Ketoconazole Patent Expiration

Ketoconazole was first introduced by Janssen Pharmaceuticals Inc in its drug Nizoral on Approved Prior to Jan 1, 1982. Other drugs containing Ketoconazole are Xolegel, Nizoral Anti-Dandruff, Extina. 23 different companies have introduced drugs containing Ketoconazole.


Ketoconazole Patents

Given below is the list of patents protecting Ketoconazole, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Xolegel US8232276 Anhydrous topical skin preparations Nov 24, 2020

(Expired)

Ina Pharms
Xolegel US7179475 Anhydrous topical skin preparations Dec 04, 2018

(Expired)

Ina Pharms
Xolegel US8735393 Anhydrous topical skin preparations Dec 04, 2018

(Expired)

Ina Pharms
Extina US7553835 Topical antifungal composition Oct 19, 2018

(Expired)

Norvium Bioscience
Extina US8026238 Topical antifungal composition Oct 19, 2018

(Expired)

Norvium Bioscience
Nizoral Anti-dandruff US5456851 Ketoconazole shampoo containing butylated hydroxytoluene or butylated hydroxyanisole Apr 07, 2014

(Expired)

Kramer



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ketoconazole's patents.

Given below is the list recent legal activities going on the following patents of Ketoconazole.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 18 Mar, 2024 US8232276
Payment of Maintenance Fee, 8th Year, Large Entity 18 Dec, 2019 US8232276
Post Issue Communication - Certificate of Correction 15 Oct, 2012 US8232276
Recordation of Patent Grant Mailed 31 Jul, 2012 US8232276
Patent Issue Date Used in PTA Calculation 31 Jul, 2012 US8232276
Issue Notification Mailed 11 Jul, 2012 US8232276
Dispatch to FDC 28 Jun, 2012 US8232276
Application Is Considered Ready for Issue 28 Jun, 2012 US8232276
Issue Fee Payment Verified 27 Jun, 2012 US8232276
Issue Fee Payment Received 27 Jun, 2012 US8232276


Ketoconazole's Family Patents

Family Patents

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Ketoconazole Generic API Manufacturers

Several generic applications have been filed for Ketoconazole. The first generic version for Ketoconazole was by Janssen Pharmaceutica Products Lp and was approved on Nov 7, 1986. And the latest generic version is by Esjay Pharma Llc and was approved on Jul 3, 2025.

Given below is the list of companies who have filed for Ketoconazole generic, along with the locations of their manufacturing plants worldwide.