Last updated: February 28, 2026
What is NDC 50228-0465?
NDC 50228-0465 corresponds to the drug Acalabrutinib, marketed as Calquence. It is a Bruton's tyrosine kinase (BTK) inhibitor approved for treating certain blood cancers, including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). Its first approval was by the FDA in 2019.
Market Size and Demographics
Current Market Volume and Revenue
| Parameter |
Data |
| Total worldwide sales (2022) |
Estimated at $1.2 billion [1] |
| U.S. sales (2022) |
Approximately $950 million [2] |
| Patient population (U.S.) |
Estimated at 15,000 patients with MCL and CLL eligible for treatment [3] |
| Market penetration (2023) |
60–70% among eligible patients based on insurance and physician adoption rates |
Market Drivers
- Increasing incidence of CLL and MCL globally.
- Expansion of indications including relapsed/refractory settings.
- Growing adoption due to oral administration and improved safety profile versus chemotherapies.
- Introduction of next-generation BTK inhibitors targeting similar indications.
Competitive Landscape
| Competitors |
Description |
Market share (2022) |
| Ibrutinib (Imbruvica) |
First-mover BTK inhibitor, generic versions available |
55% |
| Acalabrutinib (Calquence) |
Second-generation, fewer off-target effects |
35% |
| Zanubrutinib (Brukinsa) |
Approved in similar indications |
8% |
| Other emerging agents |
Non-BTK targeted therapies, pipeline drugs |
2% |
Pricing and Cost Analysis
Current Wholesale Acquisition Cost (WAC)
- Calquence (oral): Approximate $10,200 per month per 140 mg capsule [2].
Reimbursement Dynamics
- Covered largely under Medicare, Medicaid, and commercial insurance.
- Patient out-of-pocket costs vary but range from $50 to $300 per month depending on insurance coverage.
- Average treatment duration: 12-24 months [4].
Manufacturer Pricing Strategy
- Pricing maintained stable since launch.
- Offers patient assistance programs reducing out-of-pocket expenses.
- Potential for price increases aligned with inflation, R&D investments, or new indications.
Price Projections (2023-2028)
| Year |
Estimated Global Sales |
Price Adjustment |
Notes |
| 2023 |
$1.2 billion |
0–3% |
Market mature, slight inflation adjustments |
| 2024 |
$1.25 billion |
0–3% |
Market expansion, increased adoption |
| 2025 |
$1.3 billion |
0–3% |
Entry of competitor drugs into the market |
| 2026 |
$1.35 billion |
0–4% |
Patent protection continues, stable pricing |
| 2027 |
$1.4 billion |
0–4% |
Possible biosimilar entry for label drugs in the US |
| 2028 |
$1.45 billion |
0–4% |
Patent cliff approaches; price stabilization strategies |
Note: These projections assume continued market penetration, no major price reductions, and no new competing therapies displacing Calquence.
Regulatory and Patent Timeline
- Patent expiration anticipated in late 2029 in the US.
- No significant generic or biosimilar competition expected until after patent expiry.
- Ongoing clinical trials may extend the drug’s patent life through new indications.
Policy and Market Risks
- Increased pressure for drug price regulation could influence pricing strategies.
- Patent challenges and biosimilar development might erode market share.
- Emergence of alternative therapies, such as CAR-T cells and other targeted agents.
Key Takeaways
- Calquence's current global sales stand at approximately $1.2 billion, primarily driven by the US market.
- The pricing remains stable around $10,200 per month per patient.
- Market growth is expected to be modest, at 3–4% annually, influenced by competitive dynamics and patent protections.
- Biosimilar and generic entries are likely post-2029, potentially reducing drug prices.
- The drug’s market will depend on the success of pipeline transitions, new approvals, and regulatory developments.
FAQs
Q1: How is the market for NDC 50228-0465 expected to evolve beyond 2028?
Market share could diminish with generic entries, and revenues may decline unless new indications extend patent protections or drive increased uptake.
Q2: Are there significant upcoming patents or exclusivity extensions?
Patent expiration in 2029 is anticipated; however, regulatory data exclusivity and potential new indications may offer additional market protection.
Q3: What are the primary factors impacting the drug’s pricing?
Market competition, regulatory policies, inflation, and pipeline development influence pricing stability and adjustments.
Q4: How does the competition from Ibrutinib and Zanubrutinib affect Calquence?
These drugs share similar indications and market segments; market share distribution depends on efficacy profiles, side effects, and clinician preferences.
Q5: What is the outlook for biosimilar or generic versions of Calquence?
Following patent expiry in late 2029, biosimilar development may start, potentially reducing costs and impacting revenues.
References
[1] IQVIA. (2022). Biopharma Revenue Data.
[2] GoodRx. (2023). Calquence (Acalabrutinib) Cost.
[3] U.S. Food and Drug Administration. (2019). Calquence approval notice.
[4] MarketWatch. (2023). BTK inhibitor market report.
Note: These figures are projections based on current market data and trends as of 2023; actual future conditions may vary.
