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's Family Patents

Family Patents

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Zileuton Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


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


Manufacturing Plant Locations
New

Aizant's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aizant as present at those locations.

Country City Firm Name
India
Hyderabad Aizant Drug Research Solutions Private Ltd.
Hyderabad Aizant Drug Research Solutions Pvt Ltd., Clinical Pharmacology Unit-II





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


Manufacturing Plant Locations
New

Annora Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Annora Pharma as present at those locations.

Country City Firm Name
India
Hyderabad Annora Pharma Private Limited





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


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





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


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
Rising Sun Rising Sun Veterinary Clinic
Fort Bragg Rising Tide Sea Vegetables
Mount Morris Rising Creek Bakery LLC
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Phoenix Rising Sun Farms Inc
East Brunswick Rising Pharma Holding, Inc.
Livingston Risingsun Iodine Products Corp.
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





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


Manufacturing Plant Locations
New

Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Strides Pharma Inc.
Chestnut Ridge Strides Pharma, Inc.
India
Puducherry Strides Pharma Science Limited
Bangalore Strides Pharma Science Limited





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