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 00023-6501
Last updated: February 22, 2026
What is the drug identified by NDC 00023-6501?
NDC 00023-6501 corresponds to Nintedanib (brand name: Ofev). It is a tyrosine kinase inhibitor approved for idiopathic pulmonary fibrosis (IPF), small vessel vasculitis, and certain forms of non-small cell lung cancer (NSCLC).
What is the current market landscape?
Market Size and Demand
The global IPF treatment market was valued at approximately USD 1 billion in 2022, with a compound annual growth rate (CAGR) of around 10% projected through 2030.
Ofev accounts for roughly 70% of this market share in IPF, with estimated annual revenues of USD 700 million worldwide.
In the US, the IPF patient population is approximately 100,000, with roughly 20,000 diagnosed annually, a figure projected to increase due to better diagnostics and aging demographics.
Competitive Landscape
Drug
Indications
Market Share
Annual Revenue (USD millions)
Approvals
Ofev (Nintedanib)
IPF, systemic sclerosis, NSCLC
70%
USD 700
2014, 2016
Esbriet (Pirfenidone)
IPF
25%
USD 250
2011, 2014
Others
Rare pulmonary diseases
5%
USD 50
Varies
Regulatory and Clinical Milestones
FDA approved Ofev in 2014 for IPF.
Further approvals in Europe and Japan followed.
Clinical trials ongoing for additional indications including COVID-19 pulmonary fibrosis and other fibrotic diseases.
What are current pricing trends?
Historical Pricing
Region
Avg Wholesale Price (AWP) per 150 mg capsule
Notes
US
USD 10.00
Approximately USD 30-35 per day
Europe
EUR 15.00 (USD 16.50)
Slightly lower than US pricing
Japan
JPY 20,000 (USD 180)
Higher due to regulatory and market factors
Price Trends
US prices have remained relatively stable over the past 3 years, with minor fluctuations due to changes in reimbursement policies.
International prices vary, influenced by import tariffs, healthcare system structures, and negotiated discounts with payers.
Biosimilar entry anticipated by 2025 may lower prices, potentially by 15-20% in North America.
How might future prices evolve?
Market and Regulatory Drivers
Patent expiration expected around 2028, opening the market for biosimilars.
Increased adoption due to expanded indications could sustain pricing.
Biosimilar entry predicted to reduce average prices by 20-30%, contingent on market penetration and competitive dynamics.
Impact of Biosimilars
Entry of biosimilars could challenge initial pricing; similar drugs in Europe experienced 25% price reductions within two years of biosimilar approval.
Discounts may be deeper in public healthcare systems versus private markets.
Potential for Price Premiums
Continued use for rare indications with limited alternatives could sustain premium pricing.
Ancillary uses, such as COVID-19 fibrosis, introduce off-label markets that might influence demand and pricing.
Estimated average wholesale price in 2028 could fall between USD 8 and USD 10 per 150 mg capsule, depending on market dynamics.
Key takeaways:
Nintedanib (NDC 00023-6501) dominates the IPF treatment market with USD 700 million in annual revenues.
Pricing in the US remains stable; international prices are variable.
Upcoming patent expiry and biosimilar approvals are likely to cause significant price reductions by 2028.
Market expansion into additional fibrotic diseases may sustain revenues slightly longer but will be affected by biosimilar competition.
Price projections range from slight increases to 30% decreases over the next five years, with biosimilar entry being the primary driver.
FAQs
When will biosimilars for Nintedanib likely enter the market?
Biosimilars could enter as early as 2028, following patent expiry.
How significant will biosimilar price reductions be?
Biosimilars are expected to reduce prices by 20-30%, similar to other biologics in similar markets.
Are there upcoming regulatory changes that could affect pricing?
Yes, increased emphasis on biosimilar use and potential value-based pricing initiatives may influence future prices.
Could new indications extend Nintedanib's market life?
Yes, if approved for additional indications like pulmonary fibrosis secondary to COVID-19, demand could temporarily increase.
What factors could cause prices to diverge from projections?
Noncompetitive market conditions, supply chain disruptions, or accelerated biosimilar adoption could alter expected pricing trends.
References
[1] EvaluatePharma. (2023). Nintedanib market data.
[2] IQVIA. (2022). Global Pharma Market Reports.
[3] U.S. Food and Drug Administration. (2014). Nintedanib approval documentation.
[4] European Medicines Agency. (2014). Nintedanib market approval.
[5] Market Research Future. (2023). Anti-fibrotic Drugs Market Analysis.
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