➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Mallinckrodt
Colorcon
Moodys
Baxter

Last Updated: July 8, 2020

DrugPatentWatch Database Preview

Zileuton - Generic Drug Details

» See Plans and Pricing

« Back to Dashboard

What are the generic sources for zileuton and what is the scope of freedom to operate?

Zileuton is the generic ingredient in three branded drugs marketed by Lupin Ltd, Par Pharm Inc, Rising, and Chiesi, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for zileuton. Five suppliers are listed for this compound.

Recent Clinical Trials for zileuton

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Bristol-Myers SquibbPhase 1

See all zileuton clinical trials

Pharmacology for zileuton

US Patents and Regulatory Information for zileuton

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm Inc ZILEUTON zileuton TABLET, EXTENDED RELEASE;ORAL 212670-001 Dec 16, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd ZILEUTON zileuton TABLET, EXTENDED RELEASE;ORAL 211972-001 Nov 5, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Chiesi ZYFLO zileuton TABLET;ORAL 020471-003 Dec 9, 1996 RX Yes Yes   Start Trial   Start Trial   Start Trial
Chiesi ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Rising ZILEUTON zileuton TABLET, EXTENDED RELEASE;ORAL 204929-001 Mar 17, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for zileuton

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007   Start Trial   Start Trial
Chiesi ZYFLO zileuton TABLET;ORAL 020471-001 Dec 9, 1996   Start Trial   Start Trial
Chiesi ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007   Start Trial   Start Trial
Chiesi ZYFLO zileuton TABLET;ORAL 020471-003 Dec 9, 1996   Start Trial   Start Trial
Chiesi ZYFLO CR zileuton TABLET, EXTENDED RELEASE;ORAL 022052-001 May 30, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Mallinckrodt
Colorcon
Moodys
Baxter

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. 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.