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Details for Generic Name: ketoconazole

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Ketoconazole is the generic ingredient in six branded drugs marketed by Delcor Asset Corp, Perrigo Israel, Fougera Pharms, Teva, Taro, Janssen Pharma, Aqua Pharms, Perrigo New York, Tolmar, Janssen Pharms, Johnson And Johnson, Aaipharma Llc, Apotex, Mutual Pharma, Mylan, and Pliva, and is included in twenty-one NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-nine patent family members in fifteen countries.

There are fifteen drug master file entries for ketoconazole. Six suppliers are listed for this compound.

Summary for Generic Name: ketoconazole

Tradenames:6
Patents:5
Applicants:16
NDAs:21
Drug Master File Entries: see list15
Suppliers: see list6
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ketoconazole

Clinical Trials for: ketoconazole

Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally.
Status: Completed Condition: Asthma,; Pharmacokinetics,; Cmax,; Tmax,; λz,; AUC,; Ketoconazole,; Metabolite

Ketoconazole Foam 2% for the Treatment of Versicolor
Status: Completed Condition: Tinea Versicolor

Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy
Status: Active, not recruiting Condition: Prostate Cancer

Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects
Status: Completed Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ketoconazole; Healthy Adult Volunteers

Drug-drug Interaction Study (CKD-501, Ketoconazole)
Status: Completed Condition: Type 2 Diabetes Mellitus

Ketoconazole and Dexamethasone in Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex
Status: Completed Condition: Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4; Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4; Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19 Inhibitor.

Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer
Status: Completed Condition: Prostate Cancer

An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot
Status: Terminated Condition: Tinea Pedis

A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).
Status: Completed Condition: Lymphoma; Chronic Lymphocytic Leukemia; Solid Tumors

A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults
Status: Completed Condition: Healthy Subjects; Nausea and Vomiting, Chemotherapy-Induced

Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649
Status: Completed Condition: Healthy

177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Status: Recruiting Condition: Prostate Cancer

Effect of Ketoconazole on the Pharmacokinetics of JNJ-38518168 in Healthy Volunteers
Status: Completed Condition: Healthy

A Study to Assess the Potential Effects of Ketoconazole on the Pharmacokinetics of Trabectedin in Patients With Advanced Malignancies
Status: Completed Condition: Neoplasm Metastases

Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics
Status: Completed Condition: Pharmacokinetics

Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects
Status: Completed Condition: Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects

Drug Interaction Study to Investigate Co-administration of GW642444M With Ketoconazole
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive; Healthy Subjects

Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Status: Completed Condition: Healthy

VEG113971: An Open-Label Study of the Effects of Ketoconazole or Esomeprazole on Pazopanib PK
Status: Completed Condition: Cancer

Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole
Status: Completed Condition: Healthy

Docetaxel Combined With Ketoconazole in Treatment of Breast Cancer
Status: Completed Condition: Metastatic Breast Cancer

A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men
Status: Completed Condition: Healthy Volunteers

Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769]
Status: Completed Condition: Healthy Subjects; Nausea and Vomiting, Chemotherapy-Induced

Optimizing the Treatment of Toenail Onychomycosis Using a New Transdermal Patch Combined With Terbinafine/Ketoconazole
Status: Recruiting Condition: Onychomycosis

Ketoconazole as Inhibitor of the Enzyme CYP17 in Locally Advanced or Disseminated Granulosa Cell Tumour of Ovary
Status: Terminated Condition: Granulosa Cell Tumour of the Ovary

A Drug Interaction Study With Fluticasone Furoate/GW642444 Inhalation Powder and Ketoconazole
Status: Completed Condition: Asthma

To Evaluate if Multiple Doses of Ketoconazole Change the Blood Concentration of YM150 (Darexaban)
Status: Completed Condition: Pharmacokinetics of Darexaban and Metabolites; Healthy Subjects

A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
Status: Completed Condition: Chronic Central Serous Chorioretinopathy

Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
Status: Recruiting Condition: Ovarian Cancer; Cancer of Ovary; Cancer of the Ovary; Ovary Neoplasms; Primary Peritoneal Carcinoma

Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.
Status: Completed Condition: Healthy

Safety and Efficacy of Ketoconazole 2% Foam in the Treatment of Pityrosporum Folliculitis
Status: Completed Condition: Pityrosporum Folliculitis

An Interaction Study of Ketoconazole/Verapamil Versus AZD1305
Status: Completed Condition: Healthy

Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole
Status: Completed Condition: Alzheimer Disease

A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers
Status: Completed Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
Status: Completed Condition: Seborrheic Dermatitis

STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%
Status: Completed Condition: Dermatitis, Seborrheic

A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants
Status: Completed Condition: Healthy

A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers
Status: Completed Condition: Healthy; Pharmacokinetics; Drug Interactions

Effect of Ketoconazole Inhibition of CYP3A on Urinary Excretion of Docetaxel
Status: Completed Condition: Solid Tumors

CC-223 and Ketoconazole Drug-Drug Interaction Study
Status: Completed Condition: Healthy Volunteers

Drug-Drug Interaction Study Between Colchicine and Ketoconazole
Status: Completed Condition: Pharmacokinetics

Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours
Status: Completed Condition: Advanced Solid Tumors

A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)
Status: Completed Condition: Solid Tumors

To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil
Status: Completed Condition: Erectile Dysfunction

Effect of Ketoconazole on the Pharmacokinetics of Vinflunine
Status: Completed Condition: Cancer

Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers
Status: Completed Condition: Healthy

A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors
Status: Completed Condition: Cancer

Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers
Status: Completed Condition: Healthy

Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study
Status: Active, not recruiting Condition: Prostate Cancer

Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics
Status: Completed Condition: Pharmacokinetics

Trial of GM-CSF Given in Combination With Ketoconazole and Mitoxantrone in Patients With Progressive Prostate Cancer
Status: Terminated Condition: Prostatic Neoplasms

A Study to Evaluate the Relative Bioavailability, Food Effect and Effect of Ketoconazole on the Rate and Extent of Absorption of Solid Dosage Formulation(s) of JNJ-40411813
Status: Completed Condition: Healthy

Expanded Access Study of Fenretinide Lym-X-Sorb Plus Ketoconazole in Neuroblastoma
Status: Available Condition: Recurrent Neuroblastoma; Neuroblastoma

Influence of Ketoconazole on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer
Status: Completed Condition: Hematologic Malignancy; Malignant Lymphoma

Relative Bioavailability of Single Doses of Dabigatran Etexilate When Administered Alone or in Combination With a Single Dose of Ketoconazole or in Combination With q.d. Ketoconazole at Steady State in Healthy Male and Female Volunteers
Status: Completed Condition: Healthy

Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers
Status: Completed Condition: Healthy

Study Of The Repeat Dosing Of Ketoconazole On The Pharmacokinetics Of A Single Dose Of Pazopanib (GW786034) Eye Drops
Status: Completed Condition: Macular Degeneration; Age-related Macular Degeneration

Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors
Status: Active, not recruiting Condition: Unspecified Adult Solid Tumor, Protocol Specific

Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
Status: Completed Condition: Prostate Cancer

A Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Adult Volunteers
Status: Completed Condition: Healthy Subjects; Pharmacokinetics of YM178

Effect of Ketoconazole on Breathlessness
Status: Completed Condition: Chronic Obstructive Pulmonary Disease

Effect of Ketoconazole on the Pharmacokinetics of Refametinib
Status: Completed Condition: Drug Interactions

A Study of The Effects of Multiple Doses of Ketoconazole on Single Dose Pharmacokinetics of RO4602522 in Healthy Male Volunteers
Status: Completed Condition: Healthy Volunteer

A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
Status: Completed Condition: Healthy Volunteer

Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118
Status: Completed Condition: Bioavailability; Healthy Volunteers; Drug- Drug Interactions

Fenretinide Lym-X-Sorb + Ketoconazole + Vincristine for Recurrent or Resistant Neuroblastoma
Status: Recruiting Condition: Recurrent Neuroblastoma; Neuroblastoma

Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers
Status: Completed Condition: Healthy

GSK962040 Drug-drug Interaction Study With Ketoconazole
Status: Completed Condition: Healthy Volunteer; Gastroparesis

Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants
Status: Completed Condition: Healthy Volunteers

A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-199
Status: Completed Condition: Non-Hodgkin's Lymphoma

Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796
Status: Completed Condition: Healthy

Phase 0 Microdose Study
Status: Completed Condition: Healthy

Evaluating the Pharmacokinetics and Tolerance of Co-administration of Oral Multiple Dose of Ketoconazole and an IV (Bolus) Infusion of Eribulin in Patients With Advanced Solid Tumors
Status: Completed Condition: Cancer

A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
Status: Withdrawn Condition: Malignant Melanoma, Neoplasms

A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects
Status: Completed Condition: Human Volunteers

A Phase I Study To Estimate The Effect Of Ketoconazole And Omeprazole On The Pharmacokinetics Of Dimebon In Healthy Subjects Who Are Normal Or Poor CYP2D6 Metabolizers
Status: Completed Condition: Alzheimer's Disease; Huntington's Disease

The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream
Status: Completed Condition: Healthy Volunteers

Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812
Status: Completed Condition: Schizophrenia; Healthy Subjects

Study to Investigate the Effect of Ketoconazole Mediated CYP3A4 Inhibition on Pharmacokinetics of Tamsulosin in Healthy Male Volunteers
Status: Completed Condition: Healthy

Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
Status: Withdrawn Condition: Prostate Cancer

A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole
Status: Completed Condition: Obstetric Labour, Premature

ITT4 Intratesticular Hormonal Milieu in Man (ITT4)
Status: Completed Condition: Healthy Males

A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Status: Completed Condition: Essential Hypertension

Relative Bioavailability of of Olodaterol and Ketoconazole
Status: Completed Condition: Healthy; Pulmonary Disease, Chronic Obstructive

Effect of Ketoconazole on Biliary Excretion of AZD0837
Status: Completed Condition: Healthy

A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
Status: Completed Condition: Candidiasis, Esophageal; HIV Infections

Evaluation of Pharmacokinetic Interaction of Indacaterol With Ketoconazole in Healthy Adult Subjects
Status: Completed Condition: Healthy

Calcitriol, Ketoconazole, and Dexamethasone in Treating Patients With Metastatic or Unresectable Solid Tumors
Status: Completed Condition: Unspecified Adult Solid Tumor, Protocol Specific

ITT-5 Mechanisms of Spermatogenesis
Status: Not yet recruiting Condition: Gonadotropin Deficiency

Calcitriol, Ketoconazole, and Hydrocortisone in Treating Patients With Advanced or Recurrent Prostate Cancer
Status: Recruiting Condition: Prostate Cancer

A Phase 1 Study to Evaluate The Effect of Ketoconazole on the Pharmacokinetics of Tivozanib in Healthy Subjects
Status: Completed Condition: Healthy

Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects
Status: Completed Condition: Healthy

Phase 1 Pharmacokinetics Study of Oral IXAZOMIB in Patients With Advanced Nonhematologic Malignancies or Lymphoma
Status: Active, not recruiting Condition: Nonhematologic Malignancies; Lymphoma

GSK239512 DDI Study
Status: Completed Condition: Multiple Sclerosis

Study of Dasatinib in Patients With Advanced Solid Tumors
Status: Terminated Condition: Tumors

Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers
Status: Completed Condition: Pharmacokinetics

A Phase 1/2a Study of the 2S,4R Enantiomer of Ketoconazole in Subjects With Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes

Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
Status: Not yet recruiting Condition: Candidiasis; Bacterial Vaginosis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pliva
KETOCONAZOLE
ketoconazole
TABLET;ORAL075362-001Jun 15, 1999DISCNNo<disabled><disabled>
Janssen Pharms
NIZORAL
ketoconazole
SHAMPOO;TOPICAL019927-001Aug 31, 1990RXYes<disabled><disabled>
Aqua Pharms
XOLEGEL
ketoconazole
GEL;TOPICAL021946-001Jul 28, 2006RXYes7,179,475<disabled>Y<disabled>
Aqua Pharms
XOLEGEL
ketoconazole
GEL;TOPICAL021946-001Jul 28, 2006RXYes8,232,276<disabled>Y<disabled>
Taro
KETOZOLE
ketoconazole
CREAM;TOPICAL075638-001Dec 18, 2002RXNo<disabled><disabled>
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International Patent Family for Ingredient: ketoconazole

Country Document Number Publication Date
Japan2001520184Oct 30, 2001
AustraliaPP121798Jan 29, 1998
Spain2272416May 01, 2007
Germany69930004Apr 27, 2006
European Patent Office1692951Aug 23, 2006
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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