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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: Active, not recruiting Condition: Advanced Solid Tumors; Relapsed/Refractory Lymphoma

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

Steady-State Comparative Bioavailability Study in Prophylaxis Patients of Lozanoc® 50 mg With Sporanox® 100 mg
Status: Recruiting Condition: Neutropenia; Systemic Mycosis

A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male Volunteers
Status: Recruiting Condition: Superficial Mycoses; Dermatomycoses; Candidiasis; Histoplasmosis

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

Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas
Status: Active, not recruiting Condition: Skin Cancers; Carcinoma, Basal Cell; Skin Cancer; Basal Cell Carcinoma

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>
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Expired Patents for Tradename: SPORANOX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
SPORANOX
itraconazole
CAPSULE;ORAL020083-001Sep 11, 19924,267,179<disabled>
Janssen Pharms
SPORANOX
itraconazole
SOLUTION;ORAL020657-001Feb 21, 19974,727,064<disabled>
Janssen Pharms
SPORANOX
itraconazole
SOLUTION;ORAL020657-001Feb 21, 19974,267,179<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
JapanH09502989Mar 25, 1997
European Patent Office0721337Dec 05, 2001
Hungary9600804May 28, 1996
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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