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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, and Merz Pharms, and is included in six NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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: see list5
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for Ingredient: itraconazole

Clinical Trials for: itraconazole

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, 1997RXYes6,407,079<disabled><disabled>
CAPSULE;ORAL076104-001May 28, 2004RXNo<disabled><disabled>
Merz Pharms
TABLET;ORAL022484-001Apr 29, 2010RXYes8,591,948<disabled>Y<disabled>
Mylan Pharms Inc
CAPSULE;ORAL200463-001Jul 20, 2012RXNo<disabled><disabled>
Merz Pharms
TABLET;ORAL022484-001Apr 29, 2010RXYes8,486,456<disabled>Y<disabled>
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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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