Last updated: February 23, 2026
What is NDC 00527-1326?
NDC 00527-1326 is a specific drug product registered within the National Drug Code (NDC) system. This code corresponds to Xyrem (sodium oxybate), indicated primarily for narcolepsy and cataplexy. It is marketed by Jazz Pharmaceuticals. The product consists of a liquid formulation with a known Dosage Strength.
Market Overview
Drug Profile and Therapeutic Area
- Indication: Narcolepsy, cataplexy
- Formulation: Oral solution (liquid)
- Strength: 500 mg/5 mL
- Route: Oral
- Approval Status: Approved by FDA, with subsequent patent and market exclusivity periods.
Market Size
The narcolepsy treatment landscape has a narrow patient pool. Estimated prevalence of narcolepsy within the U.S. is approximately 135,000–200,000 individuals.
Competitive Landscape
- Main competitors:
- Sodium oxybate (generic versions)
- Stimulants (Modafinil, Armodafinil)
- Market share: Xyrem accounts for roughly 60-70% of narcolepsy prescriptions [1].
Market Drivers
- Increased incidence awareness.
- FDA-approved indications expanding to include pediatric populations.
- Growing recognition of narcolepsy complications.
Challenges
- Strict regulatory controls due to high abuse potential.
- Cost and insurance coverage limitations.
Pricing Dynamics
Current Price Points
- Average wholesale price (AWP): Approx. $1,062 per 5 mL (based on SSR Health data, 2023).
- Average retail price: Estimated at $2,750–$3,000 per 30-day supply.
- Insurance and Medicaid reimbursement: Reimbursements tend to align with negotiated discounts, effectively reducing patient costs.
Historical Price Trends
- Prices stabilized at around $1,000–$1,200 per 5 mL in the past five years.
- Slight increases observed due to inflation, regulatory costs, and manufacturing inputs.
Pricing Projections (Next 3-5 Years)
Factors Influencing Future Prices
-
Patent and Market Exclusivity:
- Patent expiry projected for 2026.
- No generic versions registered before that date, maintaining high prices.
-
Regulatory Changes:
- Removals of scheduling restrictions could impact manufacturing and distribution costs.
-
Market Demand:
- Stable or marginally increasing due to diagnosis expansion.
-
Supply Chain and Manufacturing Costs:
- Rising costs could lead to marginal price increases until generics enter the market.
Price Forecast Range
| Year |
Estimated Wholesale Price (per 5 mL) |
Notes |
| 2023 |
$1,060 |
Current market price |
| 2024 |
$1,070–$1,100 |
Slight increase, potential margin for inflation |
| 2025 |
$1,100–$1,150 |
Approaching patent expiry, stable pricing |
| 2026+ |
$350–$500 (generic entry expected) |
Price decline expected with generics |
Assumptions: Generic entry will reduce prices by approximately 50-70% based on historical data [2].
Implications for Stakeholders
- Manufacturers: Patent expiration offers an opportunity for generic manufacturers to capture market share, pressuring prices.
- Insurers: May push towards negotiating discounts or alternative therapies pre-patent expiry.
- Patients: Likely to face decreased medication costs post-generic entrance.
Conclusion
The market for NDC 00527-1326 (Xyrem) remains highly regulated with stable prices driven by patent protection. Expect prices to stay steady until patent expiry in 2026, after which a significant price decline is anticipated due to generic competition. The core driver for pricing pressures will be the timing and quality of generic approvals.
Key Takeaways
- NDC 00527-1326 corresponds to Xyrem, dominant in narcolepsy therapy.
- Current wholesale prices hover around $1,060 per 5 mL.
- Price stability expected until patent expiry in 2026.
- Post-patent, prices likely drop by approximately 50-70% with generics.
- Market size remains limited but stable, with growth driven by diagnosis rates and expanded indications.
FAQs
-
When will generic versions of Xyrem enter the market?
Patent expiry is projected for 2026; generic approval timelines depend on regulatory filings and patent litigation outcomes.
-
What factors influence pricing beyond patent expiration?
Manufacturing costs, market competition, regulatory changes, and insurance negotiations shape pricing post-generic entry.
-
Are there any legal or regulatory barriers for generics?
Yes, due to high abuse potential and scheduling restrictions, regulatory pathways may involve additional hurdles.
-
How does the pricing of Xyrem compare internationally?
International prices vary widely, often lower due to different regulatory and reimbursement frameworks.
-
What is the impact of pricing on patient access?
High costs limit access unless mitigated by insurance, patient assistance programs, or biosimilar competition.
References
[1] IMS Health. (2022). U.S. narcolepsy medication market overview.
[2] SSR Health. (2023). Pharmaceutical market data and price trends.
[3] U.S. Food and Drug Administration. (2022). Approved drug products with therapeutic equivalence evaluations.
[4] Jazz Pharmaceuticals. (2022). Xyrem prescribing information.
