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Last Updated: May 19, 2022

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 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 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

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SponsorPhase
Anthony Joshua, FRACPPhase 1
Prince of Wales Hospital, SydneyPhase 1
St Vincent's Hospital, SydneyPhase 1

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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
Mayne Pharma Intl TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mayne Pharma Intl TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkem Labs Ltd ITRACONAZOLE itraconazole CAPSULE;ORAL 208591-001 Jun 12, 2017 AB RX No No 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
Jubilant Generics ITRACONAZOLE itraconazole CAPSULE;ORAL 203445-001 Feb 23, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alembic Pharms Ltd ITRACONAZOLE itraconazole CAPSULE;ORAL 206741-001 Dec 13, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Annora Pharma ITRACONAZOLE itraconazole SOLUTION;ORAL 212239-001 Sep 1, 2020 AA RX 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

International Patents for itraconazole

Country Patent Number Title Estimated Expiration
Australia 2331801 See Plans and Pricing
South Korea 20210043721 이트라코나졸 조성물 및 투여형, 그리고 이것들의 사용 방법 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS AND METHODS OF USING THE SAME) See Plans and Pricing
European Patent Office 2415462 See Plans and Pricing
Japan 6757367 See Plans and Pricing
Spain 2571032 See Plans and Pricing
Brazil 112014031706 composição farmacêutica oral; forma de composição farmacêutica oral; método de redução de efeito de alimento de itraconazol em um indivíduo; método de redução de variabilidade em um mesmo indivíduo de itraconazol; método de redução de variabilidade entre indivíduos de itraconazol; método de tratamento de onicomicose; método de tratamento de uma doença ou afecção e método de tratamento de câncer See Plans and Pricing
Japan 5763735 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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