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-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 15^th, 1999.

Summary for NIZORAL

US Patents:	0
Applicants:	3
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	33
Patent Applications:	1,465
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
Milton S. Hershey Medical Center	Early Phase 1
Douglas Pharmaceuticals America Ltd	Phase 3
Novum Pharmaceutical Research Services	Phase 3

See all NIZORAL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NIZORAL

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

H02CA	Anticorticosteroids
H02C	ANTIADRENAL PREPARATIONS
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

J02AB	Imidazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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 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	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

International Patents for NIZORAL

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

Country	Patent Number	Title	Estimated Expiration
Italy	7847837
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
Yugoslavia	40319
Australia	3285078
Norway	148643
Spain	465981
United Kingdom	1594859