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NIZORAL Drug 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-four 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
Bulk Api Vendors:	35
Clinical Trials:	16
Patent Applications:	1,438
Formulation / Manufacturing:	see details
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
Douglas Pharmaceuticals America Ltd	Phase 1
Los Angeles Biomedical Research Institute	Early Phase 1
Wake Forest University Health Sciences	Early Phase 1

See all NIZORAL clinical trials

Pharmacology for NIZORAL

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors

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 A-D	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 Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990
Janssen Pharma	NIZORAL	ketoconazole	CREAM;TOPICAL	019084-001	Dec 31, 1985
Janssen Pharms	NIZORAL	ketoconazole	TABLET;ORAL	018533-001	Approved Prior to Jan 1, 1982
Janssen Pharma	NIZORAL	ketoconazole	CREAM;TOPICAL	019084-001	Dec 31, 1985
Janssen Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990

International Patents for NIZORAL

Country	Patent Number	Estimated Expiration
Switzerland	644118
Yugoslavia	40319
Greece	62553
Latvia	5015
Sweden	7801088