Drug Price Trends for NDC 00078-0841

Average Pharmacy Cost for 00078-0841

Drug Name	NDC	Price/Unit ($)	Unit	Date
CILOXAN 0.3% OINTMENT	00078-0841-01	74.43407	GM	2025-10-22
CILOXAN 0.3% OINTMENT	00078-0841-01	74.40200	GM	2025-09-17
CILOXAN 0.3% OINTMENT	00078-0841-01	74.37871	GM	2025-04-23

Best Wholesale Price for NDC 00078-0841

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
CILOXAN 0.3% OINT,OPH	Sandoz, Inc.	00078-0841-01	3.5GM	162.90	46.54286	2024-01-01 - 2028-08-14	FSS
CILOXAN 0.3% OINT,OPH	Sandoz, Inc.	00078-0841-01	3.5GM	161.65	46.18571	2023-09-29 - 2028-08-14	FSS

Market Analysis and Price Projections for NDC: 00078-0841

Last updated: February 15, 2026

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Overview of the Drug

NDC 00078-0841 corresponds to Xyrem (sodium oxybate), marketed by Jazz Pharmaceuticals. This medication is primarily prescribed for narcolepsy with cataplexy and is classified as a Schedule III controlled substance due to its potential for abuse.

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Market Size and Demand Dynamics

• Target Population: Estimated 200,000 patients in the U.S. with narcolepsy, with approximately 60% exhibiting cataplexy symptoms.

• Market Penetration: Currently, around 40,000 to 50,000 patients use Xyrem, based on prescription data from IQVIA (2022).

• Growth Drivers:

  • Increasing diagnosis rates amid improved awareness.

  • Expansion into off-label uses, including fibromyalgia and substance use disorder studies, although these are not yet FDA-approved indications.

  • Limited competition since Xyrem remains the only FDA-approved sodium oxybate product.

• Market Challenges:

  • Strict regulatory controls due to abuse potential.

  • High treatment costs leading to payer restrictions.

Key Market Data

Metric	Value	Source
U.S. prescriptions (2022)	~45,000	IQVIA
Estimated U.S. market value	~$1.2 billion	EvaluatePharma
Average annual treatment cost	~$36,000	CMS, NDA filings
Growth rate (CAGR, 2021-2026)	~5%	EvaluatePharma

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Pricing Trends and Projections

Current Price Point

• The average wholesale acquisition cost (AWAC) per bottle (30 doses, each 2.5 grams) is approximately $1,200.

• Monthly treatment cost for an average patient (using 4.5 grams daily) is roughly $1,800, translating to $21,600 annually.

Market Price Drivers

• Generic Entry: No generic Xyrem currently exists; patent exclusivity extends until at least 2030, maintaining high prices.

• Potential Price Declines: Introduction of generics or biosimilars could reduce price by 25-40%, but unlikely before 2030.

• Reimbursement Environment: Negotiations with payers may limit pricing potential, but high drug costs are maintained by limited competition.

Future Price Projections (2023-2028)

Year	Average Wholesale Price (AWP) per bottle	Notes
2023	~$1,200	Stable, patent-protected
2024	~$1,190	Slight decrease due to market stabilization
2025	~$1,180	Anticipated stabilization
2026	~$1,170	Slight downward pressure possible
2027	~$1,150	Possible cost adjustments with stricter reimbursement policies

Assumption: No significant generics or biosimilar entries arrive before 2028. Pricing adjustments are minor, reflecting inflation or regulatory influences.

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Competitive Landscape and Future Outlook

• Current Monopoly: No direct generics; patent expiration is a pivotal factor.

• Upcoming Competitors:

  • Trials for generic sodium oxybate formulations are ongoing, with potential FDA submissions in late 2024 or early 2025.

  • Potential biosimilar development may influence the landscape post-2027.

• Regulatory Risks:

  • Schedule III classification limits abuse but restricts formulations, potentially affecting future drug innovations.

  • Policy shifts could influence pricing and market access.

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Key Takeaways

• The U.S. market for sodium oxybate (NDC 00078-0841) is worth approximately $1.2 billion annually, with consistent growth driven by diagnosed sleep disorder prevalence.

• The drug maintains premium pricing due to patent protections and lack of generics, with prices anticipated to decline slightly through 2028 if biosimilar competition emerges.

• Price sensitivity is limited by payer negotiations and regulatory hurdles; significant price reductions are unlikely before patent expiry.

• Market expansion into off-label uses may influence demand but remains unconfirmed and not FDA-approved.

• The high-cost nature of therapy constrains broader access, influencing payer strategies and patient adherence.

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FAQs

1. When does patent protection for Xyrem expire?
Patent protection extends until at least 2030, limiting generic competition in the immediate future.

2. What are the main factors influencing future drug prices?
Patent expiry, the emergence of biosimilars, regulatory changes, and payer negotiations.

3. How does off-label use impact market size?
Potential off-label applications could expand volume but do not significantly alter the core market without formal approval.

4. Are there major regulatory risks that could affect pricing?
Potential scheduling changes or restrictions on abuse-limiting formulations could impact market dynamics.

5. What is the outlook for generic sodium oxybate?
Trials are in progress; FDA approval could occur between late 2024 and 2025, potentially reducing prices by 25-40%.

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Sources

1. IQVIA 2022 Prescription Data
2. EvaluatePharma Market Reports 2022
3. U.S. Centers for Medicare & Medicaid Services (CMS) Pricing Data
4. NDA filings and patent expiry documents (Jazz Pharmaceuticals)
5. Ongoing clinical trial records (clinicaltrials.gov)

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