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Last Updated: June 21, 2024

KETOCONAZOLE Drug Patent Profile


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

Ketoconazole is a drug marketed by Padagis Israel, Xiromed, Encube, Fougera Pharms, Tasman Pharma, Teva, Tolmar, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, Sun Pharm Industries, and Taro. and is included in seventeen NDAs.

The generic ingredient in KETOCONAZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-seven 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 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
Padagis Israel KETOCONAZOLE ketoconazole AEROSOL, FOAM;TOPICAL 091550-001 Aug 25, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Padagis Israel KETOCONAZOLE ketoconazole SHAMPOO;TOPICAL 076419-001 Jan 7, 2004 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fougera Pharms KETOCONAZOLE ketoconazole CREAM;TOPICAL 076294-001 Apr 28, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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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