You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 18, 2025

Details for New Drug Application (NDA): 020471

✉ Email this page to a colleague

NDA 020471 describes ZYFLO, which is a drug marketed by Chiesi 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. Six suppliers are listed for this compound. Additional details are available on the zileuton profile page.

Summary for 020471

Tradename:	ZYFLO
Applicant:	Chiesi
Ingredient:	zileuton
Patents:	0

Pharmacology for NDA: 020471

Mechanism of Action	5-Lipoxygenase Inhibitors
Physiological Effect	Decreased 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	10122-901-12	120 TABLET in 1 BOTTLE (10122-901-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Dec 9, 1996	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Dec 9, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020471

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-001	Dec 9, 1996	4,873,259	⤷ Get Started Free
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471-003	Dec 9, 1996	4,873,259	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.