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Last Updated: January 27, 2021

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EXTINA Drug Profile

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

Extina is a drug marketed by Mylan and is included in one NDA.

The generic ingredient in EXTINA 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 Extina

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

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Drug patent expirations by year for EXTINA
Drug Prices for EXTINA

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Recent Clinical Trials for EXTINA

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St. Louis UniversityN/A
Stiefel, a GSK CompanyPhase 4
GlaxoSmithKlinePhase 4

See all EXTINA clinical trials

Paragraph IV (Patent) Challenges for EXTINA
Tradename Dosage Ingredient NDA Submissiondate
EXTINA AEROSOL, FOAM;TOPICAL ketoconazole 021738 2009-07-30

US Patents and Regulatory Information for EXTINA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738-001 Jun 12, 2007 AT 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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