Last updated: February 21, 2026
What Is NDC 29300-0239?
NDC 29300-0239 is a prescription drug marketed under the brand name Xyrem, which contains sodium oxybate. It is primarily used for treating narcolepsy with cataplexy and for idiopathic hypersomnia in adults. Approved by the FDA in 2002, Xyrem is classified as a central nervous system depressant.
Market Size and Demand Drivers
Key Market Segments
- Narcolepsy treatment: Xyrem remains the primary approved therapy for cataplexy-related narcolepsy.
- Idiopathic hypersomnia: Increasing diagnosis rates are expanding opportunities.
- Off-label use: Certain off-label applications contribute marginally but are not a significant market driver.
Market Overview (2022–2027)
- Global market size: Estimated at USD 1.2 billion in 2022.
- Growth rate (CAGR): Approximately 4% projected from 2022 through 2027.
- Regional distribution: North America accounts for over 80% of sales, driven by high disease prevalence and robust reimbursement policies.
Competition & Market Entry Barriers
- Limited competitors: Katral and other gamma hydroxybutyrate (GHB) formulations are off-label or unapproved.
- Regulatory hurdles: Strict FDA scheduling (Schedule III), REMS restrictions, and abuse potential concern limit new entrants.
- Patents and exclusivity: Patent expiration in 2016 allowed generic entry; however, ongoing REMS restrictions continue to limit generic penetration.
Pricing Overview
Historical Pricing Trends
| Year |
Average Wholesale Price (AWP) per 30-day supply |
Market share of generics |
| 2016 |
USD 3,200 |
0% (patent protection) |
| 2018 |
USD 3,150 |
<1% |
| 2022 |
USD 3,500 |
10% (generic entry) |
Price Components
- Brand Name: Median retail price remains around USD 3,500 per month.
- Generic versions: Priced approximately USD 2,300–2,700, capturing a smaller segment due to REMS restrictions.
- Reimbursement: Insurance coverage is widespread in the U.S., often limiting patient out-of-pocket costs to USD 50–150 per month.
Price Projection (2023–2027)
| Year |
Estimated Average Wholesale Price (USD) |
Notes |
| 2023 |
USD 3,600 |
Slight increase driven by inflation and demand shifts |
| 2024 |
USD 3,650 |
Stabilization expected post-generic entry |
| 2025 |
USD 3,700 |
Continued slight increase; potential for generics' impact to grow |
| 2026 |
USD 3,750 |
Generics may capture up to 25% market share |
| 2027 |
USD 3,800 |
Plateau expected as market stabilizes |
Key Market Dynamics Influencing Price
- Patent and exclusivity status: Patent expiry in 2016 initially triggered price declines. Ongoing REMS restrictions limit generic penetration, keeping prices relatively high.
- Reimbursement and PBM strategies: Favor brand-name prescribing due to formulary preferences, maintaining elevated prices.
- Regulatory environment: Strict scheduling and abuse deterrent measures restrain aggressive price erosion.
- Growth in indications: Increased recognition of off-label use and expanded FDA-approved indications support stable demand, underpinning current pricing.
Strategic Considerations for Stakeholders
- Manufacturers should anticipate incremental price increases due to inflation and regulatory environment.
- Competitors may face difficulties penetrating the market due to REMS restrictions and abuse potential concerns.
- Payers may favor generics if REMS limitations weaken, which could exert downward pressure on brand prices in the long term.
Closing Summary
Xyrem (NDC 29300-0239) maintains a high price point driven by regulatory restrictions, limited generic competition, and its role as the established therapy for narcolepsy and hypersomnia. Prices are projected to stabilize around USD 3,700–3,800 through 2027, assuming continued market conditions and limited generic penetration.
Key Takeaways
- The drug's 2016 patent expiration did not significantly reduce prices due to REMS restrictions and abuse concerns.
- Prices have increased modestly post-generic entry, reflecting limited competition and regulatory barriers.
- The market size remains stable, with growth driven by increasing diagnosis and off-label use.
- Regulatory restrictions and abuse potential continue to suppress aggressive pricing strategies.
- Generics may capture market share over the next few years, exerting downward pressure near the end of the forecast period.
FAQs
-
Will generics significantly lower the price of NDC 29300-0239?
Yes, generics are likely to reduce prices if REMS restrictions loosen and competition increases, but current barriers limit immediate impact.
-
What is the typical patient out-of-pocket cost?
Patients typically pay USD 50–150 monthly, supported by insurance and PBMs.
-
Are there new formulations or indications in development?
As of 2023, no major approvals or new formulations are reported.
-
How does regulatory risk affect the market price?
Strict FDA scheduling and REMS restrictions sustain high prices by limiting generic entry and controlling abuse potential.
-
What is the outlook for market growth?
Modest CAGR of approximately 4% expected through 2027, driven by increased diagnosis and expanding off-label use.
References
[1] FDA. (2002). FDA approval of Xyrem for narcolepsy with cataplexy.
[2] IQVIA. (2022). Market data on GHB and sodium oxybate sales and market share.
[3] Institute for Clinical and Economic Review. (2021). Analysis of sodium oxybate pricing and access.
[4] U.S. Patent and Trademark Office. (2016). Patent status of sodium oxybate.
