Itraconazole Patent Expiration

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

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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, 12th Year, Large Entity 08 Jan, 2026 US8771739
Payment of Maintenance Fee, 8th Year, Large Entity 27 Jan, 2025 US9713642
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


About Veterinary Itraconazole

Itraconazole is used in a drug marketed by 1 company: Virbac Ah Inc.

Other drugs containing Itraconazole are: Itrafungol .

Itraconazole's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Itraconazole:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors BioNTech SE NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Adult Participants With Bipolar Disorder AbbVie NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study to Evaluate How Multiple Doses of Itraconazole Interacts With Nacresertib in Healthy Adult Participants AbbVie NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
A Study in Healthy Men to Find Out How Blocking Certain Transport Proteins Affects the Amount of BI 3000202 in the Blood Boehringer Ingelheim NA RECRUITING
(Sep 1, 2026)
PHASE1
A Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants Novartis Pharmaceuticals NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study of RO7890597 in Healthy Adult Volunteers Genentech, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE1
Drug-Drug Interaction Study of Vorolanib Tablets in Healthy Participants Betta Pharmaceuticals Co., Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE1
Drug-Drug Interaction Study of Befotertinib Capsules in Healthy Participants. Betta Pharmaceuticals Co., Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE1
Drug-drug Interaction Study of Clemizole (EPX-100) in Healthy Participants Epygenix NA COMPLETED
(Sep 1, 2026)
PHASE1
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis Post Graduate Institute of Medical Education and Research, Chandigarh NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults Takeda NA COMPLETED
(Aug 1, 2026)
PHASE1
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors DualityBio Inc. NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis Vertex Pharmaceuticals Incorporated NA COMPLETED
(Aug 1, 2026)
PHASE1
Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants BeiGene NA COMPLETED
(Aug 1, 2026)
PHASE1
A Study to Learn if Itraconazole Changes How the Body Processes PF-07248144 (Study Medicine) Pfizer NA COMPLETED
(Aug 1, 2026)
PHASE1
A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007) Merck Sharp & Dohme LLC NA COMPLETED
(Aug 1, 2026)
PHASE1
A Study to Learn if a Medicine Called Itraconazole Changes How the Body Processes the Study Medicine PF-08642534 in Healthy Adults. Pfizer NA COMPLETED
(Aug 1, 2026)
PHASE1
A Study of the Effects of Itraconazole on LY4395089 in Healthy Participants Eli Lilly and Company NA COMPLETED
(Aug 1, 2026)
PHASE1
A Phase 1 Study to Assess the Effect of Itraconazole on ABBV-722 in Healthy Adult Participants AbbVie NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants AstraZeneca NA RECRUITING
(Aug 1, 2026)
PHASE1
A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504 Jiangsu Hansoh Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets Chengdu Zenitar Biomedical Technology Co., Ltd NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Effect of a Known P-glycoprotein (P-gp) Inhibitor, Itraconazole, on the Pharmacokinetics (PK) of Engasertib Vaderis Therapeutics AG NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus National Cancer Institute (NCI) NA RECRUITING
(Jul 1, 2026)
PHASE2
A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants Celgene NA TERMINATED
(Jul 1, 2026)
PHASE1
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 764198 in the Blood Boehringer Ingelheim NA COMPLETED
(Jul 1, 2026)
PHASE1
A Study of LY4515100 in Healthy Participants Eli Lilly and Company NA RECRUITING
(Jul 1, 2026)
PHASE1
Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer AstraZeneca NA RECRUITING
(Jul 1, 2026)
PHASE1
A Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants BeOne Medicines NA RECRUITING
(Jul 1, 2026)
PHASE1
The Study on Effects of CYP3A and P-glycoprotein Inhibitor Itraconazole and CYP Enzyme Inducer Rifampin of HMPL-453 Tartrate Tablets Hutchmed NA COMPLETED
(Jul 1, 2026)
PHASE1
Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes OrsoBio, Inc NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1
Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer Jiangsu HengRui Medicine Co., Ltd. NA COMPLETED
(Jun 1, 2026)
PHASE1
A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants Incyte Corporation NA COMPLETED
(Jun 1, 2026)
PHASE1
Drug Interaction and Food Effect Study of CS0159 Cascade Pharmaceuticals, Inc NA COMPLETED
(Jun 1, 2026)
PHASE1
A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017) Merck Sharp & Dohme LLC NA COMPLETED
(Jun 1, 2026)
PHASE1
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Kura Oncology, Inc. NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1, PHASE2
A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood Boehringer Ingelheim NA COMPLETED
(May 1, 2026)
PHASE1
Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts Otsuka Pharmaceutical Development & Commercialization, Inc. NA COMPLETED
(Apr 1, 2026)
PHASE1
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood Boehringer Ingelheim NA COMPLETED
(Apr 1, 2026)
PHASE1
Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole in Healthy Adult Participants MindRank AI Ltd NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1
A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults ViiV Healthcare NA COMPLETED
(Mar 1, 2026)
PHASE1
A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet Guangzhou Lupeng Pharmaceutical Company LTD. NA RECRUITING
(Mar 1, 2026)
PHASE1


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.