XOLEGEL Drug Patent Profile

Which patents cover Xolegel, and when can generic versions of Xolegel launch?

Xolegel is a drug marketed by Almirall and is included in one NDA.

The generic ingredient in XOLEGEL 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 Xolegel

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

Summary for XOLEGEL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	3
Patent Applications:	4,136
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XOLEGEL
What excipients (inactive ingredients) are in XOLEGEL?	XOLEGEL excipients list
DailyMed Link:	XOLEGEL at DailyMed

See drug prices for XOLEGEL

See drug sales revenues for XOLEGEL

Recent Clinical Trials for XOLEGEL

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

Sponsor	Phase
Wake Forest University Health Sciences	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1
Mayo Clinic	Early Phase 1

See all XOLEGEL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for XOLEGEL

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 XOLEGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006		DISCN	Yes	No

Expired US Patents for XOLEGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006
Almirall	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006
Almirall	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006

EU/EMA Drug Approvals for XOLEGEL

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 XOLEGEL

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

Country	Patent Number	Title	Estimated Expiration
Austria	338538
Australia	1841200
Australia	2005201042