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Last Updated: April 22, 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
Strides Pharma ITRACONAZOLE itraconazole CAPSULE;ORAL 206410-001 Jul 2, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 RX Yes Yes ⤷  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
Accord Hlthcare ITRACONAZOLE itraconazole CAPSULE;ORAL 205991-001 May 26, 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 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 SOLUTION;ORAL 020657-001 Feb 21, 1997 ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 ⤷  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
Canada 2618255 COMPOSITIONS D'ITRACONAZOLE PRESENTANT UNE BIODISPONIBILITE AMELIOREE (ITRACONAZOLE COMPOSITIONS WITH IMPROVED BIOAVAILABILITY) ⤷  Try a Trial
Spain 2571032 ⤷  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
Japan 2018162304 イトラコナゾール組成物及び投与剤形、並びにその使用方法 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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