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Last Updated: May 19, 2024

NIZORAL ANTI-DANDRUFF Drug Patent Profile


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Which patents cover Nizoral Anti-dandruff, and what generic alternatives are available?

Nizoral Anti-dandruff is a drug marketed by Kramer and is included in one NDA.

The generic ingredient in NIZORAL ANTI-DANDRUFF 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 Nizoral Anti-dandruff

A generic version of NIZORAL ANTI-DANDRUFF was approved as ketoconazole by TARO on June 15th, 1999.

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US Patents and Regulatory Information for NIZORAL ANTI-DANDRUFF

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 OTC 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

Expired US Patents for NIZORAL ANTI-DANDRUFF

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 ⤷  Try a Trial ⤷  Try a Trial
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 ⤷  Try a Trial ⤷  Try a Trial
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for NIZORAL ANTI-DANDRUFF

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 NIZORAL ANTI-DANDRUFF

See the table below for patents covering NIZORAL ANTI-DANDRUFF around the world.

Country Patent Number Title Estimated Expiration
Switzerland 644118 1-(1,3-Dioxolan-2-ylmethyl)-1H-imidazoles and -1H-1,2,4-triazoles, and salts thereof ⤷  Try a Trial
Kenya 3270 1-(1,3-DIOXOLAN-2-YLMETHYL)-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES ⤷  Try a Trial
New Zealand 186275 2-PHENYL-2-(1HIMIDAZOL-OR 1H-1,2,4-TRIAZOL)-1-YL-METHYL)-13-DIOXOLAN-4-YL GROUP DERIVATIVES AND ANTIFUNGAL AND ANTIBACTERIAL COMPOSITIONS ⤷  Try a Trial
Luxembourg 78960 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9527471 ⤷  Try a Trial
Spain 465981 ⤷  Try a Trial
South Africa 9502856 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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