Prescription medicine
Acalabrutinib Brand names: Calquence
Acalabrutinib (Calquence) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the acalabrutinib FDA label on DailyMed (effective February 19, 2026, AstraZeneca Pharmaceuticals LP); the NDA 210259 record on Drugs@FDA; every acalabrutinib label on DailyMed.
Highlights of the record
FDA label of February 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCALQUENCE is a kinase inhibitor indicated:
In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).
Forms and strengths
- 100 mg
Film-coated tablet; gelatin-coated capsule.
On the market
- Earliest approval on file
- October 31, 2017 Calquence, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 1, 2036 Calquence tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 12,049 through July 30, 2026
What is acalabrutinib used for?
From the label: indications and usageCALQUENCE is a kinase inhibitor indicated:
In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). (1.1 )
For the treatment of adult patients with MCL who have received at least one prior therapy. ( 1.2 )
For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). […]
Conditions named in the indications of acalabrutinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (CALQUENCE), AstraZeneca Pharmaceuticals LP, effective February 19, 2026 (SPL set b1409184-3267-4d8c-8f17-4e01f69828b1), via openFDA; the full label on DailyMed
Is there a generic for acalabrutinib (Calquence)?
No generic acalabrutinib is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 8 patents for Calquence tablets: the compound patent runs to July 1, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the acalabrutinib label say about other medicines?
The acalabrutinib label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name acalabrutinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Calcium carbonate | drug interactions | If treatment with a gastric acid reducing agent is required, consider using a H2‑receptor antagonist (e.g., ranitidine or famotidine) or an antacid (e.g., calcium carbonate). |
| Famotidine | drug interactions | If treatment with a gastric acid reducing agent is required, consider using a H2‑receptor antagonist (e.g., ranitidine or famotidine) or an antacid (e.g., calcium carbonate). |
| Itraconazole | drug interactions | Co-administration of CALQUENCE with a strong CYP3A inhibitor (itraconazole) increased acalabrutinib plasma concentrations [see Clinical Pharmacology (12.3) ]. |
| Obinutuzumab | warnings and precautions | Grade 3 or 4 cytopenias included absolute neutrophil count decreased (28%), absolute lymphocyte count decreased (10%), hemoglobin decreased (9%), and platelets decreased (9%) in 1,758 patients treated with CALQUENCE alone and in combination with obinutuzumab or venetoclax; |
| Ranitidine | drug interactions | If treatment with a gastric acid reducing agent is required, consider using a H2‑receptor antagonist (e.g., ranitidine or famotidine) or an antacid (e.g., calcium carbonate). |
| Rifampin | drug interactions | Co-administration of CALQUENCE with a strong CYP3A inducer (rifampin) decreased acalabrutinib plasma concentrations [see Clinical Pharmacology (12.3) ]. |
| Venetoclax | warnings and precautions | Grade 3 or 4 cytopenias included absolute neutrophil count decreased (28%), absolute lymphocyte count decreased (10%), hemoglobin decreased (9%), and platelets decreased (9%) in 1,758 patients treated with CALQUENCE alone and in combination with obinutuzumab or venetoclax; |
Source: FDA drug label (CALQUENCE), AstraZeneca Pharmaceuticals LP, effective February 19, 2026 (SPL set b1409184-3267-4d8c-8f17-4e01f69828b1), via openFDA; the full label on DailyMed
What do FAERS reports show for acalabrutinib?
The FDA Adverse Event Reporting System holds 12,049 reports that list acalabrutinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,592 are coded as a death and 3,233 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2024 (2,719, against a median of 588 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as acalabrutinib?
37 other medicines are given the same way (oral) and in the same FDA class as acalabrutinib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Bosutinib | Leukemia, lymphoma and myeloma | 3 labelers | n/a | No current entry |
| Ibrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Ponatinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Pirtobrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Quizartinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as acalabrutinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to acalabrutinib
- 37 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Acalabrutinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other