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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.

This drug has thirty-seven patent family members in twenty-nine countries.

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

Patents:2
Applicants:1
NDAs:3
Suppliers / Packagers: see list8

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

Concentration of Itraconazole Solution in Nasal Secretions
Status: Completed Condition: Sinusitis

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

Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
Status: Recruiting Condition: Healthy

Courtesy of ClinicalTrials.org
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
SPORANOX
itraconazole
CAPSULE;ORAL020083-001Sep 11, 1992RXYes<disabled><disabled>
Janssen Pharms
SPORANOX
itraconazole
SOLUTION;ORAL020657-001Feb 21, 1997RXYes5,707,975<disabled><disabled>
Janssen Pharms
SPORANOX
itraconazole
INJECTABLE;INJECTION020966-001Mar 30, 1999DISCNNo6,407,079<disabled><disabled>
Janssen Pharms
SPORANOX
itraconazole
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

International Patent Family for Tradename: SPORANOX

Country Document Number Publication Date
Hungary221632Dec 28, 2002
European Patent Office0721337Dec 05, 2001
Canada2170622Apr 06, 1995
African Regional IP Organization (ARIPO)630Mar 10, 1998
Singapore48826May 18, 1998
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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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