Pirtobrutinib Patent Expiration

Pirtobrutinib is Used for treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy including a BTK inhibitor and a BCL-2 inhibitor. It was first introduced by Loxo Oncology Inc in its drug Jaypirca on Jan 27, 2023.


Pirtobrutinib Patents

Given below is the list of patents protecting Pirtobrutinib, 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
Jaypirca US12109193 Spray-dried dispersions, formulations, and polymorphs of (s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1H-pyrazole-4-carboxamide Sep 14, 2041 Loxo Oncol
Jaypirca US12268666 Spray-dried dispersions, formulations, and polymorphs of (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1H-pyrazole-4-carboxamide Jul 29, 2039 Loxo Oncol
Jaypirca US10342780 Compounds useful as kinase inhibitors Dec 16, 2036 Loxo Oncol
Jaypirca US10464905 Compounds useful as kinase inhibitors Dec 16, 2036 Loxo Oncol
Jaypirca US10695323 Compounds useful as kinase inhibitors Dec 16, 2036 Loxo Oncol
Jaypirca US10918622 Compounds useful as kinase inhibitors Dec 16, 2036 Loxo Oncol
Jaypirca US12220401 Compounds useful as kinase inhibitors Dec 16, 2036 Loxo Oncol



Pirtobrutinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Pirtobrutinib:

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
Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL H. Lee Moffitt Cancer Center and Research Institute NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia Eli Lilly and Company NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated With Pirtobrutinib After Previous Treatment With Zanubrutinib Peter MacCallum Cancer Centre, Australia NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma BeOne Medicines NA RECRUITING
(Sep 1, 2026)
PHASE3
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor National Heart, Lung, and Blood Institute (NHLBI) NA NOT YET RECRUITING
(Aug 25, 2026)
PHASE2
LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies Medical College of Wisconsin NA RECRUITING
(Aug 1, 2026)
PHASE1
ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL Newave Pharmaceutical Inc NA RECRUITING
(Aug 1, 2026)
PHASE3
Study of NX-5948 Versus Pirtobrutinib in R/R CLL/SLL Nurix Therapeutics, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE3
A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL). Beijing InnoCare Pharma Tech Co., Ltd. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Rituximab, Pirtobrutinib, Lisaftoclax and Liposomal Mitoxantrone for for Richter Syndrome Transformed From CLL Institute of Hematology & Blood Diseases Hospital, China NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Eli Lilly and Company NA COMPLETED
(Jul 1, 2026)
PHASE1
Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma University of California, San Francisco NA RECRUITING
(Jul 1, 2026)
PHASE2
Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). M.D. Anderson Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE2
Pirtobrutinib+Sonrotoclax(PS) Regimen in the Treatment of B-Cell Lymphoma Changzhou No.2 People's Hospital NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial University of Washington NA RECRUITING
(Jun 1, 2026)
PHASE2
A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL) Memorial Sloan Kettering Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE2
Lisaftoclax Plus Pirtobrutinib in Relapsed or Refractory Mantle Cell Lymphoma After BTK-Targeted Therapy Henan Cancer Hospital NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Loxo Oncology, Inc. NA RECRUITING
(May 1, 2026)
PHASE2
Pirtobrutinib Maintenance After CAR-T Therapy in Relapsed or Refractory B-Cell Lymphoma Sun Yat-sen University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients M.D. Anderson Cancer Center NA RECRUITING
(Apr 1, 2026)
PHASE2
Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT) M.D. Anderson Cancer Center NA RECRUITING
(Apr 1, 2026)
PHASE2
Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients M.D. Anderson Cancer Center NA RECRUITING
(Apr 1, 2026)
PHASE2
Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers Eli Lilly and Company NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Mosunetuzumab in Combination With Pirtobrutinib in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (MPOWER) University of Utah NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2


Pirtobrutinib Generic API Manufacturers

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