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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Fish and Richardson
Deloitte
Baxter
Queensland Health
Chubb
US Department of Justice
McKesson
Harvard Business School

Generated: June 17, 2018

DrugPatentWatch Database Preview

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 Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Sandoz, Zydus Pharms Usa Inc, Janssen Pharms, and Sebela Ireland Ltd, and is included in fourteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Itraconazole has eight patent family members in five countries.

There are fifteen drug master file entries for itraconazole. Eighteen suppliers are listed for this compound.
Pharmacology for itraconazole
Medical Subject Heading (MeSH) Categories for itraconazole

US Patents and Regulatory Information for itraconazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 200463-001 Jul 20, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Jubilant Generics ITRACONAZOLE itraconazole CAPSULE;ORAL 203445-001 Feb 23, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for itraconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ➤ Sign Up ➤ Sign Up
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 ➤ 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
9,149,431 Itraconazole compositions with improved bioavailability ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Julphar
Covington
US Department of Justice
Boehringer Ingelheim
Deloitte
QuintilesIMS
UBS
US Army

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