Deep knowledge on
small-molecule drugs and
the 90,000 global patents
covering them

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

DrugPatentWatch Ultimate Plan Preview

Profile for Tradename: SPORANOX

« Back to Dashboard
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

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

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

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

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
SOLUTION;ORAL020657-001Feb 21, 1997RXYes5,707,975<disabled> <disabled>
Janssen Pharms
INJECTABLE;INJECTION020966-001Mar 30, 1999DISCNNo6,407,079<disabled> <disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
Norway308985Nov 27, 2000
Hungary221632Dec 28, 2002
Singapore48826May 18, 1998
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013   2014  

For more information try a trial or see the database preview and plan comparison

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 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

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

Connect with Social Media:

Follow DrugPatentWatch on Twitter
Connect with DrugPatentWatch on Linkedin
Drug Patents on LinkedIn