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Last Updated: June 29, 2022

XOLEGEL Drug Patent Profile


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

Xolegel is a drug marketed by Almirall and is included in one NDA.

The generic ingredient in XOLEGEL 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 Xolegel

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

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Drug patent expirations by year for XOLEGEL
Drug Prices for XOLEGEL

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Drug Sales Revenue Trends for XOLEGEL

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US Patents and Regulatory Information for XOLEGEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Almirall XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006 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 XOLEGEL

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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for XOLEGEL

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

International Patents for XOLEGEL

See the table below for patents covering XOLEGEL around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1051193 PREPARATIONS TOPIQUES ANHYDRES POUR LA PEAU COMPRENANT DU KETOCONAZOLE (ANHYDROUS TOPICAL SKIN PREPARATION COMPRISING KETOCONAZOLE) See Plans and Pricing
Taiwan 590777 See Plans and Pricing
Hong Kong 1039567 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Merck
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Moodys
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AstraZeneca

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.