INFUGEM Drug Patent Profile

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

Infugem is a drug marketed by Sun Pharm and is included in one NDA. There is one patent protecting this drug.

This drug has seventeen patent family members in fourteen countries.

The generic ingredient in INFUGEM is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Infugem

A generic version of INFUGEM was approved as gemcitabine hydrochloride by HOSPIRA INC on November 15^th, 2010.

Summary for INFUGEM

International Patents:	17
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for INFUGEM
What excipients (inactive ingredients) are in INFUGEM?	INFUGEM excipients list
DailyMed Link:	INFUGEM at DailyMed

See drug prices for INFUGEM

Recent Clinical Trials for INFUGEM

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

Sponsor	Phase
Alkermes, Inc.	Phase 3
Merck Sharp & Dohme Corp.	Phase 3
Stanford University	Phase 2

See all INFUGEM clinical trials

Pharmacology for INFUGEM

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

Anatomical Therapeutic Chemical (ATC) Classes for INFUGEM

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

US Patents and Regulatory Information for INFUGEM

INFUGEM is protected by one US patents.

Patents protecting INFUGEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-001	Jul 16, 2018		RX	Yes	Yes			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-007	Jul 16, 2018		RX	Yes	Yes			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-004	Jul 16, 2018		RX	Yes	Yes			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-008	Jul 16, 2018		RX	Yes	Yes			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-002	Jul 16, 2018		RX	Yes	Yes			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-003	Jul 16, 2018		RX	Yes	Yes			Y

International Patents for INFUGEM

See the table below for patents covering INFUGEM around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2014147388
South Africa	201408502	READY TO BE INFUSED GEMCITABINE SOLUTION
European Patent Office	2656848	Solution de gemcitabine prête à être infusée (Ready to be infused gemcitabine solution)
Japan	6159567
South Korea	101716215
Spain	2537294

Supplementary Protection Certificates for INFUGEM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0122707	SPC/GB95/031	United Kingdom		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		PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327