Dasatinib Patent Expiration

Dasatinib is Used for treating protein tyrosine kinase-associated disorders and various types of cancer, including chronic myelogenous leukemia. It was first introduced by Bristol Myers Squibb Co in its drug Sprycel on Jun 28, 2006. Another drug containing Dasatinib is Phyrago. 10 different companies have introduced drugs containing Dasatinib.


Dasatinib Patents

Given below is the list of patents protecting Dasatinib, 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
Phyrago US11202778 Amorphous solid dispersions of dasatinib and uses thereof Jan 22, 2041 Handa Therap
Phyrago US11298356 Amorphous solid dispersions of dasatinib and uses thereof Jan 22, 2041 Handa Therap
Phyrago US11324745 Amorphous solid dispersions of dasatinib and uses thereof Jan 22, 2041 Handa Therap
Phyrago US12433891 Amorphous Solid Dispersions Of Dasatinib And Uses Thereof Jan 22, 2041 Handa Therap
Phyrago US12465606 Amorphous Solid Dispersions Of Dasatinib And Uses Thereof Jan 22, 2041 Handa Therap
Phyrago US12544376 Amorphous Solid Dispersions Of Dasatinib And Uses Thereof Jan 22, 2041 Handa Therap
Sprycel US7491725

(Pediatric)

Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors Sep 28, 2026

(Expired)

Bristol Myers Squibb
Sprycel US7491725 Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors Mar 28, 2026

(Expired)

Bristol Myers Squibb
Sprycel US8680103

(Pediatric)

Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors Aug 04, 2025

(Expired)

Bristol Myers Squibb
Sprycel US8680103 Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors Feb 04, 2025

(Expired)

Bristol Myers Squibb
Sprycel US6596746

(Pediatric)

Cyclic protein tyrosine kinase inhibitors Dec 28, 2020

(Expired)

Bristol Myers Squibb
Sprycel US7153856

(Pediatric)

Cyclic protein tyrosine kinase inhibitors Oct 28, 2020

(Expired)

Bristol Myers Squibb
Sprycel US7125875

(Pediatric)

Cyclic protein tyrosine kinase inhibitors Oct 13, 2020

(Expired)

Bristol Myers Squibb
Sprycel US6596746 Cyclic protein tyrosine kinase inhibitors Jun 28, 2020

(Expired)

Bristol Myers Squibb
Sprycel US7153856 Cyclic protein tyrosine kinase inhibitors Apr 28, 2020

(Expired)

Bristol Myers Squibb
Sprycel US7125875 Cyclic protein tyrosine kinase inhibitors Apr 13, 2020

(Expired)

Bristol Myers Squibb



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Dasatinib's patents.

Given below is the list recent legal activities going on the following patents of Dasatinib.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 06 Aug, 2020 US7491725
Payment of Maintenance Fee, 12th Year, Large Entity 14 Jun, 2018 US7153856(Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 12 Apr, 2018 US7125875
Post Issue Communication - Certificate of Correction 22 Nov, 2011 US7491725
Email Notification 03 Aug, 2010 US7491725
Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Allowance 28 Jul, 2010 US7491725
Record a Petition Decision of Granted for Patent Term Adjustment after Allowance 27 Jul, 2010 US7491725
Adjustment of PTA Calculation by PTO 27 Jul, 2010 US7491725
Court Processing Terminated 23 Jun, 2010 US7491725
Decision in Civil Action - Dismissed by Court 23 Jun, 2010 US7491725


Dasatinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Dasatinib:

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
Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE2
Dasatinib and Venetoclax in Treating Patients With Philadelphia Chromosome Positive or BCR-ABL1 Positive Early Chronic Phase Chronic Myelogenous Leukemia M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease ECOG-ACRIN Cancer Research Group NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Improving Physical Ability and Cellular Senescence Elimination in HIV National Institute of Allergy and Infectious Diseases (NIAID) NA COMPLETED
(Sep 1, 2026)
PHASE2
Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Frontline Asciminib Combination in Chronic Phase CML University of Jena NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation Medical College of Wisconsin NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Adding Asciminib to Usual Treatment for Adults With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia SWOG Cancer Research Network NA ENROLLING BY INVITATION
(Aug 1, 2026)
PHASE2
Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study Washington University School of Medicine NA COMPLETED
(Aug 1, 2026)
PHASE2
Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE2
Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL+ B-ALL University of Alberta NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Dasatinib for HIV-1 Reservoir Reduction National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Aug 1, 2026)
PHASE1
Asciminib Frontline Risk Adapted Prof. Dr. med. Andreas Hochhaus NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy) Versailles Hospital NA COMPLETED
(Jul 1, 2026)
PHASE2
Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
ALSENLITE: Senolytics for Alzheimer's Disease Mayo Clinic NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase University of Alabama at Birmingham NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection Eva Bonfill NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO) University of Chicago NA RECRUITING
(Jun 1, 2026)
PHASE2
Senescence in Chronic Kidney Disease Mayo Clinic NA ENROLLING BY INVITATION
(May 1, 2026)
PHASE2
Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia OHSU Knight Cancer Institute NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
COAST Therapy in Advanced Solid Tumors and Prostate Cancer Medical University of South Carolina NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Senolytics to Improve Osteoporosis Therapy Odense University Hospital NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
An Open-Label Intervention Trial to Reduce Senescence and Improve Frailty in Adult Survivors of Childhood Cancer St. Jude Children's Research Hospital NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders Washington University School of Medicine NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML The University of Hong Kong NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2


Dasatinib Generic API Manufacturers

Several generic applications have been filed for Dasatinib. The first generic version for Dasatinib was by Apotex Inc and was approved on Jun 10, 2016. And the latest generic version is by Alembic Pharmaceuticals Ltd and was approved on Nov 6, 2025.

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


Dasatinib News

Xspray Pharma enters into licensing deal with Handa Therapeutics, potentially earning up to twice...

12 Aug, 2025

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