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Last Updated: June 13, 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, Rising, 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. Eighteen 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
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and CompanyPhase 1
Shanghai Henlius BiotechPhase 1
Aligos TherapeuticsPhase 1

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
Accord Hlthcare ITRACONAZOLE itraconazole CAPSULE;ORAL 205991-001 May 26, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising ITRACONAZOLE itraconazole CAPSULE;ORAL 205724-001 Dec 13, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms ITRACONAZOLE itraconazole CAPSULE;ORAL 205080-001 Sep 26, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms ITRACONAZOLE itraconazole SOLUTION;ORAL 205573-001 Oct 30, 2015 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz ITRACONAZOLE itraconazole CAPSULE;ORAL 076104-001 May 28, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.