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Details for Generic Name: itraconazole

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Itraconazole is the generic ingredient in three branded drugs marketed by Sandoz, Janssen Pharms, Mylan Pharms Inc, Amneal Pharms, and Merz Pharms, and is included in seven NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-eight patent family members in thirty-three countries.

There are fifteen drug master file entries for itraconazole. Five suppliers are listed for this compound.

Summary for Generic Name: itraconazole

Tradenames:3
Patents:5
Applicants:5
NDAs:7
Drug Master File Entries: see list15
Suppliers / Packaging: see list9
Therapeutic Class:Antifungals

Pharmacology for Ingredient: itraconazole

Clinical Trials for: itraconazole

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

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

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

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 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
Merz Pharms
ONMEL
itraconazole
TABLET;ORAL022484-001Apr 29, 2010RXYes7,081,255<disabled>Y <disabled>
Merz Pharms
ONMEL
itraconazole
TABLET;ORAL022484-001Apr 29, 2010RXYes8,591,948<disabled>Y <disabled>
Janssen Pharms
SPORANOX
itraconazole
INJECTABLE;INJECTION020966-001Mar 30, 1999DISCNNo6,407,079<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: itraconazole

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
SPORANOX
itraconazole
SOLUTION;ORAL020657-001Feb 21, 19974,267,179<disabled>
Janssen Pharms
SPORANOX
itraconazole
CAPSULE;ORAL020083-001Sep 11, 19924,267,179<disabled>
Janssen Pharms
SPORANOX
itraconazole
INJECTABLE;INJECTION020966-001Mar 30, 19994,791,111<disabled>
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International Patent Family for Ingredient: itraconazole

Country Document Number Publication Date
Slovakia84898Mar 10, 1999
Japan2009504589Feb 05, 2009
Japan5763735Aug 12, 2015
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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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