LUPRON DEPOT (nda019732)- (7.5MG)

Generic Name	LEUPROLIDE ACETATE	Innovator	ABBVIE ENDOCRINE INC
Dosage	7.5MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2016-Dec-13	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for: • treatment of advanced prostatic cancer.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	13

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
7.5MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of LUPRON DEPOT