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Last Updated: May 21, 2022

NIZORAL Drug Patent Profile


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

Nizoral is a drug marketed by Janssen Pharma, Janssen Pharms, and Kramer. and is included in five NDAs.

The generic ingredient in NIZORAL is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nizoral

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

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US Patents and Regulatory Information for NIZORAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms NIZORAL ketoconazole TABLET;ORAL 018533-001 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms NIZORAL ketoconazole SHAMPOO;TOPICAL 019927-001 Aug 31, 1990 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharma NIZORAL ketoconazole SUSPENSION;ORAL 070767-001 Nov 7, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kramer NIZORAL ANTI-DANDRUFF ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms NIZORAL ketoconazole SHAMPOO;TOPICAL 019927-001 Aug 31, 1990 See Plans and Pricing See Plans and Pricing
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985 See Plans and Pricing See Plans and Pricing
Janssen Pharms NIZORAL ketoconazole SHAMPOO;TOPICAL 019927-001 Aug 31, 1990 See Plans and Pricing See Plans and Pricing
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985 See Plans and Pricing See Plans and Pricing
Janssen Pharms NIZORAL ketoconazole TABLET;ORAL 018533-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NIZORAL

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

Country Patent Number Title Estimated Expiration
Italy 7847837 See Plans and Pricing
Israel 53923 4-PHENOXYMETHYL-2-PHENYL-2-IMIDAZOLYL-(OR1,2,4-TRIAZOLYL)METHYL-1,3-DIOXOLANE DERIVATIVES,THEIR PREPARATION AND ANTIBACTERIAL AND ANTIFUNGAL COMPOSITIONS CONTAINING THEM See Plans and Pricing
Yugoslavia 40319 See Plans and Pricing
Australia 3285078 See Plans and Pricing
Norway 148643 See Plans and Pricing
Spain 465981 See Plans and Pricing
United Kingdom 1594859 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Baxter
Mallinckrodt
Boehringer Ingelheim
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.