Last updated: February 24, 2026
What Is the Drug Associated with NDC 55111-0532?
NDC 55111-0532 corresponds to Xyrem (sodium oxybate), approved by the FDA for the treatment of narcolepsy with cataplexy. It is a Schedule III controlled substance classified as a central nervous system depressant. As a formulation of gamma-hydroxybutyrate (GHB), Xyrem plays a critical role in narcolepsy management, with its unique pharmacological profile.
Market Size and Demand Drivers
Epidemiology and Market Sectors
- Narcolepsy prevalence: Estimated at 1 in 2,000 to 6,000 individuals globally, with higher reporting in North America and Europe.[1]
- Total addressable market (TAM): Approximately 150,000–300,000 patients in the U.S., considering diagnosed cases and unmet needs.[2]
- Current treatment landscape: Limited options, with Xyrem dominating the narcolepsy indication. Off-label use in conditions such as alcohol dependence has been observed but is not approved.
Market Growth Factors
- Increased diagnosis awareness: Campaigns and improved diagnostic tools have expanded diagnosed cases.
- Expanded indications: Research on Xyrem's off-label potential could influence future markets.
- Regulatory and reimbursement environment: Insurance coverage and FDA regulation impact adoption rates.
Competitive Landscape
- Direct competitors:
- Sodium oxybate formulations from generic manufacturers (expected post patent expiry)
- Off-label therapies such as modafinil, armodafinil, low-dose stimulants
- Pipeline drugs: Few drugs target narcolepsy with the same efficacy, aside from emerging treatments like pitolisant and solriamfetol, which may impact future market share.
Current Price and Historical Trends
Pricing Overview
- Brand-name Xyrem (NDC 55111-0532): Historically priced at approximately $30,000 to $35,000 per year per patient.
- Dosage: Usually ranges from 4.5 g/night to 9 g/night, split in two doses.
- Insurance and rebates: Net prices vary based on rebates, negotiations, and pharmacy benefit managers (PBMs).
Pricing Trends
| Year |
Avg Wholesale Price |
Notes |
| 2018 |
~$32,000 |
Consistent with prior years |
| 2020 |
~$33,000 |
Slight increase |
| 2022 |
~$34,500 |
Adjustment for inflation |
| 2023 |
~$35,000 |
Maintained with marginal rise |
Price vs. Generics
- Patent status: Patent protection expired in 2024, opening market for generics.
- Generic impact: Prices for generic sodium oxybate expected to be 25-40% lower upon market entry.[3]
Market Projections (Next 5 Years)
Assumptions
- Market penetration: Slow initial uptake of generics in the first year, with volume growth stabilizing at 15-20% annually.
- Pricing decline: 25-40% reduction in brand-name prices post-generic entry, with possible stabilization as market shares shift.
- Reimbursement rates: Will influence net prices; potential for increased copayments.
Revenue Estimates
| Year |
Estimated Patients |
Revenue (Brand) |
Revenue (Post-generic) |
| 2024 |
150,000 |
$5.25B |
$3.15B (30% drop) |
| 2025 |
180,000 |
$6.3B |
$3.78B |
| 2026 |
210,000 |
$7.35B |
$4.41B |
| 2027 |
240,000 |
$8.4B |
$5.04B |
| 2028 |
270,000 |
$9.45B |
$5.67B |
Note: Revenue is estimated as the product of the number of patients, average dose cost, and treatment prevalence.
Price Projections Summary
- 2024: Up to 30% price drop due to generic competition.
- 2025-2026: Stabilization with gradual decline in list prices, actual net prices impacted by discounts.
- Beyond 2026: Market penetration of generics increases, suppressing prices further (~40-50% below original prices).
Regulatory and Policy Impact
- FDA approvals: Accelerated generic approvals expected after patent expiry.
- Reimbursement trends: CMS and private insurers will negotiate reimbursement rates downward.
- Orphan drug status: No longer applicable post-patent expiry, impacting exclusivity and pricing.
Key Takeaways
- The market for Xyrem (NDC 55111-0532) is mature with stable demand driven by narcolepsy prevalence.
- Competitive pressure from generics expected to reduce prices by 25-40% within 1-2 years of patent expiry (2024).
- Revenue projections indicate significant decline in brand revenue but continued market size due to chronic therapy needs.
- Future growth may depend on off-label and alternative indications, as well as pipeline drugs.
- Pricing strategies are expected to shift towards value-based negotiations and rebate arrangements.
FAQs
Q1: When does patent expiry for Xyrem occur?
A1: The patent expired in 2024, opening the market for generics.
Q2: How much will generic sodium oxybate likely cost?
A2: It is projected to cost approximately 25-40% less than branded Xyrem, around $20,000 per year per patient.
Q3: What factors influence future prices for this drug?
A3: The entry of generics, reimbursement policies, discount and rebate levels, and competition from alternative therapies.
Q4: Will new formulations or delivery methods affect the market?
A4: Possible, but none are currently approved or in late-stage development. The existing formulation remains dominant.
Q5: How does the off-label use impact market size?
A5: Off-label uses are minimal and unsubstantiated, unlikely to significantly affect overall market size in the near term.
References
[1] American Psychiatric Association. (2022). Diagnostic and Statistical Manual of Mental Disorders (5th ed.).
[2] Johns Hopkins Medicine. (2022). Narcolepsy epidemiology. Retrieved from https://www.hopkinsmedicine.org
[3] IQVIA. (2023). Pharmaceutical Market Trends.
[4] U.S. Food and Drug Administration. (2024). Patent and exclusivity data.
