VIVELLE (nda020323)- (0.025MG/24HR,0.0375MG/24HR,0.05MG/24HR,0.075MG/24HR,0.1MG/24HR)

Generic Name	ESTRADIOL	Innovator	SANDOZ
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	2011-Apr-05	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Vivelle is indicated in the following: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. 4. Prevention of postmenopausal osteoporosis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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
0.025MG/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 VIVELLE