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Ketoconazole - Generic Drug Details

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Ketoconazole is the generic ingredient in six branded drugs marketed by Johnson And Johnson, Apotex, Sun Pharm Inds, Perrigo New York, Taro, Janssen Pharms, Delcor Asset Corp, Aaipharma Llc, Tolmar, Aqua Pharms, Perrigo Israel, Pliva, Janssen Pharma, Teva, Fougera Pharms, and Mylan, 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. Thirty-two suppliers are listed for this compound.

Summary for Generic Name: ketoconazole

Tradenames:6
Patents:5
Applicants:16
NDAs:21
Drug Master File Entries: see list15
Suppliers / Packaging: see list32
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
Janssen Pharms
NIZORAL
ketoconazole
SHAMPOO;TOPICAL019927-001Aug 31, 1990RXYes<disabled><disabled>
Aqua Pharms
XOLEGEL
ketoconazole
GEL;TOPICAL021946-001Jul 28, 2006RXYes7,179,475<disabled>Y <disabled>
Teva
KETOCONAZOLE
ketoconazole
CREAM;TOPICAL075581-001Apr 25, 2000RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: ketoconazole

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharma
NIZORAL
ketoconazole
CREAM;TOPICAL019084-001Dec 31, 19854,335,125<disabled>
Janssen Pharms
NIZORAL
ketoconazole
SHAMPOO;TOPICAL019927-001Aug 31, 19904,335,125<disabled>
Johnson And Johnson
NIZORAL A-D
ketoconazole
SHAMPOO;TOPICAL020310-001Oct 10, 19975,456,851<disabled>
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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<disabled in preview>
6,238,683 Anhydrous topical skin preparations<disabled in preview>
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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
Brazil9907666<disabled in preview>
Hong Kong1031342<disabled in preview>
China100341578<disabled in preview>
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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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