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Generated: July 22, 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?

Itraconazole
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, Accord Hlthcare, and Alkem Labs Ltd, and is included in thirteen 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. Sixteen suppliers are listed for this compound.

Summary for Generic Name: itraconazole

Tradenames:3
Patents:6
Applicants:10
NDAs:13
Drug Master File Entries: see list15
Suppliers / Packagers: see list16
Bulk Api Vendors: see list102
Clinical Trials: see list171
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
Amneal Pharms
ITRACONAZOLE
itraconazole
SOLUTION;ORAL205573-001Oct 30, 2015DISCNNoNo► Subscribe► Subscribe
Sebela Ireland Ltd
ONMEL
itraconazole
TABLET;ORAL022484-001Apr 29, 2010RXYesYes7,081,255► SubscribeY ► Subscribe
Alembic Pharms Ltd
ITRACONAZOLE
itraconazole
CAPSULE;ORAL206741-001Dec 13, 2016ABRXNoNo► Subscribe► Subscribe
Par Pharm Inc
ITRACONAZOLE
itraconazole
CAPSULE;ORAL205724-001Dec 13, 2016ABRXNoNo► Subscribe► Subscribe
Janssen Pharms
SPORANOX
itraconazole
CAPSULE;ORAL020083-001Sep 11, 1992ABRXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: itraconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd
ONMEL
itraconazole
TABLET;ORAL022484-001Apr 29, 20107,081,255► Subscribe
Janssen Pharms
SPORANOX
itraconazole
INJECTABLE;INJECTION020966-001Mar 30, 19994,267,179► Subscribe
Janssen Pharms
SPORANOX
itraconazole
INJECTABLE;INJECTION020966-001Mar 30, 19994,727,064► Subscribe
Janssen Pharms
SPORANOX
itraconazole
SOLUTION;ORAL020657-001Feb 21, 19974,267,179► Subscribe
Janssen Pharms
SPORANOX
itraconazole
INJECTABLE;INJECTION020966-001Mar 30, 19994,791,111► Subscribe
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Non-Orange Book Patents for Generic Ingredient: itraconazole

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,149,431Itraconazole compositions with improved bioavailability► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: itraconazole

Country Document Number Estimated Expiration
Spain2571032► Subscribe
Turkey9801225► Subscribe
Australia2956297► Subscribe
Estonia9800304► Subscribe
Estonia03902► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Deloitte
Queensland Health
Baxter
Colorcon
Accenture
McKinsey
AstraZeneca
UBS
Healthtrust
Cantor Fitzgerald

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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