Last updated: February 20, 2026
What Is NDC 00228-2571?
NDC 00228-2571 represents Xyrem (sodium oxybate), a medication approved for the treatment of narcolepsy, specifically for cataplexy and excessive daytime sleepiness. Manufactured by Jazz Pharmaceuticals, Xyrem is a Schedule III controlled substance approved by the FDA since 2002. Its active ingredient, sodium oxybate, is a central nervous system depressant with a high potential for misuse.
Market Overview
Demand Drivers
- Narcolepsy prevalence: Estimated at 25-50 per 100,000 population globally.
- Treatment landscape: Xyrem remains the primary FDA-approved medication for cataplexy and narcolepsy-associated symptoms.
- Market exclusivity: Patent protection and orphan drug designation until 2026 provide market exclusivity.
Competitive Landscape
| Drug Name |
Type |
Approval Year |
Market Share (2022) |
Key Competitors |
| Xyrem (sodium oxybate) |
Central nervous system depressant |
2002 |
~85% |
Wakix, Sunosi |
| Wakix (pitolisant) |
H3 receptor antagonist |
2019 |
~10% |
None |
| Sunosi (solriamfetol) |
Stimulant |
2019 |
~5% |
None |
Xyrem commands dominant market share due to established efficacy, safety profile, and therapeutic niche.
Pricing Trends
- Average wholesale price (AWP): Approximately $21,000 per bottle (prior to rebates).
- Monthly treatment cost: Estimated at $2,100 depending on dosage.
- Patient access: Insurance coverage and prior authorization protocols influence net pricing and market penetration.
Price Projections
Short-Term (Next 1-2 Years)
- Little scope for price reduction due to patent protection and limited competition.
- Price remains stable around $21,000 per bottle.
- Pricing pressures may happen if biosimilar or generic options emerge post-patent expiry.
Medium to Long-Term (3-5 Years)
- Patent protections expire in 2026, opening potential for generic sodium oxybate.
- Generic entry projected to reduce prices by 30-50%, depending on market penetration.
- Anticipated generic price range: $10,500 - $14,700 per bottle.
- Biosimilar or alternative therapies may impact revenue if they demonstrate comparable efficacy and safety profiles.
Market Volume and Revenue Estimates
| Year |
Estimated Units Sold |
Revenue (USD Millions) |
| 2023 |
3 million bottles |
$63 |
| 2024 |
3.2 million bottles |
$67 |
| 2025 |
3.4 million bottles |
$71 |
| 2026 |
4 million bottles |
$84 (post-patent expiry, assuming stable market share) |
Key Factors Affecting Price Trajectory
- Regulatory approvals for generics scheduled around 2026.
- Reimbursement policies influencing net revenue.
- Physician and patient acceptance of biosimilar alternatives.
- Changes in treatment guidelines favoring or disfavoring sodium oxybate.
Market Risks and Opportunities
Risks
- Patent expiry leading to generic competition.
- Regulatory actions restricting controlled substance prescriptions.
- Emerging therapies with improved safety profiles or fewer restrictions.
Opportunities
- Expansion of indications beyond narcolepsy.
- Development of formulations with improved delivery systems (e.g., extended-release).
- Entry into emerging markets with increasing healthcare expenditure.
Key Takeaways
- NDC 00228-2571 (Xyrem) holds a dominant position in narcolepsy treatment, supported by patent protection until 2026.
- Market demand remains steady with high pricing due to limited alternatives.
- Price reductions are imminent post-patent expiry, with projections indicating a 30-50% decrease in generic pricing.
- Revenue growth assumes steady market penetration until patent expiration, after which competition will lead to margin compression.
- Strategic planning should consider generic entry, reimbursement changes, and potential label extensions.
FAQs
1. When does patent exclusivity for Xyrem expire?
The patent protection is set to expire in 2026, opening opportunities for generics.
2. How will generic entry affect the market?
Generics are projected to reduce prices by up to 50%, impacting revenue margins but potentially expanding market volume.
3. Are there biosimilar options available?
No biosimilars currently exist; sodium oxybate remains a chemically synthesized small molecule, with generics being the primary competitors post-2026.
4. How is reimbursement likely to change with generics?
Reimbursement policies are expected to favor lower-cost generics, potentially reducing insurance payouts and patient copays.
5. Could new therapies replace Xyrem?
Emerging drugs, such as Wakix and Sunosi, target similar symptoms but do not replace Xyrem’s unique efficacy in cataplexy; acceptance depends on comparative safety and efficacy data.
References
[1] U.S. Food and Drug Administration. (2022). Xyrem (sodium oxybate) prescribing information.
[2] IQVIA. (2022). Pharmaceutical Market Data.
[3] Jazz Pharmaceuticals. (2022). Xyrem patent and market exclusivity status.
[4] Statista. (2022). Narcolepsy prevalence and treatment market overview.
