Itraconazole - Generic Drug Details

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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, Annora Pharma, Apotex, and Sebela Ireland Ltd, and is included in nineteen NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Summary for itraconazole

International Patents:	38
US Patents:	7
Tradenames:	4
Applicants:	16
NDAs:	19
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	354
Patent Applications:	7,037
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
Jiangsu Simcere Pharmaceutical Co., Ltd.	Phase 1
VA Puget Sound Health Care System	Phase 2
Portland VA Medical Center	Phase 2

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
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Sebela Ireland Ltd	ONMEL	itraconazole	TABLET;ORAL	022484-001	Apr 29, 2010		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Mylan Pharms Inc	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	200463-001	Jul 20, 2012		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	See Plans and Pricing	See Plans and Pricing
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	See Plans and Pricing	See Plans and Pricing
>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
Japan	2014062110	ITRACONAZOLE COMPOSITION WITH IMPROVED BIOAVAILABILITY	See Plans and Pricing
Australia	782469		See Plans and Pricing
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)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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