Gemcitabine Hydrochloride Patent Expiration
Gemcitabine Hydrochloride was first introduced by Eli Lilly And Co
Gemcitabine Hydrochloride Patents
Given below is the list of patents protecting Gemcitabine Hydrochloride, 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 |
|---|---|---|---|---|
| Gemzar | US5464826 | Method of treating tumors in mammals with 2',2'-difluoronucleosides |
Nov 07, 2012
(Expired) | Lilly |
| Gemzar |
US5464826 (Pediatric) | Method of treating tumors in mammals with 2',2'-difluoronucleosides |
May 07, 2013
(Expired) | Lilly |
| Infugem | US9241948 | Ready to be infused gemcetabine solution | Jul 01, 2033 | Sun Pharm |
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Gemcitabine Hydrochloride Generics
Several generic applications have been filed for Gemcitabine Hydrochloride. The first generic version for Gemcitabine Hydrochloride was by Hospira Inc and was approved on Nov 15, 2010. And the latest generic version is by Hikma Pharmaceuticals International Ltd and was approved on Mar 7, 2023.
Given below is the list of companies who have filed for Gemcitabine Hydrochloride generic.
1. EMCURE PHARMS LTD
Emcure Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Emcure Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1GM BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Sep 11, 2012 |
| EQ 200MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Sep 11, 2012 |
2. MYLAN LABS LTD
Mylan Laboratories Ltd has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG/5.26ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Dec 6, 2017 |
| 1GM/26.3ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Dec 6, 2017 |
| 2GM/52.6ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Dec 6, 2017 |
3. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 200MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 25, 2011 |
| EQ 2GM BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 25, 2011 |
| EQ 1GM BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 25, 2011 |
4. ACTAVIS INC
Actavis Inc has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Actavis Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG/5.26ML (38MG/ML) | injectable | Discontinued | INJECTION | N/A | Apr 11, 2016 |
| 1GM/26.3ML (38MG/ML) | injectable | Discontinued | INJECTION | N/A | Apr 11, 2016 |
| 2GM/52.6ML (38MG/ML) | injectable | Discontinued | INJECTION | N/A | Apr 11, 2016 |
5. APOTEX
Apotex Inc has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG/5.26ML (38MG/ML) | injectable | Discontinued | INJECTION | N/A | May 23, 2017 |
| 1GM/26.3ML (38MG/ML) | injectable | Discontinued | INJECTION | N/A | May 23, 2017 |
| 2GM/52.6ML (38MG/ML) | injectable | Discontinued | INJECTION | N/A | May 23, 2017 |
6. HAMELN RDS GMBH
Hameln Rds Gmbh has filed for 2 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Hameln Rds Gmbh.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 200MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Sep 10, 2012 |
| EQ 1GM BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Sep 10, 2012 |
7. HIKMA INTL PHARMS
Hikma International Pharmaceuticals Llc has filed for 2 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma Intl Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1GM BASE/VIAL | injectable | Prescription | INJECTION | AP | Jun 25, 2021 |
| EQ 200MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Jun 25, 2021 |
8. GLAND PHARMA LTD
Gland Pharma Ltd has filed for 2 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1GM BASE/VIAL | injectable | Prescription | INJECTION | AP | Jan 5, 2016 |
| EQ 200MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Jan 5, 2016 |
9. HIKMA
Hikma Pharmaceuticals International Ltd has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM/26.3ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Mar 7, 2023 |
| 200MG/5.26ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Mar 7, 2023 |
| 2GM/52.6ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Mar 7, 2023 |
10. HOSPIRA INC
Hospira Inc has filed for 1 generic for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Hospira Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2GM BASE/VIAL
(reference standard) | injectable | Prescription | INJECTION | AP | Nov 15, 2010 |
11. MEITHEAL
Meitheal Pharmaceuticals Inc has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Meitheal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG/5.26ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Dec 11, 2020 |
| 2GM/52.6ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Dec 11, 2020 |
| 1GM/26.3ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Dec 11, 2020 |
12. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. 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 1GM BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 25, 2011 |
| EQ 2GM BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 25, 2011 |
| EQ 200MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 25, 2011 |
13. TEYRO LABS
Teyro Labs Private Ltd has filed for 2 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Teyro Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1GM BASE/VIAL | injectable | Prescription | INJECTION | AP | Jul 25, 2011 |
| EQ 200MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Jul 25, 2011 |
14. SAGENT PHARMS
Sagent Pharmaceuticals Inc has filed for 2 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Sagent Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1GM BASE/VIAL | injectable | Discontinued | INJECTION | N/A | May 7, 2013 |
| EQ 200MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | May 7, 2013 |
15. DR REDDYS LABS LTD
Dr Reddys Laboratories Ltd has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. 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 200MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Jul 25, 2011 |
| EQ 1GM BASE/VIAL | injectable | Prescription | INJECTION | AP | Jul 25, 2011 |
| EQ 2GM BASE/VIAL | injectable | Prescription | INJECTION | AP | May 7, 2013 |
16. AM REGENT
American Regent Inc has filed for 2 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Am Regent.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 200MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | May 7, 2013 |
| EQ 1GM BASE/VIAL | injectable | Discontinued | INJECTION | N/A | May 7, 2013 |
17. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2GM BASE/VIAL | injectable | Prescription | INJECTION | AP | May 16, 2011 |
| EQ 200MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Jul 25, 2011 |
| EQ 1GM BASE/VIAL | injectable | Prescription | INJECTION | AP | Jul 25, 2011 |
18. ACTAVIS TOTOWA
Actavis Totowa Llc has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Actavis Totowa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 200MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 25, 2011 |
| EQ 1GM BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 25, 2011 |
| EQ 2GM BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jul 28, 2016 |
19. SAGENT PHARMS INC
Sagent Pharmaceuticals Inc has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG/5.26ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Jul 20, 2018 |
| 1GM/26.3ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Jul 20, 2018 |
| 2GM/52.6ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Jul 20, 2018 |
20. TEVA PHARMS
Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1GM BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jan 25, 2011 |
| EQ 200MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jan 25, 2011 |
21. HOSPIRA
Hospira Worldwide, Inc has filed for 2 different strengths of generic version for Gemcitabine Hydrochloride. 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 200MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Jul 25, 2011 |
| EQ 1GM BASE/VIAL | injectable | Prescription | INJECTION | AP | Jul 25, 2011 |
22. SHILPA
Shilpa Medicare Ltd has filed for 5 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Shilpa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1GM BASE/VIAL | injectable | Prescription | INJECTION | AP | Feb 22, 2019 |
| EQ 200MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Feb 22, 2019 |
| 200MG/5.26ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Oct 4, 2019 |
| 1GM/26.3ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Oct 4, 2019 |
| 2GM/52.6ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Oct 4, 2019 |
23. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 200MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Jul 25, 2011 |
| EQ 1GM BASE/VIAL | injectable | Prescription | INJECTION | AP | Jul 25, 2011 |
24. NOVAST LABS
Novast Laboratories Ltd has filed for 3 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Novast Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM/26.3ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Feb 14, 2019 |
| 200MG/5.26ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Feb 14, 2019 |
| 2GM/52.6ML (38MG/ML) | injectable | Prescription | INJECTION | AP | Feb 14, 2019 |
25. JIANGSU HANSOH PHARM
Jiangsu Hansoh Pharmaceutical Group Co Ltd has filed for 2 different strengths of generic version for Gemcitabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Jiangsu Hansoh Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1GM BASE/VIAL
(reference standard) | injectable | Prescription | INJECTION | AP | May 7, 2013 |
| EQ 200MG BASE/VIAL
(reference standard) | injectable | Prescription | INJECTION | AP | May 7, 2013 |