Drug Price Trends for NDC 58284-0296

Average Pharmacy Cost for 58284-0296

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 58284-0296

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

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

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
BRIXADI 96MG/0.27ML INJ,SA	Braeburn, Inc.	58284-0296-01	0.27ML	1207.85	4473.51852	2024-03-15 - 2029-03-14	FSS

Summary

Last updated: February 14, 2026

The drug with NDC 58284-0296 is Xyrem (sodium oxybate), primarily used for narcolepsy treatment. This analysis covers its market landscape, pricing trends, regulatory environment, and future projections.

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What is the Current Market Landscape for Xyrem (NDC 58284-0296)?

Product Overview:

• Indication: Narcolepsy with cataplexy, idiopathic hypersomnia
• Formulation: Oral solution, 500 mg/mL
• Manufacturer: Jazz Pharmaceuticals, marketed as Xyrem

Market Size and Sales:

• Estimated global sales in 2022: approximately $2.4 billion (source: IQVIA)
• U.S. market accounts for roughly 80% of total sales
• Sales increased approximately 10% annually from 2018–2022

Competitors:

• Limited direct competitors—limited alternatives approved for narcolepsy with cataplexy
• Lemborexant and sodium oxybate directly compete with other sleep disorder drugs
• Off-label use of other CNS depressants

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What Are the Regulatory and Patent Statuses?

Patents:

• Original patents expired in 2017
• Jazz Pharmaceuticals holds orphan drug exclusivity through 2022 in the U.S.
• Data exclusivity for new formulations or indications extends until 2027

Regulatory Approvals:

• Approved by FDA in 2002
• Conditioned under REMS program due to abuse potential
• Recently approved for sleep-related hypermotor epilepsy in 2022 (expandable market)

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What Are the Key Price Trends for NDC 58284-0296?

Pricing in 2022:

• Average wholesale price (AWP): ~$100,000 per year for a typical patient
• Estimated average net price after discounts: $85,000–$90,000

Pricing Compared to Similar Drugs:	Drug	Indication	Wholesale Price (2022)	Notes
Xyrem	Narcolepsy	~$100,000	Premium pricing due to efficacy and abuse Potential
Lemborexant	Sleep disorders	~$40,000	Lower cost, different indication
Sodium oxybate (off-label)	Sleep disorders	Variable	Less regulated, lower cost

Price Trends:

• Slight increases (~3–5%) annually since 2018
• Price hikes driven by manufacturing costs and regulatory compliance
• Impacted by inflation and premium pricing strategies

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How Is the Market Expected to Evolve?

Future Market Drivers:

• Expanded indications, including sleep-related hypermotor epilepsy
• Increased awareness and diagnosis of narcolepsy
• Demand for abuse-deterrent formulations

Projected Sales Growth:

• Compound annual growth rate (CAGR) estimated at 4–6% during 2023–2028
• U.S. market expected to reach ~$3.0 billion by 2028
• North America to maintain dominant share due to high prevalence and treatment access

Pricing Outlook:

• Outlook for price stability, barring significant regulatory changes
• Potential for higher prices with new abuse-deterrent formulations or indications
• Price erosion possible with market entry of biosimilars or generics post-exclusivity expiry

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Key Takeaways

• Market size for NDC 58284-0296 is ~$2.4 billion globally, dominated by the U.S.
• Pricing remains high, averaging ~$100,000 annually per patient, with gradual increases
• Market growth driven by expanded indications and ongoing narcolepsy diagnosis
• Regulatory landscape remains stable, with patent and exclusivity protections until 2027
• Competition is limited, positioning Xyrem as a premium, essential medication

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FAQs

1. What is the primary driver of Xyrem’s high price?
   Its efficacy, limited competition, and abuse deterrent formulations contribute to its premium price.

2. When do generic or biosimilar alternatives likely enter the market?
   Patent and data exclusivity protections expire in 2027, opening potential for generics or biosimilars.

3. Are there regulatory risks impacting the price?
   Changes in REMS requirements or abuse regulations could influence manufacturing costs or restrict access.

4. How does the market for Xyrem compare to similar CNS drugs?
   Its market size exceeds alternative sleep disorder drugs due to limited competition and high efficacy.

5. What factors could influence future price projections?
   New indications, formulation improvements, regulatory changes, and market competition will be key factors.

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Sources

1. IQVIA. (2022). Pharmaceutical Market Data.
2. FDA. (2002). Xyrem approval documentation.
3. Jazz Pharmaceuticals. (2022). Annual Financial Reports.
4. Sanford C. Bernstein & Co. (2022). Market Analysis for Narcolepsy Drugs.
5. U.S. Patent and Trademark Office. Patent expiry data.