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Last Updated: September 25, 2021

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KETOCONAZOLE Drug Patent Profile


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Which patents cover Ketoconazole, and what generic alternatives are available?

Ketoconazole is a drug marketed by Perrigo Israel, Xiromed, Encube, Fougera Pharms, Teva, Tolmar, Aaipharma Llc, Havix, Heritage Pharma, Mylan, Strides Pharma, Sun Pharm Industries, and Taro. and is included in sixteen NDAs.

The generic ingredient in KETOCONAZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ketoconazole

A generic version of KETOCONAZOLE was approved as ketoconazole by TARO on June 15th, 1999.

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Drug patent expirations by year for KETOCONAZOLE
Drug Prices for KETOCONAZOLE

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Drug Sales Revenue Trends for KETOCONAZOLE

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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
Perrigo Israel KETOCONAZOLE ketoconazole AEROSOL, FOAM;TOPICAL 091550-001 Aug 25, 2011 AT RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Tolmar KETOCONAZOLE ketoconazole SHAMPOO;TOPICAL 076942-001 Apr 11, 2005 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Fougera Pharms KETOCONAZOLE ketoconazole CREAM;TOPICAL 076294-001 Apr 28, 2004 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan KETOCONAZOLE ketoconazole TABLET;ORAL 075597-001 Dec 23, 1999 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Aaipharma Llc KETOCONAZOLE ketoconazole TABLET;ORAL 075341-001 Jul 27, 1999 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva KETOCONAZOLE ketoconazole TABLET;ORAL 075273-001 Jun 15, 1999 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharm Industries KETOCONAZOLE ketoconazole TABLET;ORAL 075314-001 Jun 15, 1999 DISCN 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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Moodys
Merck
Johnson and Johnson
McKinsey

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