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Itraconazole - Generic Drug Details

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What are the generic drug sources for itraconazole and what is the scope of itraconazole freedom to operate?

Itraconazole is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Sandoz, Zydus Pharms Usa Inc, Janssen Pharms, and Sebela Ireland Ltd, and is included in fourteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Itraconazole has eight patent family members in five countries.

There are fifteen drug master file entries for itraconazole. Eighteen suppliers are listed for this compound.

Summary for itraconazole

International Patents:	8
US Patents:	2
Tradenames:	3
Applicants:	11
NDAs:	14
Drug Master File Entries:	15
Suppliers / Packagers:	18
Bulk Api Vendors:	49
Clinical Trials:	183
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	itraconazole at DailyMed

Pharmacology for itraconazole

Ingredient-type	Azoles
Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for itraconazole

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

US Patents and Regulatory Information for itraconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999		DISCN	No	No
Amneal Pharms	ITRACONAZOLE	itraconazole	SOLUTION;ORAL	205573-001	Oct 30, 2015		DISCN	No	No
Alembic Pharms Ltd	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	206741-001	Dec 13, 2016	AB	RX	No	No
Amneal Pharms	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	205080-001	Sep 26, 2016	AB	RX	No	No

Expired US Patents for itraconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992

Non-Orange Book US Patents for itraconazole

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,149,431	Itraconazole compositions with improved bioavailability

International Patents for itraconazole

Country	Document Number	Estimated Expiration
Spain	2571032
Japan	2014062110
World Intellectual Property Organization (WIPO)	2007017248
Japan	2009504589