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Last Updated: April 17, 2026

Drug Price Trends for NDC 46122-0817


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Best Wholesale Price for NDC 46122-0817

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
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 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

  1. What impacts the market share of Bosentan?
    Generic competition, clinical guidelines, and formulary restrictions influence market share.

  2. How does patent expiration affect prices?
    It enables generics to enter the market, typically reducing prices by 30–50%.

  3. Are biosimilars expected for Bosentan?
    No biosimilars; Bosentan is not a biologic. Instead, oral small-molecule generics dominate.

  4. What are the primary drivers for PAH drug market growth?
    Increasing diagnoses, expanded indications, and combination therapies.

  5. 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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