Zileuton Patent Expiration

Zileuton was first introduced by Chiesi Usa Inc in its drug Zyflo on Dec 9, 1996. Another drug containing Zileuton is Zyflo Cr. 7 different companies have introduced drugs containing Zileuton.


Zileuton Patents

Given below is the list of patents protecting Zileuton, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Zyflo Cr US6183778 Pharmaceutical tablet capable of liberating one or more drugs at different release rates Sep 21, 2013

(Expired)

Chiesi



Zileuton Generics

Several generic applications have been filed for Zileuton. The first generic version for Zileuton was by Rising Pharma Holdings Inc and was approved on Mar 17, 2017. And the latest generic version is by Annora Pharma Private Ltd and was approved on Oct 11, 2022.

Given below is the list of companies who have filed for Zileuton generic.


1. AIZANT

Aizant Drug Research Solutions Private Ltd has filed for 1 generic for Zileuton. Given below are the details of the strengths of this generic introduced by Aizant.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG tablet, extended release Prescription ORAL AB Oct 23, 2020


2. ANNORA PHARMA

Annora Pharma Private Ltd has filed for 1 generic for Zileuton. Given below are the details of the strengths of this generic introduced by Annora Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG tablet, extended release Prescription ORAL AB Oct 11, 2022


3. LUPIN LTD

Lupin Ltd has filed for 1 generic for Zileuton. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG tablet, extended release Discontinued ORAL N/A Nov 5, 2019


4. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Zileuton. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

(reference standard)

tablet, extended release Prescription ORAL AB Mar 17, 2017


5. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Zileuton. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG tablet, extended release Prescription ORAL AB Dec 16, 2019


6. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Zileuton. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG tablet, extended release Discontinued ORAL N/A May 3, 2022