ANTARA (MICRONIZED) (nda021695)- (30MG,43MG,87MG,90MG,130MG)

Generic Name	FENOFIBRATE	Innovator	LUPIN
Dosage	30MG,43MG,87MG,90MG,130MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2020-Aug-20	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Antara is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and ApoB, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Antara is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	3

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
30MG	**	**	-	-	-
43MG	**	**	-	-	2
87MG	**	**	-	-	-
90MG	**	**	-	-	-
130MG	**	**	-	2	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	3

Manufacturing Details of ANTARA (MICRONIZED)