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Details for Generic Name: itraconazole

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

This ingredient has eigthy-five patent family members in forty countries.

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

Summary for Generic Name: itraconazole

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
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
SOLUTION;ORAL020657-001Feb 21, 1997RXYes5,707,975<disabled> <disabled>
Merz Pharms
TABLET;ORAL022484-001Apr 29, 2010RXYes7,081,255<disabled>Y <disabled>
Amneal Pharms
SOLUTION;ORAL205573-001Oct 30, 2015RXNo<disabled><disabled>
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International Patent Family for Ingredient: itraconazole

Country Document Number Publication Date
Norway982599Nov 19, 1998
World Intellectual Property Organization (WIPO)9508993Apr 06, 1995
Russian Federation2118899Sep 20, 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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