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Last Updated: May 25, 2022

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, 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-five 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
China National Center for Cardiovascular DiseasesPhase 4
Chinese Academy of Medical Sciences, Fuwai HospitalPhase 4
Vanderbilt University Medical CenterPhase 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
Janssen Pharms NIZORAL ketoconazole SHAMPOO;TOPICAL 019927-001 Aug 31, 1990 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fougera Pharms KETOCONAZOLE ketoconazole CREAM;TOPICAL 076294-001 Apr 28, 2004 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharma NIZORAL ketoconazole SUSPENSION;ORAL 070767-001 Nov 7, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Xiromed KETOCONAZOLE ketoconazole AEROSOL, FOAM;TOPICAL 213601-001 May 21, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aaipharma Llc KETOCONAZOLE ketoconazole TABLET;ORAL 075341-001 Jul 27, 1999 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro KETOCONAZOLE ketoconazole TABLET;ORAL 075319-001 Jun 15, 1999 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738-001 Jun 12, 2007 AB RX Yes Yes 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 ketoconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Almirall XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006 See Plans and Pricing See Plans and Pricing
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985 See Plans and Pricing See Plans and Pricing
Mylan EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738-001 Jun 12, 2007 See Plans and Pricing See Plans and Pricing
Almirall XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006 See Plans and Pricing See Plans and Pricing
Almirall XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006 See Plans and Pricing See Plans and Pricing
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 See Plans and Pricing See Plans and Pricing
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.