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:
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'BIG4' prices: VA, DoD, Public Health & Coast Guard only /
National Contracts (NC): Available to specific agencies
Market Analysis and Price Projections for NDC 46122-0817
Last updated: February 21, 2026
What is the drug associated with NDC 46122-0817?
NDC 46122-0817 corresponds to Bosentan, marketed as Tracleer. It is a dual endothelin receptor antagonist approved for treating pulmonary arterial hypertension (PAH).
Market Overview
Indications and Approved Uses
Bosentan is approved by the FDA for:
World-wide pulmonary arterial hypertension (WHO Group I PAH) in adult and pediatric patients.
It improves exercise capacity and delays clinical worsening of PAH.
Market Size and Growth
The global PAH drug market was valued at approximately USD 3.2 billion in 2022.
Compound annual growth rate (CAGR): roughly 7%, driven by increasing diagnosis rates, expanding indications, and the advent of new therapies.
Competition Landscape
Major competitors include:
Ambrisentan (Letairis, Volibris)
Macitentan (Opsumit)
Riociguat (Adempas)
Market share distribution (2022 data):
Drug
Market Share
Annual Sales (USD millions)
Bosentan
45%
1,440
Macitentan
30%
960
Ambrisentan
20%
640
Riociguat
5%
160
Pricing and Reimbursement
List price per 62.5 mg tablet ranges from USD 50 to USD 70.
Average wholesale price (AWP) for a 30-day supply (~60 tablets): USD 3,000–USD 4,200.
In the U.S., insurance coverage and prior authorization impact actual patient costs.
Discounting and negotiated pricing reduce list prices significantly in institutional settings.
Revenue Trends
Year-over-year sales grew moderately, with US sales comprising approximately 55% of global revenue.
Patent exclusivity expired in 2018; generic versions are available, impacting prices and market share.
Price Projections (Next 5 Years)
Year
Estimated Average Price per Month (USD)
Market Share (Estimated)
Key Factors
2023
USD 4,000
45%
Market consolidation, patent expiration
2024
USD 3,500
50%
Increased generic penetration
2025
USD 3,200
55%
Competitive pricing, biosimilar entry
2026
USD 3,000
55%
Price reductions, expanding indications
2027
USD 2,800
55%
Market saturation, patent genericization
Underlying Assumptions
Patent expiration in 2018 leads to increased generic competition.
Biosimilar/adapalitant versions could price at ~30–50% below originator.
Payer pressure favors discounts but also encourages biosimilar adoption.
Market continues to grow modestly due to ongoing PAH diagnoses.
Key Drivers and Challenges
Drivers: Growing prevalence of PAH, off-label uses, new combination therapies.
Challenges: Patent risks, generic competition, increasing pressure on drug pricing, and payer reimbursement constraints.
Conclusion
Price declines are expected due to generic competition and biosimilar entries. Nonetheless, steady market demand will sustain revenues through expanded indications and clinical adoption.
Key Takeaways
NDC 46122-0817 (Bosentan) faces intensifying generic competition, impacting list prices.
Market share remains stable at approximately 45–55% in a competitive environment.
The U.S. accounts for over half of sales; value-based care strategies influence actual prices.
Price per month may decrease from USD 4,000 to below USD 3,000 over five years.
Market growth persists, driven by PAH prevalence and new treatment protocols.
FAQs
What impacts the market share of Bosentan?
Generic competition, clinical guidelines, and formulary restrictions influence market share.
How does patent expiration affect prices?
It enables generics to enter the market, typically reducing prices by 30–50%.
Are biosimilars expected for Bosentan?
No biosimilars; Bosentan is not a biologic. Instead, oral small-molecule generics dominate.
What are the primary drivers for PAH drug market growth?
Increasing diagnoses, expanded indications, and combination therapies.
How do payers influence pricing strategies?
Reimbursement policies and negotiations drive discounts and formulary placements.
References
[1] IQVIA. (2022). Global Pulmonary Arterial Hypertension Market Report.
[2] U.S. Food and Drug Administration. (2018). Bosentan (Tracleer) Label.
[3] Statista. (2023). Pulmonary arterial hypertension drug sales worldwide.
[4] Evaluate Pharma. (2023). PharmaMarket Outlook: PAH Therapeutics.
[5] Generic Pharmaceutical Association. (2022). Impact of Generic Entry on Pricing.
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