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. Thirteen 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
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	2
Patent Applications:	7,911
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
Merck Sharp & Dohme Corp.	Phase 3
Alkermes, Inc.	Phase 3
Stanford University	Phase 2

See all INFUGEM clinical trials

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		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-007	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-004	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-008	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-002	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-003	Jul 16, 2018		DISCN	Yes	No			Y
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-006	Jul 16, 2018		DISCN	Yes	No			Y

International Patents for INFUGEM

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20150014438
Mexico	2014013101	SOLUCION DE GEMCITABINA LISTA PARA INFUNDIR. (READY TO BE INFUSED GEMCITABINE SOLUTION.)
European Patent Office	2656848	Solution de gemcitabine prête à être infusée (Ready to be infused gemcitabine solution)
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)
Australia	2013261012
Portugal	2656848
World Intellectual Property Organization (WIPO)	2013171763

Supplementary Protection Certificates for INFUGEM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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