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Last Updated: July 10, 2020

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XOLEGEL Drug 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-four suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

US ANDA 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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Recent Clinical Trials for XOLEGEL

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SponsorPhase
Wake Forest University Health SciencesEarly Phase 1
National Cancer Institute (NCI)Early Phase 1
Mayo ClinicEarly Phase 1

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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   Start Trial   Start Trial   Start Trial
>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:

Mallinckrodt
Merck
Colorcon
Moodys
Harvard Business School
AstraZeneca

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