➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Baxter
McKinsey
Boehringer Ingelheim
Medtronic
Colorcon

Last Updated: August 12, 2020

DrugPatentWatch Database Preview

KETOCONAZOLE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for ketoconazole and what is the scope of patent protection?

Ketoconazole is the generic ingredient in six branded drugs marketed by Mylan, Perrigo Israel, Fougera Pharms, Teva, Taro, Janssen Pharma, Almirall, Tolmar, Janssen Pharms, Kramer, Aaipharma Llc, Havix, Heritage Pharma, Strides Pharma, and Sun Pharm Industries, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for ketoconazole. Twenty-four suppliers are listed for this compound.

Drug Prices for KETOCONAZOLE

See drug prices for KETOCONAZOLE

Drug Sales Revenue Trends for KETOCONAZOLE

See drug sales revenues for KETOCONAZOLE

Recent Clinical Trials for KETOCONAZOLE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Maimonides Medical CenterPhase 2
Yonsei UniversityPhase 4
Douglas Pharmaceuticals America LtdPhase 1

See all KETOCONAZOLE clinical trials

Medical Subject Heading (MeSH) Categories for KETOCONAZOLE
Paragraph IV (Patent) Challenges for KETOCONAZOLE
Tradename Dosage Ingredient NDA Submissiondate
EXTINA AEROSOL, FOAM;TOPICAL ketoconazole 021738 2009-07-30

US Patents and Regulatory Information for KETOCONAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms NIZORAL ketoconazole TABLET;ORAL 018533-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan KETOCONAZOLE ketoconazole TABLET;ORAL 075597-001 Dec 23, 1999 AB RX No No   Start Trial   Start Trial   Start Trial
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738-001 Jun 12, 2007 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Tolmar KETOCONAZOLE ketoconazole SHAMPOO;TOPICAL 076942-001 Apr 11, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for KETOCONAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Almirall XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006   Start Trial   Start Trial
Mylan EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738-001 Jun 12, 2007   Start Trial   Start Trial
Janssen Pharms NIZORAL ketoconazole SHAMPOO;TOPICAL 019927-001 Aug 31, 1990   Start Trial   Start Trial
Kramer NIZORAL A-D ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997   Start Trial   Start Trial
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Express Scripts
Medtronic
Johnson and Johnson
Merck

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 verification 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.