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Last Updated: March 19, 2024

Itraconazole - Generic Drug Details


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What are the generic drug 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, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Janssen Pharms, Mayne Pharma, Annora Pharma, Apotex, and Sebela Ireland Ltd, and is included in nineteen 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 twenty-six patent family members in eleven countries.

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

Drug Prices for itraconazole

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Recent Clinical Trials for itraconazole

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SponsorPhase
Shanghai Henlius BiotechPhase 1
Aligos TherapeuticsPhase 1
Dhaka Medical CollegePhase 2/Phase 3

See all itraconazole clinical trials

Medical Subject Heading (MeSH) Categories for itraconazole
Paragraph IV (Patent) Challenges for ITRACONAZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SPORANOX Oral Solution itraconazole 10 mg/mL 020657 1 2013-05-03

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
Torrent ITRACONAZOLE itraconazole CAPSULE;ORAL 209460-001 Aug 24, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma ITRACONAZOLE itraconazole CAPSULE;ORAL 206410-001 Jul 2, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex ITRACONAZOLE itraconazole SOLUTION;ORAL 208481-001 Aug 2, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz ITRACONAZOLE itraconazole CAPSULE;ORAL 076104-001 May 28, 2004 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 ⤷  Try a Trial ⤷  Try a Trial
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ⤷  Try a Trial ⤷  Try a Trial
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for itraconazole

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Avimedical B.V. Fungitraxx itraconazole EMEA/V/C/002722
For the treatment of aspergillosis and candidiasis in companion birds,
Authorised no no no 2014-03-12
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for itraconazole

Country Patent Number Title Estimated Expiration
Japan 2009504589 ⤷  Try a Trial
European Patent Office 2863911 COMPOSITIONS ET FORMES GALÉNIQUES D'ITRACONAZOLE ET LEURS PROCÉDÉS D'UTILISATION (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME) ⤷  Try a Trial
China 109674795 伊曲康唑组合物和剂型及其使用方法 (Itraconazole compositions and dosage forms, and methods of using the same) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013192566 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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