.

Make Better Decisions

  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
Accenture
Julphar
Novartis
QuintilesIMS
Mallinckrodt
US Army
Cantor Fitzgerald
McKesson
Merck

Generated: September 25, 2017

DrugPatentWatch Database Preview

Ketoconazole - Generic Drug Details

« Back to Dashboard

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 five 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:5
Applicants:16
NDAs:21
Drug Master File Entries: see list15
Suppliers / Packagers: see list35
Bulk Api Vendors: see list107
Clinical Trials: see list202
Patent Applications: see list8,245
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
Mylan
KETOCONAZOLE
ketoconazole
TABLET;ORAL075597-001Dec 23, 1999ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
EXTINA
ketoconazole
AEROSOL, FOAM;TOPICAL021738-001Jun 12, 2007ATRXYesYes► Subscribe► SubscribeY ► Subscribe
Perrigo New York
KETOCONAZOLE
ketoconazole
SHAMPOO;TOPICAL076419-001Jan 7, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Tolmar
KETOCONAZOLE
ketoconazole
SHAMPOO;TOPICAL076942-001Apr 11, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Janssen Pharms
NIZORAL
ketoconazole
TABLET;ORAL018533-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Aqua Pharms
XOLEGEL
ketoconazole
GEL;TOPICAL021946-001Jul 28, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Aqua Pharms
XOLEGEL
ketoconazole
GEL;TOPICAL021946-001Jul 28, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Fougera Pharms
KETOCONAZOLE
ketoconazole
CREAM;TOPICAL076294-001Apr 28, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Aqua Pharms
XOLEGEL
ketoconazole
GEL;TOPICAL021946-001Jul 28, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Pliva
KETOCONAZOLE
ketoconazole
TABLET;ORAL075362-001Jun 15, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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, 1997► Subscribe► Subscribe
Janssen Pharma
NIZORAL
ketoconazole
CREAM;TOPICAL019084-001Dec 31, 1985► Subscribe► Subscribe
Janssen Pharma
NIZORAL
ketoconazole
CREAM;TOPICAL019084-001Dec 31, 1985► Subscribe► Subscribe
Janssen Pharms
NIZORAL
ketoconazole
SHAMPOO;TOPICAL019927-001Aug 31, 1990► Subscribe► Subscribe
Johnson And Johnson
NIZORAL A-D
ketoconazole
SHAMPOO;TOPICAL020310-001Oct 10, 1997► Subscribe► Subscribe
Janssen Pharms
NIZORAL
ketoconazole
SHAMPOO;TOPICAL019927-001Aug 31, 1990► Subscribe► Subscribe
Johnson And Johnson
NIZORAL A-D
ketoconazole
SHAMPOO;TOPICAL020310-001Oct 10, 1997► Subscribe► Subscribe
Janssen Pharms
NIZORAL
ketoconazole
TABLET;ORAL018533-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: ketoconazole

Country Document Number Estimated Expiration
European Patent Office1645287► Subscribe
AustraliaPO983897► Subscribe
Australia1841200► Subscribe
Japan4610741► Subscribe
Hong Kong1039567► Subscribe
Hong Kong1031342► Subscribe
Austria346588► Subscribe
China1204923► Subscribe
Brazil9907666► Subscribe
AustraliaPP121798► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
Farmers Insurance
Queensland Health
US Army
Cantor Fitzgerald
Fuji
Healthtrust
US Department of Justice
Chinese Patent Office

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot