Itraconazole - Generic Drug Details
✉ Email this page to a colleague
What are the generic 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, 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 six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Itraconazole has twenty-six patent family members in eleven countries.
There are fifteen drug master file entries for itraconazole. Nineteen suppliers are listed for this compound.
Summary for itraconazole
International Patents: | 26 |
US Patents: | 6 |
Tradenames: | 4 |
Applicants: | 16 |
NDAs: | 19 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 19 |
Raw Ingredient (Bulk) Api Vendors: | 84 |
Clinical Trials: | 370 |
Patent Applications: | 4,347 |
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 |
---|---|
Shanghai Henlius Biotech | Phase 1 |
Aligos Therapeutics | Phase 1 |
Dhaka Medical College | Phase 2/Phase 3 |
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
Expired US Patents for itraconazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | SPORANOX | itraconazole | INJECTABLE;INJECTION | 020966-001 | Mar 30, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | SPORANOX | itraconazole | CAPSULE;ORAL | 020083-001 | Sep 11, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | SPORANOX | itraconazole | SOLUTION;ORAL | 020657-001 | Feb 21, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | SPORANOX | itraconazole | CAPSULE;ORAL | 020083-001 | Sep 11, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Mexico | 366829 | COMPOSICIONES Y FORMAS DE DOSIFICACION DE ITRACONAZOL Y METODOS DE USO DE LAS MISMAS. (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME.) | ⤷ Try a Trial |
European Patent Office | 2863911 | COMPOSITIONS ET FORMES GALÉNIQUES D'ITRACONAZOLE ET LEURS PROCÉDÉS D'UTILISATION (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME) | ⤷ Try a Trial |
Japan | 2018162304 | イトラコナゾール組成物及び投与剤形、並びにその使用方法 (ITRACONAZOLE COMPOSITIONS AND DOSAGE FORMS, AND METHODS OF USING THE SAME) | ⤷ Try a Trial |
China | 104507480 | Itraconazole compositions and dosage forms, and methods of using the same | ⤷ Try a Trial |
Japan | 2015531749 | イトラコナゾール組成物及び投与剤形、並びにその使用方法 | ⤷ Try a Trial |
Japan | 2009504589 | ⤷ Try a Trial | |
China | 109674795 | 伊曲康唑组合物和剂型及其使用方法 (Itraconazole compositions and dosage forms, and methods of using the same) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.