UNITHROID (nda021210)- (0.025MG,0.025MG,0.025MG,0.05MG,0.05MG,0.05MG,0.075MG,0.075MG,0.075MG,0.088MG,0.088MG,0.088MG,0.1MG,0.1MG,0.1MG,0.112MG,0.112MG,0.112MG,0.125MG,0.125MG,0.125MG,0.137MG,0.137MG,0.137MG,0.15MG,0.15MG,0.15MG,0.175MG,0.175MG,0.175MG,0.2MG,0.2MG,0.2MG,0.3MG,0.3MG,0.3MG)

Generic Name	LEVOTHYROXINE SODIUM	Innovator	STEVENS J
Dosage	0.025MG,0.025MG,0.025MG,0.05MG,0.05MG,0.05MG,0.075MG,0.075MG,0.075MG,0.088MG,0.088MG,0.088MG,0.1MG,0.1MG,0.1MG,0.112MG,0.112MG,0.112MG,0.125MG,0.125MG,0.125MG,0.137MG,0.137MG,0.137MG,0.15MG,0.15MG,0.15MG,0.175MG,0.175MG,0.175MG,0.2MG,0.2MG,0.2MG,0.3MG,0.3MG,0.3MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	UNITHROID is L-thyroxine (T4) indicated in pediatric and adult patients for: • Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. • Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	2

Other Developers

Total Other Developers	20

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.025MG	**	**	Down	-	4
0.05MG	**	**	-	-	1
0.075MG	**	**	Up	-	4
0.088MG	**	**	Up	-	4
0.1MG	**	**	Up	-	4
0.112MG	**	**	-	-	1
0.125MG	**	**	-	-	3
0.137MG	**	**	-	-	3
0.15MG	**	**	Up	-	4
0.175MG	**	**	-	-	1
0.2MG	**	**	-	-	-
0.3MG	**	**	Down	-	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of UNITHROID