Itraconazole - Generic Drug Details

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What are the generic 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, 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.

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

There are fifteen drug master file entries for itraconazole. Eighteen 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:	18
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	389
Patent Applications:	5,141
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
Emalex Biosciences Inc.	Phase 1
Syneos Health	Phase 1
Cambridge Cognition Ltd	Phase 1

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
Zydus Pharms	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	204672-001	Sep 19, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	205080-001	Sep 26, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010	⤷ Sign Up	⤷ Sign Up
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018	⤷ Sign Up	⤷ Sign Up
>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
European Patent Office	2863911	COMPOSITIONS ET FORMES GALÉNIQUES D'ITRACONAZOLE ET LEURS PROCÉDÉS D'UTILISATION (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME)	⤷ Sign Up
European Patent Office	1912625	COMPOSITIONS D'ITRACONAZOLE PRESENTANT UNE BIODISPONIBILITE AMELIOREE (ITRACONAZOLE COMPOSITIONS WITH IMPROVED BIOAVAILABILITY)	⤷ Sign Up
South Korea	20150043296	이트라코나졸 조성물 및 투여형, 그리고 이것들의 사용 방법 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME)	⤷ Sign Up
South Korea	20200065093	이트라코나졸 조성물 및 투여형, 그리고 이것들의 사용 방법 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS AND METHODS OF USING THE SAME)	⤷ Sign Up
Australia	2020217438	Itraconazole compositions and dosage forms, and methods of using the same	⤷ Sign Up
Japan	6757367		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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