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Last Updated: August 7, 2020

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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 patent protection?

Gemcitabine hydrochloride is the generic ingredient in three branded drugs 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, Teva Pharms, and Lilly, and is included in twenty-nine NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Gemcitabine hydrochloride has seventeen patent family members in fourteen countries.

There are thirty drug master file entries for gemcitabine hydrochloride. Seventeen suppliers are listed for this compound.

Summary for GEMCITABINE HYDROCHLORIDE
Recent Clinical Trials for GEMCITABINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

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
Shilpa Medicare Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 210991-001 Oct 4, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Ingenus Pharms Llc GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 210383-001 Feb 14, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Cipla GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 078759-001 Jul 25, 2011 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 079183-001 Nov 15, 2010 AP RX No Yes   Start Trial   Start Trial   Start Trial
Sun Pharm INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313-010 Jul 16, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hospira GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 078339-002 Jul 25, 2011 AP RX No No   Start Trial   Start Trial   Start Trial
Sagent Pharms Inc GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 209077-003 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

Expired US Patents for GEMCITABINE HYDROCHLORIDE

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

Supplementary Protection Certificates for GEMCITABINE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0122707 SPC/GB95/031 United Kingdom   Start Trial PRODUCT NAME: GEMCITABINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY- ACCEPTABLE SALT; REGISTERED: NL RVG17854 19950327; UK 00006/0301 19951026; UK 00006/0302 19951026
0122707 96C0030 Belgium   Start Trial PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim
AstraZeneca
Medtronic

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