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Last Updated: May 7, 2021

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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, Perrigo Israel, Fougera Pharms, Teva, Taro, Janssen Pharma, Almirall, Tolmar, Janssen Pharms, Kramer, Aaipharma Llc, Havix, Heritage Pharma, Strides Pharma, and Sun Pharm Industries, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for ketoconazole. Twenty-four 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
Milton S. Hershey Medical CenterEarly Phase 1
Cairo UniversityN/A
Aswan Heart CentreN/A

See all ketoconazole clinical trials

Medical Subject Heading (MeSH) Categories for ketoconazole
Paragraph IV (Patent) Challenges for KETOCONAZOLE
Tradename Dosage Ingredient NDA Submissiondate
EXTINA AEROSOL, FOAM;TOPICAL ketoconazole 021738 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
Aaipharma Llc KETOCONAZOLE ketoconazole TABLET;ORAL 075341-001 Jul 27, 1999 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Fougera Pharms KETOCONAZOLE ketoconazole CREAM;TOPICAL 076294-001 Apr 28, 2004 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Janssen Pharms NIZORAL ketoconazole SHAMPOO;TOPICAL 019927-001 Aug 31, 1990 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Heritage Pharma KETOCONAZOLE ketoconazole TABLET;ORAL 075362-001 Jun 15, 1999 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Perrigo Israel KETOCONAZOLE ketoconazole AEROSOL, FOAM;TOPICAL 091550-001 Aug 25, 2011 AT RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Heritage Pharma KETOCONAZOLE ketoconazole TABLET;ORAL 074971-001 Jun 15, 1999 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
>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 TABLET;ORAL 018533-001 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
Almirall XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006   Get Started for $10   Get Started for $10
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985   Get Started for $10   Get Started for $10
Mylan EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738-001 Jun 12, 2007   Get Started for $10   Get Started for $10
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997   Get Started for $10   Get Started for $10
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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