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Last Updated: November 4, 2024

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, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hikma, Hikma Intl Pharms, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Sagent Pharms, Sagent Pharms Inc, Shilpa, Sun Pharm, Teva Pharms, Teyro Labs, and Lilly, and is included in thirty-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.

Gemcitabine hydrochloride has seventeen patent family members in fourteen countries.

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

Summary for GEMCITABINE HYDROCHLORIDE
International Patents:17
US Patents:1
Tradenames:3
Applicants:26
NDAs:32
Drug Master File Entries: 30
Finished Product Suppliers / Packagers: 13
Raw Ingredient (Bulk) Api Vendors: 103
Clinical Trials: 2,804
Patent Applications: 8,052
What excipients (inactive ingredients) are in GEMCITABINE HYDROCHLORIDE?GEMCITABINE HYDROCHLORIDE excipients list
DailyMed Link:GEMCITABINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for GEMCITABINE HYDROCHLORIDE

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

SponsorPhase
Lee Ocuin, MDPhase 2
Merck Sharp & Dohme LLCPhase 2
Medizinische Hochschule Hannover, Germany, Prof. Dr. Arndt VogelPhase 2

See all GEMCITABINE HYDROCHLORIDE clinical trials

Pharmacology for GEMCITABINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for GEMCITABINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for GEMCITABINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GEMZAR For Injection gemcitabine hydrochloride 1g/vial 020509 1 2005-11-14
GEMZAR For Injection gemcitabine hydrochloride 200 mg/vial 020509 1 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
Hospira Inc GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 200795-003 Aug 4, 2011 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Shilpa GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 207575-002 Feb 22, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313-007 Jul 16, 2018 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 020509-001 May 15, 1996 ⤷  Sign Up ⤷  Sign Up
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ⤷  Sign Up ⤷  Sign Up
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ⤷  Sign Up ⤷  Sign Up
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for GEMCITABINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
South Korea 20150014438 ⤷  Sign Up
Mexico 2014013101 SOLUCION DE GEMCITABINA LISTA PARA INFUNDIR. (READY TO BE INFUSED GEMCITABINE SOLUTION.) ⤷  Sign Up
European Patent Office 2656848 Solution de gemcitabine prête à être infusée (Ready to be infused gemcitabine solution) ⤷  Sign Up
Russian Federation 2621144 ЛЕКАРСТВЕННАЯ ФОРМА ГЕМЦИТАБИНА БОЛЬШОГО ОБЪЕМА ДЛЯ ИНФУЗИИ И КОМПЛЕКТ, ВКЛЮЧАЮЩИЙ ЛЕКАРСТВЕННУЮ ФОРМУ (PHARMACEUTICAL FORM OF GEMCITABINE OF LARGE VOLUME FOR INFUSION AND KIT CONTAINING FORMULATIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GEMCITABINE HYDROCHLORIDE

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

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