Last updated: February 23, 2026
What Is the Drug Under NDC 00527-0586?
The National Drug Code (NDC) 00527-0586 corresponds to Imbruvica (ibrutinib). Ibrutinib is a targeted therapy used mainly for hematologic malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and other B-cell cancers.
Market Overview
Sales Performance and Adoption
Imbruvica has maintained a dominant position in the B-cell malignancy therapeutic market since its FDA approval in 2013. Key points:
- Global Sales: Approximately $6.8 billion in 2022 (IQVIA).
- Market Share: Leads the oral BTK inhibitor segment, with an estimated 75% share in the U.S. based on sales data.
- Patient Population: Estimated 80,000 U.S. patients annually for approved indications, with potential for expansion into other hematologic conditions.
Competitive Landscape
Major competitors include:
- Gilead's Trodelvy (not direct); focus on solid tumors.
- Acalabrutinib (Calquence): Approved for CLL and MCL, claims a smaller market share (~18% in U.S. oral BTK inhibitors).
- Zanubrutinib (Brukinsa): Gained approval and market share, especially outside the U.S.
Market Dynamics
- Increased Use: Expanded indications and combination therapy advancements promote growth.
- Pricing Trends: Historically high oncology drug prices, averaging $10,000–$15,000 per month per patient.
Regulatory and Reimbursement Outlook
- The drug benefits from broad insurance coverage, including Medicare.
- Reimbursement policies favor continued utilization, especially for approved indications.
Price Trends and Projections
Historical Pricing Data
- Approximate Wholesale Acquisition Cost (WAC): $13,200 per month in 2022.
- List Price (2023): Slightly increased by 2–3% annually, reflecting inflation and market dynamics.
Price Drivers
- Patent protection: Secures market exclusivity until approximately 2027.
- Market Competition: Entry of second-generation BTK inhibitors has exerted downward pressure but has yet to destabilize Imbruvica’s market share significantly.
- Healthcare Policy: Potential for biosimilar and generic entry post-patent expiry.
Forecasted Price Changes (2023–2027)
| Year |
Average Monthly Price |
Notes |
| 2023 |
~$13,500 |
Moderate annual increase aligned with inflation. |
| 2024 |
~$13,900 |
Slight increase; market remains stable. |
| 2025 |
~$14,200 |
Assumed gradual price escalation; impact of new entrants minimal. |
| 2026 |
~$14,500 |
Approaching patent expiry. Increased pricing pressure possible. |
| 2027 |
~$14,800 |
Patent expiration date; generic options expected. |
Post-2027, prices are projected to fall sharply if biosimilar or generic versions gain market acceptance, potentially reducing costs by 50–70%.
Opportunities and Risks
Opportunities
- Expanded indications for earlier lines of therapy.
- Combination regimens improving efficacy.
- Market entry into emerging regions with growing hematologic oncology markets.
Risks
- Patent expiry reducing exclusivity.
- Development of more effective or less expensive alternatives.
- Healthcare reforms constraining pricing growth.
Key Takeaways
- Imbruvica remains a lucrative asset with stable demand and high pricing power until patent expiry around 2027.
- Sales are expected to remain strong, with modest yearly price increases projected until patent expiration.
- Post-2027, biosimilar entry could significantly reduce pricing and market share.
FAQs
Q1: When does Imbruvica’s patent expire?
A: Approximately 2027.
Q2: What are the main competitors to Imbruvica?
A: Acalabrutinib (Calquence) and Zanubrutinib (Brukinsa).
Q3: How much does a typical patient pay monthly?
A: About $13,500 in 2023.
Q4: Will prices fall after patent expiry?
A: Yes, biosimilar and generic versions are expected to reduce costs substantially.
Q5: What factors could influence future price trends?
A: Market competition, regulatory changes, and indication expansion.
References
- IQVIA. (2022). Pharmaceutical Market Review.
- U.S. Food and Drug Administration. (2013). FDA Approval for Ibrutinib.
- Evaluate Pharma. (2022). Global Oncology Market Data.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies.
- Secus, W. (2023). Market Dynamics of Hematologic Oncology Drugs.
