DrugPatentWatch Database Preview

Itraconazole - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for itraconazole and what is the scope of patent protection?

Itraconazole is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Janssen Pharms, Mayne Pharma Intl, Annora Pharma, Apotex, and Sebela Ireland Ltd, and is included in nineteen NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Itraconazole has thirty-seven patent family members in twelve countries.

There are fifteen drug master file entries for itraconazole. Twenty-two suppliers are listed for this compound.

Summary for itraconazole

International Patents:	37
US Patents:	6
Tradenames:	4
Applicants:	16
NDAs:	19
Drug Master File Entries:	15
Suppliers / Packagers:	22
Bulk Api Vendors:	132
Clinical Trials:	267
Patent Applications:	6,545
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for itraconazole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for itraconazole
DailyMed Link:	itraconazole at DailyMed

See drug prices for itraconazole

Recent Clinical Trials for itraconazole

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Kafrelsheikh University	Phase 2
Taisho Pharmaceutical Co., Ltd.	Phase 1
Impact Therapeutics, Inc.	Phase 1

See all itraconazole clinical trials

Pharmacology for itraconazole

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Breast Cancer Resistance Protein Inhibitors

Medical Subject Heading (MeSH) Categories for itraconazole

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Paragraph IV (Patent) Challenges for ITRACONAZOLE

Tradename	Dosage	Ingredient	NDA	Submissiondate
SPORANOX	SOLUTION;ORAL	itraconazole	020657	2013-05-03
SPORANOX	CAPSULE;ORAL	itraconazole	020083

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
Sandoz	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	076104-001	May 28, 2004	AB	RX	No	No
Mayne Pharma Intl	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes			Y
Par Pharm Inc	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	205724-001	Dec 13, 2016	AB	RX	No	No
Apotex	ITRACONAZOLE	itraconazole	SOLUTION;ORAL	208481-001	Aug 2, 2019		DISCN	No	No
Strides Pharma	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	206410-001	Jul 2, 2019	AB	RX	No	No
Alembic Pharms Ltd	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	206741-001	Dec 13, 2016	AB	RX	No	No
Mylan Pharms Inc	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	200463-001	Jul 20, 2012	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	INJECTABLE;INJECTION	020966-001	Mar 30, 1999
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997

International Patents for itraconazole

Country	Patent Number	Estimated Expiration
European Patent Office	2863911
Portugal	1239831
Japan	5763735
World Intellectual Property Organization (WIPO)	0147492
Mexico	2015000179
Australia	782469
World Intellectual Property Organization (WIPO)	2007017248