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Last Updated: July 5, 2020

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ZILEUTON Drug Profile


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Which patents cover Zileuton, and what generic alternatives are available?

Zileuton is a drug marketed by Lupin Ltd, Par Pharm Inc, and Rising. and is included in three NDAs.

The generic ingredient in ZILEUTON is zileuton. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the zileuton profile page.

US ANDA Litigation and Generic Entry Outlook for Zileuton

A generic version of ZILEUTON was approved as zileuton by RISING on March 17th, 2017.

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Drug patent expirations by year for ZILEUTON
Recent Clinical Trials for ZILEUTON

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

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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
Lupin Ltd ZILEUTON zileuton TABLET, EXTENDED RELEASE;ORAL 211972-001 Nov 5, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc ZILEUTON zileuton TABLET, EXTENDED RELEASE;ORAL 212670-001 Dec 16, 2019 AB RX No No   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

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Serving leading biopharmaceutical companies globally:

Merck
Dow
AstraZeneca
Express Scripts
Medtronic
Baxter

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