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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 Infugem, Gemcitabine Hydrochloride. 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 Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


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


Manufacturing Plant Locations
New

Actavis Inc'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 Actavis Inc as present at those locations.

Country City Firm Name
United States
Morristown Actavis Inc.
Mt Prospect Actavis Incorporated





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


Manufacturing Plant Locations
New

Actavis Totowa'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 Actavis Totowa as present at those locations.

Country City Firm Name
United States
Totowa Actavis Totowa LLC
Little Falls Actavis Totowa LLC





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


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Etobicoke Apotex, Inc.
Richmond Hill Apotex Inc.
Brantford Apotex Pharmachem Inc.
North York Apotex Inc.
Toronto Apotex Inc.
Winnipeg Apotex Fermentation Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bengaluru Apotex Research Private Limited
Bangalore Apotex Research Private Limited - Bioequivalence Centre





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


Manufacturing Plant Locations
New

Fresenius Kabi Usa'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 Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
North Andover Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
Wilson Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Melrose Park Fresenius Kabi USA LLC
Lake Zurich Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC





9. GLAND

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.

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


Manufacturing Plant Locations
New

Gland'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 Gland as present at those locations.

Country City Firm Name
India
Hyderabad Gland Pharma Limited
Malur Gland Chemicals Pvt Ltd.
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Parawada, Visakhapatnam Gland Pharma Limited
Sriperumbudur Gland Chemical Private Limited
Aurangabad Gland Chemical Private Limited
Visakhapatnam Gland Pharma Limited





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


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Eatontown Hikma Pharmaceuticals USA, Inc.
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





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


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
Mcpherson Hospira, Inc., A Pfizer Company
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Clayton Hospira, Inc.
Morgan Hill Hospira Inc
Rocky Mount Hospira, Inc.
Lake Forest Hospira Inc
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





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


Manufacturing Plant Locations
New

Hospira Inc'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 Hospira Inc as present at those locations.

Country City Firm Name
United States
Morgan Hill Hospira Inc
Lake Forest Hospira Inc





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


Manufacturing Plant Locations
New

Jiangsu Hansoh Pharm'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 Jiangsu Hansoh Pharm as present at those locations.

Country City Firm Name
China
Lianyungang Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Lianyungang Jiangsu Hansoh Pharmaceutical Group Co., Ltd





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


Manufacturing Plant Locations
New

Shilpa'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 Shilpa as present at those locations.

Country City Firm Name
United States
Minneapolis Shilpa Gupta
India
Chicksugur, Raichur Shilpa Pharma Lifesciences Limited
Hyderabad Shilpa Medicare Limited
Bengaluru Shilpa Medicare Limited
Polepally, Jadcherla Shilpa Medicare Limited
Hyderbad Shilpa Medicare Limited





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


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Billerica Sun Pharmaceutical Industries, Inc.
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Lexington Sun Pharmaceutical Industries Inc
India
Mohali Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd
Dadra Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Ahmednagar Sun Pharmaceutical Industries Limited
Halol Sun Pharmaceutical Industries Ltd.
Punjab Sun Pharmaceutical Industries, Inc.
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
New Delhi Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd





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