SPORANOX Drug Patent Profile
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Which patents cover Sporanox, and when can generic versions of Sporanox launch?
Sporanox is a drug marketed by Janssen Pharms and is included in three NDAs.
The generic ingredient in SPORANOX is itraconazole. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sporanox
A generic version of SPORANOX was approved as itraconazole by SANDOZ on May 28th, 2004.
Summary for SPORANOX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 84 |
Clinical Trials: | 40 |
Patent Applications: | 4,738 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SPORANOX |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SPORANOX |
What excipients (inactive ingredients) are in SPORANOX? | SPORANOX excipients list |
DailyMed Link: | SPORANOX at DailyMed |
Recent Clinical Trials for SPORANOX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Chicago | Phase 1 |
Arvinas Estrogen Receptor, Inc. | Phase 1 |
Postgraduate Institute of Medical Education and Research | N/A |
Pharmacology for SPORANOX
Drug Class | Azole Antifungal |
Mechanism of Action | Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for SPORANOX
Paragraph IV (Patent) Challenges for SPORANOX
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 SPORANOX
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Janssen Pharms | SPORANOX | itraconazole | INJECTABLE;INJECTION | 020966-001 | Mar 30, 1999 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Pharms | SPORANOX | itraconazole | SOLUTION;ORAL | 020657-001 | Feb 21, 1997 | AA | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 SPORANOX
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 | 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for SPORANOX
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 SPORANOX
See the table below for patents covering SPORANOX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ireland | 863369 | ⤷ Try a Trial | |
Ireland | 791178 | ⤷ Try a Trial | |
Cyprus | 2105 | Beads having a core coated with an antifungal and a polymer | ⤷ Try a Trial |
Austria | 73799 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPORANOX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0006711 | SPC/GB93/038: EXPIRE | United Kingdom | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |