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Last Updated: August 10, 2020

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GEMZAR Drug Profile

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

Gemzar is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in GEMZAR 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.

Drug patent expirations by year for GEMZAR
Drug Prices for GEMZAR

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Recent Clinical Trials for GEMZAR

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

SponsorPhase
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2
ECOG-ACRIN Cancer Research GroupPhase 3
Lexicon PharmaceuticalsPhase 2

See all GEMZAR clinical trials

Pharmacology for GEMZAR
Paragraph IV (Patent) Challenges for GEMZAR
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 GEMZAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 AP RX Yes Yes   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 GEMZAR

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

Supplementary Protection Certificates for GEMZAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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 SPC/GB95/03 United Kingdom   Start Trial SPC/GB95/03: 20040306, EXPIRES: 20090305
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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