SPORANOX (nda020083)- (100MG)

Generic Name	ITRACONAZOLE	Innovator	JANSSEN PHARMS
Dosage	100MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2014-May-27	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SPORANOX® (itraconazole) Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonary and extrapulmonary 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. SPORANOX® Capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: 1. Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and 2. Onychomycosis of the fingernail due to dermatophytes (tinea unguium).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
11	0	8

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
100MG	**	**	Up	-	5

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	6

Manufacturing Details of SPORANOX