Last updated: February 25, 2026
What is the drug associated with NDC 68462-0421?
The National Drug Code (NDC) 68462-0421 corresponds to a specific pharmaceutical product. According to available databases and manufacturer disclosures, this NDC likely refers to Xyrem (sodium oxybate), a central nervous system depressant used for treating narcolepsy, specifically cataplexy and excessive daytime sleepiness.
Market Landscape
Market Size and Patient Population
- U.S. Narcolepsy Market: Estimated at approximately 200,000 diagnosed patients.
- Xyrem’s Market Reach: Based on prescription data, approximately 12,000–15,000 patients receive Xyrem annually, considering approval for narcolepsy and certain sleep disorders.
- Growth Drivers:
- Increased diagnosis rates.
- Expanded indications for related conditions.
- Rising awareness and reimbursement coverage.
Competitive Environment
Regulatory and Reimbursement Factors
- FDA Status: Approved since 2002, with REMS restrictions due to abuse potential.
- Reimbursement Landscape: Coverage depends on insurance provider policies, with Medicare and Medicaid covering Xyrem under specific conditions.
Price Analysis and Projection
Current Pricing
- Average Wholesale Price (AWP): Approximately $70–$80 per milliliter.
- Pack Pricing:
- Typical bottles (50 mL): $3,500–$4,000 each.
- Monthly therapy: Estimated at $15,000–$20,000.
Price Trends
-
Historical Price Stability: Prices have remained relatively stable over the past five years, driven by:
- Abuse deterrent REMS program.
- Limited generic competition due to patent protections.
- High treatment cost associated with medication management.
-
Potential Price Impact Factors:
- Launch of generic sodium oxybate products, expected post-patent expiry (anticipated around 2027).
- Introduction of biosimilars or reformulations.
- Changes in insurance reimbursement policies.
Price Projections (Next 3–5 Years)
| Year |
Projected Wholesale Price per mL |
Expected Market Dynamics |
Implication |
| 2023 |
$70–$80 |
Stable; patent protections active |
Prices maintain current levels |
| 2024 |
$70–$80 |
Possible negotiations for discounts |
Slight downward pressure possible |
| 2025 |
$65–$75 |
Patent nearing expiry; potential for biosimilar entry |
Prices could decline by 10–15% |
| 2026 |
$60–$70 |
Increased generic competition expected |
Significant price erosion anticipated |
| 2027+ |
$50–$60 |
Market penetration of generics; biosimilars |
Price decline of 30–40% from peak |
Commercial Outlook
-
Revenue Potential:
- With current pricing and patient base (~15,000 patients), annual revenue estimates are around $300–$600 million.
- Price erosion post-patent expiry could reduce revenues by 50–60%.
-
Market Risks:
- Off-label use restrictions.
- Regulatory changes impacting REMS or prescribing.
- Entry of competing therapies, especially extended-release formulations.
-
Opportunity Areas:
- Differentiation via formulation improvements.
- Expanded insurance coverage.
- International market expansion.
Key Takeaways
- NDC 68462-0421 likely pertains to Xyrem, a high-price prescription drug with stable pricing dominated by patent protections.
- Market size remains steady, centered around narcolepsy treatment but constrained by limited patient numbers.
- Price projections indicate stability in the short term, with potential declines starting around 2025-2026 due to patent expiration and rising generic competition.
- Revenue growth prospects depend on maintaining market share, expanding indications, and delaying generic entries.
- Future profitability hinges on patent strategies, formulation innovation, and regulatory navigation.
FAQs
1. When does the patent for Xyrem expire?
Patent protections for Xyrem are expected to expire around 2027, opening the market to generic sodium oxybate products.
2. How will generic entry affect current pricing?
Generic entry generally results in significant price reductions, with estimates around 30–50% depending on market uptake.
3. Are there any upcoming regulatory changes that could impact pricing?
Potential REMS modifications or new abuse-deterrent requirements could influence distribution costs and pricing strategies.
4. What are alternative treatments for narcolepsy?
Stimulants like Modafinil and Armodafinil, sodium oxybate formulations like FT218, and lifestyle modifications serve as alternatives.
5. How does insurance coverage impact pricing?
Coverage policies significantly affect patient out-of-pocket costs and, indirectly, sales volume and revenue figures.
References
[1] U.S. Food and Drug Administration. (2022). Xyrem (sodium oxybate) REMS.
[2] IQVIA. (2022). Prescription Trends and Market Share Data.
[3] EvaluatePharma. (2022). 2022 World Preview: Oncology & Hematology.
[4] PhRMA. (2022). Annual Pharmaceutical Innovation Report.
[5] MedTechsInsider. (2022). Impact of Generic Entry on High-Price Drug Markets.
