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Last Updated: March 28, 2024

Itraconazole - Generic Drug Details


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What are the generic drug sources for itraconazole and what is the scope of freedom to operate?

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

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

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
Annora Pharma ITRACONAZOLE itraconazole SOLUTION;ORAL 212239-001 Sep 1, 2020 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan Pharms Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 200463-001 Jul 20, 2012 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
Alkem Labs Ltd ITRACONAZOLE itraconazole CAPSULE;ORAL 208591-001 Jun 12, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic ITRACONAZOLE itraconazole CAPSULE;ORAL 206741-001 Dec 13, 2016 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 SOLUTION;ORAL 020657-001 Feb 21, 1997 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997 ⤷  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
World Intellectual Property Organization (WIPO) 2007017248 ⤷  Try a Trial
Mexico 366829 COMPOSICIONES Y FORMAS DE DOSIFICACION DE ITRACONAZOL Y METODOS DE USO DE LAS MISMAS. (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME.) ⤷  Try a Trial
Japan 2009504589 ⤷  Try a Trial
Canada 2876909 COMPOSITIONS ET FORMES GALENIQUES D'ITRACONAZOLE ET LEURS PROCEDES D'UTILISATION (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013192566 ⤷  Try a Trial
Japan 2014062110 ITRACONAZOLE COMPOSITION WITH IMPROVED BIOAVAILABILITY ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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