VAGIFEM (nda020908)- (10MCG,25MCG)

Generic Name	ESTRADIOL	Innovator	NOVO NORDISK INC
Dosage	10MCG,25MCG
ParaIV Filing	Yes	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	Vagifem is an estrogen indicated for the treatment of atrophic vaginitis due to menopause.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	4

Other Developers

Total Other Developers	6

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
10MCG	**	**	Down	-	3
25MCG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	3

Manufacturing Details of VAGIFEM