Gemcitabine Hydrochloride Patent Expiration

Gemcitabine Hydrochloride was first introduced by Eli Lilly And Co in its drug Gemzar on May 15, 1996. Other drugs containing Gemcitabine Hydrochloride are Gemcitabine Hydrochloride, Infugem. 26 different companies have introduced drugs containing Gemcitabine Hydrochloride.


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
Infugem US9241948 Ready to be infused gemcetabine solution Jul 01, 2033 Sun Pharm
Gemzar US5464826

(Pediatric)

Method of treating tumors in mammals with 2',2'-difluoronucleosides May 07, 2013

(Expired)

Lilly
Gemzar US5464826 Method of treating tumors in mammals with 2',2'-difluoronucleosides Nov 07, 2012

(Expired)

Lilly



Gemcitabine Hydrochloride's Family Patents

Family Patents

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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. 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


2. 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


3. 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


4. 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


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. 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


7. 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


8. 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


9. 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


10. 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


11. 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


12. 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


13. 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


14. 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


15. 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


16. 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


17. 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


18. 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


19. 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


20. 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


21. 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


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. 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


25. 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