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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
QuintilesIMS
Moodys
Deloitte
Accenture
Covington
Chubb
Harvard Business School
Daiichi Sankyo

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020471

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NDA 020471 describes ZYFLO, which is a drug marketed by Chiesi Usa Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the ZYFLO profile page.

The generic ingredient in ZYFLO is zileuton. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the zileuton profile page.
Summary for 020471
Tradename:ZYFLO
Applicant:Chiesi Usa Inc
Ingredient:zileuton
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020471
Mechanism of Action5-Lipoxygenase Inhibitors
Physiological EffectDecreased Leukotriene Production
Suppliers and Packaging for NDA: 020471
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYFLO zileuton TABLET;ORAL 020471 NDA Chiesi USA, Inc. 10122-901 N 10122-901-12

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG
Approval Date:Dec 9, 1996TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Dec 9, 1996TE:RLD:Yes

Expired US Patents for NDA 020471

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi Usa Inc ZYFLO zileuton TABLET;ORAL 020471-001 Dec 9, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Chiesi Usa Inc ZYFLO zileuton TABLET;ORAL 020471-003 Dec 9, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Healthtrust
Argus Health
Fuji
Cantor Fitzgerald
Farmers Insurance
Chubb
Accenture

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