$200–$400 |
2.6 million |
Final year before patent expiry; prices decline further. |
Pricing Drivers
- Competitive pressure from generics.
- Reimbursement policies and insurance coverage.
- Patient and prescriber preference for branded or generic versions.
Competitive Landscape
| Competitors |
Product Name |
Status |
Market Share |
Price (Approximate) |
Notes |
| Jazz Pharmaceuticals |
Xyrem |
Market leader |
70% |
~$950 / 30 mL |
Proprietary formulation, patent protection until 2027 |
| Multiple generics (e.g., Zybrest) |
Sodium oxybate |
Post-expiry |
25–30% |
$400–$600 / 30 mL |
Widely used after patent expiry |
| Emerging therapies (e.g., solriamfetol) |
JZP-258 (Xywav) |
Recently approved |
Limited |
Higher than branded Xyrem initially |
Orphan drug status, alternative indications |
External Factors
- Regulatory: Pending re-evaluation of drug scheduling due to abuse potential could influence prescribing habits.
- Policy: Increase in generic approval pathways; Medicaid, Medicare, and private insurer reimbursement strategies affecting pricing.
- Market Entries: Potential new entrants or novel formulations could compress margins further.
Conclusions
The market for NDC 24658-0350 is transitioning from branded dominance to a predominantly generic environment. Prices are expected to decline steadily, with the branded drug’s revenue diminishing accordingly. The intensity of price drops will depend on market acceptance, regulatory decisions, and new therapies.
Key Takeaways
- Xyrem’s patent protection ends in 2027, opening market share to generics.
- Prices for branded Xyrem hovered around $950 per 30 mL in 2020, projected to decline to approximately $750 by 2027.
- The market volume is projected to increase modestly as generics gain acceptance.
- Competition from generic sodium oxybate formulations will drive prices downward.
- Regulatory changes and potential new treatments could influence market dynamics beyond 2027.
FAQs
-
When will generics of sodium oxybate become widely available?
Generics expanded in 2028 post patent expiration, with initial entry in 2027 in some markets.
-
How does the pricing of generics compare to the branded drug?
Generics are approximately 40–60% cheaper, with prices around $400–$600 per 30 mL.
-
What factors could slow the price decline?
Regulatory restrictions, supply chain issues, or manufacturer delays could slow generic entry or uptake.
-
Are there any new formulations or indications expected?
Yes, reformulations like Xywav have been approved for narcolepsy and idiopathic hypersomnia, potentially influencing market share.
-
What is the outlook for patient access and insurance reimbursement?
Increased generic availability should improve affordability, though reimbursement policies vary and could impact overall access.
References
[1] Fatima, S., et al. (2021). Prevalence and diagnosis of narcolepsy: An overview. Journal of Sleep Medicine, 22(4), 351–362.
[2] Jazz Pharmaceuticals. (2023). Annual Report 2022. Retrieved from https://www.jazzpharma.com/financials/
[3] U.S. Patent and Trademark Office. (2023). Patent expiration data for Xyrem. Retrieved from https://uspto.gov/
[4] RedBook Data. (2020). Average Wholesale Price of Sodium Oxybate. Elsevier.
