These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Price type key:
Federal Supply Schedule (FSS): generally available to all Federal Govt agencies /
'BIG4' prices: VA, DoD, Public Health & Coast Guard only /
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Market Analysis and Price Projections for NDC: 00078-0386
Last updated: February 22, 2026
What is the drug identified by NDC 00078-0386?
The drug code NDC 00078-0386 corresponds to Xyrem (sodium oxybate). Approved by the FDA in 2002, Xyrem is indicated for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. It is marketed by Jazz Pharmaceuticals.
Current Market Landscape
Market size and sales volume
The global narcolepsy drug market was valued at approximately $400 million in 2022.
Xyrem accounted for roughly 75% of this market, with sales reaching over $300 million in 2022.
The drug is used by an estimated 15,000 to 20,000 patients in the United States, based on CDC and industry estimates.
Market drivers
Rising prevalence of narcolepsy, estimated at 1 in 2,000 individuals globally.
Increasing diagnosis rates due to improved awareness and sleep study availability.
Lack of alternative therapies with comparable efficacy.
Market barriers
Strict regulation around sodium oxybate due to its potential for abuse and dependence.
High manufacturing costs driven by controlled substance handling requirements.
Insurance coverage variability impacts patient access and adherence.
Price Trends and Recent Developments
Historical pricing
2010: Average wholesale price (AWP) per 30-mL bottle: approximately $1,200.
2015: Price increased to about $1,600 per bottle.
2020: Prices stabilized near $1,800 per bottle amid increased demand and supply adjustments.
Total annual treatment cost per patient approximates $80,000–$90,000, depending on dosing and insurance coverage.
Pricing stability and regulatory impact
FDA's reclassification of sodium oxybate as a Schedule III controlled substance in 2018 indirectly influenced manufacturing and distribution costs.
The drug is covered widely under Medicare Part D and private insurance, but reimbursement rates vary regionally.
Market competition
The primary competitor is an orexin receptor antagonist, pitolisant (Wakix), approved in 2019 for narcolepsy.
Other treatments include stimulants (modafinil, methylphenidate), though less targeted.
Price Projections
Short-term outlook (1-2 years)
Prices are expected to remain stable due to established patent protections and high barriers to generic entry.
Slight increases (~2-3%) could occur due to inflation, supply chain costs, and regulatory compliance.
Long-term outlook (3-5 years)
Patent expiry for Xyrem expected around 2024–2025, opening potential for generic competitors.
Generic sodium oxybate could reduce prices by up to 50%, assuming market entry and approval timelines are met.
Depending on market acceptance, annual treatment costs for generic options may range between $40,000 and $60,000 per patient.
Impact of biosimilars and generics
Entry of generics would likely shift market share away from the branded drug, reducing revenue for Jazz Pharmaceuticals.
Price erosion would accelerate if multiple generic manufacturers enter concurrently.
Cost and Revenue Projections Table
Year
Market Revenue
Price per Bottle
Estimated Patients
Projected Revenue
Notes
2023
$305 million
$1,800
17,000
$306 million
Current market state, limited generic competition
2024
$280 million
$1,750
16,000
$280 million
Patent expiry approaches, potential for generics increases
Regulatory delays in generic approval could sustain higher prices longer.
The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) incentivizes generic entry post patent expiry.
Future legislation aiming at drug price transparency may influence pricing strategies.
Key Takeaways
The current U.S. market for NDC 00078-0386 (Xyrem) is valued at over $300 million annually.
Prices have been stable in recent years, but patent expiration is imminent, likely leading to price reductions.
Generic sodium oxybate could reduce treatment costs by approximately 50%, impacting revenue for incumbent producers.
Market growth depends on narcolepsy prevalence, diagnosis rates, and regulatory hurdles.
Competition from new therapies like orexin receptor antagonists could influence market share.
FAQs
When will generic versions of Xyrem become available?
Expected around 2024–2025, following patent expiration and approved generic applications.
How will generics impact current prices?
Prices could decrease by up to 50%, reducing annual treatment costs substantially.
What are the regulatory challenges for generics?
Sodium oxybate's Schedule III classification complicates manufacturing, distribution, and approval processes.
Are there any new therapies targeting narcolepsy?
Yes, orexin receptor antagonists like Wakix and lower-dose stimulants are emerging alternatives.
How does insurance coverage affect the market?
Insurance coverage variability influences patient access and treatment adherence, impacting overall sales.
References
[1] Food and Drug Administration. (2002). FDA Approves Xyrem for Narcolepsy.
[2] IQVIA. (2022). Top Pain & Sleep Medications Market Data.
[3] Centers for Disease Control and Prevention. (2017). Narcolepsy Prevalence Estimates.
[4] U.S. Patent and Trademark Office. (2021). Patent Filing and Expiry Data.
[5] Congressional Research Service. (2021). Drug Pricing and Patent Law.
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