PROSTIN E2 (nda017810)- (20MG)

Generic Name	DINOPROSTONE	Innovator	PFIZER
Dosage	20MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	1. PROSTIN E2 Vaginal Suppository is indicated for the termination of pregnancy from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period. 2. PROSTIN E2 is also indicated for evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period. 3. PROSTIN E2 is indicated in the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
20MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of PROSTIN E2