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Serving hundreds of leading biopharmaceutical companies globally:

Merck
US Army
Queensland Health
Accenture
Chinese Patent Office
Express Scripts
McKinsey
Cerilliant
Medtronic

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020657

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NDA 020657 describes SPORANOX, which 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. Additional details are available on the SPORANOX profile page.

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.
Summary for 020657
Tradename:SPORANOX
Applicant:Janssen Pharms
Ingredient:itraconazole
Patents:1
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 020657
Medical Subject Heading (MeSH) Categories for 020657
Suppliers and Packaging for NDA: 020657
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPORANOX itraconazole SOLUTION;ORAL 020657 NDA Janssen Pharmaceuticals, Inc. 50458-295 N 50458-295-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Feb 21, 1997TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 18, 2019Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 020657

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 SOLUTION;ORAL 020657-001 Feb 21, 1997 ➤ Sign Up ➤ Sign Up
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997 ➤ Sign Up ➤ Sign Up
Janssen Pharms SPORANOX itraconazole SOLUTION;ORAL 020657-001 Feb 21, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Queensland Health
Citi
Dow
Teva
Moodys
Fish and Richardson
McKesson
Harvard Business School

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