Itraconazole - Generic Drug Details
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
What are the generic drug sources for itraconazole and what is the scope of patent protection?
Itraconazole
is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Janssen Pharms, Mayne Pharma, Annora Pharma, Apotex, and Sebela Ireland Ltd, and is included in nineteen NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Itraconazole has thirty-eight patent family members in twelve countries.
There are fifteen drug master file entries for itraconazole. Twenty-one suppliers are listed for this compound.
Summary for itraconazole
International Patents: | 38 |
US Patents: | 7 |
Tradenames: | 4 |
Applicants: | 16 |
NDAs: | 19 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 21 |
Raw Ingredient (Bulk) Api Vendors: | 80 |
Clinical Trials: | 354 |
Patent Applications: | 7,037 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for itraconazole |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for itraconazole |
What excipients (inactive ingredients) are in itraconazole? | itraconazole excipients list |
DailyMed Link: | itraconazole at DailyMed |
Recent Clinical Trials for itraconazole
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Jiangsu Simcere Pharmaceutical Co., Ltd. | Phase 1 |
VA Puget Sound Health Care System | Phase 2 |
Portland VA Medical Center | Phase 2 |
Pharmacology for itraconazole
Drug Class | Azole Antifungal |
Mechanism of Action | Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for itraconazole
Paragraph IV (Patent) Challenges for ITRACONAZOLE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SPORANOX | Oral Solution | itraconazole | 10 mg/mL | 020657 | 1 | 2013-05-03 |
US Patents and Regulatory Information for itraconazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | SPORANOX | itraconazole | CAPSULE;ORAL | 020083-001 | Sep 11, 1992 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Mylan Pharms Inc | ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 200463-001 | Jul 20, 2012 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for itraconazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | SPORANOX | itraconazole | SOLUTION;ORAL | 020657-001 | Feb 21, 1997 | See Plans and Pricing | See Plans and Pricing |
Janssen Pharms | SPORANOX | itraconazole | SOLUTION;ORAL | 020657-001 | Feb 21, 1997 | See Plans and Pricing | See Plans and Pricing |
Janssen Pharms | SPORANOX | itraconazole | CAPSULE;ORAL | 020083-001 | Sep 11, 1992 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for itraconazole
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Avimedical B.V. | Fungitraxx | itraconazole | EMEA/V/C/002722 For the treatment of aspergillosis and candidiasis in companion birds, |
Authorised | no | no | no | 2014-03-12 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for itraconazole
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2014062110 | ITRACONAZOLE COMPOSITION WITH IMPROVED BIOAVAILABILITY | See Plans and Pricing |
Australia | 782469 | See Plans and Pricing | |
Hong Kong | 1207288 | 伊曲康唑組合物和劑型及其使用方法 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.