Zanubrutinib Patent Expiration

Zanubrutinib is used for treating adult patients with various types of lymphomas and leukemias who have not responded to prior therapies. It was first introduced by Beone Medicines Usa Inc in its drug Brukinsa on Nov 14, 2019.


Zanubrutinib Patents

Given below is the list of patents protecting Zanubrutinib, 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
Brukinsa US11786531 Methods of treating B-cell proliferative disorder Jan 19, 2043 Beone Medicines Usa
Brukinsa US11896596 Methods of treating B-cell proliferative disorder Jan 19, 2043 Beone Medicines Usa
Brukinsa US11911386 Methods of treating B-cell proliferative disorder Jan 19, 2043 Beone Medicines Usa
Brukinsa US12233069 Oral solid tablet comprising Bruton's Tyrosine Kinase inhibitor and preparation method therefor Jun 10, 2040 Beone Medicines Usa
Brukinsa US11701357 Treatment of B cell cancers using a combination comprising Btk inhibitors Jun 24, 2039 Beone Medicines Usa
Brukinsa US10927117 Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof Aug 15, 2037 Beone Medicines Usa
Brukinsa US11591340 Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof Aug 15, 2037 Beone Medicines Usa
Brukinsa US11851437 Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof Aug 15, 2037 Beone Medicines Usa
Brukinsa US11884674 Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof Aug 15, 2037 Beone Medicines Usa
Brukinsa US11970500 Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)- 2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof Aug 15, 2037 Beone Medicines Usa
Brukinsa US10570139 Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators Apr 22, 2034 Beone Medicines Usa
Brukinsa US11142528 Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators Apr 22, 2034 Beone Medicines Usa
Brukinsa US9447106 Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators Apr 22, 2034 Beone Medicines Usa



Zanubrutinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Zanubrutinib:

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
Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma Alliance for Clinical Trials in Oncology NA RECRUITING
(Sep 1, 2026)
PHASE3
Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma Alvaro Alencar, MD NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients Fondazione Italiana Linfomi - ETS NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies BeOne Medicines NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Zanubrutinib in Combination With Odronextamab for the Treatment of Patients With Richter's Transformation City of Hope Medical Center NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL) BeOne Medicines NA RECRUITING
(Sep 1, 2026)
PHASE3
Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL Alliance for Clinical Trials in Oncology NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib BeOne Medicines NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma Memorial Sloan Kettering Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE2
Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM Massachusetts General Hospital NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers. BeOne Medicines NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Zanubrutinib, Obinutuzumab, Sonrotoclax (BOSon) or BGB-16673, Obinutuzumab, Sonrotoclax (DOSon) in TN CLL/SLL Massachusetts General Hospital NA RECRUITING
(Aug 1, 2026)
PHASE2
Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy Canadian Cancer Trials Group NA RECRUITING
(Aug 1, 2026)
PHASE2
Zanubritnib and Anti-MAG Neuropathy Azienda Ospedaliera di Padova NA RECRUITING
(Aug 1, 2026)
PHASE2
Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients International Extranodal Lymphoma Study Group (IELSG) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma M.D. Anderson Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE2
A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia BeOne Medicines NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Testing Mosunetuzumab Alone, With Zanubrutinib, or With Polatuzumab Vedotin for Treating Marginal Zone Lymphoma That Came Back or Didn't Get Better With Treatment SWOG Cancer Research Network NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Study of Zanubrutinib in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) The Lymphoma Academic Research Organisation NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies BeOne Medicines NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1
A Study to Evaluate Zanubrutinib and Tislelizumab in Progressive Lymphoma Post CAR-T University Health Network, Toronto NA RECRUITING
(Jun 1, 2026)
PHASE2
Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma PETHEMA Foundation NA RECRUITING
(Jun 1, 2026)
PHASE2
A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies Curis, Inc. NA RECRUITING
(Jun 1, 2026)
PHASE2
Rituximab+ Zanubrutinib for Patients With Hairy Cell Leukemia and Hairy Cell Variant Bnai Zion Medical Center NA ENROLLING BY INVITATION
(Jun 1, 2026)
PHASE2
A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation BeOne Medicines NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Zanubrutinib and Rituximab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study City of Hope Medical Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Zanubrutinib Treatment in Patients With IgM Monoclonal Gammopathy and Antri-MAG Related Polyneuropathy UMC Utrecht NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
An Open Label Study of the Effects and Safety of Zanubrutinib in NMOSDs Adult Patients Xuanwu Hospital, Beijing NA TERMINATED
(Apr 1, 2026)
PHASE2
Tazemetostat in Combination With Zanubrutinib and Anti-CD20 Monoclonal Antibody in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma University of Utah NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma Fred Hutchinson Cancer Center NA RECRUITING
(Apr 1, 2026)
PHASE2
Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma City of Hope Medical Center NA RECRUITING
(Apr 1, 2026)
PHASE1
A Study to Investigate the Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332) in Healthy Adults BeOne Medicines NA COMPLETED
(Apr 1, 2026)
PHASE1
The Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined With Obinutuzumab in MCL Ruijin Hospital NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1
Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma Sun Yat-sen University NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib BeiGene NA COMPLETED
(Mar 1, 2026)
PHASE2


Zanubrutinib Generic API Manufacturers

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


Zanubrutinib News

Single-Page Overview" for Grasping Industrial Chains: Novel Pharmaceuticals and Licensing - 36氪

30 Sep, 2025

Silently Overcoming Cancer? Struggles with Prior Authorization; FDA's Generic Drug Division Continues to Operate

13 Jun, 2025

Glenmark receives DCGI approval to introduce Brukinsa, a blood cancer medication, in India.

09 Jun, 2025

BeiGene marks a significant profit achievement driven by rising pharmaceutical sales - Insights for global investors in Chinese stocks.

15 May, 2025

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