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Generated: May 29, 2017

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Itraconazole - Generic Drug Details

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

is the generic ingredient in three branded drugs marketed by Sandoz, Par Pharm Inc, Alembic Pharms Ltd, Jubilant Generics, Janssen Pharms, Mylan Pharms Inc, Amneal Pharms, Sebela Ireland Ltd, and Accord Hlthcare, and is included in twelve 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 forty-nine patent family members in thirty-three countries.

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

Summary for Generic Name: itraconazole

Drug Master File Entries: see list15
Suppliers / Packagers: see list14
Bulk Api Vendors: see list102
Clinical Trials: see list43
Patent Applications: see list6,407
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:itraconazole at DailyMed

Pharmacology for Ingredient: itraconazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
CAPSULE;ORAL020083-001Sep 11, 1992ABRXYesYes► Subscribe► Subscribe
Alembic Pharms Ltd
CAPSULE;ORAL206741-001Dec 13, 2016ABRXNoNo► Subscribe► Subscribe
CAPSULE;ORAL076104-001May 28, 2004ABRXNoNo► Subscribe► Subscribe
Amneal Pharms
SOLUTION;ORAL205573-001Oct 30, 2015DISCNNoNo► Subscribe► Subscribe
Janssen Pharms
SOLUTION;ORAL020657-001Feb 21, 1997RXYesYes6,407,079► Subscribe ► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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