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Last Updated: October 23, 2021

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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 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

See drug prices for itraconazole

Recent Clinical Trials for itraconazole

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sunshine Lake Pharma Co., Ltd.Phase 1
Montreal Heart InstitutePhase 2
Kyorin Pharmaceutical Co.,LtdPhase 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
Apotex ITRACONAZOLE itraconazole SOLUTION;ORAL 208481-001 Aug 2, 2019 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Par Pharm Inc ITRACONAZOLE itraconazole CAPSULE;ORAL 205724-001 Dec 13, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Alkem Labs Ltd ITRACONAZOLE itraconazole CAPSULE;ORAL 208591-001 Jun 12, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ⤷  Try it Free ⤷  Try it Free
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
McKinsey
Baxter
Medtronic
McKesson

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