Mycophenolate Mofetil Patent Expiration

Mycophenolate Mofetil was first introduced by Roche Palo Alto Llc in its drug Cellcept on May 3, 1995. Another drug containing Mycophenolate Mofetil is Myhibbin. 27 different companies have introduced drugs containing Mycophenolate Mofetil.


Mycophenolate Mofetil Patents

Given below is the list of patents protecting Mycophenolate Mofetil, 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
Myhibbin US11931455 Pharmaceutical suspension for oral dosage Aug 16, 2039 Azurity
Myhibbin US12097284 Mycophenolate oral suspension Aug 16, 2039 Azurity
Myhibbin US12097285 Mycophenolate oral suspension Aug 16, 2039 Azurity
Myhibbin US12194143 Mycophenolate oral suspension Aug 16, 2039 Azurity
Myhibbin US12226526 Mycophenolate oral suspension Aug 16, 2039 Azurity
Cellcept US5688529 Mycophenolate mofetil high dose oral suspensions Nov 18, 2014

(Expired)

Roche Palo



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Clinical Trials

Recent Clinical Trials on Mycophenolate Mofetil:

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


Mycophenolate Mofetil Generic API Manufacturers

Several generic applications have been filed for Mycophenolate Mofetil. The first generic version for Mycophenolate Mofetil was by Hikma Pharmaceuticals Usa Inc and was approved on Jul 29, 2008. And the latest generic version is by Neocubes Pharma Llp and was approved on Jun 1, 2026.

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