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Last Updated: April 24, 2024

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-seven 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 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

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

International Patents for EXTINA

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

Country Patent Number Title Estimated Expiration
Spain 2277394 ⤷  Try a Trial
Japan 2001520184 ⤷  Try a Trial
Australia 732456 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9920250 ⤷  Try a Trial
Canada 2306560 COMPOSITION ANTIFONGIQUE TOPIQUE (TOPICAL ANTIFUNGAL COMPOSITION) ⤷  Try a Trial
Japan 4917204 ⤷  Try a Trial
Portugal 1024792 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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