DIVIGEL (nda022038)- (0.1% (0.25GM/PACKET),0.1% (0.5GM/PACKET),0.1% (1GM/PACKET),0.1% (0.75GM/PACKET),0.1% (1.25GM/PACKET))

Generic Name	ESTRADIOL	Innovator	VERTICAL PHARMS
Dosage	0.1% (0.25GM/PACKET),0.1% (0.5GM/PACKET),0.1% (1GM/PACKET),0.1% (0.75GM/PACKET),0.1% (1.25GM/PACKET)
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	Divigel is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	4

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.1% (0.25GM/PACKET)	**	**	Down	-	-
0.1% (0.5GM/PACKET)	**	**	-	-	-
0.1% (1GM/PACKET)	**	**	-	-	-
0.1% (0.75GM/PACKET)	**	**	-	-	-
0.1% (1.25GM/PACKET)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of DIVIGEL