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Profile for Tradename: SPORANOX

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Sporanox is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from four suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in SPORANOX is itraconazole. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for Tradename: SPORANOX

Suppliers: see list4

Pharmacology for Tradename: SPORANOX

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

A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Status: Recruiting Condition: Advanced Solid Tumors; Relapsed/Refractory Lymphoma

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

Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules
Status: Completed Condition: Onychomycosis, Toe

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

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

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

Topical Itraconazole in the Treatment of Basal Cell Carcinoma
Status: Recruiting Condition: Basal Cell Carcinoma

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

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
CAPSULE;ORAL020083-001Sep 11, 1992RXYes<disabled><disabled>
Janssen Pharms
INJECTABLE;INJECTION020966-001Mar 30, 1999DISCNNo6,407,079<disabled><disabled>
Janssen Pharms
SOLUTION;ORAL020657-001Feb 21, 1997RXYes5,707,975<disabled><disabled>
Janssen Pharms
SOLUTION;ORAL020657-001Feb 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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Preferred citation:

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

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