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SPORANOX Drug Profile

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Sporanox is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in SPORANOX is itraconazole. There are fifteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for Tradename: SPORANOX

Patents:1
Applicants:1
NDAs:3
Suppliers / Packagers: see list4

Pharmacology for Tradename: SPORANOX

Clinical Trials for: SPORANOX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
SPORANOX
itraconazole
SOLUTION;ORAL020657-001Feb 21, 1997RXYes6,407,079<disabled> <disabled>
Janssen Pharms
SPORANOX
itraconazole
INJECTABLE;INJECTION020966-001Mar 30, 1999DISCNNo6,407,079<disabled> <disabled>
Janssen Pharms
SPORANOX
itraconazole
CAPSULE;ORAL020083-001Sep 11, 1992RXYes<disabled><disabled>
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Expired Patents for Tradename: SPORANOX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
SPORANOX
itraconazole
CAPSULE;ORAL020083-001Sep 11, 19924,267,179<disabled>
Janssen Pharms
SPORANOX
itraconazole
CAPSULE;ORAL020083-001Sep 11, 19924,791,111<disabled>
Janssen Pharms
SPORANOX
itraconazole
SOLUTION;ORAL020657-001Feb 21, 19974,267,179<disabled>
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Paragraph IV activity for: SPORANOX

Drugname Dosage Strength RLD Submissiondate
itraconazoleOral Solution10 mg/mLSporanox5/3/2013
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