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
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 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
Onmel US8486456 Itraconazole compositions with improved bioavailability Oct 03, 2028 Sebela Ireland Ltd
Tolsura US8771739 Pharmaceutical compositions for poorly soluble drugs Jul 25, 2023

(Expired)

Mayne Pharma
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
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 US8591948 Antifungal compositions with improved bioavailability May 12, 2017

(Expired)

Sebela Ireland Ltd
Sporanox US5707975 Oral formulations on an antifungal Jan 13, 2015

(Expired)

Janssen Pharms
Sporanox US5633015 Beads having a core coated with an antifungal and a polymer May 27, 2014

(Expired)

Janssen Pharms



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.

Activity Date Patent Number
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


Itraconazole's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List

Itraconazole Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


1. 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





2. 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


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Ltd
Panelav Alembic Pharmaceuticals Limited
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal Alembic Pharmaceuticals Limited





3. 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





4. 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





5. 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


Manufacturing Plant Locations
New

Annora Pharma'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 Annora Pharma as present at those locations.

Country City Firm Name
India
Hyderabad Annora Pharma Private Limited





6. 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


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
Toronto Apotex Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Brantford Apotex Pharmachem Inc.
India
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre





7. 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


Manufacturing Plant Locations
New

Jubilant Generics'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 Jubilant Generics as present at those locations.

Country City Firm Name
India
Roorkee Jubilant Generics Limited





8. 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





9. 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


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Rising Sun Rising Sun Veterinary Clinic
Phoenix Rising Sun Farms Inc
Livingston Risingsun Iodine Products Corp.
Saddle Brook Rising Pharmaceuticals, Inc.
Decatur Rising Pharma Holdings, Inc
East Brunswick Rising Pharma Holding, Inc.
Mount Morris Rising Creek Bakery LLC
Fort Bragg Rising Tide Sea Vegetables
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





10. 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


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Langkampfen Sandoz GmbH
Kundl Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





11. 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


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
Chestnut Ridge Strides Pharma, Inc.
East Brunswick Strides Pharma Inc.
India
Bangalore Strides Pharma Science Limited
Puducherry Strides Pharma Science Limited





12. 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


Manufacturing Plant Locations
New

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

Country City Firm Name
India
Bharuch Torrent Pharmaceuticals Limited
Pithampur Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
Gandhi Nagar Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
United States
Basking Ridge Torrent Pharma Inc.
Kalamazoo Torrent Pharma Inc.





13. 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