PREFEST (nda021040)- (1MG,1MG;N/A,0.09MG)

Generic Name	ESTRADIOL; NORGESTIMATE	Innovator	TEVA WOMENS
Dosage	1MG,1MG;N/A,0.09MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2020-Mar-30	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PREFEST is indicated in women who have a uterus for 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 prescribed solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

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
1MG,1MG;N/A,0.09MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of PREFEST