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Itraconazole - Generic Drug Details

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Itraconazole is the generic ingredient in three branded drugs marketed by Sandoz, Janssen Pharms, Mylan Pharms Inc, Amneal Pharms, Merz Pharms, and Accord Hlthcare, and is included in eight NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-nine patent family members in thirty-three countries.

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

Summary for Generic Name: itraconazole

Tradenames:3
Patents:5
Applicants:6
NDAs:8
Drug Master File Entries: see list15
Suppliers / Packaging: see list7
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for Ingredient: itraconazole

Clinical Trials for: itraconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare
ITRACONAZOLE
itraconazole
CAPSULE;ORAL205991-001May 26, 2016RXNo<disabled><disabled>
Amneal Pharms
ITRACONAZOLE
itraconazole
SOLUTION;ORAL205573-001Oct 30, 2015DISCNNo<disabled><disabled>
Merz Pharms
ONMEL
itraconazole
TABLET;ORAL022484-001Apr 29, 2010RXYes8,486,456<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: itraconazole

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
SPORANOX
itraconazole
SOLUTION;ORAL020657-001Feb 21, 19974,727,064<disabled>
Janssen Pharms
SPORANOX
itraconazole
SOLUTION;ORAL020657-001Feb 21, 19974,791,111<disabled>
Janssen Pharms
SPORANOX
itraconazole
CAPSULE;ORAL020083-001Sep 11, 19924,267,179<disabled>
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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<disabled in preview>
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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
Ukraine72424<disabled in preview>
CroatiaP970270<disabled in preview>
Denmark0904060<disabled in preview>
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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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