DELESTROGEN (nda009402)- (10MG/ML,20MG/ML,40MG/ML)

Generic Name	ESTRADIOL VALERATE	Innovator	ENDO OPERATIONS
Dosage	10MG/ML,20MG/ML,40MG/ML
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	DELESTROGEN (estradiol valerate injection, USP) is indicated in the: 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. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	3

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
10MG/ML	**	**	-	-	2
20MG/ML	**	**	-	-	3
40MG/ML	**	**	-	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of DELESTROGEN