ANNOVERA (nda209627)- (0.013MG/24HR;0.15MG/24HR)

Generic Name	ETHINYL ESTRADIOL; SEGESTERONE ACETATE	Innovator	MAYNE PHARMA
Dosage	0.013MG/24HR;0.15MG/24HR
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2039-Jun-21	NCE Excl Expiry	2023-Aug-10
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ANNOVERA ™ is a progestin/estrogen CHC indicated for use by females of reproductive potential to prevent pregnancy.

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
0.013MG/24HR;0.15MG/24HR	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ANNOVERA