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Last Updated: May 19, 2024

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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Drug patent expirations by year for SPORANOX
Drug Prices for SPORANOX

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Recent Clinical Trials for SPORANOX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of ChicagoPhase 1
Arvinas Estrogen Receptor, Inc.Phase 1
Postgraduate Institute of Medical Education and ResearchN/A

See all SPORANOX clinical trials

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 SOLUTION;ORAL 020657-001 Feb 21, 1997 ⤷  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
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992 ⤷  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
Bulgaria 60430 ⤷  Try a Trial
African Intellectual Property Organization (OAPI) 10276 Oral formulations of an antifungal ⤷  Try a Trial
Japan H01211561 NITROGEN-CONTAINING HETEROCYCLIC GROUP SUBSTITUTED PHENYLPHYPERADINYL PHENOL ⤷  Try a Trial
Singapore 119094 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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