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Serving 500+ biopharmaceutical companies globally:

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Generated: July 22, 2017

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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 Lilly, Gland Pharma Ltd, Luitpold Pharms Inc, Sun Pharma Global, Hospira, Fresenius Kabi Usa, Mylan Labs Ltd, Actavis Inc, Cipla Ltd, Actavis Totowa, Emcure Pharms Ltd, Hameln Rds Gmbh, Dr Reddys Labs Ltd, Apotex Inc, Hospira Inc, Teva Pharms, Jiangsu Hansoh Pharm, Accord Hlthcare, Sagent Pharms, and Fresenius Kabi Oncol, and is included in twenty-two NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: gemcitabine hydrochloride

Tradenames:2
Patents:1
Applicants:20
NDAs:22
Drug Master File Entries: see list28
Suppliers / Packagers: see list17
Bulk Api Vendors: see list50
Clinical Trials: see list3,880
Patent Applications: see list7,771
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:gemcitabine hydrochloride at DailyMed

Pharmacology for Ingredient: 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;INJECTION078433-001Jul 25, 2011APRXNoNo► Subscribe► Subscribe
Fresenius Kabi Oncol
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION090799-001Jul 25, 2011APRXNoNo► Subscribe► Subscribe
Sagent Pharms
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION091597-002May 7, 2013APRXNoNo► Subscribe► Subscribe
Dr Reddys Labs Ltd
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION091365-001Jul 25, 2011APRXNoNo► Subscribe► Subscribe
Apotex Inc
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION206776-002May 23, 2017APRXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: gemcitabine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 19964,808,614*PED► Subscribe
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-001May 15, 19964,808,614*PED► Subscribe
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-001May 15, 19965,464,826*PED► Subscribe
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 19965,464,826*PED► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

UBS
Daiichi Sankyo
US Department of Justice
Boehringer Ingelheim
Novartis
Dow
Citi
Teva
Express Scripts
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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