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Serving leading biopharmaceutical companies globally:

Baxter
Deloitte
Covington
Fuji
Farmers Insurance
Chubb
US Army
UBS
Harvard Business School
Fish and Richardson

Generated: February 18, 2018

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Gemcitabine hydrochloride - Generic Drug Details

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What are the generic sources for gemcitabine hydrochloride and what is the scope of gemcitabine hydrochloride freedom to operate?

Gemcitabine hydrochloride
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Apotex Inc, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Oncol, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Luitpold Pharms Inc, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, Teva Pharms, and Lilly, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for gemcitabine hydrochloride. Seventeen suppliers are listed for this compound.
Pharmacology for gemcitabine hydrochloride

US Patents and Regulatory Information for gemcitabine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 078433-002 Jul 25, 2011 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 078339-002 Jul 25, 2011 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dr Reddys Labs Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 091365-001 Jul 25, 2011 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 090242-003 May 16, 2011 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Oncol GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 090799-001 Jul 25, 2011 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira Inc GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 200795-003 Aug 4, 2011 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Accord Hlthcare GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 091594-002 Jul 25, 2011 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gland Pharma Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 204520-002 Jan 5, 2016 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Accord Hlthcare GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride SOLUTION;IV (INFUSION) 209604-001 Aug 3, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for gemcitabine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
UBS
Daiichi Sankyo
Federal Trade Commission
Chinese Patent Office
Deloitte
AstraZeneca
Merck

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