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Details for Generic Name: zileuton

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Zileuton is the generic ingredient in two branded drugs marketed by Chiesi Usa Inc and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for zileuton. One supplier is listed for this compound.

Summary for Generic Name: zileuton

Tradenames:2
Patents:0
Applicants:1
NDAs:2
Drug Master File Entries: see list6
Suppliers / Packaging: see list3
Therapeutic Class:Respiratory Tract Agents

Pharmacology for Ingredient: zileuton

Clinical Trials for: zileuton

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi Usa Inc
ZYFLO CR
zileuton
TABLET, EXTENDED RELEASE;ORAL022052-001May 30, 2007RXYes<disabled><disabled>
Chiesi Usa Inc
ZYFLO
zileuton
TABLET;ORAL020471-001Dec 9, 1996DISCNNo<disabled><disabled>
Chiesi Usa Inc
ZYFLO
zileuton
TABLET;ORAL020471-003Dec 9, 1996RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: zileuton

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi Usa Inc
ZYFLO CR
zileuton
TABLET, EXTENDED RELEASE;ORAL022052-001May 30, 20074,873,259<disabled>
Chiesi Usa Inc
ZYFLO
zileuton
TABLET;ORAL020471-003Dec 9, 19964,873,259<disabled>
Chiesi Usa Inc
ZYFLO CR
zileuton
TABLET, EXTENDED RELEASE;ORAL022052-001May 30, 20075,422,123<disabled>
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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