You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

xolegel Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

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-seven 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.

  Try a Trial

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 DISCN Yes 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

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 ⤷  Try a Trial ⤷  Try a Trial
Almirall XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
Almirall XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
>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
China 1714869 ⤷  Try a Trial
Portugal 1051193 ⤷  Try a Trial
Denmark 1051193 ⤷  Try a Trial
Spain 2258347 ⤷  Try a Trial
China 100341578 ⤷  Try a Trial
Argentina 021539 PREPARACIONES TOPICAS ANHIDRAS PARA LA PIEL ⤷  Try a Trial
Taiwan 590777 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.