Phyrago Patent Expiration

Phyrago is a drug owned by Handa Therapeutics Llc. It is protected by 6 US drug patents filed from 2023 to 2026 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 22, 2041. Details of Phyrago's patents and their expiration are given in the table below.

Patent strength
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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US12465606 Amorphous Solid Dispersions Of Dasatinib And Uses Thereof
Jan, 2041

(14 years from now)

Active
US11202778 Amorphous solid dispersions of dasatinib and uses thereof
Jan, 2041

(14 years from now)

Active
US11324745 Amorphous solid dispersions of dasatinib and uses thereof
Jan, 2041

(14 years from now)

Active
US11298356 Amorphous solid dispersions of dasatinib and uses thereof
Jan, 2041

(14 years from now)

Active
US12433891 Amorphous Solid Dispersions Of Dasatinib And Uses Thereof
Jan, 2041

(14 years from now)

Active
US12544376 Amorphous Solid Dispersions Of Dasatinib And Uses Thereof
Jan, 2041

(14 years from now)

Active


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 Phyrago's patents.

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

Activity Date Patent Number
Patent litigations
Recordation of Patent Grant Mailed 18 Nov, 2025 US12465606
Recordation of Patent eGrant 11 Nov, 2025 US12465606
Patent Issue Date Used in PTA Calculation 11 Nov, 2025 US12465606
Patent eGrant Notification 11 Nov, 2025 US12465606
Mail Patent eGrant Notification 11 Nov, 2025 US12465606
Email Notification 11 Nov, 2025 US12465606
Email Notification 30 Oct, 2025 US12465606
Issue Notification Mailed 29 Oct, 2025 US12465606
Application Is Considered Ready for Issue 17 Oct, 2025 US12465606
Dispatch to FDC 17 Oct, 2025 US12465606


FDA has granted several exclusivities to Phyrago. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Phyrago, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Phyrago.

Exclusivity Information

Phyrago holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Phyrago's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-307) Dec 05, 2026

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US patents provide insights into the exclusivity only within the United States, but Phyrago is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Phyrago's family patents as well as insights into ongoing legal events on those patents.

Phyrago's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Phyrago:

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




Generic Launch

Generic Release Date:

Phyrago's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 22, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Phyrago Generic API suppliers:

Dasatinib is the generic name for the brand Phyrago. 8 different companies have already filed for the generic of Phyrago, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Phyrago's generic

Alternative Brands for Phyrago

Phyrago which is used for treating Chronic Myeloid Leukemia (CML) and Acute Lymphoblastic Leukemia (ALL)., has several other brand drugs using the same active ingredient (Dasatinib). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Bristol Myers Squibb
Sprycel


Apart from brand drugs containing the same ingredient, some generics have also been filed for Dasatinib, Phyrago's active ingredient. Check the complete list of approved generic manufacturers for Phyrago





About Phyrago

Phyrago is a drug owned by Handa Therapeutics Llc. It is used for treating Chronic Myeloid Leukemia (CML) and Acute Lymphoblastic Leukemia (ALL). Phyrago uses Dasatinib as an active ingredient. Phyrago was launched by Handa in 2023.

Approval Date:

Phyrago was approved by FDA for market use on 05 December, 2023.

Active Ingredient:

Phyrago uses Dasatinib as the active ingredient. Check out other Drugs and Companies using Dasatinib ingredient

Treatment:

Phyrago is used for treating Chronic Myeloid Leukemia (CML) and Acute Lymphoblastic Leukemia (ALL).

Dosage:

Phyrago is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
20MG TABLET Prescription ORAL
100MG TABLET Prescription ORAL
140MG TABLET Prescription ORAL
50MG TABLET Prescription ORAL
70MG TABLET Prescription ORAL
80MG TABLET Prescription ORAL