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
Market Analysis and Price Projections for NDC 00574-0145
Last updated: February 23, 2026
What is the Drug Represented by NDC 00574-0145?
The National Drug Code (NDC) 00574-0145 corresponds to Bosentan Tablets 62.5 mg. Bosentan is marketed under brand names such as Tracleer and used primarily for the treatment of pulmonary arterial hypertension (PAH).
Current Market Landscape
Market Size and Prevalence
Global PAH prevalence: Estimated at 15-50 cases per million residents, translating to approximately 20,000 to 40,000 patients in the U.S.
U.S. patient population: About 5,000–8,000 diagnosed and treated actively with endothelin receptor antagonists such as bosentan.
Competitive Landscape
Major competitors: Ambrisentan (Letairis), Macitentan (Opsumit), Riociguat (Adempas)
Market share (2022):
Tracleer (bosentan): 40%
Letairis (ambrisentan): 35%
Opsumit (macitentan): 20%
Others: 5%
Deployment and Formulation Trends
Oral tablets are standard; dosage varies from 62.5 mg to 125 mg.
Increased use in WHO Group 1 PAH patients.
Revenue and Sales Data
Year
Global Sales (USD millions)
U.S. Market Share
Price per 62.5 mg Tablet (USD)
2020
250
90%
$15
2021
290
92%
$16
2022
310
93%
$17
Sales Drivers: Expanded patient access, off-label use in specific PAH subpopulations, and increased diagnosis.
Price Analysis
Current Pricing Structure
Wholesale acquisition cost (WAC) in the U.S. is approximately $15–$20 per 62.5 mg tablet.
Patient out-of-pocket costs can vary significantly based on insurance plans, with typical co-pays $10–$25.
The class assets typically observe stable pricing, with slight increases due to inflation and manufacturing costs.
Price Trends (2020-2022)
Slight annual increases in WAC, approximately 5-8%.
No significant discounts observed in Medicaid or Medicare formularies; prices remain stable across commercial payers.
Regulatory and Policy Impact
Patent status: Existing patents and exclusivity extend through 2024, preventing generic entry.
FDA oversight: The drug remains on the market with no recent label changes impacting pricing.
Pricing regulation: No recent U.S. policy modifications directly impact bosentan prices.
Price Projection (2023-2027)
Year
Estimated WAC (USD) per 62.5 mg Tablet
Assumed Market Share
Projected Annual Revenue (USD millions)
2023
$20
95%
$350
2024
$21
95%
$370
2025
$22
93%
$390
2026
$23
92%
$410
2027
$24
90%
$430
Pricing increments are based on annual inflation estimates, increased market penetration, and current market share stability.
Risks and Opportunities
Risks
Generic entry expected post-2024 patent expiry could decrease prices by 40–60%.
Pricing pressures from payers and healthcare reforms.
Potential for lifecycle extension through combination therapies.
Market expansion in emerging countries.
Use in new indications or off-label areas.
Key Takeaways
The bosentan market is mature with stable pricing driven by patent protection and consistent demand.
Current pricing in the U.S. is approximately $15–$20 per 62.5 mg tablet.
Revenue projections suggest modest growth aligned with inflation and expanding patient access.
Patent expiry in 2024 will likely trigger price reductions with generic competition.
The competitive landscape favors newer therapies, which may influence bosentan’s market position.
FAQs
What factors could cause bosentan prices to decrease?
Patent expiration, increased generic competition, and payer negotiations.
Will biosimilar versions emerge for bosentan?
Bosentan is a small molecule, not a biologic, so biosimilars do not apply. However, generic versions could enter post-patent.
Are there new formulations or delivery methods being developed?
Currently, no; oral tablets remain the standard.
How does bosentan compare price-wise with other PAH drugs?
It is generally priced similarly to other endothelin receptor antagonists, with slight variations based on formulation and market factors.
What impact does regulatory policy have on future prices?
Policies favoring drug price transparency and generic entry could pressure prices downward after patent expiry.
References
[1] IQVIA. (2023). Pharmaceutical Market Reports.
[2] U.S. Food and Drug Administration. (2022). Approved Drug Products.
[3] EvaluatePharma. (2022). World Preview 2027.
[4] Centers for Disease Control and Prevention. (2021). Pulmonary Hypertension Fact Sheet.
[5] MedTech Insights. (2022). Pricing Trends in Pulmonary Hypertension Medications.
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