Ketoconazole - Generic Drug Details

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What are the generic sources for ketoconazole and what is the scope of patent protection?

Ketoconazole is the generic ingredient in six branded drugs marketed by Norvium Bioscience, Padagis Israel, Xiromed, Encube, Fougera Pharms, Teva, Trupharma, Taro, Janssen Pharma, Almirall, Cosette, Novitium Pharma, Janssen Pharms, Kramer, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, and Sun Pharm Industries, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for ketoconazole. Twenty-eight suppliers are listed for this compound.

Summary for ketoconazole

US Patents:	0
Tradenames:	6
Applicants:	21
NDAs:	26
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	243
Patent Applications:	7,388
Drug Prices:	Drug price trends for ketoconazole
Drug Sales Revenues:	Drug sales revenues for ketoconazole
What excipients (inactive ingredients) are in ketoconazole?	ketoconazole excipients list
DailyMed Link:	ketoconazole at DailyMed

See drug prices for ketoconazole

Drug Sales Revenue Trends for ketoconazole

See drug sales revenues for ketoconazole

Recent Clinical Trials for ketoconazole

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

Sponsor	Phase
Fernando De la Garza Salazar	Phase 2
Hospital Universitario Dr. Jose E. Gonzalez	Phase 2
Universitas Padjadjaran	Phase 4

See all ketoconazole clinical trials

Pharmacology for ketoconazole

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

Medical Subject Heading (MeSH) Categories for ketoconazole

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP3A Inhibitors

Paragraph IV (Patent) Challenges for KETOCONAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXTINA	Foam	ketoconazole	2%	021738	1	2009-07-30

US Patents and Regulatory Information for ketoconazole

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharma	NIZORAL	ketoconazole	CREAM;TOPICAL	019084-001	Dec 31, 1985		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	KETOCONAZOLE	ketoconazole	CREAM;TOPICAL	075581-001	Apr 25, 2000	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	KETOZOLE	ketoconazole	CREAM;TOPICAL	075638-001	Dec 18, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	KETOCONAZOLE	ketoconazole	AEROSOL, FOAM;TOPICAL	091550-001	Aug 25, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	KETOCONAZOLE	ketoconazole	TABLET;ORAL	074971-001	Jun 15, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 ketoconazole

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	NIZORAL	ketoconazole	TABLET;ORAL	018533-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997	⤷ Sign Up	⤷ Sign Up
Norvium Bioscience	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	⤷ Sign Up	⤷ Sign Up
Janssen Pharma	NIZORAL	ketoconazole	CREAM;TOPICAL	019084-001	Dec 31, 1985	⤷ Sign Up	⤷ Sign Up
Almirall	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ketoconazole

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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