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Generated: May 24, 2017

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Ketoconazole - Generic Drug Details

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What are the generic drug sources for ketoconazole and what is the scope of ketoconazole freedom to operate?

Ketoconazole
is the generic ingredient in six branded drugs marketed by Johnson And Johnson, Apotex, Sun Pharm Inds, Perrigo New York, Taro, Janssen Pharms, Mylan Pharms Inc, Aaipharma Llc, Tolmar, Aqua Pharms, Perrigo Israel, Pliva, Janssen Pharma, Teva, Fougera Pharms, and Mylan, and is included in twenty-one NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ketoconazole has thirty-nine patent family members in fifteen countries.

There are fifteen drug master file entries for ketoconazole. Thirty-six suppliers are listed for this compound.

Summary for Generic Name: ketoconazole

Tradenames:6
Patents:6
Applicants:16
NDAs:21
Drug Master File Entries: see list15
Suppliers / Packagers: see list36
Bulk Api Vendors: see list107
Clinical Trials: see list66
Patent Applications: see list9,759
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ketoconazole at DailyMed

Pharmacology for Ingredient: ketoconazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva
KETOCONAZOLE
ketoconazole
CREAM;TOPICAL075581-001Apr 25, 2000ABRXNoYes► Subscribe► Subscribe
Fougera Pharms
KETOCONAZOLE
ketoconazole
CREAM;TOPICAL076294-001Apr 28, 2004ABRXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
EXTINA
ketoconazole
AEROSOL, FOAM;TOPICAL021738-001Jun 12, 2007ATRXYesYes7,553,835► SubscribeY ► Subscribe
Janssen Pharms
NIZORAL
ketoconazole
SHAMPOO;TOPICAL019927-001Aug 31, 1990ABRXYesYes► Subscribe► Subscribe
Aaipharma Llc
KETOCONAZOLE
ketoconazole
TABLET;ORAL075341-001Jul 27, 1999DISCNNoNo► Subscribe► Subscribe
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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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