Ketoconazole Patent Expiration
Ketoconazole was first introduced by Janssen Pharmaceuticals Inc
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 |
|---|---|---|---|---|
| Extina | US7553835 | Topical antifungal composition |
Oct 19, 2018
(Expired) | Mylan |
| Extina | US8026238 | Topical antifungal composition |
Oct 19, 2018
(Expired) | Mylan |
| Nizoral Anti-dandruff | US5456851 | Ketoconazole shampoo containing butylated hydroxytoluene or butylated hydroxyanisole |
Apr 07, 2014
(Expired) | Kramer |
| Xolegel | US7179475 | Anhydrous topical skin preparations |
Dec 04, 2018
(Expired) | Almirall |
| Xolegel | US8232276 | Anhydrous topical skin preparations |
Nov 24, 2020
(Expired) | Almirall |
| Xolegel | US8735393 | Anhydrous topical skin preparations |
Dec 04, 2018
(Expired) | Almirall |
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.
Latest 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 |
|---|---|---|
 | ||
| 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 |
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Ketoconazole Generics
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 Tasman Pharma Inc and was approved on Nov 17, 2021.
Given below is the list of companies who have filed for Ketoconazole generic.
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 |
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 |
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 |
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 |
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 |
9. 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 |
10. 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 |
11. 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 |
12. 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 |
13. 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 |
14. TASMAN PHARMA
Tasman Pharma Inc has filed for 1 generic for Ketoconazole. Given below are the details of the strengths of this generic introduced by Tasman Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2% | cream | Prescription | TOPICAL | AB | Nov 17, 2021 |
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 |
16. 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 |