Last Updated: September 24, 2026

ITRACONAZOLE - Generic Drug Details

Name: ITRACONAZOLE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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

Itraconazole is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Rising, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Janssen Pharms, Mayne Pharma, 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.

Fourteen suppliers are listed for this compound.

Summary for ITRACONAZOLE

International Patents:	26
US Patents:	6
Tradenames:	4
Applicants:	16
NDAs:	19
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	477
Patent Applications:	6,239
Drug Prices:	Drug price trends for ITRACONAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ITRACONAZOLE
What excipients (inactive ingredients) are in ITRACONAZOLE?	ITRACONAZOLE excipients list
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
Sunshine Lake Pharma Co., Ltd.	PHASE1
Combined Military Hospital Abbottabad	PHASE1
University of Minnesota	PHASE3

See all ITRACONAZOLE clinical trials

Pharmacology for ITRACONAZOLE

Drug Class	Azole Antifungal
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors 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

Anatomical Therapeutic Chemical (ATC) Classes for ITRACONAZOLE

J02AC	Triazole and tetrazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ITRACONAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPORANOX	Oral Solution	itraconazole	10 mg/mL	020657	1	2013-05-03

US Patents and Regulatory Information for ITRACONAZOLE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	209460-001	Aug 24, 2018	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sandoz	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	076104-001	May 28, 2004	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes	9,713,642	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ITRACONAZOLE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	4,727,064	⤷ Start Trial
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	4,267,179	⤷ Start Trial
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999	4,267,179	⤷ Start Trial
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018	8,771,739	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ITRACONAZOLE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Avimedical B.V.	Fungitraxx	itraconazole	EMEA/V/C/002722For the treatment of aspergillosis and candidiasis in companion birds,	Authorised	no	no	no	2014-03-12
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ITRACONAZOLE

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Country	Patent Number	Title	Estimated Expiration
Australia	2013278001		⤷ Start Trial
Australia	2018201298	Itraconazole compositions and dosage forms, and methods of using the same	⤷ Start Trial
Australia	2020217438	Itraconazole compositions and dosage forms, and methods of using the same	⤷ Start Trial
Brazil	112014031706	composição farmacêutica oral; forma de composição farmacêutica oral; método de redução de efeito de alimento de itraconazol em um indivíduo; método de redução de variabilidade em um mesmo indivíduo de itraconazol; método de redução de variabilidade entre indivíduos de itraconazol; método de tratamento de onicomicose; método de tratamento de uma doença ou afecção e método de tratamento de câncer	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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