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Generated: December 17, 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 Mylan Pharms Inc, Perrigo Israel, Fougera Pharms, Teva, Taro, Janssen Pharma, Aqua Pharms, Perrigo New York, Tolmar, Janssen Pharms, Johnson And Johnson, Aaipharma Llc, Apotex, Mylan, Pliva, and Sun Pharm Industries, 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.

Ketoconazole has forty-one patent family members in fifteen countries.

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

Pharmacology for ketoconazole

Medical Subject Heading (MeSH) Categories for ketoconazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
PlivaKETOCONAZOLEketoconazoleTABLET;ORAL075362-001Jun 15, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
Janssen PharmsNIZORALketoconazoleTABLET;ORAL018533-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
TaroKETOCONAZOLEketoconazoleTABLET;ORAL075319-001Jun 15, 1999ABRXNoNo► Subscribe► Subscribe► Subscribe
TevaKETOCONAZOLEketoconazoleTABLET;ORAL075273-001Jun 15, 1999ABRXNoYes► Subscribe► Subscribe► Subscribe
Aqua PharmsXOLEGELketoconazoleGEL;TOPICAL021946-001Jul 28, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Perrigo New YorkKETOCONAZOLEketoconazoleSHAMPOO;TOPICAL076419-001Jan 7, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
TaroKETOZOLEketoconazoleCREAM;TOPICAL075638-001Dec 18, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Aaipharma LlcKETOCONAZOLEketoconazoleTABLET;ORAL075341-001Jul 27, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm IndustriesKETOCONAZOLEketoconazoleTABLET;ORAL075314-001Jun 15, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
Janssen PharmaNIZORALketoconazoleCREAM;TOPICAL019084-001Dec 31, 1985DISCNYesNo► Subscribe► 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 JohnsonNIZORAL A-DketoconazoleSHAMPOO;TOPICAL020310-001Oct 10, 1997► Subscribe► Subscribe
Janssen PharmaNIZORALketoconazoleCREAM;TOPICAL019084-001Dec 31, 1985► Subscribe► Subscribe
Janssen PharmsNIZORALketoconazoleTABLET;ORAL018533-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Johnson And JohnsonNIZORAL A-DketoconazoleSHAMPOO;TOPICAL020310-001Oct 10, 1997► Subscribe► Subscribe
Janssen PharmsNIZORALketoconazoleSHAMPOO;TOPICAL019927-001Aug 31, 1990► Subscribe► Subscribe
Johnson And JohnsonNIZORAL A-DketoconazoleSHAMPOO;TOPICAL020310-001Oct 10, 1997► Subscribe► Subscribe
Janssen PharmsNIZORALketoconazoleSHAMPOO;TOPICAL019927-001Aug 31, 1990► Subscribe► Subscribe
Janssen PharmaNIZORALketoconazoleCREAM;TOPICAL019084-001Dec 31, 1985► Subscribe► 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
Austria346588► Subscribe
Spain2277394► Subscribe
Austria318148► Subscribe
Australia9728898► Subscribe
Australia1841200► Subscribe
Germany60122827► Subscribe
World Intellectual Property Organization (WIPO)0033877► Subscribe
Denmark1024792► Subscribe
China1292707► Subscribe
China100341578► 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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Serving leading biopharmaceutical companies globally:

Fuji
Farmers Insurance
Federal Trade Commission
AstraZeneca
Chubb
Cerilliant
Baxter
Deloitte
Mallinckrodt
Argus Health

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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