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Last Updated: March 29, 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, 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. Fourteen suppliers are listed for this compound.

Summary for GEMCITABINE HYDROCHLORIDE
International Patents:17
US Patents:1
Tradenames:3
Applicants:25
NDAs:32
Drug Master File Entries: 30
Finished Product Suppliers / Packagers: 14
Raw Ingredient (Bulk) Api Vendors: 103
Clinical Trials: 2,747
Patent Applications: 8,052
Formulation / Manufacturing:see details
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
College of Pharmaceutical Sciences at Zhejiang UniversityN/A
Zhang Xiaofeng,MDN/A
The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang UniversityN/A

See all GEMCITABINE HYDROCHLORIDE clinical trials

Pharmacology 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
Apotex GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 206776-001 May 23, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 078339-002 Jul 25, 2011 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Emcure Pharms Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 202063-001 Sep 11, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hameln Rds Gmbh GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 090663-001 Sep 10, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ⤷  Try a Trial ⤷  Try a Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ⤷  Try a Trial ⤷  Try a Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ⤷  Try a Trial ⤷  Try a 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 96C0030 Belgium ⤷  Try a 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
0122707 SPC/GB95/031 United Kingdom ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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