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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 Envarsus Xr, Astagraf Xl, 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.

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 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

Family Patents

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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.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 5 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE

capsule Prescription ORAL BX Aug 31, 2011
EQ 5MG BASE

capsule Prescription ORAL BX Aug 31, 2011
EQ 1MG BASE

capsule Prescription ORAL BX Aug 31, 2011
0.1%

ointment Prescription TOPICAL AB Jan 31, 2019
0.03%

ointment Prescription TOPICAL AB Jan 31, 2019





2. AJENAT PHARMS

Ajenat Pharmaceuticals Llc has filed for 3 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Ajenat Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE

capsule Prescription ORAL AB Nov 30, 2017
EQ 0.5MG BASE

capsule Prescription ORAL AB Nov 30, 2017
EQ 1MG BASE

capsule Prescription ORAL AB Nov 30, 2017





3. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 3 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE

capsule Prescription ORAL AB Nov 12, 2020
EQ 5MG BASE

capsule Prescription ORAL AB Nov 12, 2020
EQ 1MG BASE

capsule Prescription ORAL AB Nov 12, 2020





4. BIOCON PHARMA

Biocon Pharma Ltd has filed for 3 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Biocon Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE

capsule Prescription ORAL AB Nov 10, 2020
EQ 5MG BASE

capsule Prescription ORAL AB Nov 10, 2020
EQ 1MG BASE

capsule Prescription ORAL AB Nov 10, 2020


Manufacturing Plant Locations
New

Biocon Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Biocon Pharma as present at those locations.

Country City Firm Name
India
Bengaluru Biocon Pharma Limited





5. CHENGDU

Chengdu Suncadia Medicine Co Ltd has filed for 3 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Chengdu.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE

capsule, extended release Prescription ORAL AB Jan 25, 2024
EQ 1MG BASE

capsule, extended release Prescription ORAL AB Jan 25, 2024
EQ 5MG BASE

capsule, extended release Prescription ORAL AB Jan 25, 2024


Manufacturing Plant Locations
New

Chengdu's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Chengdu as present at those locations.

Country City Firm Name
China
Chengdu Chengdu Yuanxian Food Co., Ltd.
Pengzhou Chengdu Jiaying Livestock Product Biotechnical Co.
Chengdou Chengdu Xin Hong Wang Food Co.Ltd.
Chengdu Chengdu Wagott Bio-tech Co., Ltd.
Chengdu Chengdu Xiangxiangzui Soybean Products Co., Ltd.
Chengdu Chengdu Pioneer Food Co., Ltd.
Qionglai Chengdu Okay Pharmaceutical Co., Ltd
Chengdu CHENGDU FOUNTAIN OPTICAL & ELECTRONIC CO., LTD.
Chengdu Chengdu Wagott Pharmaceutical Co., Ltd.
Chengdu Chengdu Shengnuo Biopharm Co Ltd





6. CONCORD BIOTECH LTD

Concord Biotech Ltd has filed for 3 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Concord Biotech Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE

capsule Prescription ORAL AB Nov 10, 2020
EQ 1MG BASE

capsule Prescription ORAL AB Nov 10, 2020
EQ 0.5MG BASE

capsule Prescription ORAL AB Nov 10, 2020





7. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 3 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE

capsule Prescription ORAL AB May 12, 2010
EQ 0.5MG BASE

capsule Prescription ORAL AB May 12, 2010
EQ 1MG BASE

capsule Prescription ORAL AB May 12, 2010





8. ENCUBE

Encube Ethicals Private Ltd has filed for 1 generic for Tacrolimus. Given below are the details of the strengths of this generic introduced by Encube.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1%

ointment Prescription TOPICAL BX Oct 10, 2023


Manufacturing Plant Locations
New

Encube's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Encube as present at those locations.

Country City Firm Name
India
Andheri East, Mumbai Encube Ethicals Private Ltd
Ponda Encube Ethicals Pvt. Ltd.





9. FOUGERA PHARMS INC

Fougera Pharmaceuticals Inc has filed for 2 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Fougera Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.03%

ointment Prescription TOPICAL AB Sep 9, 2014
0.1%

ointment Prescription TOPICAL AB Sep 9, 2014





10. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 5 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1%

ointment Prescription TOPICAL AB Apr 16, 2018
EQ 5MG BASE

capsule Prescription ORAL AB Nov 10, 2020
EQ 0.5MG BASE

capsule Prescription ORAL AB Nov 10, 2020
EQ 1MG BASE

capsule Prescription ORAL AB Nov 10, 2020
0.03%

ointment Prescription TOPICAL AB Aug 16, 2023





11. HANGZHOU ZHONGMEI

Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd has filed for 3 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Hangzhou Zhongmei.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1MG BASE

capsule Prescription ORAL AB Apr 17, 2023
EQ 0.5MG BASE

capsule Prescription ORAL AB Apr 17, 2023
EQ 5MG BASE

capsule Prescription ORAL AB Apr 17, 2023


Manufacturing Plant Locations
New

Hangzhou Zhongmei's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Hangzhou Zhongmei as present at those locations.

Country City Firm Name
China
Hangzhou Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co., Ltd
Hangzhou Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd





12. HERITAGE PHARMA AVET

Heritage Pharma Labs Inc Dba Avet Pharmaceuticals Labs Inc has filed for 1 generic for Tacrolimus. Given below are the details of the strengths of this generic introduced by Heritage Pharma Avet.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE

capsule Discontinued ORAL N/A Jul 1, 2010





13. HOSPIRA

Hospira Inc has filed for 1 generic for Tacrolimus. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE/ML

injectable Discontinued INJECTION N/A Aug 25, 2017


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Lake Forest Hospira Inc
Rocky Mount Hospira, Inc.
Mcpherson Hospira, Inc., A Pfizer Company
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Morgan Hill Hospira Inc
Clayton Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





14. MYLAN

Mylan Pharmaceuticals Inc has filed for 3 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE

capsule Prescription ORAL AB Sep 17, 2010
EQ 1MG BASE

capsule Prescription ORAL AB Sep 17, 2010
EQ 5MG BASE

capsule Prescription ORAL AB Sep 17, 2010


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Greensboro Mylan Pharmaceuticals Inc
Morgantown Mylan Specialty, L.P.
Saint Albans Mylan Technologies, Inc.
San Carlos Mylan Pharmaceuticals Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Rockford Mylan Institutional, Inc.
India
Sinnar Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Anekal Taluk, Bangalore Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





15. NEXUS

Nexus Pharmaceuticals Llc has filed for 1 generic for Tacrolimus. Given below are the details of the strengths of this generic introduced by Nexus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE/ML

injectable Prescription INJECTION AP Feb 12, 2025


Manufacturing Plant Locations
New

Nexus's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Nexus as present at those locations.

Country City Firm Name
United States
Adams Nexus Cooperative
Conger Nexus Cooperative
Santa Fe Springs Nexus Foods, Inc.
Lansing Nexus Cooperative
Lincolnshire Nexus Pharmaceuticals, LLC
Brownsdale Nexus Cooperative
Emmons Nexus Cooperative
Rose Creek Nexus Cooperative
San Diego Nexus Dx, Inc
Alden Nexus Cooperative
Bedford Park Nexus Distribution Corporation
Cerritos Nexus Foods Inc
Le Roy Nexus Cooperative
Cottonwood Heights Nexus CMF, LLC
Pleasant Prairie Nexus Pharmaceuticals Inc
Bedford Park Nexus Distribution Corp.
Lenexa Nexus Medical LLC
Salt Lake City Nexus Spine, LLC





16. PANACEA

Panacea Biotec Pharma Ltd has filed for 3 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Panacea.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.5MG BASE

capsule Prescription ORAL AB Sep 28, 2012
EQ 1MG BASE

capsule Prescription ORAL AB Sep 28, 2012
EQ 5MG BASE

capsule Prescription ORAL AB Sep 28, 2012


Manufacturing Plant Locations
New

Panacea's manufacturing plants are situated in 3 countries - Bulgaria, India, United States. Given below are the details of these plant locations as well as the firm names of Panacea as present at those locations.

Country City Firm Name
Bulgaria
Sofia Panacea 2001, SD
India
Solan Panacea Biotec Pharma Limited
United States
Houston PANACEA ORGANICS LLC





17. SANDOZ

Sandoz Inc has filed for 3 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE

capsule Prescription ORAL AB Aug 10, 2009
EQ 0.5MG BASE

capsule Prescription ORAL AB Aug 10, 2009
EQ 1MG BASE

capsule Prescription ORAL AB Aug 10, 2009


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





18. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 3 different strengths of generic version for Tacrolimus. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE

capsule Prescription ORAL AB Jul 22, 2014
EQ 0.5MG BASE

capsule Prescription ORAL AB Jul 22, 2014
EQ 1MG BASE

capsule Prescription ORAL AB Jul 22, 2014


Manufacturing Plant Locations
New

Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.

Country City Firm Name
United States
Chestnut Ridge Strides Pharma, Inc.
East Brunswick Strides Pharma Inc.
India
Bangalore Strides Pharma Science Limited
Puducherry Strides Pharma Science Limited