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Itraconazole Patent Expiration

Itraconazole was first introduced by Janssen Pharmaceuticals Inc in its drug Sporanox on Sep 11, 1992. Other drugs containing Itraconazole are Onmel, Tolsura. 16 different companies have introduced drugs containing Itraconazole.


Itraconazole Patents

Given below is the list of patents protecting Itraconazole, 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
Onmel US6509038 Antifungal compositions with improved bioavailability May 12, 2017

(Expired)

 Sebela Ireland Ltd
Onmel US7081255 Antifungal compositions with improved bioavailability May 12, 2017

(Expired)

 Sebela Ireland Ltd
Onmel US8486456 Itraconazole compositions with improved bioavailability Oct 03, 2028 Sebela Ireland Ltd
Onmel US8591948 Antifungal compositions with improved bioavailability May 12, 2017

(Expired)

 Sebela Ireland Ltd
Sporanox US5633015 Beads having a core coated with an antifungal and a polymer May 27, 2014

(Expired)

 Janssen Pharms
Sporanox US5707975 Oral formulations on an antifungal Jan 13, 2015

(Expired)

 Janssen Pharms
Sporanox US6407079 Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation Jun 18, 2019

(Expired)

 Janssen Pharms
Tolsura US10463740 Itraconazole compositions and dosage forms, and methods of using the same Jun 21, 2033 Mayne Pharma
Tolsura US10806792 Itraconazole compositions and dosage forms, and methods of using the same Jun 21, 2033 Mayne Pharma
Tolsura US8771739 Pharmaceutical compositions for poorly soluble drugs Jul 25, 2023

(Expired)

 Mayne Pharma
Tolsura US8921374 Itraconazole compositions and dosage forms, and methods of using the same Jun 21, 2033 Mayne Pharma
Tolsura US9272046 Itraconazole compositions and dosage forms, and methods of using the same Jun 21, 2033 Mayne Pharma
Tolsura US9713642 Itraconazole compositions and dosage forms, and methods of using the same Jun 21, 2033 Mayne Pharma


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 Itraconazole's patents.

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

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 22 Apr, 2024 US10806792
Payment of Maintenance Fee, 8th Year, Large Entity 30 Aug, 2023 US9272046
Payment of Maintenance Fee, 4th Year, Large Entity 04 Apr, 2023 US10463740
Payment of Maintenance Fee, 8th Year, Large Entity 09 May, 2022 US8921374
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 28 Apr, 2022 US8921374
Payment of Maintenance Fee, 8th Year, Large Entity 08 Dec, 2021 US8771739
Recordation of Patent Grant Mailed 20 Oct, 2020 US10806792
Patent Issue Date Used in PTA Calculation 20 Oct, 2020 US10806792
Email Notification 01 Oct, 2020 US10806792
Issue Notification Mailed 30 Sep, 2020 US10806792



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Itraconazole Generics

Several generic applications have been filed for Itraconazole. The first generic version for Itraconazole was by Sandoz Inc and was approved on May 28, 2004. And the latest generic version is by Annora Pharma Private Ltd and was approved on Sep 1, 2020.

Given below is the list of companies who have filed for Itraconazole generic.


1. TORRENT

Torrent Pharmaceuticals Ltd has filed for 1 generic for Itraconazole. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Prescription ORAL AB Aug 24, 2018


2. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 1 generic for Itraconazole. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Discontinued ORAL N/A May 26, 2016


3. MYLAN PHARMS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Discontinued ORAL N/A Jul 20, 2012


4. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Itraconazole. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Discontinued ORAL N/A Dec 13, 2016


5. SANDOZ

Sandoz Inc has filed for 1 generic for Itraconazole. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Prescription ORAL AB May 28, 2004


6. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Itraconazole. 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
100MG capsule Discontinued ORAL N/A Jul 2, 2019


7. ANNORA PHARMA

Annora Pharma Private Ltd has filed for 1 generic for Itraconazole. Given below are the details of the strengths of this generic introduced by Annora Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/ML solution Prescription ORAL AA Sep 1, 2020


8. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 2 different strengths of generic version for Itraconazole. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/ML solution Prescription ORAL AA Oct 30, 2015
100MG capsule Prescription ORAL AB Sep 26, 2016


9. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 1 generic for Itraconazole. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Prescription ORAL AB Jun 12, 2017


10. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Itraconazole. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Prescription ORAL AB Sep 19, 2017


11. APOTEX

Apotex Inc has filed for 1 generic for Itraconazole. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG/ML solution Discontinued ORAL N/A Aug 2, 2019


12. JUBILANT GENERICS

Jubilant Generics Ltd has filed for 1 generic for Itraconazole. Given below are the details of the strengths of this generic introduced by Jubilant Generics.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Discontinued ORAL N/A Feb 23, 2017


13. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 1 generic for Itraconazole. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG capsule Prescription ORAL AB Dec 13, 2016