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Last Updated: May 8, 2021

DrugPatentWatch Database Preview

Itraconazole - Generic Drug Details

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What are the generic sources for itraconazole and what is the scope of patent protection?

Itraconazole is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Janssen Pharms, Mayne Pharma Intl, Annora Pharma, Apotex, and Sebela Ireland Ltd, and is included in nineteen NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Itraconazole has thirty-seven patent family members in twelve countries.

There are fifteen drug master file entries for itraconazole. Twenty-one suppliers are listed for this compound.

Drug Prices for itraconazole

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Recent Clinical Trials for itraconazole

Identify potential brand extensions & 505(b)(2) entrants

Nanjing Sanhome Pharmaceutical, Co., Ltd.Phase 1
Ascletis Pharmaceuticals Co., Ltd.Phase 1
George R ThompsonPhase 2

See all itraconazole clinical trials

Medical Subject Heading (MeSH) Categories for itraconazole
Paragraph IV (Patent) Challenges for ITRACONAZOLE
Tradename Dosage Ingredient NDA Submissiondate
SPORANOX SOLUTION;ORAL itraconazole 020657 2013-05-03
SPORANOX CAPSULE;ORAL itraconazole 020083

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
Amneal Pharms ITRACONAZOLE itraconazole SOLUTION;ORAL 205573-001 Oct 30, 2015 AA RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Mylan Pharms Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 200463-001 Jul 20, 2012 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Mayne Pharma Intl TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Strides Pharma ITRACONAZOLE itraconazole CAPSULE;ORAL 206410-001 Jul 2, 2019 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Par Pharm Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 205724-001 Dec 13, 2016 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Amneal Pharms ITRACONAZOLE itraconazole CAPSULE;ORAL 205080-001 Sep 26, 2016 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for itraconazole

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim

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