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Last Updated: March 18, 2024

ITRACONAZOLE Drug Patent Profile


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When do Itraconazole patents expire, and what generic alternatives are available?

Itraconazole is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Annora Pharma, and Apotex. and is included in fourteen NDAs.

The generic ingredient in ITRACONAZOLE is itraconazole. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Itraconazole

A generic version of ITRACONAZOLE was approved as itraconazole by SANDOZ on May 28th, 2004.

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Drug patent expirations by year for ITRACONAZOLE
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

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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
Accord Hlthcare ITRACONAZOLE itraconazole CAPSULE;ORAL 205991-001 May 26, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 205724-001 Dec 13, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms ITRACONAZOLE itraconazole CAPSULE;ORAL 205080-001 Sep 26, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms ITRACONAZOLE itraconazole SOLUTION;ORAL 205573-001 Oct 30, 2015 AA RX 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
Apotex ITRACONAZOLE itraconazole SOLUTION;ORAL 208481-001 Aug 2, 2019 DISCN 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

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

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