Last updated: February 20, 2026
What Is the Drug NDC 00113-0214?
NDC 00113-0214 is marketed as Xyrem (sodium oxybate), primarily used to treat narcolepsy with cataplexy and also approved for other off-label uses. It is a prescription medication with a complex patent and regulatory history, owned by Jazz Pharmaceuticals.
Market Size and Demographics
Current Market Scope
- The global narcolepsy treatment market was valued at approximately $308 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6% through 2030.[1]
- In the U.S., estimated prevalence of narcolepsy is around 1 in 2,000 people. The adult patient population is approximately 155,000, with around 50% diagnosed and treated.[2]
- Off-label use includes treatment for excessive daytime sleepiness (EDS) and other sleep disorders.
Competitive Landscape
- Xyrem faces competition from drugs like modafinil (Provigil), armodafinil (Nuvigil), and upcoming gabapentinoids.
- Patent expirations are scheduled for 2024-2028 for certain formulations, risking generic entry.
Revenue and Pricing Trends
Historical Revenue
- Jazz Pharmaceuticals reported global sales of approximately $744 million for Xyrem in 2022.[3]
- U.S. sales account for roughly 85% of revenue, with the remainder from international markets.
Price Point and Distribution
- The average wholesale price (AWP) for a 60 mL bottle (500 mg/mL) was around $2,000 in early 2023.[4]
- The cost to insurers varies, with Medicaid and private insurers negotiating substantially lower rebates. The negotiated net price likely falls near $1,200–$1,400 per bottle.
- The average annual treatment cost per patient ranges between $30,000 and $40,000 depending on dosage and duration.
Price Trends
- Historically, the price for Xyrem increased steadily since its launch in 2002.
- Patent protections maintained high pricing through 2024, with potential increases due to inflation and formulary shifts.
- Generic entry anticipated post-patent expiry could reduce prices by 60%–80%, similar to other CNS drugs.
Regulatory and Patent Outlook
Patent and Exclusivity
- The last patent is set to expire around 2024-2025.[5]
- Jazz Pharmaceuticals has secured additional formulation patents extending market exclusivity to 2028.
Regulatory Pathways
- The FDA has approved a novel formulation (XYWAV) with an alternative delivery system aiming to extend patent life.
- Biosimilars are unlikely due to the drug's complex structure.
Price Projection (2024–2028)
| Year |
Estimated Average Wholesale Price (AWP) per Bottle |
Key Drivers |
| 2024 |
$2,000 |
Patent expiry approaches, launch of generics |
| 2025 |
$1,200–$1,400 |
Entry of generics, increased competition |
| 2026 |
$1,000–$1,200 |
Market stabilization, increased generic uptake |
| 2027 |
$800–$1,000 |
Penetration of generics, price competition |
| 2028 |
$750–$900 |
Patent loss, full generic market penetration |
Market Risks and Opportunities
Risks
- Patent expiry leads to loss of exclusivity and revenue erosion.
- Regulatory decisions that favor biosimilar or alternative treatments could also impact market share.
- Price reduction initiatives by payers and federal agencies.
Opportunities
- New formulations with extended patent protection.
- Off-label indications expanding the patient base.
- International expansion, especially in emerging markets with less price regulation.
Key Takeaways
- The U.S. narcolepsy market for Xyrem generated $744 million in 2022; growth continues as awareness and diagnosis improve.
- Pricing peaked at around $2,000 per bottle pre-patent expiry; post-2024, prices are likely to fall sharply due to generic competition.
- The 2028 market will reflect significant price reductions, with potential negotiation by payers accelerating these effects.
- Patent strategies, formulation innovations, and expansion into broader indications will influence revenue and pricing strategies until 2028.
FAQs
1. When does the patent for NDC 00113-0214 expire?
The last patent protection is scheduled to expire around 2024-2025.
2. What is the expected impact of generic entry on the price?
Generic competition could reduce prices by 60–80%, significantly affecting revenue.
3. How does the international market compare?
International markets, especially in Europe and Asia, face different pricing regulations, leading to potentially lower prices than in the U.S.
4. What are the key regulatory developments affecting future pricing?
The FDA's approval of alternative formulations, like XYWAV, may extend market exclusivity and influence pricing strategies.
5. What therapies are likely to challenge Xyrem’s market share?
Modafinil, armodafinil, and emerging CNS drugs could limit growth post-patent expiry.
References
[1] Grand View Research. (2023). Sleep Disorder market size, share & trends analysis.
[2] American Sleep Association. (2022). Narcolepsy prevalence and diagnostics.
[3] Jazz Pharmaceuticals. (2023). Annual Report.
[4] Red Book. (2023). Average Wholesale Price Data.
[5] U.S. Patent and Trademark Office. (2023). Patent filings for sodium oxybate formulations.
