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Serving leading biopharmaceutical companies globally:

US Army
Fish and Richardson
Johnson and Johnson
Cipla
Boehringer Ingelheim
Novartis
Chinese Patent Office
Covington
Dow
Cantor Fitzgerald

Generated: January 24, 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 five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Itraconazole has fifty-one 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 itraconazole
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
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Alkem Labs Ltd ITRACONAZOLE itraconazole CAPSULE;ORAL 208591-001 Jun 12, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Alembic Pharms Ltd ITRACONAZOLE itraconazole CAPSULE;ORAL 206741-001 Dec 13, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 200463-001 Jul 20, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz ITRACONAZOLE itraconazole CAPSULE;ORAL 076104-001 May 28, 2004 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 205724-001 Dec 13, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amneal Pharms ITRACONAZOLE itraconazole SOLUTION;ORAL 205573-001 Oct 30, 2015 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997 ➤ Subscribe ➤ Subscribe
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 ➤ Subscribe ➤ Subscribe
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997 ➤ Subscribe ➤ Subscribe
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999 ➤ Subscribe ➤ Subscribe
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997 ➤ Subscribe ➤ Subscribe
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ➤ Subscribe ➤ Subscribe
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999 ➤ Subscribe ➤ Subscribe
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 ➤ Subscribe ➤ Subscribe
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for itraconazole

Country Document Number Estimated Expiration
Slovakia 284145 ➤ Subscribe
Poland 188566 ➤ Subscribe
Japan 2014062110 ➤ Subscribe
Croatia P970270 ➤ Subscribe
Norway 982599 ➤ Subscribe
Cyprus 2434 ➤ Subscribe
Slovenia 904060 ➤ Subscribe
Argentina 007195 ➤ Subscribe
Denmark 0904060 ➤ Subscribe
Canada 2618255 ➤ Subscribe
Country Document Number Estimated Expiration

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

Serving leading biopharmaceutical companies globally:

US Department of Justice
Merck
Fish and Richardson
Argus Health
Covington
McKinsey
Baxter
Chubb
Farmers Insurance

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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