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Last Updated: October 29, 2020

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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 Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Janssen Pharms, Mayne Pharma Intl, 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 thirty-seven patent family members in twelve countries.

There are fifteen drug master file entries for itraconazole. Twenty-two 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
Kafrelsheikh UniversityPhase 2
Taisho Pharmaceutical Co., Ltd.Phase 1
Impact Therapeutics, Inc.Phase 1

See all itraconazole clinical trials

Medical Subject Heading (MeSH) Categories for itraconazole
Paragraph IV (Patent) Challenges for ITRACONAZOLE
Tradename Dosage Ingredient NDA Submissiondate
SPORANOX SOLUTION;ORAL itraconazole 020657 2013-05-03
SPORANOX CAPSULE;ORAL itraconazole 020083

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
Sandoz ITRACONAZOLE itraconazole CAPSULE;ORAL 076104-001 May 28, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Mayne Pharma Intl TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Par Pharm Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 205724-001 Dec 13, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex ITRACONAZOLE itraconazole SOLUTION;ORAL 208481-001 Aug 2, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Strides Pharma ITRACONAZOLE itraconazole CAPSULE;ORAL 206410-001 Jul 2, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd ITRACONAZOLE itraconazole CAPSULE;ORAL 206741-001 Dec 13, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 200463-001 Jul 20, 2012 AB RX No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992   Start Trial   Start Trial
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997   Start Trial   Start Trial
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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