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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. 21 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)

 Almirall
Xolegel US7179475 Anhydrous topical skin preparations Dec 04, 2018

(Expired)

 Almirall
Xolegel US8735393 Anhydrous topical skin preparations Dec 04, 2018

(Expired)

 Almirall
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
Critical
 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
Critical
 31 Jul, 2012 US8232276
Patent Issue Date Used in PTA Calculation
Critical
 31 Jul, 2012 US8232276
Issue Notification Mailed
Critical
 11 Jul, 2012 US8232276
Dispatch to FDC 28 Jun, 2012 US8232276
Application Is Considered Ready for Issue
Critical
 28 Jun, 2012 US8232276
Issue Fee Payment Verified
Critical
 27 Jun, 2012 US8232276
Issue Fee Payment Received
Critical
 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 Novitium Pharma Llc and was approved on Sep 16, 2024.

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


1. AAIPHARMA LLC

Aaipharma Llc has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Aaipharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A Jul 27, 1999





2. AUROBINDO PHARMA USA

Aurobindo Pharma Usa Inc has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A Dec 23, 1999


Manufacturing Plant Locations
New

Aurobindo Pharma Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Usa as present at those locations.

Country City Firm Name
United States
East Windsor Aurobindo Pharma USA Inc





3. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A Jun 15, 1999





4. COSETTE

Cosette Pharmaceuticals Inc has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Cosette.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

shampoo Prescription TOPICAL AB Apr 11, 2005


Manufacturing Plant Locations
New

Cosette's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Cosette as present at those locations.

Country City Firm Name
United States
Lincolnton Cosette Pharmaceuticals NC Laboratories, LLC
South Plainfield Cosette Pharmaceuticals, Inc.





5. ENCUBE

Encube Ethicals Private Ltd has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Encube.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

cream Prescription TOPICAL AB May 20, 2021


Manufacturing Plant Locations
New

Encube's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Encube as present at those locations.

Country City Firm Name
India
Ponda Encube Ethicals Pvt. Ltd.
Andheri East, Mumbai Encube Ethicals Private Ltd





6. FOUGERA PHARMS

Fougera Pharmaceuticals Inc has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Fougera Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

cream Prescription TOPICAL AB Apr 28, 2004





7. HERITAGE PHARMA

Heritage Pharma Labs Inc has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Heritage Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A Jun 15, 1999


Manufacturing Plant Locations
New

Heritage Pharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Heritage Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Heritage Pharmaceuticals, Inc. DBA AVET Pharmaceutical LABS
East Brunswick Heritage Pharmaceuticals Inc





8. JANSSEN PHARMA

Janssen Pharmaceutica Products Lp has filed for 1 generic for Ketoconazole. This 100mg/5ml version comes by the name NIZORAL. Given below are the details of the strengths of this generic introduced by Janssen Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML

suspension Discontinued ORAL N/A Nov 7, 1986


Manufacturing Plant Locations
New

Janssen Pharma's manufacturing plants are situated in 3 countries - Ireland, United States, Belgium. Given below are the details of these plant locations as well as the firm names of Janssen Pharma as present at those locations.

Country City Firm Name
Ireland
Little Island Janssen Pharmaceutical Sciences Unlimited Company
United States
Raritan Janssen Pharmaceuticals Inc.
South San Francisco Janssen Pharmaceuticals, dba Actelion Pharmaceutical
Athens Janssen Pharmaceuticals, Inc.
Belgium
Olen Janssen Pharmaceutica NV
Beerse Janssen Pharmaceutica, N.V.
Geel Janssen Pharmaceutica N.V.





9. NOVITIUM PHARMA

Novitium Pharma Llc has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Novitium Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

shampoo Prescription TOPICAL AB Sep 16, 2024


Manufacturing Plant Locations
New

Novitium Pharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Novitium Pharma as present at those locations.

Country City Firm Name
United States
East Windsor Novitium Pharma LLC





10. PADAGIS ISRAEL

Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Padagis Israel.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

aerosol, foam Prescription TOPICAL AB Aug 25, 2011


Manufacturing Plant Locations
New

Padagis Israel's manufacturing plants are situated in 1 country - Israel. Given below are the details of these plant locations as well as the firm names of Padagis Israel as present at those locations.

Country City Firm Name
Israel
Yerucham Padagis Israel Pharmaceuticals Ltd.





11. SENORES PHARMS

Senores Pharmaceuticals Inc has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Senores Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Prescription ORAL AB Jan 10, 2002





12. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Prescription ORAL AB Jun 18, 2018


Manufacturing Plant Locations
New

Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Strides Pharma Inc.
Chestnut Ridge Strides Pharma, Inc.
India
Bangalore Strides Pharma Science Limited
Puducherry Strides Pharma Science Limited





13. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A Jun 15, 1999





14. TARO

Taro Pharmaceuticals Inc has filed for 2 different strengths of generic version for Ketoconazole. Out of these 2% version comes by the name KETOZOLE. Given below are the details of the strengths of this generic introduced by Taro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

(reference standard)

tablet Prescription ORAL AB Jun 15, 1999
2%

cream Prescription TOPICAL AB Dec 18, 2002


Manufacturing Plant Locations
New

Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.

Country City Firm Name
United States
Hawthorne Taro Pharmaceuticals U.S.A., Inc.
Honolulu Taro Delight, LLC
Israel
Haifa Taro Pharmaceutical Industries, Ltd.
Canada
Brampton Taro Pharmaceuticals Inc.





15. TEVA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Ketoconazole. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A Jun 15, 1999
2%

(reference standard)

cream Prescription TOPICAL AB Apr 25, 2000


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Miami Teva Branded Pharmaceutical Products R & D, Inc.
Horsham Teva Branded Pharmaceutical Products R&D
Fort Dodge TEVA Animal Health Inc
India
Gajraula, Amroha Teva API India Private Ltd.
Bhind Teva API India Ltd- Malanpur
Canada
Scarborough Teva Canada Limited
Markham Teva Canada Limited
Stouffville Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





16. TRUPHARMA

Trupharma Llc has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Trupharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

cream Prescription TOPICAL AB Nov 17, 2021





17. XIROMED

Xiromed Pharma Espana Sl has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Xiromed.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

(reference standard)

aerosol, foam Prescription TOPICAL AB May 21, 2021


Manufacturing Plant Locations
New

Xiromed's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Xiromed as present at those locations.

Country City Firm Name
United States
Florham Park XIROMED LLC