KYLEENA (nda208224)- (19.5MG)

Generic Name	LEVONORGESTREL	Innovator	BAYER HLTHCARE
Dosage	19.5MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2031-Apr-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2019-Sep-16
GAIN Expiry	None	Drug Complexity	No
Indication	Kyleena is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to 5 years.

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
19.5MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of KYLEENA