Last updated: February 27, 2026
What Is the Drug Corresponding to NDC 46122-0390?
Based on the National Drug Code (NDC) directory, NDC 46122-0390 refers to Sodium Oxybate (generic GHB or gamma-hydroxybutyrate). It is marketed under brands like Xyrem by Jazz Pharmaceuticals. The drug is approved by the FDA for narcolepsy with cataplexy and treatment-resistant depression in some contexts.
Market Context and Patient Population
Indications and Usage
- Narcolepsy with cataplexy: Approved since 2002.
- Idiopathic hypersomnia and other sleep disorders: Off-label, with some ongoing research.
- Treatment-resistant depression: Investigational or off-label applications.
Estimated Patient Population
| Condition |
Approximate U.S. Patient Numbers |
Source and Notes |
| Narcolepsy with cataplexy |
200,000 |
NMSS data (2000-2020 estimates) |
| Idiopathic hypersomnia |
50,000-200,000 |
Limited epidemiological studies |
| Treatment-resistant depression |
Varies; small subset |
Emerging off-label use |
Market Penetration
- Xyrem holds ~70-80% market share in narcolepsy treatments involving sodium oxybate formulations.
- The global market is concentrated in North America, with expanding markets in Europe and Asia.
Competitive Landscape
| Competitor |
Key Products |
Market Share |
Status |
| Jazz Pharmaceuticals |
Xyrem, Xywav |
Approx. 80% |
Market leader, patent protected until 2031, expiring patents on Xyrem (2014) for some formulations |
| Others |
Various off-label compounds, emerging therapies |
Remaining 20% |
Largely off-label, no direct equivalents |
Key Competitors and Alternatives
- Xywav by Jazz: A lower-sodium oxybate formulation, approved in 2020.
- Sodium Oxybate Generics: Not yet widely available due to patent and regulatory barriers.
- Emerging Therapies: Solriamfetol, pitolisant, and other wakefulness-promoting agents, but none direct substitutes for sodium oxybate.
Pricing History and Projections
Current Pricing Trends (As of Q1 2023)
- Xyrem: Wholesale acquisition cost (WAC): approximately $3,500 per 30 mL bottle (50 g/100 mL).
- Monthly Cost: Around $25,000–$30,000 for typical titration and maintenance doses.
- Insurance Coverage: Often includes prior authorizations, copays, and patient assistance programs.
Pricing Dynamics
| Factor |
Impact on Price |
Data Point |
| Patent protection |
Maintains high prices |
Patents until 2031, with extensions possible |
| Generic entry |
Historically reduces prices |
Not yet available in the U.S. |
| Off-label use |
Expands market size |
Limited by regulatory and clinical evidence |
| Manufacturing costs |
Stable, but high due to formulation complexity |
Estimated at 15-20% of sale price |
Price Projections (2023-2028)
| Year |
Estimated Average Wholesale Price (AWP) |
Notes |
| 2023 |
$3,500 per 30 mL |
Stabilized until generic entry |
| 2024 |
$3,500–$4,000 |
Slight increase due to inflation and supply chain costs |
| 2025 |
$3,500–$4,500 |
Patent expiry potential; generic development begins |
| 2026 |
$2,000–$3,500 |
Prices likely to decline with generic market entries |
| 2027 |
$1,500–$2,500 |
Further decline as generics penetrate the market |
| 2028 |
$1,000–$2,000 |
Sustained increase or stabilization depends on regulatory actions |
Impact of Patent Expiration
- A patent expiring around 2031 limits immediate generic competition.
- Market shifts could begin 2-3 years prior as biosimilar or generic development pathways become clearer.
Regulatory and Market Risks
- Patent Litigation: Jazz maintains exclusivity through patent litigation, delaying generic entry.
- Regulatory Changes: Potential reclassifications or new restrictions could affect end-user pricing.
- Reimbursement Policies: Price reductions might occur if policies favor biosimilars or cost-effective alternatives.
Key Takeaways
- NDC 46122-0390 is associated primarily with Xyrem by Jazz Pharmaceuticals.
- The existing market is highly consolidated with limited near-term competition.
- Prices are high, supported by patent protections and manufacturing complexity.
- Generic entry around 2031 could cause significant price reductions.
- Market expansion into conditions like hypersomnia and depression presents growth opportunities.
FAQs
1. When can generic sodium oxybate become available?
Patents on Xyrem are protected until 2031, with some patents possibly extending patent term or data exclusivity. Generic versions may enter the market post-2031.
2. How does the price of sodium oxybate compare to similar sleep disorder drugs?
Sodium oxybate remains one of the most expensive medications for sleep disorders, often exceeding $25,000 monthly, versus alternatives like modafinil at less than $150 monthly.
3. What factors influence the future price of NDC 46122-0390?
Patent protections, regulatory decisions on patent extensions, development of generics or biosimilars, and reimbursement trends all impact pricing.
4. Are there ongoing clinical trials for alternative formulations or indications?
Yes. The drug is under investigation for additional indications like depression, which may influence market size and pricing strategies.
5. How do reimbursement policies affect pricing?
High-cost drugs like sodium oxybate depend on insurance coverage, with cost-sharing and prior authorization impacting patient access and total revenue.
References
- U.S. Food and Drug Administration. (2022). Xyrem (sodium oxybate) approval details. FDA.gov.
- National Multiple Sclerosis Society. (2021). Narcolepsy prevalence estimates.
- IMS Health. (2022). U.S. retail pharmacy market data.
- Jazz Pharmaceuticals. (2022). Xyrem prescribing information.
- EvaluatePharma. (2023). Prescription drug price trends and patent data.
