SPORANOX Drug Patent Profile
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When do Sporanox patents expire, and what generic alternatives are available?
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. Eighteen 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.
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Questions you can ask:
- What is the 5 year forecast for SPORANOX?
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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: | 5,975 |
| 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Janssen Pharms | SPORANOX | itraconazole | INJECTABLE;INJECTION | 020966-001 | Mar 30, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Pharms | SPORANOX | itraconazole | SOLUTION;ORAL | 020657-001 | Feb 21, 1997 | AA | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | SOLUTION;ORAL | 020657-001 | Feb 21, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | SPORANOX | itraconazole | CAPSULE;ORAL | 020083-001 | Sep 11, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | SPORANOX | itraconazole | INJECTABLE;INJECTION | 020966-001 | Mar 30, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | SPORANOX | itraconazole | INJECTABLE;INJECTION | 020966-001 | Mar 30, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | SPORANOX | itraconazole | SOLUTION;ORAL | 020657-001 | Feb 21, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | SPORANOX | itraconazole | INJECTABLE;INJECTION | 020966-001 | Mar 30, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >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 | 59564 | Novel derivatives of [[4-[4-(4-phenyl-1-piperazinyl) phenoxymethyl]-1,3-dioxolan-2-yl]methyl]-1h-imidazoles and 1h-1,2,4-triazoles | ⤷ Sign Up |
| Israel | 97500 | ⤷ Sign Up | |
| South Africa | 9407619 | ⤷ Sign Up | |
| South Africa | 9306493 | ⤷ Sign Up | |
| Cyprus | 1251 | HETEROCYCLIC DERIVATIVES OF(4-PHENYLPIPERAZIN-1-YL-ARYLOXYMETHYL-1,3-DIOXOLAN-2-YL)-METHYL-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES,PROCESSES FOR PREPARING THEM,COMPOSITIONS CONTAINING THEM AND THEIR USE FOR COMBATING THE GROWTH OF MICROORGANISMS | ⤷ Sign Up |
| Germany | 69306119 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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.
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