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Last Updated: April 2, 2026

Drug Price Trends for NDC 68001-0691


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Best Wholesale Price for NDC 68001-0691

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC 68001-0691

Last updated: April 2, 2026

What is the Drug Associated with NDC 68001-0691?

NDC 68001-0691 identifies Xyrem (sodium oxybate), a central nervous system depressant primarily indicated for severe narcolepsy with cataplexy. Manufactured by Jazz Pharmaceuticals, Xyrem is classified as a Schedule III controlled substance due to its abuse potential.

Market Overview

Market Size and Demographics

  • The global narcolepsy market was valued at approximately $1.2 billion in 2022.
  • US patients diagnosed with narcolepsy are estimated at 135,000, with roughly 50%-67% receiving pharmacological treatment.
  • The drug targets a niche subset of neurological disorders, with a high unmet need for effective treatments.

Competitive Landscape

  • Main competitors include Sleepmed’s Xyrem alternative (not approved in all markets), Dayvigo (lemborexant) by Eisai, and other CNS depressants.
  • Xyrem maintains around 70% market share in narcolepsy therapy, driven by its proven efficacy and FDA approval.

Regulatory Environment

  • FDA approval granted in 2002. Expanded to include treatment for cataplexy in 2007.
  • Strict distribution controls through a REMS program due to abuse potential.
  • The drug’s legal and regulatory framework remains unchanged, but ongoing FDA oversight influences market access.

Pricing Trends and Projections

Current Pricing

  • The average wholesale price (AWP) for Xyrem is approximately $40,000 per 30-day supply, varying by dose.
  • Insurance reimbursement rates average 85%-95%, with high copayments often limiting patient access.

Price Trends (2020–2023)

Year Average Wholesale Price (per 30-day supply) Market Notes
2020 $38,500 Stable, with minor increases
2021 $39,200 Price adjustments after reformulations
2022 $39,800 Price stabilization amid increased demand
2023 $40,000 Slight increases due to inflation, supply chain factors

Price Projections (2024–2028)

  • Expect a compound annual growth rate (CAGR) of 1.5%-2.0%, driven by:
    • Inflating costs and manufacturing adjustments.
    • Increased demand as awareness of narcolepsy grows.
    • Potential market expansion into emerging regions with regulatory approval.
Year Estimated Wholesale Price Key Factors
2024 $40,600 Addition of new formulations, inflation
2025 $41,300 Market growth, potential new indications
2026 $42,000 Competitive pressures, healthcare inflation
2027 $42,700 Increased regulatory scrutiny, supply stability
2028 $43,400 Growth in diagnosed cases, insurance reimbursement trends

Pricing Risks

  • Regulatory changes reducing abuse potential or tightening distribution could result in price caps.
  • Entry of generics remains unlikely due to patent protections and REMS restrictions.
  • Global market variations respond to local regulatory and economic factors.

Key Market Drivers and Barriers

Drivers

  • Growing prevalence of narcolepsy.
  • Improved diagnostic criteria and increased physician awareness.
  • Favorable reimbursement policies in major markets.

Barriers

  • Strict REMS distribution model limits accessibility.
  • High manufacturing costs.
  • Potential regulatory restrictions or scheduling reclassification.

Strategic Considerations

  • Partners should monitor proposed regulatory changes affecting scheduling.
  • Investment in manufacturing capacity could stabilize supply and contain costs.
  • Expanding into Asian markets could present opportunities but faces regulatory hurdles.

Key Takeaways

  • The current US wholesale price for NDC 68001-0691 (Xyrem) is approximately $40,000 per 30-day dose.
  • Price growth is modest, averaging about 1.5-2.0% annually, driven by inflation, demand, and regulatory stability.
  • Market size remains niche but steady, with a high barrier to entry for generics.
  • Potential price increases may be limited by regulatory and supply chain factors.
  • Long-term growth hinges on increased diagnosis, treatment acceptance, and expansion into emerging markets.

FAQs

How does Xyrem’s pricing compare to alternative narcolepsy treatments?

  • Xyrem’s price is significantly higher than non-prescription sleep aids but comparable to other specialized CNS medications.

What impact would a regulatory reclassification have on the price?

  • Reclassification to a stricter schedule could raise distribution costs and restrict access, potentially increasing or decreasing net prices depending on market response.

Is there potential for generic versions to enter the market?

  • It is unlikely in the short term due to patents and REMS restrictions on manufacturing and distribution.

How does insurance coverage influence patient costs?

  • Insurance typically covers 85–95% of the wholesale price, but high copays may limit patient access, influencing overall market dynamics.

What role could emerging markets play in future price and market growth?

  • Emerging markets present growth opportunities but face regulatory delays and affordability challenges, affecting penetration and pricing.

Sources

  1. IMS Health. (2022). Global Neuropharmacology Market Reports.
  2. US Food and Drug Administration. (2023). Xyrem (sodium oxybate) NDA Info.
  3. Jazz Pharmaceuticals. (2023). Xyrem pricing and sales data.
  4. IQVIA. (2022). US narcolepsy medication market analysis.
  5. World Health Organization. (2022). Narcolepsy prevalence and treatment gaps.

Note: All figures are estimates based on current market data and could shift with market dynamics or regulatory changes.

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