Last updated: April 2, 2026
What is NDC 65162-0745?
NDC 65162-0745 is related to a specific pharmaceutical product. According to the National Drug Code (NDC) directory, it corresponds to Imbruvica (ibrutinib), developed by Pharmacyclics LLC, a subsidiary of AbbVie. This drug is used primarily for treating certain types of B-cell malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström’s macroglobulinemia.
Market Landscape Overview
Market Size
The global hematologic malignancies market was valued at $8.7 billion in 2021 and is projected to reach $15.2 billion by 2028, growing at a compound annual growth rate (CAGR) of 8.3%. Ibrutinib's segment accounts for approximately 35-40% of this market, driven by its approvals in multiple indications.
Competitors
Key competitors include:
- Acalabrutinib (Calquence) — AstraZeneca
- Zanubrutinib (Brukinsa) — BeiGene
- Ibrutinib (Imbruvica) — AbbVie and Johnson & Johnson
Imbruvica holds roughly 50% market share among BTK inhibitors for B-cell malignancies. The patent expiration timeline indicates potential generic entry starting from 2028, contingent on patent litigations and orphan drug exclusivities.
Geographic Reach
The U.S. market dominates, representing approximately 80% of sales. Europe accounts for 12%, with Asia-Pacific and other regions sharing the remaining market share. Adoption rates differ based on drug approvals and healthcare policies.
Price and Revenue Trends
Historical Pricing Data
- 2013: Launch price of Imbruvica was approximately $9,808 per month per patient in the U.S.
- 2020: The price increased marginally by 2-3%, with monthly costs approaching $10,130.
- 2022: The average list price stabilized around $10,200 per month, though actual net prices may be lower due to discounts and rebates.
Annual Revenue Projections
- 2021: Revenues of approximately $5.8 billion (AbbVie's data).
- 2023: Projected revenues are roughly $6.2 billion, assuming continued growth driven by increased diagnoses and expanded indications.
Price Trends & Factors
- Patent protections and exclusivity have allowed pricing stability.
- Entry of competitors or biosimilars may pressure prices starting around 2028.
- Insurance coverage and payer negotiations tend to reduce net sale prices.
Future Price and Market Projections
Short-Term Projections (2023–2025)
- Prices are expected to stay flat or slightly decline (~1-2%) as payers negotiate better rebates.
- Revenue growth will primarily come from increased patient access and expansion into new indications.
Long-Term Projections (2028–2030)
- Generic or biosimilar competition could reduce list prices by 30-50%.
- Authorized generics and biosimilars could enter the market around 2028, following patent expiry.
- Projected revenue decline could reach 40-50% if biosimilar penetration is aggressive and healthcare systems adopt cost-containment measures.
Pricing for Future Indications
- As new indications gain approval, pricing strategies may vary:
- Higher prices for orphan indications.
- Discounting for maintenance therapy to ensure market penetration.
Risks Affecting Market and Price Trajectory
- Regulatory delays or rejection of new indications.
- Patent litigations extending exclusivity.
- Competitive entry, especially from biosimilars.
- Evolving reimbursement policies and value-based pricing models.
Summary Table: Market Size, Revenue, and Price Trends
| Year |
Market Size (USD billions) |
Imbruvica Revenue (USD billions) |
Monthly Price (USD) |
Price Change (%) |
| 2021 |
8.7 |
5.8 |
10,130 |
+2-3 |
| 2022 |
9.2 |
6.0 |
10,200 |
Stable |
| 2023 (Projected) |
10.0 |
6.2 |
10,200 |
Stable |
| 2028 (Post-patent) |
15.2 |
Decline |
Potential biosimilar pricing |
-30 to -50 |
Key Takeaways
- The current U.S. market for NDC 65162-0745 (Imbruvica) centers on a high-value hematologic oncology therapy with revenues exceeding $6 billion annually.
- Pricing has stabilized around $10,200 per month since 2020.
- Market growth will continue due to expanded indications, increased diagnosis rates, and geographic expansion.
- Significant price reductions are likely post-patent expiration in 2028 due to biosimilar competition.
- Revenue projections depend heavily on competitive dynamics, regulatory approvals, and healthcare reimbursement policies.
FAQs
1. What is the patent expiration date for Imbruvica?
Patent protections are expected to expire around 2028, opening the market to biosimilars and generics.
2. How do biosimilars impact the pricing for NDC 65162-0745?
Biosimilars typically reduce prices by 30-50%, leading to potentially sharp revenue declines for the originator.
3. Are there any approved alternative therapies for the indications treated by Imbruvica?
Yes. Other BTK inhibitors like acalabrutinib and zanubrutinib serve as competitors, with some studies suggesting comparable efficacy.
4. What factors influence the demand for Imbruvica?
Demand hinges on approval for new indications, diagnosis rates, pricing, and reimbursement frameworks.
5. How do international markets compare in terms of pricing and access?
European markets generally have lower prices due to price negotiations and healthcare system structures; Asian markets show variable access levels.
Sources:
[1] IQVIA. (2022). Hematologic Oncology Market Reports.
[2] FDA. (2022). Approval summaries for Ibrutinib indications.
[3] PwC. (2022). Pharmaceutical Pricing Dynamics.
[4] EvaluatePharma. (2022). Oncology Market Outlook.
