Balsalazide Disodium Patent Expiration

Balsalazide Disodium is Used for treating mildly to moderately active ulcerative colitis in male patients. It was first introduced by Valeant Pharmaceuticals International in its drug Colazal on Jul 18, 2000. Another drug containing Balsalazide Disodium is Giazo. 6 different companies have introduced drugs containing Balsalazide Disodium.


Balsalazide Disodium Patents

Given below is the list of patents protecting Balsalazide Disodium, 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
Giazo US8497256 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males Jun 23, 2031 Valeant Pharms Intl
Colazal US7452872

(Pediatric)

Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Feb 24, 2027 Valeant Pharms Intl
Colazal US7625884

(Pediatric)

Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Feb 24, 2027 Valeant Pharms Intl
Colazal US7452872 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Aug 24, 2026 Valeant Pharms Intl
Colazal US7625884 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Aug 24, 2026 Valeant Pharms Intl
Giazo US7452872 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Aug 24, 2026 Valeant Pharms Intl
Giazo US7625884 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Aug 24, 2026 Valeant Pharms Intl
Giazo US9192616 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Aug 02, 2026 Valeant Pharms Intl
Giazo US6197341 Formulations of balsalazide and its derivatives Mar 13, 2018

(Expired)

Valeant Pharms Intl



Balsalazide Disodium's Family Patents

Family Patents

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Balsalazide Disodium Generic API Manufacturers

Several generic applications have been filed for Balsalazide Disodium. The first generic version for Balsalazide Disodium was by Hikma Pharmaceuticals Usa Inc and was approved on Dec 28, 2007. And the latest generic version is by Zydus Lifesciences Global Fze and was approved on Jun 8, 2023.

Given below is the list of companies who have filed for Balsalazide Disodium generic, along with the locations of their manufacturing plants worldwide.


1. APOTEX INC

Apotex Inc Etobicoke Site has filed for 1 generic for Balsalazide Disodium. Given below are the details of the strengths of this generic introduced by Apotex Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
750MG

capsule Prescription ORAL AB Dec 28, 2007


Manufacturing Plant Locations
New

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

Country City Firm Name
Canada
Richmond Hill Apotex Inc.
North York Apotex Inc.
Toronto Apotex Inc.





2. DASH PHARMS NATCO

Dash Pharmaceuticals Llc A Fully Owned Sub Of Natco Pharma Ltd has filed for 1 generic for Balsalazide Disodium. Given below are the details of the strengths of this generic introduced by Dash Pharms Natco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
750MG

capsule Discontinued ORAL N/A Dec 28, 2007





3. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Balsalazide Disodium. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
750MG

capsule Prescription ORAL AB Dec 28, 2007


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





4. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Balsalazide Disodium. 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
1.1GM

tablet Discontinued ORAL N/A Sep 8, 2015


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
Bangalore Strides Pharma Science Limited
Puducherry Strides Pharma Science Limited





5. ZYDUS LIFESCIENCES

Zydus Lifesciences Global Fze has filed for 1 generic for Balsalazide Disodium. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
750MG

capsule Prescription ORAL AB Jun 8, 2023


Manufacturing Plant Locations
New

Zydus Lifesciences'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 Zydus Lifesciences as present at those locations.

Country City Firm Name
India
Ankleshwar Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED
Ahmedabad Zydus Lifesciences Limited
Matoda Zydus Lifesciences Limited
Jarod Zydus Lifesciences Limited
Thane Zydus Lifesciences Limited
Moraiya, Ahmedabad Zydus Lifesciences Limited
District Solan Zydus Lifesciences Limited