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 00904-6767
Last updated: February 27, 2026
What is the Drug Identified by NDC 00904-6767?
NDC 00904-6767 corresponds to Ibrutinib (brand name Imbruvica). Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor approved for multiple hematologic malignancies, including:
Mantle cell lymphoma (MCL)
Chronic lymphocytic leukemia (CLL)
Waldenström’s macroglobulinemia (WM)
Marginal zone lymphoma (MZL)
Chronic graft-versus-host disease (cGVHD)
Manufactured primarily by AbbVie and Janssen Pharmaceuticals, Ibrutinib is a blockbuster medication with broad oncology indications.
Market Size and Dynamics
Parameter
Data
Notes
2022 U.S. Oncology Prescription Volume
~60,000 prescriptions
Steady growth over past 5 years (Source: IQVIA)
Global Market Size (2022)
~$6.8 billion
Estimated based on prescription rates and pricing (Source: Evaluate Pharma)
Key Indications
CLL (40%), MCL (25%), WM (15%), others (20%)
Prescription volumes vary per indication
Factors influencing the market:
Aging population drives demand, especially in CLL and NHL.
Competitive landscape: Other BTK inhibitors (e.g., acalabrutinib, zanubrutinib) entered the market, impacting sales.
Regulatory approvals: Expanded use cases increase market penetration.
Pricing pressures: Biosimilars and generic competition expected from patent expiry.
Price Overview and Projections
Current Pricing (U.S. Market)
Pricing Parameters
Data
Notes
Average Wholesale Price (AWP)
~$10,800 per 30-count bottle
Monthly therapy cost varies with dose; for 420 mg daily (standard dose)
Wholesale Acquisition Cost (WAC)
~$9,600 per 30-count
Slightly lower than AWP
Patient Out-of-Pocket
~$2,800–$4,200/month
Depends on insurance plan and discounts
Historical Price Trends
2015: Launch price at ~$10,000 per month.
2020–2022: Slight reductions due to marketplace saturation and insurance negotiations.
2023: Incremental price stabilization; no significant discounts observed.
Price Projections (2024–2028)
Year
Expected Average Monthly Price
Remarks
2024
~$10,200
Minimal inflation; competitive pressures persist
2025
~$10,000
Slight price erosion from biosimilar entry anticipated
2026
~$9,800
Market saturation; price stabilization expected
2027
~$9,600
Potential discounts on off-patent formulations
2028
~$9,400
Entry of biosimilar-like products may impact pricing
Factors Affecting Price Trajectory
Patent expiry: The primary patent expires in 2027 (U.S.), enabling biosimilar competition.
Biosimilar development: Several biosimilar candidates are in early development phases; impact might materialize post-2027.
Market exclusivity extensions: Additional patents or exclusivities could delay generic entry.
Regulatory actions: Price controls or value-based pricing policies could influence the cost.
Competitive Landscape and Impact
Competitors
Indications
Market Share (2022)
Price Positioning
Acalabrutinib (Calquence)
CLL, MCL
~20%
Similar price point, slightly higher composition for select indications
Zanubrutinib (Bruksvy)
MCL, WM
~15%
Competitive pricing to gain market share
Generic BTK inhibitors
Not widely available yet
0%
Expected post-2027
Key competitors have gained market share based on safety and tolerability profiles, influencing pricing strategies for Ibrutinib.
Key Market Trends
Increased adoption driven by expanded indications.
Shift toward combination therapy: Potential for price adjustments as combination regimens emerge.
Payor negotiations: Focus on outcomes and value-based contracts could reduce net prices.
Biotech and pharmaceutical alliances: These facilitate market penetration and influence pricing negotiations.
Conclusions
The current market for NDC 00904-6767 (Imbruvica) remains substantial, with a steady or slightly declining price trend forecasted over the next five years.
The upcoming patent expiry is expected to introduce biosimilar competition, exerting downward pressure on prices starting around 2027.
Growth is primarily driven by expanding indications and aging populations, but increased competition from other BTK inhibitors moderates growth.
Key Takeaways
Imbruvica holds a dominant position in hematologic malignancies but faces imminent biosimilar entry.
Pricing has remained relatively stable, with incremental declines forecasted post-patent expiration.
Market competition, regulatory developments, and payor negotiations will be primary determinants of future pricing.
The landscape shows moderate growth, sustained by expanding indications and approval for new conditions.
Cost management by providers and payors may accelerate pressure on net prices.
FAQs
When will biosimilar versions of Ibrutinib likely enter the market?
Patent expiry in the U.S. is expected in 2027, allowing biosimilar development and potential entry thereafter.
How does the price of Ibrutinib compare internationally?
Prices vary significantly; notably lower in countries with price controls, such as Canada and Europe.
Are there any recent regulatory actions affecting pricing?
No major FDA or CMS actions directly targeted Ibrutinib pricing, but ongoing discussions about value-based models may influence future adjustments.
What are the primary drivers for Ibrutinib’s market growth?
Increasing incidence of hematologic malignancies, expanded FDA approvals, and higherreatment adoption rates.
How might new BTK inhibitors impact Ibrutinib's pricing?
They could erode market share, prompting aggressive pricing strategies and discounts for Ibrutinib.
References
[1] IQVIA. (2022). Prescription drug data.
[2] Evaluate Pharma. (2022). Global oncology market reports.
[3] U.S. Food & Drug Administration. (2020-2023). Drug approvals and patent status updates.
[4] GoodRx. (2023). Drug pricing overview.
[5] FDA. (2022). Market exclusivity and biosimilar pathway details.
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