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Last Updated: August 13, 2020

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GEMCITABINE HYDROCHLORIDE Drug Profile

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When do Gemcitabine Hydrochloride patents expire, and when can generic versions of Gemcitabine Hydrochloride launch?

Gemcitabine Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Am Regent, Apotex, Cipla, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hospira, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hansoh Pharm, Mylan Labs Ltd, Sagent Pharms, Sagent Pharms Inc, Shilpa Medicare Ltd, Sun Pharm, and Teva Pharms. and is included in twenty-seven NDAs.

The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Gemcitabine Hydrochloride

A generic version of GEMCITABINE HYDROCHLORIDE was approved as gemcitabine hydrochloride by HOSPIRA INC on November 15th, 2010.

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Drug patent expirations by year for GEMCITABINE HYDROCHLORIDE
Recent Clinical Trials for GEMCITABINE HYDROCHLORIDE

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SponsorPhase
ADC Therapeutics S.A.Phase 3
Hamilton Health Sciences CorporationPhase 2
MedSIRPhase 2

See all GEMCITABINE HYDROCHLORIDE clinical trials

Pharmacology for GEMCITABINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for GEMCITABINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
GEMZAR INJECTABLE;INJECTION gemcitabine hydrochloride 020509 2005-11-14
GEMZAR INJECTABLE;INJECTION gemcitabine hydrochloride 020509 2005-11-01

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
Mylan Labs Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 200145-002 Jul 25, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira Inc GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 200795-002 Aug 4, 2011 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Sagent Pharms Inc GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 209077-002 Jul 20, 2018 AP RX No No   Start Trial   Start Trial   Start 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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