LEUPROLIDE ACETATE FOR DEPOT SUSPENSION (nda205054)- (22.5MG/VIAL)

Generic Name	LEUPROLIDE ACETATE	Innovator	INVAGEN PHARMS
Dosage	22.5MG/VIAL
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2020-Dec-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LUTRATE DEPOT is a gonadotropin-releasing hormone (GnRH) agonist indicated for: • Palliative treatment of advanced prostatic cancer.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
22.5MG/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of LEUPROLIDE ACETATE FOR DEPOT SUSPENSION