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Last Updated: May 19, 2024

Ketoconazole - Generic Drug Details


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What are the generic sources for ketoconazole and what is the scope of patent protection?

Ketoconazole is the generic ingredient in six branded drugs marketed by Mylan, Padagis Israel, Xiromed, Encube, Fougera Pharms, Tasman Pharma, Teva, Taro, Janssen Pharma, Almirall, Tolmar, Janssen Pharms, Kramer, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, and Sun Pharm Industries, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for ketoconazole. Twenty-seven suppliers are listed for this compound.

Drug Prices for ketoconazole

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Drug Sales Revenue Trends for ketoconazole

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Recent Clinical Trials for ketoconazole

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

SponsorPhase
Fernando De la Garza SalazarPhase 2
Hospital Universitario Dr. Jose E. GonzalezPhase 2
Maria Sklodowska-Curie National Research Institute of OncologyPhase 2

See all ketoconazole clinical trials

Medical Subject Heading (MeSH) Categories for ketoconazole
Paragraph IV (Patent) Challenges for KETOCONAZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EXTINA Foam ketoconazole 2% 021738 1 2009-07-30

US Patents and Regulatory Information for ketoconazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva KETOCONAZOLE ketoconazole CREAM;TOPICAL 075581-001 Apr 25, 2000 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma KETOCONAZOLE ketoconazole TABLET;ORAL 210457-001 Jun 18, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tasman Pharma KETOCONAZOLE ketoconazole CREAM;TOPICAL 215185-001 Nov 17, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Almirall XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heritage Pharma KETOCONAZOLE ketoconazole TABLET;ORAL 075362-001 Jun 15, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Industries KETOCONAZOLE ketoconazole TABLET;ORAL 075314-001 Jun 15, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ketoconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms NIZORAL ketoconazole SHAMPOO;TOPICAL 019927-001 Aug 31, 1990 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms NIZORAL ketoconazole SHAMPOO;TOPICAL 019927-001 Aug 31, 1990 ⤷  Try a Trial ⤷  Try a Trial
Mylan EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738-001 Jun 12, 2007 ⤷  Try a Trial ⤷  Try a Trial
Almirall XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms NIZORAL ketoconazole TABLET;ORAL 018533-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ketoconazole

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
HRA Pharma Rare Diseases Ketoconazole HRA ketoconazole EMEA/H/C/003906
Ketoconazole HRA is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.
Authorised no no yes 2014-11-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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