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.
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.
Latest 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
Payment of Maintenance Fee, 4th Year, Large Entity
Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
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NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
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Recently Granted Patents in EP
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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.
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
Brantford
Apotex Pharmachem Inc.
Winnipeg
Apotex Fermentation Inc.
Etobicoke
Apotex, Inc.
North York
Apotex Inc.
Richmond Hill
Apotex Inc.
Toronto
Apotex Inc.
India
Bangalore
Apotex Research Private Limited - Bioequivalence Centre
Bengaluru
Apotex Research Private Limited
Bangalore
Apotex Pharmachem India Pvt Ltd.
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
Fort Bragg
Rising Tide Sea Vegetables
Mount Morris
Rising Creek Bakery LLC
Decatur
Rising Pharma Holdings, Inc
Saddle Brook
Rising Pharmaceuticals, Inc.
East Brunswick
Rising Pharma Holding, Inc.
Livingston
Risingsun Iodine Products Corp.
Phoenix
Rising Sun Farms Inc
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
Kundl
Sandoz GmbH
Langkampfen
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
East Brunswick
Strides Pharma Inc.
Chestnut Ridge
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
Indrad
Torrent Pharmaceuticals Limited
Gandhi Nagar
Torrent Pharmaceuticals Limited
Thanam
Torrent Pharmaceuticals Limited
United States
Kalamazoo
Torrent Pharma Inc.
Basking Ridge
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.
