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Details for Generic Name: ketoconazole

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Ketoconazole is the generic ingredient in six branded drugs marketed by Delcor Asset Corp, Perrigo Israel, Fougera Pharms, Teva, Taro, Janssen Pharma, Aqua Pharms, Perrigo New York, Tolmar, Janssen Pharms, Johnson And Johnson, Aaipharma Llc, Apotex, Mutual Pharma, Mylan, and Pliva, and is included in twenty-one 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 thirty-nine patent family members in fifteen countries.

There are fifteen drug master file entries for ketoconazole. Six suppliers are listed for this compound.

Summary for Generic Name: ketoconazole

Drug Master File Entries: see list15
Suppliers: see list6
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ketoconazole

Clinical Trials for: ketoconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
SHAMPOO;TOPICAL076942-001Apr 11, 2005RXNo<disabled><disabled>
Aaipharma Llc
TABLET;ORAL075341-001Jul 27, 1999DISCNNo<disabled><disabled>
CREAM;TOPICAL075638-001Dec 18, 2002RXNo<disabled><disabled>
TABLET;ORAL074971-001Jun 15, 1999DISCNNo<disabled><disabled>
Janssen Pharma
SUSPENSION;ORAL070767-001Nov 7, 1986DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: ketoconazole

Country Document Number Publication Date
Argentina021539Jul 24, 2002
China1204923Jun 08, 2005
China1292707Apr 25, 2001
Australia2005201042Apr 07, 2005
European Patent Office1159956Dec 05, 2001
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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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