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Last Updated: June 9, 2023

EXTINA Drug Patent 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-nine suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

DrugPatentWatch® 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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Paragraph IV (Patent) Challenges for EXTINA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EXTINA Foam ketoconazole 2% 021738 1 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 AB RX Yes Yes ⤷  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 EXTINA

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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