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Last Updated: April 19, 2024

Itraconazole - Generic Drug Details

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What are the generic 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, Par Pharm Inc, 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.

Itraconazole has twenty-six patent family members in eleven countries.

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

Summary for itraconazole

International Patents:	26
US Patents:	6
Tradenames:	4
Applicants:	16
NDAs:	19
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	370
Patent Applications:	4,347
Formulation / Manufacturing:	see details
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
Shanghai Henlius Biotech	Phase 1
Aligos Therapeutics	Phase 1
Dhaka Medical College	Phase 2/Phase 3

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

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
Zydus Pharms	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	204672-001	Sep 19, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	AA	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Jubilant Generics	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	203445-001	Feb 23, 2017		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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	CAPSULE;ORAL	020083-001	Sep 11, 1992	⤷ Try a Trial	⤷ Try a Trial
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018	⤷ Try a Trial	⤷ Try a Trial
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010	⤷ Try a Trial	⤷ Try a Trial
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	⤷ Try a Trial	⤷ Try a 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/002722 For 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
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	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007017248		⤷ Try a Trial
Canada	2618255	COMPOSITIONS D'ITRACONAZOLE PRESENTANT UNE BIODISPONIBILITE AMELIOREE (ITRACONAZOLE COMPOSITIONS WITH IMPROVED BIOAVAILABILITY)	⤷ Try a Trial
Hong Kong	1207288	伊曲康唑組合物和劑型及其使用方法 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME)	⤷ Try a Trial
Australia	2013278001	Itraconazole compositions and dosage forms, and methods of using the same	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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