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Last Updated: January 27, 2023

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, Annora Pharma, Apotex, and Sebela Ireland Ltd, and is included in nineteen NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Itraconazole has thirty-eight patent family members in twelve countries.

There are fifteen drug master file entries for itraconazole. Twenty-one 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
Jiangsu Simcere Pharmaceutical Co., Ltd.Phase 1
VA Puget Sound Health Care SystemPhase 2
Portland VA Medical CenterPhase 2

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
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mylan Pharms Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 200463-001 Jul 20, 2012 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997 See Plans and Pricing See Plans and Pricing
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 See Plans and Pricing See Plans and Pricing
>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

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