Help paying · Medicare negotiated price · pharmacy cost · cycle 2027
Calquence (acalabrutinib): where help paying exists, what Medicare negotiated and what pharmacies pay
Medicare's negotiated price for a 30-day supply is $8,600 on January 1, 2027. 1 non-manufacturing label change is dated in the last 12 months in the FDA's file. ClinicalTrials.gov lists 37 recruiting trials that name acalabrutinib.
Every package we can price
Per-unit prices (per unit, as the files state). "Scheduled" is a price the CMS file already dates for the future.
| NDC | Product | Unit | Negotiated now | Scheduled | NADAC | Share |
|---|---|---|---|---|---|---|
| 00310-0512-60 | CALQUENCE 100MG 60CT | n/a | n/a | $155 | n/a | no NADAC price |
| 00310-3512-60 | CALQUENCE TAB 100MG BT 1X60 EA US | n/a | n/a | $155 | n/a | no NADAC price |
When could a generic arrive
Each date below is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
| Application | Product | Latest listed patent expiry | Latest listed exclusivity expiry | Latest of the two | Set by |
|---|---|---|---|---|---|
| NDA216387 | Calquence Tab 100mg Bt 1x60 Ea Us | July 1, 2036 | February 19, 2029 | July 1, 2036 | patent 11059829; 10 dated entries listed |
Source: FDA Orange Book data files, edition September 2026, read November 7, 2026; patent listings are as submitted by applicants and not verified by FDA. FDA data file.
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Calquence of $1.70 billion in 2024, across 122,356 claims and 15,056 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
| Year | Gross spending | Claims | Beneficiaries | Average spending per claim |
|---|---|---|---|---|
| 2024 | $1.70 billion | 122,356 | 15,056 | $13,910 |
| 2023 | $1.29 billion | 89,978 | 12,390 | $14,301 |
| 2022 | $164.38 million | 11,685 | 5,519 | $14,067 |
Source: CMS Medicare Part D spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. All manufacturers combined; the figures are a drug-level aggregate of claims and say nothing about a formulary or coverage.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 6 designations for acalabrutinib, 5 with an approval recorded. A designation is not an approval and not a statement that the drug treats the condition; the status column is the database's own.
| Designated | Designated use | Status | Sponsor |
|---|---|---|---|
| October 22, 2015 | Treatment of Waldenstrom macroglobulinemia. | Designated | Acerta Pharma, LLC (a member of the AstraZeneca Group) |
| September 21, 2015 | Treatment of mantle cell lymphoma. | Designated/Approved | Acerta Pharma, LLC (a member of the AstraZeneca Group) |
| September 21, 2015 | Treatment of mantle cell lymphoma. | Designated/Approved | Acerta Pharma, LLC (a member of the AstraZeneca Group) |
| September 21, 2015 | Treatment of mantle cell lymphoma. | Designated/Approved | Acerta Pharma, LLC (a member of the AstraZeneca Group) |
| May 13, 2015 | Treatment of chronic lymphocytic leukemia (CLL). | Designated/Approved | Acerta Pharma, LLC (a member of the AstraZeneca Group) |
| May 13, 2015 | Treatment of chronic lymphocytic leukemia (CLL). | Designated/Approved | Acerta Pharma, LLC (a member of the AstraZeneca Group) |
Source: FDA Orphan Drug Designations and Approvals database, read November 7, 2026. FDA orphan drug search.
Medicaid use by state
CMS's State Drug Utilization Data records, for 2025, how many prescriptions each state's Medicaid program paid for under this drug's packages and what it reimbursed. The 3 states with the largest reimbursement are shown. Reimbursement is before the rebates manufacturers pay states, so it is not a net cost and not a price a patient pays.
| State | Medicaid-paid prescriptions | Medicaid reimbursed | Covers |
|---|---|---|---|
| KY | 96 | $1,393,440 | All record types |
| MN | 93 | $1,195,936 | Fee-for-service only |
| LA | 75 | $1,137,441 | All record types |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (1 state and package figure is marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 24 older-year figures are held and left out of the table.
Source: CMS State Drug Utilization Data (State Drug Utilization Data 2025, modified 2026-07-13T15:28:32Z), read November 7, 2026. CMS dataset page. State-reported data compiled by CMS; aggregate by state and package, no provider or patient data.
Where help paying exists
No program in our finder currently lists this drug as open to new patients.
Label changes
FDA actions on the applications behind Calquence dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| February 19, 2026 | Efficacy | NDA216387 | 6 | Label (PDF) posted February 24, 2026FDA letter posted February 23, 2026 |
Source: FDA Drugs@FDA data file, read November 7, 2026. Dates are the FDA action dates; the documents are on FDA's own site. FDA data file. All recent changes across these drugs: label changes feed.
Clinical trials recruiting
ClinicalTrials.gov lists 37 interventional trials that name acalabrutinib and are recruiting, and 4 more not yet recruiting. By phase: Phase 2: 19, Phase 3: 7, PHASE1/PHASE2: 6, Phase 1: 2, Phase 4: 1, Not applicable: 1, PHASE2/PHASE3: 1. The 10 most recently updated are below. A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.
| Trial | Title and conditions | Phase | Lead sponsor | Last updated | Countries |
|---|---|---|---|---|---|
| NCT07582159 | Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaChronic Lymphocytic Leukemia; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Small Lymphocytic Lymphoma | Phase 2 | City of Hope Medical Center | November 6, 2026 | United States |
| NCT06054776 | Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell LymphomaMantle Cell Lymphoma | Phase 2 | City of Hope Medical Center | November 3, 2026 | United States |
| NCT04404088 | Acalabrutinib, Lenalidomide, and Rituximab for the Treatment of CD20 Positive Stage III-IV, Grade 1-3a Follicular LymphomaAnn Arbor Stage III Grade 1 Follicular Lymphoma; Ann Arbor Stage III Grade 2 Follicular Lymphoma; Ann Arbor Stage III Grade 3 Follicular Lymphoma | Phase 2 | M.D. Anderson Cancer Center | November 2, 2026 | United States |
| NCT05952024 | Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCLDiffuse Large B-Cell Lymphoma | Phase 2 | AstraZeneca | October 30, 2026 | United States, Brazil, Puerto Rico and 2 more |
| NCT06520098 | A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma | Phase 2 | VA Office of Research and Development | October 30, 2026 | United States |
| NCT06564038 | A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell MalignanciesChronic Lymphocytic Leukaemia; Small Lymphocytic Lymphoma; Mantle-cell Lymphoma | Phase 1 / Phase 2 | AstraZeneca | October 28, 2026 | United States, Australia, China and 7 more |
| NCT07029737 | A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in SpainMantle-cell Lymphoma | Phase 2 | AstraZeneca | October 27, 2026 | Spain |
| NCT04002947 | Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell LymphomaNon-Hodgkin's Lymphoma; Diffuse Large B-Cell Lymphoma; DLBCL | Phase 2 | National Cancer Institute (NCI) | October 26, 2026 | United States |
| NCT03516617 | Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaChronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma | Phase 2 | Mayo Clinic | October 26, 2026 | United States |
| NCT04941716 | Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 TrialRecurrent Chronic Lymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia | Phase 2 | Fred Hutchinson Cancer Center | October 23, 2026 | United States |
Source: ClinicalTrials.gov, registry data processed November 6, 2026, summarized and trimmed by OmniRx. Search on ClinicalTrials.gov.
Questions
What is the Medicare negotiated price of Calquence?
The CMS file publishes $8,600 from January 1, 2027. This is a price CMS agreed with the manufacturer for Medicare Part D, not what a person pays at the counter.
How does the negotiated price compare with what pharmacies pay?
The two CMS files do not give a comparable per-unit price for this drug.
Is there help paying for Calquence?
No program in our finder lists this drug yet.
When could a generic version of Calquence arrive?
For Calquence, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA216387, July 1, 2036. Each date is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
Can I join a clinical trial for Calquence?
ClinicalTrials.gov lists 37 recruiting interventional trials that name acalabrutinib (registry data processed November 6, 2026). A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.
How much does Medicare Part D spend on Calquence?
CMS's Medicare Part D spending dataset reports gross spending on Calquence of $1.70 billion in 2024, across 122,356 claims and 15,056 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
For developers: this drug as data
One call returns price, generic-entry upper bound, label history, recalls, trials, assistance, and where facts exist the FDA safety program (REMS), DEA schedule, orphan designations, safety notices and Medicaid use by state, each with receipts.
Example file: https://omnirx.org/api/v1/dossier/calquence.json
The licence page sets out what a data licence covers, and the API page documents these files.
Evaluation files with receipts; contract may change; not clinical advice.
Sources and terms. CMS Medicare Drug Price Negotiation Program data file (read November 6, 2026; the CMS page states no licence or restriction); CMS NADAC from data.medicaid.gov under the labels in the OmniRx licence ledger; program details read from each program's own pages; CMS Medicare Part D spending by drug; FDA Drugs@FDA and Orange Book data files; ClinicalTrials.gov registry data. Figures are stored with their sources in the OmniRx library (edition 2026-11). Free to cite with attribution. Not medical, legal or financial advice. Report an error through the contact page. Licence the data.