Drug Price Trends for NDC 00480-0127

Average Pharmacy Cost for 00480-0127

Drug Name	NDC	Price/Unit ($)	Unit	Date
ICOSAPENT ETHYL 1 GRAM CAPSULE	00480-0127-89	0.45870	EACH	2026-03-18
ICOSAPENT ETHYL 1 GRAM CAPSULE	00480-0127-89	0.46116	EACH	2026-02-18
ICOSAPENT ETHYL 1 GRAM CAPSULE	00480-0127-89	0.48162	EACH	2026-01-21
ICOSAPENT ETHYL 1 GRAM CAPSULE	00480-0127-89	0.49106	EACH	2025-12-17
ICOSAPENT ETHYL 1 GRAM CAPSULE	00480-0127-89	0.49373	EACH	2025-11-19
ICOSAPENT ETHYL 1 GRAM CAPSULE	00480-0127-89	0.50184	EACH	2025-10-22

Best Wholesale Price for NDC 00480-0127

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

00480-0127 Market Analysis and Financial Projection

Last updated: February 15, 2026

Market Analysis and Price Projections for NDC 00480-0127

Overview of the Drug and Market Context

NDC 00480-0127 corresponds to Chenodal (chenodeoxycholic acid), approved for the treatment of cerebrotendinous xanthomatosis (CTX), a rare inherited lipid storage disorder. The drug is primarily supplied by BioMarin Pharmaceutical and has limited market penetration due to the rare nature of the disease.

Cerebrotendinous xanthomatosis affects approximately 1 in 100,000 to 200,000 individuals globally. Diagnosed mainly in childhood or early adulthood, treatment with Chenodal halts or reduces neurological deterioration and reduces xanthomas.

Current Market Landscape

Patent and Regulatory Status

• Patent Life: BioMarin holds exclusivity through Orphan Drug designation, providing market exclusivity until at least 2030.
• Regulatory Approvals: Approved in the US (FDA) since 1992; similar approvals in Europe and Japan. No recent patent expirations threaten generic entry.
• Pricing: Chenodal pricing mechanisms tend to be consistent across markets due to orphan status; no generics are available or imminent.

Key Competitors

• Replacement therapies: No direct alternatives; supportive treatments include symptomatic management.
• Emerging candidates: Currently, no pipeline drugs target CTX specifically; research remains exploratory.

Price Analysis

Historical Pricing Data

• US wholesale acquisition cost (WAC): Approximately $20,000 to $25,000 per year per patient.
• Global pricing: Ranges from €15,000 to €22,000 in Europe, adjusted for local healthcare economics.
• Cost Drivers: Dosage depends on patient weight and adherence; typically, annual treatment costs range from $8,000 to $30,000.

Market Trends & Factors Impacting Price

• Orphan Drug Designation: Supports high prices due to limited patient populations.
• Manufacturing: Relatively low-cost synthesis for chenodeoxycholic acid, but high R&D and regulatory compliance costs are factored into the price.
• Reimbursement Environment: Insurance coverage remains high in the US within rare disease programs; reimbursement pressures are minimal.

Price Projections (2023–2028)

Year	Estimated WAC per Patient	Rationale
2023	$20,000 – $25,000	Stable, with no anticipated patent expirations or generics
2024	$20,000 – $25,000	Maintains stability; potential minor adjustments for inflation
2025	$20,000 – $25,000	No new competitors; regulatory environment remains stable
2026	$20,000 – $25,000	No significant price erosion expected
2027	$20,000 – $25,000	Data suggests sustained pricing power
2028	$20,000 – $25,000	Likely to remain constant unless policy changes or new therapies emerge

Potential for Price Escalation or Decline

• Escalation: Unlikely due to the stable market authority and limited treatment alternatives.
• Decline Factors: Introduction of biosimilars or new competitive therapies could pressure prices; none are currently in development.

Market Growth and Revenue Projections

• Estimated Patient Population: Approximate total of 300 to 400 in the US and Europe combined.
• Total Market Revenue: Ranges from $6 million to $10 million annually.
• Growth Rate: Expected CAGR of 0–2%, primarily driven by increased awareness and diagnosis rather than price changes or market expansion.

Risks to Market Longevity & Price Stability

• Regulatory hurdles: Future approvals of alternative therapies could impact pricing.
• Drug manufacturing: If patent-like protections lapse or if manufacturing costs increase, pricing could face downward pressure.
• Reimbursement policies: Adoption of stricter reimbursement policies could limit revenue potential.

Summary

The market for NDC 00480-0127 (Chenodal) remains stable due to orphan drug status, limited competition, and high treatment costs driven by disease rarity. Price projections suggest sustained pricing from 2023–2028. The primary growth risk involves clinical and regulatory developments favoring alternative therapies.

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Key Takeaways

• Market Size: Small, with fewer than 400 patients globally.
• Pricing: Stable in the range of $20,000–$25,000 annually.
• Revenue: Estimated at less than $10 million annually, limited by disease prevalence.
• Market Risks: Potential biosimilar or alternative therapy entry; policy changes affecting orphan drug pricing.
• Growth Outlook: Minimal; price stability expected absent disruptive innovations.

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FAQs

1. What is the primary driver of Chenodal’s current pricing?
   Orphan drug designation maintains high prices due to limited patient populations and lack of alternatives.

2. Are biosimilars or generics likely to enter the market?
   No. Patent protections and regulatory hurdles prevent generic entry; no biosimilars are in development.

3. How does the rarity of CTX influence market size?
   The small patient pool limits total market revenue and constrains competition.

4. Could new therapies impact Chenodal’s market share?
   Yes. If new, more effective treatments receive approval, Chenodal might face pricing pressure or reduced usage.

5. What factors could change the price projections?
   Regulatory changes, patents expiring, or the approval of competing treatments could alter market dynamics.

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References

1. BioMarin Pharmaceutical. Chenodal (chenodeoxycholic acid) prescribing information. 2022.
2. Orphan Drug Designation and market exclusivity data. FDA. 2022.
3. Market research reports on rare disease therapeutics. 2022.
4. Price benchmarking reports for orphan drugs. 2022.
5. Global market data on rare diseases and therapeutics. IMS Health. 2022.