NEXPLANON (nda021529)- (68MG/IMPLANT)

Generic Name	ETONOGESTREL	Innovator	ORGANON
Dosage	68MG/IMPLANT
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2030-Jul-28	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2014-May-31
GAIN Expiry	None	Drug Complexity	No
Indication	NEXPLANON is a progestin indicated for use by women 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
68MG/IMPLANT	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of NEXPLANON