Last updated: February 16, 2026
What is the drug associated with NDC 00713-0552?
The National Drug Code (NDC) 00713-0552 corresponds to Xyrem (sodium oxybate) oral solution, indicated primarily for the treatment of narcolepsy with cataplexy in adults. It is marketed by Jazz Pharmaceuticals.
Market Overview
Therapeutic Category: Central Nervous System (CNS) depressant, specifically a gamma-hydroxybutyrate (GHB) derivative.
Target Population:
- Estimated U.S. narcolepsy prevalence: approximately 138,000 individuals[1].
- Xyrem's main prescriber base comprises around 8,000–10,000 patients, considering off-label use is limited.
Market Dynamics:
- The drug holds a near-monopoly status in narcolepsy treatment, with limited competition.
- The drug is used also off-label for alcohol dependence and fibromyalgia, but these indications are not FDA-approved.
Key Competitors:
- Lower-dose sodium oxybate formulations from alternative brands are unavailable.
- Off-label treatments predominantly include stimulants and antidepressants, but none directly compete on mechanism.
Regulatory Environment:
- Classified as a Schedule III controlled substance.
- Subject to REMS (Risk Evaluation and Mitigation Strategy) restrictions for safety.
Market Trends:
- The U.S. narcolepsy market has slightly grown, driven by increased diagnosis rates and awareness.
- The aging population and rising sleep disorder awareness contribute to market stability.
Current Pricing and Cost Analysis
Wholesale Acquisition Cost (WAC):
- As of recent reports, the average WAC for Xyrem has been approximately $30.00 per mL[2].
- The standard 30 mL bottle prices are around $900.
Pricing per Dose:
- Dosing usually ranges from 4.5 g to 9 g per night, administered in divided doses.
- A typical dose: 4.5 g (equivalent to 15 mL), which costs about $450.
Reimbursement and Insurance Dynamics:
- Average patient co-pays fluctuate around $10–$150 per month depending on insurance.
- Medicaid and Medicare have formulary coverage, with utilization management restrictions.
Price Projections: Future Trends
Factors Influencing Price Changes:
- Regulatory developments: Continued REMS restrictions may limit competition and keep prices stable.
- Competitive pressures: No imminent generic or biosimilar entrants are expected within the short-term horizon due to patent protections and exclusivity periods.
- Manufacturing costs: Stability expected given existing manufacturing infrastructure.
Projected Price Range (Next 3–5 Years):
- Scenario 1: Price Stability — Given market exclusivity, prices are unlikely to decrease significantly, maintaining the current $30 per mL or slightly higher considering inflation.
- Scenario 2: Slight Increase — Introduction of new formulations or improvements in supply chain may push prices up to $35–$40 per mL, especially if demand increases or cost pressures emerge.
Potential Price Decline Factors:
- Patent expiration or legal challenges could lead to generic competition, pressuring prices downward.
- New oral formulations or alternative treatments in development might offer substitutes, impacting market share and price levels.
Strategic Considerations for Stakeholders
- Pharmaceutical companies should monitor patent status and generic market entry risks.
- Providers and payers need to consider the cost implications of long-term therapy versus emerging therapies.
- Investors should evaluate Jazz Pharmaceuticals’ pipeline for competing or derivative products that could affect Xyrem's pricing.
Key Takeaways
- NDC 00713-0552 corresponds to Xyrem (sodium oxybate), with a dominant market position in narcolepsy treatment.
- Current WAC is approximately $30 per mL, translating into a typical annual cost of about $15,000–$20,000 per patient.
- Market is insulated from competition due to patent protections, regulatory restrictions, and limited off-label substitutes.
- Future prices likely to remain stable or increase slightly through inflation, barring patent expiration or regulatory changes.
FAQs
1. When do patent protections for Xyrem expire?
Patents are expected to expire between 2025 and 2028; patent exclusivity extensions could alter this timeline.
2. Are biosimilars or generics entering the market?
No; given the drug’s patent protections and REMS restrictions, generic competition is unlikely in the near term.
3. How does the REMS program impact pricing?
It restricts access and utilization, supporting stable pricing but may limit market expansion.
4. What other treatments are available for narcolepsy?
Stimulants (e.g., modafinil, methylphenidate), antidepressants for cataplexy, and off-label off-brands.
5. Are there ongoing clinical trials for new formulations?
Limited; most research focuses on adjunct therapies or alternative delivery systems, but none are immediate competitors.
References
- American Sleep Association. Narcolepsy facts. https://www.sleepassociation.org
- Redbook. Wholesale Acquisition Cost reports, 2023.
