ORTHO TRI-CYCLEN LO (nda021241)- (0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG)

Generic Name	ETHINYL ESTRADIOL; NORGESTIMATE	Innovator	JANSSEN PHARMS
Dosage	0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2019-Dec-09	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ORTHO TRI-CYCLEN are estrogen/progestin COCs, indicated for use by women to prevent pregnancy. ORTHO TRI-CYCLEN is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. ORTHO TRI-CYCLEN should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	0	4

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
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG	**	**	-	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	4

Manufacturing Details of ORTHO TRI-CYCLEN LO