Gemcitabine hydrochloride - Generic Drug Details

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What are the generic drug sources for gemcitabine hydrochloride and what is the scope of freedom to operate?

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

Sponsor	Phase
Lee Ocuin, MD	Phase 2
Merck Sharp & Dohme LLC	Phase 2
State University of New York - Downstate Medical Center	Phase 1/Phase 2

See all gemcitabine hydrochloride clinical trials

Pharmacology for gemcitabine hydrochloride

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for gemcitabine hydrochloride

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	202031-002	May 7, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-002	Jul 16, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Meitheal	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	212129-001	Dec 11, 2020	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	212129-003	Dec 11, 2020	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sagent Pharms	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	091597-001	May 7, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Totowa	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	079160-001	Jul 25, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	020509-001	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

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Country	Patent Number	Title	Estimated Expiration
Japan	2013231029	READY TO BE INFUSED GEMCITABINE SOLUTION	⤷ Sign Up
Spain	2537294		⤷ Sign Up
China	104254319		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013171763		⤷ Sign Up
Brazil	112014026334		⤷ Sign Up
Russian Federation	2014147388		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for gemcitabine hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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