Tacrolimus Patent Expiration
Tacrolimus is Used for preventing organ rejection in transplant patients. It was first introduced by Astellas Pharma Us Inc
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 |
|---|---|---|---|---|
| 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 |
| Envarsus Xr | US10166190 | Stabilized tacrolimus composition | May 30, 2028 | Veloxis Pharms Inc |
| Envarsus Xr | US10548880 | Solid dispersions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| Envarsus Xr | US10864199 | Tacrolimus for improved treatment of transplant patients | May 30, 2028 | Veloxis Pharms Inc |
| Envarsus Xr | US11077096 | Modified release compositions comprising tacrolimus | Aug 30, 2024 | 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 | US7994214 | Solid dispersions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| Envarsus Xr | US8486993 | Solid dispersions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| Envarsus Xr | US8586084 | Modified release compositions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| Envarsus Xr | US8591946 | Modified release compositions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| Envarsus Xr | US8617599 | Modified release compositions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| Envarsus Xr | US8623410 | Modified release compositions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| Envarsus Xr | US8623411 | Modified release compositions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| 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 | US8889185 | Modified release compositions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| Envarsus Xr | US8889186 | Modified release compositions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| Envarsus Xr | US9161907 | Modified release compositions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| Envarsus Xr | US9549918 | Stabilized tacrolimus composition | May 30, 2028 | Veloxis Pharms Inc |
| Envarsus Xr | US9757362 | Modified release compositions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| Envarsus Xr | US9763920 | Solid dispersions comprising tacrolimus | Aug 30, 2024 | Veloxis Pharms Inc |
| 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 |
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Tacrolimus Generics
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 Chengdu Suncadia Medicine Co Ltd and was approved on Jan 25, 2024.
Given below is the list of companies who have filed for Tacrolimus generic.
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. 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 |
3. BELCHER
Belcher 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 Belcher.
| 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 |
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 |
5. 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 | AB | Oct 10, 2023 |
6. 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 |
7. 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 |
8. 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 |
9. 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 |
10. 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 |
11. 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 |
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. 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 |
14. 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 | Discontinued | ORAL | N/A | Nov 10, 2020 |
15. 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 |
16. 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 5MG BASE | capsule, extended release | Prescription | ORAL | AB | Jan 25, 2024 |
| 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 |
17. 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 |