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Last Updated: July 13, 2024

Itraconazole - Generic Drug Details


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What are the generic 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, Rising, 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. Eighteen 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
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
Strides Pharma ITRACONAZOLE itraconazole CAPSULE;ORAL 206410-001 Jul 2, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd ITRACONAZOLE itraconazole CAPSULE;ORAL 208591-001 Jun 12, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic ITRACONAZOLE itraconazole CAPSULE;ORAL 206741-001 Dec 13, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 AB RX Yes Yes ⤷  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

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 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999 ⤷  Sign Up ⤷  Sign Up
>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
China 104507480 Itraconazole compositions and dosage forms, and methods of using the same ⤷  Sign Up
European Patent Office 1912625 COMPOSITIONS D'ITRACONAZOLE PRESENTANT UNE BIODISPONIBILITE AMELIOREE (ITRACONAZOLE COMPOSITIONS WITH IMPROVED BIOAVAILABILITY) ⤷  Sign Up
Japan 2014062110 ITRACONAZOLE COMPOSITION WITH IMPROVED BIOAVAILABILITY ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2007017248 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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