ITRACONAZOLE Drug Patent Profile
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When do Itraconazole patents expire, and what generic alternatives are available?
Itraconazole is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Rising, Sandoz, Strides Pharma, Torrent, Zydus Pharms, Annora Pharma, and Apotex. and is included in fourteen NDAs.
The generic ingredient in ITRACONAZOLE is itraconazole. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Itraconazole
A generic version of ITRACONAZOLE was approved as itraconazole by SANDOZ on May 28th, 2004.
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Questions you can ask:
- What is the 5 year forecast for ITRACONAZOLE?
- What are the global sales for ITRACONAZOLE?
- What is Average Wholesale Price for ITRACONAZOLE?
Summary for ITRACONAZOLE
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 14 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 477 |
| Patent Applications: | 5,870 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Sunshine Lake Pharma Co., Ltd. | PHASE1 |
| Combined Military Hospital Abbottabad | PHASE1 |
| University of Minnesota | PHASE3 |
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
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 205991-001 | May 26, 2016 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Rising | ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 205724-001 | Dec 13, 2016 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Amneal Pharms | ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 205080-001 | Sep 26, 2016 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Amneal Pharms | ITRACONAZOLE | itraconazole | SOLUTION;ORAL | 205573-001 | Oct 30, 2015 | AA | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sandoz | ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 076104-001 | May 28, 2004 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Apotex | ITRACONAZOLE | itraconazole | SOLUTION;ORAL | 208481-001 | Aug 2, 2019 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Alembic | ITRACONAZOLE | itraconazole | CAPSULE;ORAL | 206741-001 | Dec 13, 2016 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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/002722For 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 |
