Acalabrutinib Patent Expiration

Acalabrutinib is used for treating adult patients with various types of leukemia and lymphoma. It was first introduced by Astrazeneca Uk Ltd in its drug Calquence on Oct 31, 2017.


Acalabrutinib Patents

Given below is the list of patents protecting Acalabrutinib, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Calquence US10167291 Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide Jul 01, 2036 Astrazeneca
Calquence US9796721 Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide Jul 01, 2036 Astrazeneca
Calquence US11166951 Therapeutic Combinations Of A Btk Inhibitor, A Pi3K Inhibitor, A Jak-2 Inhibitor, And/Or A Bcl-2 Inhibitor Aug 11, 2035 Astrazeneca
Calquence US10272083 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Jan 21, 2035 Astrazeneca
Calquence US11771696 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Jan 21, 2035 Astrazeneca
Calquence US10239883 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors Jul 11, 2032 Astrazeneca
Calquence US9290504 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as Btk inhibitors Jul 11, 2032 Astrazeneca
Calquence US9758524 4-imidazopyridazin-1-yl-benzamides as Btk inhibitors Jul 11, 2032 Astrazeneca
Calquence US7459554 Imidazopyrazine tyrosine kinase inhibitors Nov 24, 2026 Astrazeneca



Acalabrutinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Acalabrutinib:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma National Cancer Institute (NCI) NA RECRUITING
(Sep 9, 2026)
PHASE2
An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia Acerta Pharma BV NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia AstraZeneca NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma ECOG-ACRIN Cancer Research Group NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Acalabrutinib and Durvalumab in Primary and Secondary Central Nervous System Lymphoma Washington University School of Medicine NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
REtreatment With VEnetoclax and Acalabrutinib After Venetoclax Limited Duration (REVEAL) Stichting Hemato-Oncologie voor Volwassenen Nederland NA RECRUITING
(Sep 1, 2026)
PHASE2
Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) Loxo Oncology, Inc. NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Rituximab, Acalabrutinib, and Durvalumab (RAD) in Primary CNS Lymphoma. National Health Research Institutes, Taiwan NA COMPLETED
(Sep 1, 2026)
PHASE1
Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia BeOne Medicines NA RECRUITING
(Sep 1, 2026)
PHASE3
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma Acerta Pharma BV NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL Acerta Pharma BV NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL) Acerta Pharma BV NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Trial of CHOP-R Therapy, With or Without Acalabrutinib, in Patients With Newly Diagnosed Richter's Syndrome University of Birmingham NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients AstraZeneca NA COMPLETED
(Aug 1, 2026)
PHASE3
Acalabrutinib, Lenalidomide, and Rituximab for the Treatment of CD20 Positive Stage III-IV, Grade 1-3a Follicular Lymphoma M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Acalabrutinib and Rituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL German CLL Study Group NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Pacritinib in Combination With a BTK Inhibitor for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma City of Hope Medical Center NA RECRUITING
(Aug 1, 2026)
PHASE1
Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab AstraZeneca NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain AstraZeneca NA RECRUITING
(Aug 1, 2026)
PHASE2
Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL Acerta Pharma BV NA COMPLETED
(Jul 1, 2026)
PHASE2
A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL Acerta Pharma BV NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL Acerta Pharma BV NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Acerta Pharma BV NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma M.D. Anderson Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE2
A Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL. Ascentage Pharma Group Inc. NA RECRUITING
(Jul 1, 2026)
PHASE3
Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma Acerta Pharma BV NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) Acerta Pharma BV NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma University Health Network, Toronto NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma Academic and Community Cancer Research United NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma City of Hope Medical Center NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Acalabrutinib in CNSL Dana-Farber Cancer Institute NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Pirtobrutinib for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia Jennifer Woyach NA RECRUITING
(Jun 1, 2026)
PHASE2
ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia Acerta Pharma BV NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1, PHASE2
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL Acerta Pharma BV NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma University of Washington NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1, PHASE2
A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas UNC Lineberger Comprehensive Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial Fred Hutchinson Cancer Center NA RECRUITING
(May 1, 2026)
PHASE2
Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study M.D. Anderson Cancer Center NA RECRUITING
(May 1, 2026)
PHASE2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma City of Hope Medical Center NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Acalabrutinib Maleate and Bortezomib for Patients With HLA Antibodies The First Affiliated Hospital of Soochow University NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies Acerta Pharma BV NA COMPLETED
(Apr 1, 2026)
PHASE1, PHASE2
Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL Weill Medical College of Cornell University NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies AstraZeneca NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Acalabrutinib in Combination With R-CHOP for Previously Untreated Diffuse Large B-cell Lymphoma (DLBCL) University Hospital Southampton NHS Foundation Trust NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL Massachusetts General Hospital NA RECRUITING
(Apr 1, 2026)
PHASE2
Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia City of Hope Medical Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL) AbbVie NA RECRUITING
(Apr 1, 2026)
PHASE3
A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM) Acerta Pharma BV NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy Acerta Pharma BV NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma Washington University School of Medicine NA COMPLETED
(Mar 1, 2026)
PHASE2
Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma University College, London NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma Jonsson Comprehensive Cancer Center NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Mayo Clinic NA RECRUITING
(Mar 1, 2026)
PHASE2


Acalabrutinib Generic API Manufacturers

Given below is the list of companies who have filed for Acalabrutinib generic, along with the locations of their manufacturing plants worldwide.