Tacrolimus Patent Expiration

Tacrolimus is Used for preventing organ rejection in transplant patients. It was first introduced by Astellas Pharma Us Inc in its drug Prograf on Apr 8, 1994. Other drugs containing Tacrolimus are Astagraf Xl, Envarsus Xr, Protopic. 21 different companies have introduced drugs containing Tacrolimus.


Tacrolimus Patents

Given below is the list of patents protecting Tacrolimus, 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
Envarsus Xr US8644239 Method and apparatus for allocating and processing sequences in communication system Aug 30, 2028 Veloxis Pharms Inc
Envarsus Xr US8664239 Tacrolimus for improved treatment of transplant patients Aug 30, 2028 Veloxis Pharms Inc
Envarsus Xr US8685998 Tacrolimus for improved treatment of transplant patients Aug 30, 2028 Veloxis Pharms Inc
Envarsus Xr US10166190 Stabilized tacrolimus composition May 30, 2028 Veloxis Pharms Inc
Envarsus Xr US10864199 Tacrolimus for improved treatment of transplant patients May 30, 2028 Veloxis Pharms Inc
Envarsus Xr US11110081 Tacrolimus for improved treatment of transplant patients May 30, 2028 Veloxis Pharms Inc
Envarsus Xr US11123331 Tacrolimus for improved treatment of transplant patients May 30, 2028 Veloxis Pharms Inc
Envarsus Xr US11419823 Stabilized tacrolimus composition May 30, 2028 Veloxis Pharms Inc
Envarsus Xr US12083103 Tacrolimus for improved treatment of transplant patients May 30, 2028 Veloxis Pharms Inc
Envarsus Xr US12403095 Stabilized Tacrolimus Composition May 30, 2028 Veloxis Pharms Inc
Envarsus Xr US9549918 Stabilized tacrolimus composition May 30, 2028 Veloxis Pharms Inc
Envarsus Xr US10548880 Solid dispersions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US11077096 Modified release compositions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US7994214 Solid dispersions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US8486993 Solid dispersions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US8586084 Modified release compositions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US8591946 Modified release compositions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US8617599 Modified release compositions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US8623410 Modified release compositions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US8623411 Modified release compositions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US8889185 Modified release compositions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US8889186 Modified release compositions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US9161907 Modified release compositions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US9757362 Modified release compositions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Envarsus Xr US9763920 Solid dispersions comprising tacrolimus Aug 30, 2024

(Expired)

Veloxis Pharms Inc
Astagraf Xl US6440458 Sustained release preparations Mar 25, 2019

(Expired)

Astellas
Astagraf Xl US6576259 Sustained release formulations containing tacrolimus Mar 25, 2019

(Expired)

Astellas
Astagraf Xl US6884433 Sustained release formulation containing tacrolimus Mar 25, 2019

(Expired)

Astellas
Astagraf Xl US8551522 Sustained-release formulation Mar 25, 2019

(Expired)

Astellas
Protopic US5665727 Use of 11,28-dioxa-4-azatricyclo[22.3.1.04,9 ]octacos-18-ene derivatives and pharmaceutical compositions containing them Sep 09, 2014

(Expired)

Leo Pharma As



Tacrolimus's Family Patents

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Clinical Trials

Recent Clinical Trials on Tacrolimus:

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
A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy BeOne Medicines NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN) Vertex Pharmaceuticals Incorporated NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation Sanofi NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Sep 1, 2026)
PHASE2
Phase 3 Randomized Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation Eledon Pharmaceuticals NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Human Craniomaxillofacial Allotransplantation Johns Hopkins University NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration Astellas Institute for Regenerative Medicine NA RECRUITING
(Aug 1, 2026)
PHASE1
BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR) Sanofi NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN) Biogen NA RECRUITING
(Aug 1, 2026)
PHASE3
VEL-101 to Prevent Rejection After Kidney Transplantation Veloxis Pharmaceuticals NA RECRUITING
(Aug 1, 2026)
PHASE2
Human Penile Allotransplantation Johns Hopkins University NA RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation Eledon Pharmaceuticals NA COMPLETED
(Jul 1, 2026)
PHASE2
Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Orca Biosystems, Inc. NA RECRUITING
(Jul 1, 2026)
PHASE2
CC-101 (f/k/a NR1) Neural Stem Cell Transplantation for Adults With Chronic Ischemic Stroke Clarion Cells, Inc. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Everolimus bAsed caLcineurin inhibiTor frEe immunosuppRession oNe Year AfTer lIver transplantatiON (ALTERNATION) Hannover Medical School NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf® Astellas Pharma Europe Ltd. NA COMPLETED
(Jun 1, 2026)
PHASE2
Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R) University Hospital, Rouen NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT Stanford University NA RECRUITING
(Jun 1, 2026)
PHASE1
Human Upper Extremity Allotransplantation Johns Hopkins University NA RECRUITING
(May 1, 2026)
PHASE2
A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations VIVUS LLC NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor Jeffrey Veale, MD NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients University of Wisconsin, Madison NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
A Study of TCD601 in de Novo Renal Transplant Recipients ITB-Med LLC NA COMPLETED
(Apr 1, 2026)
PHASE2
Eight-Treg Study:Trial of Adoptive Immunotherapy With Autologous ex Vivo Expanded Regulatory CD8+ T Cells in Living Donor Kidney Transplant Recipients Nantes University Hospital NA RECRUITING
(Apr 1, 2026)
PHASE1
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile Roberto Gedaly NA RECRUITING
(Mar 1, 2026)
PHASE2, PHASE3
US Study of ECT-001-CB in Pediatric and Young Adult Patients With High-Risk Myeloid Malignancies ExCellThera inc. NA COMPLETED
(Mar 1, 2026)
PHASE1, PHASE2
Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD) Children's Hospital Medical Center, Cincinnati NA COMPLETED
(Mar 1, 2026)
PHASE1
Immune Tolerance Induction After Liver Transplantation University of California, Los Angeles NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2


Tacrolimus Generic API Manufacturers

Several generic applications have been filed for Tacrolimus. The first generic version for Tacrolimus was by Sandoz Inc and was approved on Aug 10, 2009. And the latest generic version is by Nexus Pharmaceuticals Llc and was approved on Feb 12, 2025.

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