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Tradename: SPORANOX

Summary for Tradename: SPORANOX

Patents:3
Applicants:1
NDAs:3
Suppliers: see list4
drug
patent expirations by year for
 SPORANOX

Pharmacology for Tradename: SPORANOX

Ingredient-typeAzoles
Drug ClassAzole Antifungal

Clinical Trials for: SPORANOX

Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
Status: Completed Condition: Onychomycosis, Toenail Onychomychosis, Toenail Fungus.

The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants
Status: Completed Condition: Hematologic Neoplasms; Neutropenia; Fever

Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis
Status: Completed Condition: Onychomycosis

A Study to Assess the Interaction Between ASP1707 and Itraconazole in Healthy Female Subjects
Status: Completed Condition: Pharmacokinetics; DDI (Drug-Drug Interaction); Healthy Subjects

A Randomized Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous Non-Small Cell Lung Cancer
Status: Terminated Condition: Recurrent Non Small Cell Lung Cancer

A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy
Status: Completed Condition: Prostate Cancer

Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
Status: Completed Condition: Renal Insufficiency, Chronic; Hepatic Insufficiency; Healthy

Long-term Versus Short-term Sequential Therapy (Intravenous Itraconazole Followed by Oral Solution) of Itraconazole as Primary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation
Status: Recruiting Condition: Hematological Diseases; Allogeneic Stem Cell Transplantation

A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer
Status: Active, not recruiting Condition: Breast Neoplasms; Neoplasm Metastasis

A Study of Empirical Antifungal Therapy With Itraconazole
Status: Completed Condition: Neutropenia

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
Janssen Pharms
SPORANOX
itraconazole
CAPSULE;ORAL020083Sep 11, 1992RXYes5,633,015<disabled><disabled>
Janssen Pharms
SPORANOX
itraconazole
INJECTABLE;INJECTION020966Mar 30, 1999DISCNNo6,407,079<disabled><disabled>
Janssen Pharms
SPORANOX
itraconazole
SOLUTION;ORAL020657Feb 21, 1997RXYes5,707,975<disabled><disabled>
Janssen Pharms
SPORANOX
itraconazole
SOLUTION;ORAL020657Feb 21, 1997RXYes6,407,079<disabled><disabled>
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Paragraph IV activity for: SPORANOX

Drugname Dosage Strength RLD Submissiondate
itraconazoleOral Solution10 mg/mLSporanox5/3/2013

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