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
Colazal US7452872 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Aug 24, 2026 Valeant Pharms Intl
Colazal US7452872

(Pediatric)

Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Feb 24, 2027 Valeant Pharms Intl
Colazal US7625884 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Aug 24, 2026 Valeant Pharms Intl
Colazal US7625884

(Pediatric)

Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Feb 24, 2027 Valeant Pharms Intl
Giazo US6197341 Formulations of balsalazide and its derivatives Mar 13, 2018

(Expired)

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 US8497256 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males Jun 23, 2031 Valeant Pharms Intl
Giazo US9192616 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Aug 02, 2026 Valeant Pharms Intl


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Balsalazide Disodium Generics

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.


1. 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


2. 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


3. 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


4. 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


5. 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