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Generated: December 17, 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 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-three 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord HlthcareGEMCITABINE HYDROCHLORIDEgemcitabine hydrochlorideSOLUTION;IV (INFUSION)209604-004Aug 3, 2017RXYesYes► Subscribe► Subscribe► Subscribe
LillyGEMZARgemcitabine hydrochlorideINJECTABLE;INJECTION020509-001May 15, 1996APRXYesYes► Subscribe► Subscribe► Subscribe
Mylan Labs LtdGEMCITABINE HYDROCHLORIDEgemcitabine hydrochlorideINJECTABLE;INJECTION200145-003Jul 25, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira IncGEMCITABINE HYDROCHLORIDEgemcitabine hydrochlorideINJECTABLE;INJECTION200795-001Aug 4, 2011APRXYesYes► Subscribe► Subscribe► Subscribe
Accord HlthcareGEMCITABINE HYDROCHLORIDEgemcitabine hydrochlorideSOLUTION;IV (INFUSION)209604-003Aug 3, 2017RXYesYes► Subscribe► Subscribe► Subscribe
Hospira IncGEMCITABINE HYDROCHLORIDEgemcitabine hydrochlorideINJECTABLE;INJECTION079183-001Nov 15, 2010APRXNoYes► Subscribe► Subscribe► Subscribe
Emcure Pharms LtdGEMCITABINE HYDROCHLORIDEgemcitabine hydrochlorideINJECTABLE;INJECTION202063-001Sep 11, 2012APRXNoNo► Subscribe► Subscribe► Subscribe
Jiangsu Hansoh PharmGEMCITABINE HYDROCHLORIDEgemcitabine hydrochlorideINJECTABLE;INJECTION202485-001May 7, 2013APRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharma GlobalGEMCITABINE HYDROCHLORIDEgemcitabine hydrochlorideINJECTABLE;INJECTION078433-001Jul 25, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Gland Pharma LtdGEMCITABINE HYDROCHLORIDEgemcitabine hydrochlorideINJECTABLE;INJECTION204520-002Jan 5, 2016APRXNoNo► Subscribe► 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
LillyGEMZARgemcitabine hydrochlorideINJECTABLE;INJECTION020509-002May 15, 1996► Subscribe► Subscribe
LillyGEMZARgemcitabine hydrochlorideINJECTABLE;INJECTION020509-001May 15, 1996► Subscribe► Subscribe
LillyGEMZARgemcitabine hydrochlorideINJECTABLE;INJECTION020509-001May 15, 1996► Subscribe► Subscribe
LillyGEMZARgemcitabine hydrochlorideINJECTABLE;INJECTION020509-002May 15, 1996► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Chubb
Daiichi Sankyo
Covington
Baxter
Moodys
McKinsey
Medtronic
US Department of Justice
UBS
Boehringer Ingelheim

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