ESCLIM (nda020847)- (0.025MG/24HR,0.0375MG/24HR,0.05MG/24HR,0.075MG/24HR,0.1MG/24HR)

Generic Name	ESTRADIOL	Innovator	WOMEN FIRST HLTHCARE
Dosage	0.025MG/24HR,0.0375MG/24HR,0.05MG/24HR,0.075MG/24HR,0.1MG/24HR
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2008-Mar-25	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Esclim (estradiol transdermal system) is indicated in the following: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. There is no adequate evidence that estrogens are effective for nervous symptoms of depression that might occur during menopause and they should not be used to treat these conditions. 2. Treatment of vulval and vaginal atrophy. 3. Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

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
0.025MG/24HR	**	**	-	-	-
0.0375MG/24HR	**	**	-	-	-
0.05MG/24HR	**	**	-	-	-
0.075MG/24HR	**	**	-	-	-
0.1MG/24HR	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ESCLIM