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Ketoconazole - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ketoconazole?

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-five 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 list35
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan
KETOCONAZOLE
ketoconazole
TABLET;ORAL075597-001Dec 23, 1999RXNoNo► Subscribe► Subscribe
Aqua Pharms
XOLEGEL
ketoconazole
GEL;TOPICAL021946-001Jul 28, 2006RXYesYes7,179,475► SubscribeY ► Subscribe
Tolmar
KETOCONAZOLE
ketoconazole
SHAMPOO;TOPICAL076942-001Apr 11, 2005RXNoNo► Subscribe► Subscribe
Apotex
KETOCONAZOLE
ketoconazole
TABLET;ORAL075912-001Jan 10, 2002DISCNNoNo► Subscribe► Subscribe
Taro
KETOCONAZOLE
ketoconazole
TABLET;ORAL075319-001Jun 15, 1999RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ketoconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Johnson And Johnson
NIZORAL A-D
ketoconazole
SHAMPOO;TOPICAL020310-001Oct 10, 19974,335,125► Subscribe
Janssen Pharms
NIZORAL
ketoconazole
TABLET;ORAL018533-001Approved Prior to Jan 1, 19824,335,125► Subscribe
Janssen Pharma
NIZORAL
ketoconazole
CREAM;TOPICAL019084-001Dec 31, 19854,942,162► Subscribe
Johnson And Johnson
NIZORAL A-D
ketoconazole
SHAMPOO;TOPICAL020310-001Oct 10, 19974,942,162► Subscribe
Janssen Pharms
NIZORAL
ketoconazole
SHAMPOO;TOPICAL019927-001Aug 31, 19904,942,162► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ketoconazole

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,586,066Topical antifungal composition► Subscribe
6,238,683 Anhydrous topical skin preparations► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ketoconazole

Country Document Number Estimated Expiration
China1292707► Subscribe
European Patent Office1024792► Subscribe
Australia9728898► Subscribe
Spain2277394► Subscribe
China1204923► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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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