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Last Updated: March 29, 2024

KETOCONAZOLE Drug Patent Profile


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Which patents cover Ketoconazole, and when can generic versions of Ketoconazole launch?

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, Rise Pharma, 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Padagis Israel KETOCONAZOLE ketoconazole SHAMPOO;TOPICAL 076419-001 Jan 7, 2004 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms KETOCONAZOLE ketoconazole CREAM;TOPICAL 076294-001 Apr 28, 2004 AB RX No 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
Tolmar KETOCONAZOLE ketoconazole SHAMPOO;TOPICAL 076942-001 Apr 11, 2005 AB RX 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

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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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.