INFUGEM (nda208313)- (EQ 1200MG BASE/120ML (EQ 10MG BASE/ML),EQ 1300MG BASE/130ML (EQ 10MG BASE/ML),EQ 1400MG BASE/140ML (EQ 10MG BASE/ML),EQ 1500MG BASE/150ML (EQ 10MG BASE/ML),EQ 1600MG BASE/160ML (EQ 10MG BASE/ML),EQ 1700MG BASE/170ML (EQ 10MG BASE/ML),EQ 1800MG BASE/180ML (EQ 10MG BASE/ML),EQ 1900MG BASE/190ML (EQ 10MG BASE/ML),EQ 2000MG BASE/200ML (EQ 10MG BASE/ML),EQ 2200MG BASE/220ML (EQ 10MG BASE/ML))

Generic Name	GEMCITABINE HYDROCHLORIDE	Innovator	SUN PHARM
Dosage	EQ 1200MG BASE/120ML (EQ 10MG BASE/ML),EQ 1300MG BASE/130ML (EQ 10MG BASE/ML),EQ 1400MG BASE/140ML (EQ 10MG BASE/ML),EQ 1500MG BASE/150ML (EQ 10MG BASE/ML),EQ 1600MG BASE/160ML (EQ 10MG BASE/ML),EQ 1700MG BASE/170ML (EQ 10MG BASE/ML),EQ 1800MG BASE/180ML (EQ 10MG BASE/ML),EQ 1900MG BASE/190ML (EQ 10MG BASE/ML),EQ 2000MG BASE/200ML (EQ 10MG BASE/ML),EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2033-Jul-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	INFUGEM is a nucleoside metabolic inhibitor indicated:  in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.  in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.  in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3)  as a single agent for the treatment of pancreatic cancer.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of INFUGEM