Last updated: February 23, 2026
What is the drug associated with NDC 49348-0042?
NDC 49348-0042 corresponds to a specific formulation of a medication marketed primarily within the United States. The NDC (National Drug Code) indicates a drug's manufacturer, product, and package size. As of current data, NDC 49348-0042 is associated with Xyrem (sodium oxybate), indicated chiefly for narcolepsy with cataplexy.
Market size and current adoption
Market overview
- The global narcolepsy drug market was valued at approximately USD 1.1 billion in 2022.
- The U.S. market accounted for roughly 60%, i.e., USD 660 million, driven by diagnosis rates, prescription volume, and formulary coverage.
- Xyrem holds an estimated 70% market share within narcolepsy treatments, primarily due to its efficacy and FDA approval for narcolepsy with cataplexy.
Prescription trends (2020–2022)
| Year |
Prescriptions (million units) |
Growth Rate |
Estimated Sales (USD millions) |
| 2020 |
0.35 |
5% |
350 |
| 2021 |
0.37 |
5.7% |
385 |
| 2022 |
0.39 |
5.4% |
420 |
The rising trend correlates with increased diagnosis rates and expanded acceptance of this treatment.
Competitive landscape
- Xyrem remains the leading drug, with Sunosi (solriamfetol) and Narcolepsy medications like modafinil occupying smaller segments.
- Generic versions are unavailable due to patent protections and orphan drug status.
Patent and regulatory landscape
Patent status
- The primary patent covering Xyrem expired or is nearing expiration in 2027.
- The drug benefits from orphan exclusivity until 2024-2025 in certain markets.
- Patent cliff expected to prompt generic entry around 2027, potentially reducing prices and market share.
Regulatory environment
- Approved by FDA in 2002 for narcolepsy with cataplexy.
- Controlled substance classification (Schedule III) limits prescribing and distribution, impacting market dynamics.
Price projections and future trends
Current pricing
- Retail price per 30-mL bottle: approximately USD 2,500.
- Treatment dose: 4.5 g nightly, resulting in approximately 180 prescriptions annually per patient.
Price trend expectations (2023–2028)
- 2023: Prices hold steady, with average wholesale prices (AWP) ranging from USD 2,450 to USD 2,600 per bottle.
- 2024–2025: Slight discounts expected due to formularies and insurance negotiations, reducing retail prices by 5-10%.
- 2026–2028: Pending patent expiration, generic entry could reduce prices by 25-40%, depending on manufacturer competition.
Volume and volume-driven revenue
Post-patent loss, sales volume may increase due to reduced prices and expanded access but with lower average prices.
| Year |
Estimated Prescriptions |
Average Price per Bottle (USD) |
Projected Revenue (USD millions) |
| 2023 |
0.4 million |
2,500 |
1,000 |
| 2024 |
0.45 million |
2,375 |
1,065 |
| 2025 |
0.5 million |
2,250 |
1,125 |
| 2026 |
0.55 million |
1,850 |
1,018 |
| 2027 |
0.6 million |
1,400 |
840 |
Note: The projections assume steady prescription growth, driven by increased diagnosis, with a significant price decline upon patent expiry.
Risks and opportunities
Risks
- Patent invalidation or delayed generic approval.
- Stringent regulation or insurance coverage reductions.
- Shift to competing therapies like Sunosi.
Opportunities
- Market expansion through new indications.
- Potential for biosimilar or alternative formulations.
- Growth in global markets with unmet narcolepsy treatment needs.
Key Takeaways
- NDC 49348-0042 is associated with Xyrem (sodium oxybate), with a dominant market position.
- The U.S. narcolepsy market is growing modestly, expected to reach USD 1.3 billion by 2028, driven by diagnosis and prescription increases.
- Price stability exists until patent expiration, projected around 2027, after which generic competition could reduce prices substantially.
- Revenue growth relies on volume increases prior to patent cliff, with prices declining sharply afterward.
- Market dynamics hinge on regulatory developments, patent status, and competing therapies.
FAQs
-
When will generic versions of Xyrem become available?
Patent expiration is anticipated around 2027, potentially permitting generic competition shortly thereafter.
-
How does pricing vary across payers?
Wholesale prices are around USD 2,500 per bottle, but actual patient costs depend on insurance coverage, copay assistance, and discounts negotiated with payers.
-
What jurisdictions regulate sodium oxybate?
The U.S. FDA classifies it as a Schedule III controlled substance. Similar classifications exist in other countries, influencing prescribability.
-
Are there upcoming regulatory changes that could impact this drug?
Any modifications in scheduling, new approvals for different indications, or changes in orphan drug status could alter market dynamics.
-
What are alternative therapies for narcolepsy?
Modafinil, armodafinil, Solriamfetol (Sunosi), and behavioral therapies are alternatives, serving as options beyond sodium oxybate.
References
[1] Grand View Research. (2023). Narcolepsy Drugs Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration. (2022). FDA Approval and Labeling Data.
[3] IQVIA. (2022). The Impact of Patent Expiry on Drug Pricing and Market Shares.
[4] Centers for Disease Control and Prevention. (2021). Narcolepsy Prevalence and Diagnosis Data.
[5] Bloomberg Intelligence. (2023). Biopharma Price Trends and Patent Analyses.
