Last updated: February 14, 2026
What is NDC 16729-0435?
NDC 16729-0435 identifies Acalabrutinib (Calquence), marketed by AstraZeneca. It is a Bruton’s tyrosine kinase (BTK) inhibitor approved for treating mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL). Its approval by the FDA was granted in 2017.[1]
Market Size and Key Drivers
Indications and Market Penetration
- Primary Indications: MCL, CLL, SLL.
- Market Entry: Launched in 2017.
- Estimated US Patients:
- MCL: 2,600 annually[Citation needed].
- CLL/SLL: 140,000 diagnosed in the US[2].
- Competitors:
- Ibrutinib (Imbruvica)
- Zanubrutinib (Brukinsa)
- Acalabrutinib's differentiation: potentially fewer side effects, efficacy data.
Market Trends
- Increase in targeted therapy adoption for hematologic malignancies.
- Growing approval of BTK inhibitors across multiple regions.
- Price competition among BTK inhibitors could influence market share.
Competitive Landscape
| Drug |
Approval Year |
Indications |
Market Share (2022) |
Price (per treatment year) |
Notes |
| Acalabrutinib |
2017 |
MCL, CLL, SLL |
15% (estimated) |
~$150,000 |
Prescribed post-ibrutinib failure for CLL |
| Ibrutinib (Imbruvica) |
2013 |
Multiple B-cell malignancies |
60% |
~$159,000 |
First-in-class BTK inhibitor |
| Zanubrutinib (Brukinsa) |
2019 |
MCL, CLL |
20% |
~$140,000 |
Approved later, aggressive market entry |
Note: Prices are approximate annual retail costs, varying by insurer discounts and patient Medicare/Medicaid coverage.
Price Projections (2023–2028)
Base Case Scenario
- Current Price: Approximately $150,000 per year in the US.
- Projected Trends:
- Slight decrease in list price by 2-3% annually due to market competition and biosimilar/biologic pricing pressures.
- Increased adoption may stabilize revenues amid competitive pricing.
| Year |
Estimated Price (USD) |
Notes |
| 2023 |
$150,000 |
Current list price |
| 2024 |
$146,500 |
Slight 2.33% decline |
| 2025 |
$143,000 |
Market competition intensifies |
| 2026 |
$140,000 |
Price stabilization expected |
| 2027 |
$137,000 |
Entry of biosimilar-like competitors |
| 2028 |
$135,000 |
Post-patent-adaptation adjustments |
Future Influences
- Generic/Biosimilar Entry: Limited for biologics due to patent protections, but biosimilar development could influence pricing after patent expiry (~2032).
- Regulatory and Policy Changes: Value-based pricing models could lower list prices.
- Market Expansion: Approval in Europe, Asia may introduce new pricing dynamics and volume growth.
Key Risks and Opportunities
Risks:
- Price erosion from biosimilars or intensified competition.
- Slower-than-expected adoption in newer indications.
- Regulatory delays in emerging markets affecting global pricing.
Opportunities:
- Expanding indications and combination therapies.
- Increasing use as first-line therapy, potentially raising prices.
- Partnering with payers for value-based agreements.
Key Takeaways
- NDC 16729-0435, Acalabrutinib, is a targeted hematologic malignancy therapy facing market competition from Ibrutinib and Zanubrutinib.
- Current list price is approximately $150,000 annually, with a projected annual decline of 2-3% over five years.
- Market penetration remains moderate due to competition, but expansion into additional indications and regions could sustain revenue growth.
- Regulatory and market developments, including biosimilar entry post-2032, could significantly impact pricing.
FAQs
Q1: When is patent expiry for Acalabrutinib?
A1: Patent protection is expected to last into the early 2030s, with US patent expiry around 2032.
Q2: How does Acalabrutinib differ from Ibrutinib?
A2: Acalabrutinib has increased selectivity for BTK, potentially leading to fewer off-target effects and side effects.
Q3: What are the primary healthcare payer considerations?
A3: Payors are assessing cost-effectiveness, especially given multiple BTK inhibitors available. Value-based agreements are increasingly common.
Q4: Are biosimilars likely to impact this drug soon?
A4: Biosimilars are unlikely before patent expiration; biologic off-patent competition may begin post-2032.
Q5: Which markets have approved Acalabrutinib beyond the US?
A5: Approval is in select regions including Europe, Japan, and Canada, with potential growth in Asia and Latin America.
References
- AstraZeneca. Calquence (Acalabrutinib) FDA Approval Documentation.
- American Cancer Society. "Cancer Statistics." 2022.
