Myhibbin Patent Expiration

Myhibbin is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2024 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 16, 2039. Details of Myhibbin's patents and their expiration are given in the table below.

Patent strength
7
/ 10

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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).
US12226526 Mycophenolate oral suspension
Aug, 2039

(12 years from now)

Active
US12097285 Mycophenolate oral suspension
Aug, 2039

(12 years from now)

Active
US12194143 Mycophenolate oral suspension
Aug, 2039

(12 years from now)

Active
US11931455 Pharmaceutical suspension for oral dosage
Aug, 2039

(12 years from now)

Active
US12097284 Mycophenolate oral suspension
Aug, 2039

(12 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 Myhibbin's patents.

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

Activity Date Patent Number
Patent litigations
Mail Patent eGrant Notification 18 Feb, 2025 US12226526
Email Notification 18 Feb, 2025 US12226526
Patent eGrant Notification 18 Feb, 2025 US12226526
Recordation of Patent eGrant 18 Feb, 2025 US12226526
Patent Issue Date Used in PTA Calculation 18 Feb, 2025 US12226526
Recordation of Patent Grant Mailed 18 Feb, 2025 US12226526
Email Notification 29 Jan, 2025 US12226526
Issue Notification Mailed 29 Jan, 2025 US12226526
Patent Issue Date Used in PTA Calculation 14 Jan, 2025 US12194143
Recordation of Patent eGrant 14 Jan, 2025 US12194143

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US patents provide insights into the exclusivity only within the United States, but Myhibbin 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 Myhibbin's family patents as well as insights into ongoing legal events on those patents.

Myhibbin's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Myhibbin:

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
Immune Monitoring and CNI Withdrawal in Low Risk Recipients of Kidney Transplantation National Institute of Allergy and Infectious Diseases (NIAID) NA TERMINATED
(Sep 1, 2026)
PHASE2
Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML Heinrich-Heine University, Duesseldorf NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Advancing Transplantation Outcomes in Children National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Sep 1, 2026)
PHASE2
Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D) University of Chicago NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Mycophenolate Mofetil w/ Prednisone for Immune Related Hepatitis From Checkpoint Inhibitor Therapy Fox Chase Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE2
Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma Northwestern University NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Fludarabine and Total Body Irradiation 800 Centigray (cGy) or 1125 cGy For Allogeneic Stem Cell Transplant Using Graft Versus Host Disease Prophylaxis With Post-Transplant Cyclophosphamide and Tacrolimus, Without Mycophenolate Mofetil Ronald Paquette NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Tocilizumab in Lung Transplantation National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Aug 1, 2026)
PHASE2
Mycophenolate After Stem Cell Transplant for Systemic Sclerosis Ottawa Hospital Research Institute NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
A Trial to Explore the Efficacy and Safety of O-triple as Initial Therapy in the Active Lupus Nephritis Patients (INITIAL Trial) Zhao Minghui NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Belatacept in Heart Transplantation National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Jul 1, 2026)
PHASE2
Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs. Stephan Busque NA RECRUITING
(Jun 1, 2026)
PHASE1
TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation Stanford University NA RECRUITING
(Jun 1, 2026)
PHASE1
Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies University Hospital, Tours NA RECRUITING
(Jun 1, 2026)
PHASE3
Islet Transplantation With Recipient T-Reg Cells or Deceased Donor Vertebral Bone Marrow Therapy Stanford University NA ENROLLING BY INVITATION
(Jun 1, 2026)
PHASE1
Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure Nantes University Hospital NA RECRUITING
(Jun 1, 2026)
PHASE3
Testing the Addition of an Anti-Cancer Drug, Mycophenolate Mofetil, to the Usual Treatment (Radiation Therapy and Temozolomide) for Advanced Brain Cancer Alliance for Clinical Trials in Oncology NA NOT YET RECRUITING
(May 1, 2026)
PHASE2, PHASE3
Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney Transplantation University Hospital, Rouen NA TERMINATED
(Apr 1, 2026)
PHASE3
Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma University of Michigan Rogel Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Mar 1, 2026)
PHASE2
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) argenx NA RECRUITING
(Mar 1, 2026)
PHASE2




Generic Launch

Generic Release Date:

Myhibbin's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 16, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Myhibbin Generic API suppliers:

Mycophenolate Mofetil is the generic name for the brand Myhibbin. 24 different companies have already filed for the generic of Myhibbin, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Myhibbin's generic

Alternative Brands for Myhibbin

There are several other brand drugs in the same treatment category and using the same active ingredient (Mycophenolate Mofetil) as Myhibbin. 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 Treatment Area
Veloxis Pharms Inc
Envarsus Xr Used for preventing organ rejection in transplant patients.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Mycophenolate Mofetil. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Roche Palo
Cellcept


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





About Myhibbin

Myhibbin is a drug owned by Azurity Pharmaceuticals Inc. Myhibbin uses Mycophenolate Mofetil as an active ingredient. Myhibbin was launched by Azurity in 2024.

Approval Date:

Myhibbin was approved by FDA for market use on 01 May, 2024.

Active Ingredient:

Myhibbin uses Mycophenolate Mofetil as the active ingredient. Check out other Drugs and Companies using Mycophenolate Mofetil ingredient

Dosage:

Myhibbin is available in suspension form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
200MG/ML SUSPENSION Prescription ORAL