NIZORAL Drug Patent Profile

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-eight 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 15^th, 1999.

Summary for NIZORAL

US Patents:	0
Applicants:	3
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	34
Patent Applications:	1,512
Drug Prices:	Drug price information for NIZORAL
What excipients (inactive ingredients) are in NIZORAL?	NIZORAL excipients list
DailyMed Link:	NIZORAL at DailyMed

See drug prices for NIZORAL

See drug sales revenues for NIZORAL

Recent Clinical Trials for NIZORAL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hospital Universitario Dr. Jose E. Gonzalez	Phase 2
Fernando De la Garza Salazar	Phase 2
Milton S. Hershey Medical Center	Early Phase 1

See all NIZORAL clinical trials

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
Janssen Pharms	NIZORAL	ketoconazole	TABLET;ORAL	018533-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Janssen Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990		DISCN	Yes	No
Janssen Pharma	NIZORAL	ketoconazole	SUSPENSION;ORAL	070767-001	Nov 7, 1986		DISCN	No	No
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997		OTC	Yes	Yes

Expired US Patents for NIZORAL

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

EU/EMA Drug Approvals for NIZORAL

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

International Patents for NIZORAL

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

Country	Patent Number	Title	Estimated Expiration
Germany	2804096
Norway	780335
South Africa	7800548
Cyprus	1192	1-(1,3-DIOXOLAN-2-YL-METHYL)-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES
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
Canada	1094559	1-(1,3 DIOXOLAN-2-YLMETHYL)-1H-IMIDAZOLES ET 1H-1,2,4- TRIAZOLES (1-(1,3-DIOXOLAN-2-YLMETHYL)-1H-IMIDAZOLES AND 1H-1,2, 4-TRIAZOLES)